Cigna oncology value-based pathways
Cigna oncology value-based pathways program was created to promote the use of evidence-based, high value, cancer treatment regimens. Pathway regimens are a subset of regimens recommended by the National Comprehensive Cancer Network® (NCCN) that deliver the best clinical outcomes for patients.
Anal Cancer Pathways:
Localized Disease: Definitive Chemoradiation
|
Advanced/Metastatic: First Line
|
Advanced/Metastatic: Subsequent Therapy
|
References
Localized Disease: Definitive Chemoradiation
- Ajani JA et al. Fluorouracil, mitomycin, and radiotherapy vs fluorouracil, cisplatin, and radiotherapy for carcinoma of the anal canal: a randomized controlled trial. JAMA 2008;299:1914-21 Fluorouracil, Mitomycin, and Radiotherapy vs Fluorouracil, Cisplatin, and Radiotherapy for Carcinoma of the Anal Canal: A Randomized Controlled Trial | Cancer Biomarkers | JAMA | JAMA Network
- Flam M et al. Role of mitomycin in combination with fluorouracil and radiotherapy, and of salvage chemoradiation in the definitive nonsurgical treatment of epidermoid carcinoma of the anal canal: results of a phase III randomized intergroup study. J Clin Oncol 1996; 14:2527-39. Role of mitomycin in combination with fluorouracil and radiotherapy, and of salvage chemoradiation in the definitive nonsurgical treatment of epidermoid carcinoma of the anal canal: results of a phase III randomized intergroup study. | Journal of Clinical Oncology (ascopubs.org)
- Goodman K et al. Capecitabine plus mitomycin in patients undergoing definitive chemoradiation for anal squamous cell carcinoma. Int J Radiat Oncol Phys 2014; 90:S32-S33. Capecitabine Plus Mitomycin in Patients Undergoing Definitive Chemoradiation for Anal Squamous Cell Carcinoma - International Journal of Radiation Oncology, Biology, Physics (redjournal.org)
- Thind G et al. Chemoradiation with capecitabine and mitomycin-C for stage I-III anal squamous cell carcinoma. Ratiat Oncol 2014;9: 124 Chemoradiation with capecitabine and mitomycin-C for stage I-III anal squamous cell carcinoma | Radiation Oncology | Full Text (biomedcentral.com)
- Gunderson LL et al. Long-term update of US GI Intergroup RTOG 98-11 Phase III trial for anal carcinoma: survival, relapse, and colostomy failure with concurrent chemoradiation involving fluorouracil/mitomycin versus fluorouracil/cisplatin. J Clin Oncol 2012; 30:4344-51. Long-Term Update of US GI Intergroup RTOG 98-11 Phase III Trial for Anal Carcinoma: Survival, Relapse, and Colostomy Failure With Concurrent Chemoradiation Involving Fluorouracil/Mitomycin Versus Fluorouracil/Cisplatin | Journal of Clinical Oncology (ascopubs.org)
- James RD et al. Mitomycin or cisplatin chemoradiation with or without maintenance chemortherapy for treatment of squamous-cell carcinoma of the anus (ACT II): a randomized, phase 3, open-label, 2x2 factorial trial. Lancet Oncol 2013; 14:516-24. Mitomycin or cisplatin chemoradiation with or without maintenance chemotherapy for treatment of squamous-cell carcinoma of the anus (ACT II): a randomised, phase 3, open-label, 2×2 factorial trial - The Lancet Oncology
Advanced/Metastatic: First Line
- Rao S et al. International Rare Cancers Initiative Multicenter Randomized Phase II Trial of Cisplatin and Fluorouracil Versus Carboplatin and Paclitaxel in Advanced Anal Cancer: InterAACT. J Clin Oncol 2020; 38:2510-18. International Rare Cancers Initiative Multicenter Randomized Phase II Trial of Cisplatin and Fluorouracil Versus Carboplatin and Paclitaxel in Advanced Anal Cancer: InterAAct | Journal of Clinical Oncology (ascopubs.org)
- Mondaca S et al. FOLFCIS Treatment and Genomic Correlates of Response in Advanced Anal Squamous Cell Cancer. Clin Colorectal Cancer 2019; 18:e39-52. FOLFCIS Treatment and Genomic Correlates of Response in Advanced Anal Squamous Cell Cancer - Clinical Colorectal Cancer (clinical-colorectal-cancer.com)
- Kim S, et al. Docetaxel, cisplatin, and fluorouracil chemotherapy for metastatic or unresectable locally recurrent anal squamous cell carcinoma (Epitopes-HPV02): a multicenter, single-arm, phase 2 study. Lancet Oncol 2018; 19:1094-1106. Docetaxel, cisplatin, and fluorouracil chemotherapy for metastatic or unresectable locally recurrent anal squamous cell carcinoma (Epitopes-HPV02): a multicentre, single-arm, phase 2 study - The Lancet Oncology
- Kim S et al. DCF chemotherapy is a promising treatment for recurrent advanced squamous cell anal carcinoma. Ann Oncol 2013; 24:3045-50. DCF (docetaxel, cisplatin and 5-fluorouracil) chemotherapy is a promising treatment for recurrent advanced squamous cell anal carcinoma - Annals of Oncology
Advanced/Metastatic: Subsequent Therapy
- Morris VK et al. Nivolumab for previously treated unresectable metastatic anal cancer (NCI9673): a multicenter, single-arm, phase 2 study. Lancet Oncol 2017; 18:446-53. Nivolumab for previously treated unresectable metastatic anal cancer (NCI9673): a multicentre, single-arm, phase 2 study - The Lancet Oncology
- Ott PA et al. Safety and antitumor activity of the anti-PD-1 antibody pembrolizumab in patients with recurrent carcinoma of the anal canal. Ann Oncol 2017; 28:1036-41. Safety and antitumor activity of the anti-PD-1 antibody pembrolizumab in patients with recurrent carcinoma of the anal canal - Annals of Oncology
Biliary Tract Cancers (Gallbladder/Cholangiocarcinoma) Pathways:
Advanced/Metastatic: First Line
|
Advanced/Metastatic: Subsequent Therapy
|
References
Advanced/Metastatic: First Line
- Valle J et al. Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. N Eng J Med 2010; 103:469-74.Cisplatin plus Gemcitabine versus Gemcitabine for Biliary Tract Cancer | NEJM
- Sahai V et al. Nap-paclitaxel and gemcitabine as first-line treatment of advanced or metastatic cholangiocarcinoma: a phase 2 clinical trial. JAMA Oncol 2018; 4:1707-12.Nab-Paclitaxel and Gemcitabine as First-line Treatment of Advanced or Metastatic Cholangiocarcinoma: A Phase 2 Clinical Trial | Gastroenterology | JAMA Oncology | JAMA Network
- Schroff RT et al. Gemcitabine, Cisplatin, and nab-paclitaxel for the treatment of advanced biliary tract cancers: a phase 2 clinical trial. JAMA Oncol 2019; 5:824-30.Gemcitabine, Cisplatin, and nab-Paclitaxel for the Treatment of Advanced Biliary Tract Cancers: A Phase 2 Clinical Trial | Gastroenterology | JAMA Oncology | JAMA Network
- Sharma A et al. Best supportive care compared with chemotherapy for unresectable gall bladder cancer: a randomized controlled study. Journal of Clinical Oncology 2010; 28: 4581-86.Best Supportive Care Compared With Chemotherapy for Unresectable Gall Bladder Cancer: A Randomized Controlled Study | Journal of Clinical Oncology (ascopubs.org)
- Oh D et al. Durvalumab plus Gemcitabine and Cisplatin in Advanced Biliary Tract Cancer. NEJM Evidence June 1stDurvalumab plus Gemcitabine and Cisplatin in Advanced Biliary Tract Cancer (nejm.org)
Advanced/Metastatic: Subsequent Therapy
- Lamarca A et al. Second-line FOLFOX chemotherapy versus active symptom control for advanced biliary tract cancer (ABC-06): a phase 3, open-label, randomized, controlled trial. Lancet Oncol 2021; 22(5): 690-701.Second-line FOLFOX chemotherapy versus active symptom control for advanced biliary tract cancer (ABC-06): a phase 3, open-label, randomised, controlled trial - The Lancet Oncology
- Demols A et al. Regorafenib after failure of gemcitabine and platinum-based chemotherapy for locally advanced/metastatic biliary tumors: REACHIN, a randomized, double-blind, phase II trial. Ann Oncol 2020; 31: 1169-77.Regorafenib after failure of gemcitabine and platinum-based chemotherapy for locally advanced/metastatic biliary tumors: REACHIN, a randomized, double-blind, phase II trial - Annals of Oncology
- Caparica R et al. FOLFIRI as second-line treatment of metastatic biliary tract cancer patients. Autops Case Rep 2019; 9:e2019087.FOLFIRI as second-line treatment of metastatic biliary tract cancer patients - PMC (nih.gov)
Bladder Cancer Pathways:
Neoadjuvant/Adjuvant Therapy:
|
Advanced/Metastatic: First Line, Cisplatin eligible
|
Advanced/Metastatic: First Line, Cisplatin ineligible
|
Advanced/Metastatic: Subsequent Therapy, Post-Platinum
|
References
Neoadjuvant/Adjuvant Therapy:
- Sternberg CN et al. Randomized phase III trial of high-dose-intensity methotrexate, vinblastine, doxorubicin, and cisplatin (MVAC) chemotherapy and recombinant human granulocyte colony-stimulating factor versus classic MVAC in advanced urothelial tract tumors: European Organization for Research and Treatment of Cancer Protocol no. 30924. J Clin Oncol 2001; 19:2638-46.Randomized Phase III Trial of High–Dose-Intensity Methotrexate, Vinblastine, Doxorubicin, and Cisplatin (MVAC) Chemotherapy and Recombinant Human Granulocyte Colony-Stimulating Factor Versus Classic MVAC in Advanced Urothelial Tract Tumors: European Organization for Research and Treatment of Cancer Protocol No. 30924 | Journal of Clinical Oncology (ascopubs.org)
- Von der Maase H et al. Gemcitabine and cisplatin versus methotrexate, vinblastine, doxorubicin, and cisplatin in advanced or metastatic bladder cancer: results of a large, randomized, multinational, multicenter, phase III study. J Clin Oncol 2000; 18:3068-3077.Gemcitabine and Cisplatin Versus Methotrexate, Vinblastine, Doxorubicin, and Cisplatin in Advanced or Metastatic Bladder Cancer: Results of a Large, Randomized, Multinational, Multicenter, Phase III Study | Journal of Clinical Oncology (ascopubs.org)
- Pfister C et al. Randomized Phase III Trial of Dose-dense Methotrexate, Vinblastine, Doxorubicin, and Cisplatin, or Gemcitabine and Cisplatin as perioperative Chemotherapy for Patients with Muscle-Invasive Bladder Cancer. Annals of Oncology 2021; 32:S678.652O Dose-dense methotrexate, vinblastine, doxorubicin and cisplatin (dd-MVAC) or gemcitabine and cisplatin (GC) as perioperative chemotherapy for patients with muscle-invasive bladder cancer (MIBC): Results of the GETUG/AFU VESPER V05 phase III trial - Annals of Oncology
Advanced/Metastatic: First Line, platinum eligible
- Sternberg CN et al. Randomized phase III trial of high-dose-intensity methotrexate, vinblastine, doxorubicin, and cisplatin (MVAC) chemotherapy and recombinant human granulocyte colony-stimulating factor versus classic MVAC in advanced urothelial tract tumors: European Organization for Research and Treatment of Cancer Protocol no. 30924. J Clin Oncol 2001; 19:2638-46.Randomized Phase III Trial of High–Dose-Intensity Methotrexate, Vinblastine, Doxorubicin, and Cisplatin (MVAC) Chemotherapy and Recombinant Human Granulocyte Colony-Stimulating Factor Versus Classic MVAC in Advanced Urothelial Tract Tumors: European Organization for Research and Treatment of Cancer Protocol No. 30924 | Journal of Clinical Oncology (ascopubs.org)
- Von der Maase H et al. Gemcitabine and cisplatin versus methotrexate, vinblastine, doxorubicin, and cisplatin in advanced or metastatic bladder cancer: results of a large, randomized, multinational, multicenter, phase III study. J Clin Oncol 2000; 18:3068-77.Gemcitabine and cisplatin versus methotrexate, vinblastine, doxorubicin, and cisplatin in advanced or metastatic bladder cancer: results of a large, randomized, multinational, multicenter, phase III study - PubMed (nih.gov)
- De Santis et al. Randomized phase II/III trial assessing gemcitabine/carboplatin and methotrexate/carboplatin/vinblastine in patients with advanced urothelial cancer who are unfit for Cisplatin-based chemotherapy: EORTC study 30986. J Clin Oncol 2012; 30:191-99.Randomized Phase II/III Trial Assessing Gemcitabine/Carboplatin and Methotrexate/Carboplatin/Vinblastine in Patients With Advanced Urothelial Cancer Who Are Unfit for Cisplatin-Based Chemotherapy: EORTC Study 30986 | Journal of Clinical Oncology (ascopubs.org)
- Powles T et al. Avelumab maintenance therapy for advanced or metastatic urothelial carcinoma. N Eng J Med 2020; 383:1218-30.Avelumab Maintenance Therapy for Advanced or Metastatic Urothelial Carcinoma | NEJM
Advanced/Metastatic: First Line, platinum ineligible
- Balar AV et al. Atezolizumab as first-line treatment in cisplatin-ineligible patients with locally advanced and metastatic urothelial carcinoma: a single-arm multicentre, phase 2 trial. Lancet 2017; 389:67-76Atezolizumab as first-line treatment in cisplatin-ineligible patients with locally advanced and metastatic urothelial carcinoma: a single-arm, multicentre, phase 2 trial - The Lancet
- Balar Av et al. First-line pembrolizumab in cisplatin-ineligible patients with locally advanced and unresectable or metastatic urothelial cancer (KEYNOTE-052): a multicentre, single-arm, phase 2 study. Lancet Oncol 2017; 18:1483-92.First-line pembrolizumab in cisplatin-ineligible patients with locally advanced and unresectable or metastatic urothelial cancer (KEYNOTE-052): a multicentre, single-arm, phase 2 study - The Lancet Oncology
- Powles T et al. Pembrolizumab alone or combined with chemotherapy versus chemotherapy as first-line therapy for advanced urothelial carcinoma (KEYNOTE-361): a randomized, open-label, phase 3 trial. Lancet Oncol 2021; 22:931-45.Pembrolizumab alone or combined with chemotherapy versus chemotherapy as first-line therapy for advanced urothelial carcinoma (KEYNOTE-361): a randomised, open-label, phase 3 trial - The Lancet Oncology
- Stadler WM et al. Phase II study of single-agent gemcitabine in previously untreated patients with metastatic urothelial cancer. J Clin Oncol 1997; 15:3394-98.Phase II study of single-agent gemcitabine in previously untreated patients with metastatic urothelial cancer. | Journal of Clinical Oncology (ascopubs.org)
- Albers P et al. Randomized phase III trial of 2nd line gemcitabine and paclitaxel chemotherapy in patients with advanced bladder cancer: short-term versus prolonged treatment. Ann Oncol 2011; 22:288-94.Randomized phase III trial of 2nd line gemcitabine and paclitaxel chemotherapy in patients with advanced bladder cancer: short-term versus prolonged treatment [German Association of Urological Oncology (AUO) trial AB 20/99] - Annals of Oncology
- Siefker-Radtke AO et al. A phase 2 clinical trial of sequential neoadjuvant chemotherapy with ifosfamide, doxorubicin, and gemcitabine followed by cisplatin, gemcitabine, and ifosfamide in locally advanced urothelial cancer: final results. Cancer 2013; 119:540-47.A phase 2 clinical trial of sequential neoadjuvant chemotherapy with ifosfamide, doxorubicin, and gemcitabine followed by cisplatin, gemcitabine, and ifosfamide in locally advanced urothelial cancer - Siefker-Radtke - 2013 - Cancer - Wiley Online Library
Advanced/Metastatic: Subsequent Therapy, Post-Platinum
- Bellmunt et al. Pembrolizumab as second-line therapy for advanced urothelial carcinoma. N Eng J Med 2017; 376:1015-26.Pembrolizumab as Second-Line Therapy for Advanced Urothelial Carcinoma | NEJM
- Sharma P et al. Nivolumab in metastatic urothelial carcinoma after platinum therapy (CheckMate 275): A multicentre, single-arm, phase 2 trial. Lancet Oncol 2017; 18:312-22.Nivolumab in metastatic urothelial carcinoma after platinum therapy (CheckMate 275): a multicentre, single-arm, phase 2 trial - The Lancet Oncology
- Patel M et al. Avelumab in metastatic urothelial carcinoma after platinum failure (JAVELIN Solid Tumor): pooled results from two expansion cohorts or an open-label, phase 2 trial. Lancet Oncol 2018; 19:51-64.Avelumab in metastatic urothelial carcinoma after platinum failure (JAVELIN Solid Tumor): pooled results from two expansion cohorts of an open-label, phase 1 trial - The Lancet Oncology
- Stadler WM et al. Phase II study of single-agent gemcitabine in previously untreated patients with metastatic urothelial cancer. J Clin Oncol 1997; 15:3394-98.Phase II study of single-agent gemcitabine in previously untreated patients with metastatic urothelial cancer. | Journal of Clinical Oncology (ascopubs.org)
- Sideris S et al. Efficacy of weekly paclitaxel treatment as a single agent chemotherapy following first-line cisplatin treatment in urothelial bladder cancer. Mol Clin Oncol 2016; 4:1063-67.Efficacy of weekly paclitaxel treatment as a single agent chemotherapy following first-line cisplatin treatment in urothelial bladder cancer - PMC (nih.gov)
- McCaffrey JA et al. Phase ii trial of docetaxel in patients with advanced or metastatic transitional-cell carcinoma. J Clin Oncol 1997; 15:1853-57.Phase II trial of docetaxel in patients with advanced or metastatic transitional-cell carcinoma. | Journal of Clinical Oncology (ascopubs.org)
Breast Cancer Pathways:
Neoadjuvant/Adjuvant: HER2 Negative
|
Advanced/Metastatic: HER2 Negative
|
|
Advanced/Metastatic HER2 Positive, First Line
|
Advanced/Metastatic: HER2 Positive, Second Line and beyond
|
Advanced/Metastatic: HER2 Positive, Third Line and beyond
|
*Use of preferred oncology medication products may be required for coverage. Refer to Cigna’s Drug and Biologic Coverage Policy 1403 for additional criteria.
§Pertuzumab, trastuzumab, and hyaluronidase-zzxf injection for subcutaneous use may be substituted for intravenous pertuzumab and intravenous trastuzumab
References
Neoadjuvant/adjuvant: HER2 negative
- Citron ML et al. Randomized trial of dose-dense versus conventionally scheduled and sequential versus concurrent combination chemotherapy as postoperative adjuvant treatment of node-positive primary breast cancer. J Clin Oncol 2003; 21:1431-39.Randomized Trial of Dose-Dense Versus Conventionally Scheduled and Sequential Versus Concurrent Combination Chemotherapy as Postoperative Adjuvant Treatment of Node-Positive Primary Breast Cancer: First Report of Intergroup Trial C9741/Cancer and Leukemia Group B Trial 9741 | Journal of Clinical Oncology (ascopubs.org)
- Sparano JA et al. Weekly paclitaxel in adjuvant treatment of breast cancer. N Eng J Med 2008; 358:1663-71.Weekly Paclitaxel in the Adjuvant Treatment of Breast Cancer | NEJM
- Budd GT et al. SWOG S0221: a phase III Trial Comparing Chemotherapy Schedules in High-Risk Early-Stage Breast Cancer. J Clin Oncol 2015; 33(1):58-64.SWOG S0221: A Phase III Trial Comparing Chemotherapy Schedules in High-Risk Early-Stage Breast Cancer | Journal of Clinical Oncology (ascopubs.org)
- Jones S et al. Docetaxel with cyclophosphamide is associated with an overall survival benefit compared with doxorubicin and cyclophosphamide. J Clin Oncol 2009; 27:1177-83.Docetaxel With Cyclophosphamide Is Associated With an Overall Survival Benefit Compared With Doxorubicin and Cyclophosphamide: 7-Year Follow-Up of US Oncology Research Trial 9735 | Journal of Clinical Oncology (ascopubs.org)
HER2 positive metastatic disease
- Swain et al. Pertuzumab, trastuzumab, and docetaxel for HER2-positive metastatic breast cancer (CLEOPATRA): end-of-study results from a double-blind, randomised, placebo-controlled, phase 3 study. Lancet Oncol 2020; 21:P519-530.Pertuzumab, trastuzumab, and docetaxel for HER2-positive metastatic breast cancer (CLEOPATRA): end-of-study results from a double-blind, randomised, placebo-controlled, phase 3 study - The Lancet Oncology
- Swain S et al. Confirmatory overall survival analysis of CLEOPATRA: a randomized, double-blind, placebo-controlled Phase III study with pertuzumab, trastuzumab, and docetaxel in patients with HER2-positive first-line metastatic breast cancer. Cancer Research 2012; 72:p5-18-26.Abstract P5-18-26: Confirmatory overall survival (OS) analysis of CLEOPATRA: a randomized, double-blind, placebo-controlled Phase III study with pertuzumab (P), trastuzumab (T), and docetaxel (D) in patients (pts) with HER2-positive first-line (1L) metastatic breast cancer (MBC) | Cancer Research | American Association for Cancer Research (aacrjournals.org)
- Bachelot T et al. Preliminary safety and efficacy of first-line pertuzumab combined with trastuzumab and taxane therapy for HER2-positive locally recurrent or metastatic breast cancer (PERUSE). Ann Oncol 2019; 30:766-773.Preliminary safety and efficacy of first-line pertuzumab combined with trastuzumab and taxane therapy for HER2-positive locally recurrent or metastatic breast cancer (PERUSE) - Annals of Oncology
- Baselga J et al. Pertuzumab plus trastuzumab plus docetaxel for metastatic breast cancer. N Eng J Med 2012; 366: 109-119.Pertuzumab plus Trastuzumab plus Docetaxel for Metastatic Breast Cancer | NEJM
- Verma S et al. Trastuzumab emtansine for HER2-positive advanced breast cancer. N Eng J Med 2012; 367: 1783-91.Trastuzumab Emtansine for HER2-Positive Advanced Breast Cancer | NEJM
- Modi S et al. Trastuzumab deruxtecan in previously treated HER2-positive advanced breast cancer. N Eng J Med 2020; 382:610-21.Trastuzumab Deruxtecan in Previously Treated HER2-Positive Breast Cancer | NEJM
- Cortes J et al. Trastuzumab Deruxtecan versus Trastuzumab Emtansine for Breast Cancer. N Eng J Med 2022; 386:1143-54.Trastuzumab Deruxtecan versus Trastuzumab Emtansine for Breast Cancer | NEJM
- Murthy RK et al. Tucatinib, trastuzumab, and capecitabine for HER-2 positive metastatic breast cancer. N Eng J Med 2020; 382:597-609.Tucatinib, Trastuzumab, and Capecitabine for HER2-Positive Metastatic Breast Cancer | NEJM
- Blackwell KL et al. Overall survival benefit with lapatinib in combination with trastuzumab for patients with human epidermal growth factor receptor 2-positive metastatic breast cancer: final results from the EFG104900 study. J Clin Oncol 2012; 30: 2585-92.Overall Survival Benefit With Lapatinib in Combination With Trastuzumab for Patients With Human Epidermal Growth Factor Receptor 2–Positive Metastatic Breast Cancer: Final Results From the EGF104900 Study | Journal of Clinical Oncology (ascopubs.org)
- Geyer C et al. Lapatinib plus capecitabine for HER2-Positive advanced breast cancer. N Eng J Med 2006; 355: 2733-43.Lapatinib plus Capecitabine for HER2-Positive Advanced Breast Cancer | NEJM
- Saura C et al. Neratinib + capecitabine versus lapatinib + capecitabine in patients with HER2+ metastatic breast cancer previously treated with ≥ HER2-directed regimens: Findings from the multinational, randomized, phase III NALA trial. J Clin Oncol 2019; 37:1002-1002.Neratinib + capecitabine versus lapatinib + capecitabine in patients with HER2+ metastatic breast cancer previously treated with ≥ 2 HER2-directed regimens: Findings from the multinational, randomized, phase III NALA trial. | Journal of Clinical Oncology (ascopubs.org)
- Rugo HS et al. Efficacy of margetuximab vs trastuzumab in patients with pretreated ERBB2-positive advanced breast cancer. JAMA Oncol 2021; 7:573-84.Efficacy of Margetuximab vs Trastuzumab in Patients With Pretreated ERBB2-Positive Advanced Breast Cancer: A Phase 3 Randomized Clinical Trial | Breast Cancer | JAMA Oncology | JAMA Network
HER2 negative metastatic disease
- Seidman, A.D et al. Phase II Trial of Paclitaxel by 3-Hour Infusion as Initial and Salvage Chemotherapy for Metastatic Breast Cancer. J Clin Oncol 1995; 13:2575-81.Phase II trial of paclitaxel by 3-hour infusion as initial and salvage chemotherapy for metastatic breast cancer. | Journal of Clinical Oncology (ascopubs.org)
- Perez, E.A et al. Multicenter Phase II Trial of Weekly Paclitaxel in Women with Metastatic Breast Cancer. J Clin Oncol 2001; 19:4216-23.Multicenter Phase II Trial of Weekly Paclitaxel in Women With Metastatic Breast Cancer | Journal of Clinical Oncology (ascopubs.org)
- Burris HA, 3rd. Single-agent docetaxel (Taxotere) in randomized phase III trials. Semin Oncol 1999; 26:1-6.Single-agent docetaxel (Taxotere) in randomized phase III trials - PubMed (nih.gov)
- Harvey V et al. Phase III trial comparing three doses of docetaxel for second-line treatment of advanced breast cancer. J Clin Oncol. 2006; 24:4963-70.Phase III Trial Comparing Three Doses of Docetaxel for Second-Line Treatment of Advanced Breast Cancer | Journal of Clinical Oncology (ascopubs.org)
- Rivera E et al. Phase 3 study comparing the use of docetaxel on an every-3-week versus weekly schedule in the treatment of metastatic breast cancer. Cancer. 2008; 112:1455-61.Phase 3 study comparing the use of docetaxel on an every 3 week versus weekly schedule in the treatment of metastatic breast cancer - Rivera - 2008 - Cancer - Wiley Online Library
- Chan S et al. Prospective randomized trial of docetaxel versus doxorubicin in patients with metastatic breast cancer. J Clin Oncol 1999; 17:2341-54.Prospective Randomized Trial of Docetaxel Versus Doxorubicin in Patients With Metastatic Breast Cancer | Journal of Clinical Oncology (ascopubs.org)
- Gasparini G et al. Weekly epirubicin versus doxorubicin as second line therapy in advanced breast cancer. A randomized clinical trial. Am J Clin Oncol 1991; 14:38-44.Weekly epirubicin versus doxorubicin as second line therapy in advanced breast cancer. A randomized clinical trial - PubMed (nih.gov)
- O’Brien ME et al. Reduced cardiotoxicity and comparable efficacy in a phase III trial of pegylated liposomal doxorubicin HCL versus conventional doxorubicin for first-line treatment of metastatic breast cancer. Ann Oncol 2004; 15:440-49.Reduced cardiotoxicity and comparable efficacy in a phase IIItrial of pegylated liposomal doxorubicin HCl(CAELYX™/Doxil®) versus conventional doxorubicin forfirst-line treatment of metastatic breast cancer - Annals of Oncology
- Seidman AD. Gemcitabine as single-agent therapy in the management of advanced breast cancer. Oncology. 2001; 15:11-14.Gemcitabine as Single-Agent Therapy in the Management of Advanced Breast Cancer (cancernetwork.com)
- Zelek L et al. Weekly vinorelbine is an effective palliative regimen after failure with anthracyclines and taxanes in metastatic breast carcinoma. Cancer. 2001; 92:2267-72.Weekly vinorelbine is an effective palliative regimen after failure with anthracyclines and taxanes in metastatic breast carcinoma - PubMed (nih.gov)
- Bajetta E et al. Safety and efficacy of two different doses of capecitabine in the treatment of advanced breast cancer in older women. J Clin Oncol. 2005; 23:2155-61.Safety and Efficacy of Two Different Doses of Capecitabine in the Treatment of Advanced Breast Cancer in Older Women | Journal of Clinical Oncology (ascopubs.org)
- Gradishar WJ et al. Phase III trial of nanoparticle albumin-bound paclitaxel compared with polyethylated castor oil-based paclitaxel in women with breast cancer. J Clin Oncol. 2005; 23:7794-803.Phase III Trial of Nanoparticle Albumin-Bound Paclitaxel Compared With Polyethylated Castor Oil–Based Paclitaxel in Women With Breast Cancer | Journal of Clinical Oncology (ascopubs.org)
- Perez EA et al. Efficacy and safety of ixabepilone (BMS-247550) in a phase II study of patients with advanced breast cancer resistant to an anthracycline, a taxane, and capecitabine. J Clin Oncol. 2007; 25:3407-14.Efficacy and Safety of Ixabepilone (BMS-247550) in a Phase II Study of Patients With Advanced Breast Cancer Resistant to an Anthracycline, a Taxane, and Capecitabine | Journal of Clinical Oncology (ascopubs.org)
- Cortes J et al. Eribulin monotherapy versus treatment of physician's choice in patients with metastatic breast cancer (EMBRACE): a phase 3 open-label randomised study. Lancet. 2011; 377:914-23.Eribulin monotherapy versus treatment of physician's choice in patients with metastatic breast cancer (EMBRACE): a phase 3 open-label randomised study - The Lancet
Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Pathways:
First line : WITHOUT del (17P)/TP53 mutation
|
First line : WITH del (17P)/TP53 mutation
|
*Use of preferred oncology medication products may be required for coverage. Refer to Cigna’s Drug and Biologic Coverage Policy 1403 for additional criteria.
References
First line
- Burger JA et al. Ibrutinib as initial therapy for patients with chronic lymphocytic leukemia. N Eng J Med 2015; 373:2425-37.Ibrutinib as Initial Therapy for Patients with Chronic Lymphocytic Leukemia | NEJM
- Burger JA et al. Long-term efficacy and safety of first-line ibrutinib treatment for patients with CLL/SLL: 5 years of follow-up from the phase 3 RESONATE-2 study. Leukemia. 2020; 34:787-98.Long-term efficacy and safety of first-line ibrutinib treatment for patients with CLL/SLL: 5 years of follow-up from the phase 3 RESONATE-2 study | Leukemia (nature.com)
- Fischer K et al. Venetoclax and obinutuzumab in patients with CLL and coexisting conditions. N Eng J Med 2019; 380:2225-36.Venetoclax and Obinutuzumab in Patients with CLL and Coexisting Conditions | NEJM
- Al-Sawaf O et al. Venetoclax plus obinutuzumab versus chlorambucil plus obinutuzumab for previously untreated chronic lymphocytic leukaemia (CLL14): follow-up results from a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2020; 21:1188-200.Venetoclax plus obinutuzumab versus chlorambucil plus obinutuzumab for previously untreated chronic lymphocytic leukaemia (CLL14): follow-up results from a multicentre, open-label, randomised, phase 3 trial - The Lancet Oncology
- Awan FT et al. Acalabrutinib monotherapy in patients with chronic lymphocytic leukemia who are intolerant to ibrutinib. Blood Adv. 2019; 3:1553-62.Acalabrutinib monotherapy in patients with chronic lymphocytic leukemia who are intolerant to ibrutinib | Blood Advances | American Society of Hematology (ashpublications.org)
- Sharman JP et al. Acalabrutinib with or without obinutuzumab versus chlorambucil and obinutuzmab for treatment-naive chronic lymphocytic leukaemia (ELEVATE TN): a randomised, controlled, phase 3 trial. Lancet. 2020; 395:1278- 91.Acalabrutinib with or without obinutuzumab versus chlorambucil and obinutuzumab for treatment-naive chronic lymphocytic leukaemia (ELEVATE-TN): a randomised, controlled, phase 3 trial - The Lancet
Chronic Myeloid Leukemia Pathways:
First Line: Low Risk Score Disease
|
References
First Line: Low Risk Score Disease
- O’Brien SG et al. Imatinib compared with interferon and low-dose cytarabine for newly diagnosed chronic-phase chronic myeloid leukemia. N Eng J Med 2003; 348:994-1004.Imatinib Compared with Interferon and Low-Dose Cytarabine for Newly Diagnosed Chronic-Phase Chronic Myeloid Leukemia | NEJM
- Jabbour E et al. Imatinib mesylate dose escalation is associated with durable responses in patients with chronic myeloid leukemia after cytogenetic failure on standard-dose imatinib therapy. Blood 2009; 113:2154-60.Imatinib mesylate dose escalation is associated with durable responses in patients with chronic myeloid leukemia after cytogenetic failure on standard-dose imatinib therapy | Blood | American Society of Hematology (ashpublications.org)
- Cortes JE et al. Final 5-year study results of DASISION: the dasatinib versus imatinib study in treatment-naive chronic myeloid leukemia patients trial. J Clin Oncol. 2016; 34:2333-40.Final 5-Year Study Results of DASISION: The Dasatinib Versus Imatinib Study in Treatment-Naïve Chronic Myeloid Leukemia Patients Trial | Journal of Clinical Oncology (ascopubs.org)
- Hochhaus A et al. Long-term benefits and risks of frontline nilotinib vs imatinib for chronic myeloid leukemia in chronic phase: 5-year update of the randomized ENESTnd trial. Leukemia. 2016; 30:1044-54.Long-term benefits and risks of frontline nilotinib vs imatinib for chronic myeloid leukemia in chronic phase: 5-year update of the randomized ENESTnd trial | Leukemia (nature.com)
- Cortes JE et al. Bosutinib versus imatinib for newly diagnosed chronic myeloid leukemia: results from the randomized BFORE trial. J Clin Oncol. 2018;36:231-7Bosutinib Versus Imatinib for Newly Diagnosed Chronic Myeloid Leukemia: Results From the Randomized BFORE Trial | Journal of Clinical Oncology (ascopubs.org)
Colorectal Cancer Pathways:
Metastatic disease: First/second line RAS/RAF wild type
|
Metastatic disease: RAS/RAF mutant or unknown subsequent therapy
|
Advanced/Metastatic: dMMR/MSI-H or POLE/POLD1 mutation
|
*Use of preferred oncology medication products may be required for coverage. Refer to Cigna’s Drug and Biologic Coverage Policy 1403 for additional criteria.
References
Metastatic disease: First/second line RAS/RAF wild type
- Qin S et al. Efficacy and Tolerability of First-Line Cetuximab Plus Leucovorin, Fluorouracil, and Oxaliplatin (FOLFOX-4) Versus FOLFOX-4 in Patients With RAS Wild-Type Metastatic Colorectal Cancer: The Open-Label, Randomized, Phase III TAILOR Trial. J Clin Oncol. 2018; 36:3031-39.Efficacy and Tolerability of First-Line Cetuximab Plus Leucovorin, Fluorouracil, and Oxaliplatin (FOLFOX-4) Versus FOLFOX-4 in Patients With RAS Wild-Type Metastatic Colorectal Cancer: The Open-Label, Randomized, Phase III TAILOR Trial | Journal of Clinical Oncology (ascopubs.org)
- Douillard JY et al. Final results from PRIME: randomized phase III study of panitumumab with FOLFOX4 for first-line treatment of metastatic colorectal cancer. Ann Oncol. 2014; 25:1346-55.Final results from PRIME: randomized phase III study of panitumumab with FOLFOX4 for first-line treatment of metastatic colorectal cancer - Annals of Oncology
- Bylsma L et al. The incidence of infusion reactions associated with monoclonal antibody drugs targeting the epidermal growth factor receptor in metastatic colorectal cancer patients: A systematic literature review and meta-analysis of patient and study characteristics. Cancer Med. 2019; 8:5800-09.The incidence of infusion reactions associated with monoclonal antibody drugs targeting the epidermal growth factor receptor in metastatic colorectal cancer patients: A systematic literature review and meta‐analysis of patient and study characteristics (nih.gov)
Metastatic disease: RAS/RAF mutant or unknown subsequent therapy
- Bennouna J et al. Continuation of bevacizumab after first progression in metastatic colorectal cancer (ML18147): a randomised phase 3 trial. Lancet Oncol. 2013; 14:29-37.Continuation of bevacizumab after first progression in metastatic colorectal cancer (ML18147): a randomised phase 3 trial - The Lancet Oncology
- Tabernero J et al. Ramucirumab versus placebo in combination with second-line FOLFIRI in patients with metastatic colorectal carcinoma that progressed during or after first-line therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine (RAISE): a randomised, double-blind, multicentre, phase 3 study. Lancet Oncol. 2015; 16:499-508.Ramucirumab versus placebo in combination with second-line FOLFIRI in patients with metastatic colorectal carcinoma that progressed during or after first-line therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine (RAISE): a randomised, double-blind, multicentre, phase 3 study - The Lancet Oncology
- Tabernero J et al. Aflibercept versus placebo in combination with fluorouracil, leucovorin and irinotecan in the treatment of previously treated metastatic colorectal cancer: prespecified subgroup analyses from the VELOUR trial. Eur J Cancer. 2014; 50:320-31.Aflibercept versus placebo in combination with fluorouracil, leucovorin and irinotecan in the treatment of previously treated metastatic colorectal cancer: Prespecified subgroup analyses from the VELOUR trial - European Journal of Cancer (ejcancer.com)
Metastatic disease: Third line and beyond
- Mayer RJ et al. Randomized trial of TAS-102 for refractory metastatic colorectal cancer. N Eng J Med 2015; 372:1909-19.Randomized Trial of TAS-102 for Refractory Metastatic Colorectal Cancer | NEJM
- Grothey A et al. Regorafenib monotherapy for previously treated metastatic colorectal cancer (CORRECT): an international, multicentre, randomised, placebo-controlled, phase 3 trial. Lancet. 2013; 381:303-12.Regorafenib monotherapy for previously treated metastatic colorectal cancer (CORRECT): an international, multicentre, randomised, placebo-controlled, phase 3 trial - The Lancet
- Pfeiffer P et al. TAS-102 with or without bevacizumab in patients with chemorefractory metastatic colorectal cancer: an investigator-initiated, open-label, randomised, phase 2 trial. Lancet Oncol. 2020; 21:412-20.TAS-102 with or without bevacizumab in patients with chemorefractory metastatic colorectal cancer: an investigator-initiated, open-label, randomised, phase 2 trial - The Lancet Oncology
Diffuse Large B-cell Lymphoma Pathways:
Subsequent Therapy: Transplant-Eligible
|
Subsequent Therapy: Transplant-Ineligible
|
*Use of preferred oncology medication products may be required for coverage. Refer to Cigna’s Drug and Biologic Coverage Policy 1403 or additional criteria.
References
Subsequent therapy: transplant-ineligible
- Lopez A et al. GEMOX-R regimen is a highly effective salvage regimen in patients with refractory/relapsing diffuse large-cell lymphoma: a phase II study. Eur J Haematol. 2008; 80:127-32.GEMOX-R regimen is a highly effective salvage regimen in patients with refractory/relapsing diffuse large-cell lymphoma: a phase II study - López - 2008 - European Journal of Haematology - Wiley Online Library
- Gopal AK et al. Efficacy and safety of gemcitabine, carboplatin, dexamethasone, and rituximab in patients with relapsed/refractory lymphoma: a prospective multi-center phase II study by the Puget Sound Oncology Consortium. Leuk Lymphoma. 2010; 51:1523-9.Efficacy and safety of gemcitabine, carboplatin, dexamethasone, and rituximab in patients with relapsed/refractory lymphoma: a prospective multi-center phase II study by the Puget Sound Oncology Consortium: Leukemia & Lymphoma: Vol 51, No 8 (tandfonline.com)
- Sehn LH et al. Polatuzumab vedotin in relapsed or refractory diffuse large B-cell lymphoma. J Clin Oncol. 2020; 38:155-65Polatuzumab Vedotin in Relapsed or Refractory Diffuse Large B-Cell Lymphoma | Journal of Clinical Oncology (ascopubs.org)
- Salles G et al. Tafasitamab plus lenalidomide in relapsed or refractory diffuse large B-cell lymphoma (L-MIND): a multicentre, prospective, single-arm, phase 2 study. Lancet Oncol. 2020; 21:978-88.Tafasitamab plus lenalidomide in relapsed or refractory diffuse large B-cell lymphoma (L-MIND): a multicentre, prospective, single-arm, phase 2 study - The Lancet Oncology
Subsequent therapy: transplant-eligible
- Kewalramani T et al. Rituximab and ICE as second-line therapy before autologous stem cell transplantation for relapsed or primary refractory diffuse large B-cell lymphoma. Blood. 2004; 103:3684-8.Rituximab and ICE as second-line therapy before autologous stem cell transplantation for relapsed or primary refractory diffuse large B-cell lymphoma | Blood | American Society of Hematology (ashpublications.org)
- Crump M et al. Randomized comparison of gemcitabine, dexamethasone, and cisplatin versus dexamethasone, cytarabine, and cisplatin chemotherapy before autologous stem-cell transplantation for relapsed and refractory aggressive lymphomas: NCIC-CTG LY.12. J Clin Oncol. 2014; 32:3490-6.Randomized Comparison of Gemcitabine, Dexamethasone, and Cisplatin Versus Dexamethasone, Cytarabine, and Cisplatin Chemotherapy Before Autologous Stem-Cell Transplantation for Relapsed and Refractory Aggressive Lymphomas: NCIC-CTG LY.12 | Journal of Clinical Oncology (ascopubs.org)
- Velasquez WS et al. Effective salvage therapy for lymphoma with cisplatin in combination with high-dose Ara-C and dexamethasone (DHAP). Blood. 1988; 71:117-22.Effective Salvage Therapy for Lymphoma With Cisplatin in Combination With High-Dose Ara-C and Dexamethasone (DHAP) - ScienceDirect
- Velasquez WS et al. ESHAP--an effective chemotherapy regimen in refractory and relapsing lymphoma: a 4-year follow-up study. J Clin Oncol. 1994; 12:1169-76.ESHAP--an effective chemotherapy regimen in refractory and relapsing lymphoma: a 4-year follow-up study. | Journal of Clinical Oncology (ascopubs.org)
- Lignon J, et al. Rituximab, dexamethasone, cytarabine, and oxaliplatin (R-DHAX) is an effective and safe salvage regimen in relapsed/refractory B-cell non-Hodgkin lymphoma. Clin Lymphoma Myeloma Leuk. 2010; 10:262-9.Rituximab, Dexamethasone, Cytarabine, and Oxaliplatin (R-DHAX) Is an Effective and Safe Salvage Regimen in Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma - Clinical Lymphoma, Myeloma and Leukemia (clinical-lymphoma-myeloma-leukemia.com)
- Rigacci L et al. Oxaliplatin-based chemotherapy (dexamethasone, high-dose cytarabine, and oxaliplatin)+/-rituximab is an effective salvage regimen in patients with relapsed or refractory lymphoma. Cancer. 2010; 116:4573-9.Oxaliplatin-based chemotherapy (dexamethasone, high-dose cytarabine, and oxaliplatin) ± rituximab is an effective salvage regimen in patients with relapsed or refractory lymphoma - Rigacci - 2010 - Cancer - Wiley Online Library
Endometrial Cancer Pathways:
Recurrent/Metastatic: First Line and Subsequent Therapy
|
*Use of preferred oncology medication products may be required for coverage. Refer to Cigna’s Drug and Biologic Coverage Policy 1403 for additional criteria.
References
Recurrent/Metastatic: First Line and Subsequent Therapy
- Miller DS et al. Carboplatin and paclitaxel for advanced endometrial cancer: final overall survival and adverse event analysis of a phase III trial (NRG Oncology/GOG0209). J Clin Oncol. 2020; 38:3841-50.Carboplatin and Paclitaxel for Advanced Endometrial Cancer: Final Overall Survival and Adverse Event Analysis of a Phase III Trial (NRG Oncology/GOG0209) | Journal of Clinical Oncology (ascopubs.org)
- Secord AA et al. Weekly low-dose paclitaxel and carboplatin in the treatment of advanced or recurrent cervical and endometrial cancer. Int J Clin Oncol. 2007; 12:31-6.Weekly low-dose paclitaxel and carboplatin in the treatment of advanced or recurrent cervical and endometrial cancer | SpringerLink
- Fleming GF et al. Phase III trial of doxorubicin plus cisplatin with or without paclitaxel plus filgrastim in advanced endometrial carcinoma: a Gynecologic Oncology Group study. J Clin Oncol. 2004; 22:2159-66.Phase III Trial of Doxorubicin Plus Cisplatin With or Without Paclitaxel Plus Filgrastim in Advanced Endometrial Carcinoma: A Gynecologic Oncology Group Study | Journal of Clinical Oncology (ascopubs.org)
- Cella D et al. Patient-reported peripheral neuropathy of doxorubicin and cisplatin with and without paclitaxel in the treatment of advanced endometrial cancer: results from GOG 184. Gynecol Oncol. 2010; 119:538-42.Patient-reported peripheral neuropathy of doxorubicin and cisplatin with and without paclitaxel in the treatment of advanced endometrial cancer: Results from GOG 184 - Gynecologic Oncology (gynecologiconcology-online.net)
- Fader AN et al. Randomized phase II trial of carboplatin-paclitaxel versus carboplatin-paclitaxel-trastuzumab in uterine serous carcinomas that overexpress human epidermal growth factor receptor 2/neu. J Clin Oncol. 2018; 36:2044-51.Randomized Phase II Trial of Carboplatin-Paclitaxel Versus Carboplatin-Paclitaxel-Trastuzumab in Uterine Serous Carcinomas That Overexpress Human Epidermal Growth Factor Receptor 2/neu | Journal of Clinical Oncology (ascopubs.org)
- Lorusso D et al. Carboplatin-paclitaxel compared to carboplatin-paclitaxel-bevacizumab in advanced or recurrent endometrial cancer: MITO END-2 - a randomized phase II trial. Gynecol Oncol. 2019; 155:406-12.Carboplatin-paclitaxel compared to Carboplatin-Paclitaxel-Bevacizumab in advanced or recurrent endometrial cancer: MITO END-2 - A randomized phase II trial - Gynecologic Oncology (gynecologiconcology-online.net)
- Nomura H et al. Randomized phase II study comparing docetaxel plus cisplatin, docetaxel plus carboplatin, and paclitaxel plus carboplatin in patients with advanced or recurrent endometrial carcinoma: a Japanese Gynecologic Oncology Group study (JGOG2041). Ann Oncol. 2011; 22:636-42.Randomized phase II study comparing docetaxel plus cisplatin, docetaxel plus carboplatin, and paclitaxel plus carboplatin in patients with advanced or recurrent endometrial carcinoma: a Japanese Gynecologic Oncology Group study (JGOG2041) - Annals of Oncology
- Lissoni A et al. Phase II study of paclitaxel as salvage treatment in advanced endometrial cancer. Ann Oncol. 1996; 7:861-3.Phase II study of paclitaxel as salvage treatment in advanced endometrial cancer (annalsofoncology.org)
- Thigpen JT et al. A randomized comparison of doxorubicin alone versus doxorubicin plus cyclophosphamide in the management of advanced or recurrent endometrial carcinoma: a Gynecologic Oncology Group study. J Clin Oncol. 1994; 12:1408-14.A randomized comparison of doxorubicin alone versus doxorubicin plus cyclophosphamide in the management of advanced or recurrent endometrial carcinoma: A Gynecologic Oncology Group study. | Journal of Clinical Oncology (ascopubs.org)
- Wadler S et al. Topotecan is an active agent in the first-line treatment of metastatic or recurrent endometrial carcinoma: Eastern Cooperative Oncology Group study E3E93. J Clin Oncol. 2003; 21:2110-4.Topotecan Is an Active Agent in the First-Line Treatment of Metastatic or Recurrent Endometrial Carcinoma: Eastern Cooperative Oncology Group Study E3E93 | Journal of Clinical Oncology (ascopubs.org)
- Seski JC et al. Cisplatin chemotherapy for disseminated endometrial cancer. Obstet Gynecol. 1982; 59:225-8.Cisplatin chemotherapy for disseminated endometrial cancer - PubMed (nih.gov)
- Van Wijk FH et al. Phase II study of carboplatin in patients with advanced or recurrent endometrial carcinoma. a trial of the EORTC Gynaecological Cancer Group. Eur J Cancer. 2003; 39:78-85.Phase II study of carboplatin in patients with advanced or recurrent endometrial carcinoma. A trial of the EORTC Gynaecological Cancer Group - European Journal of Cancer (ejcancer.com)
- Aghajanian et al. Phase II trial of bevacizumab in recurrent or persistent endometrial cancer: a Gynecologic Oncology Group study. J Clin Oncol. 2011; 29:2259-65.Phase II Trial of Bevacizumab in Recurrent or Persistent Endometrial Cancer: A Gynecologic Oncology Group Study | Journal of Clinical Oncology (ascopubs.org)
- Muggia FM et al. Phase II trial of the pegylated liposomal doxorubicin in previously treated metastatic endometrial cancer: a Gynecologic Oncology Group study. J Clin Oncol. 2002; 20:2360-4.Phase II Trial of the Pegylated Liposomal Doxorubicin in Previously Treated Metastatic Endometrial Cancer: A Gynecologic Oncology Group Study | Journal of Clinical Oncology (ascopubs.org)
- Oza AM et al. Phase II study of temsirolimus in women with recurrent or metastatic endometrial cancer: a trial of the NCIC Clinical Trials group. J Clin Oncol. 2011; 29:3278-85.Phase II Study of Temsirolimus in Women With Recurrent or Metastatic Endometrial Cancer: A Trial of the NCIC Clinical Trials Group | Journal of Clinical Oncology (ascopubs.org)
- Katsumata N et al. Phase II trial of docetaxel in advanced or metastatic endometrial cancer: a Japanese Cooperative study. British Journal of Cancer. 2005; 93:999-1004.Phase II trial of docetaxel in advanced or metastatic endometrial cancer: a Japanese Cooperative Study - PMC (nih.gov)
Esophageal and Esophagogastric Junction Cancer Pathways:
Advanced/Metastatic: First Line, adenocarcinoma, HER2 Negative, MSS
|
Advanced/Metastatic: First Line, squamous cell, MSS
|
Advanced/Metastatic: Subsequent Therapy, adenocarcinoma or squamous cell
|
References
Advanced/Metastatic: First Line, adenocarcinoma, HER2 Negative
- Al-Batran SE et al. Phase III trial in metastatic gastroesophageal adenocarcinoma with fluorouracil, leucovorin plus either oxaliplatin or cisplatin: a study of the Arbeitsgemeinschaft Internistische Onkologie. J Clin Oncol. 2008; 26:1435-42.Phase III Trial in Metastatic Gastroesophageal Adenocarcinoma with Fluorouracil, Leucovorin Plus Either Oxaliplatin or Cisplatin: A Study of the Arbeitsgemeinschaft Internistische Onkologie | Journal of Clinical Oncology (ascopubs.org)
- Van Meerten E et al. First-line treatment with oxaliplatin and capecitabine in patients with advanced or metastatic oesophageal cancer: a phase II study. British Journal of Cancer. 2007; 96:1348-52.First-line treatment with oxaliplatin and capecitabine in patients with advanced or metastatic oesophageal cancer: a phase II study | British Journal of Cancer (nature.com)
- Cunningham D et al. Capecitabine and oxaliplatin for advanced esophagogastric cancer. N Eng J Med 2008; 358:36-46.Capecitabine and Oxaliplatin for Advanced Esophagogastric Cancer | NEJM
- Kim GM et al. A randomized phase II trial of S-1-oxaliplatin versus capecitabine-oxaliplatin in advanced gastric cancer. Eur J Cancer. 2012; 48:518-26.A randomized phase II trial of S-1-oxaliplatin versus capecitabine–oxaliplatin in advanced gastric cancer - European Journal of Cancer (ejcancer.com)
- Dank M et al. Randomized phase III study comparing irinotecan combined with 5-fluorouracil and folinic acid to cisplatin combined with 5-fluorouracil in chemotherapy naive patients with advanced adenocarcinoma of the stomach or esophagogastric junction. Ann Oncol. 2008; 19:1450-7.Randomized phase III study comparing irinotecan combined with 5-fluorouracil and folinic acid to cisplatin combined with 5-fluorouracil in chemotherapy naive patients with advanced adenocarcinoma of the stomach or esophagogastric junction - Annals of Oncology
- Janjigian YY et al. First-line nivolumab plus chemotherapy versus chemotherapy alone for advanced gastric, gastrooesophageal junction, and oesophageal adenocarcinoma (CheckMate 649): a randomised, open-label, phase 3 trial. Lancet. 2021; 398:27-40.First-line nivolumab plus chemotherapy versus chemotherapy alone for advanced gastric, gastro-oesophageal junction, and oesophageal adenocarcinoma (CheckMate 649): a randomised, open-label, phase 3 trial - The Lancet
- Sun JM et al. Pembrolizumab plus chemotherapy versus chemotherapy alone for first-line treatment of advanced oesophageal cancer (KEYNOTE-590): a randomised, placebo-controlled, phase 3 study. Lancet. 2021; 398:759-71.Pembrolizumab plus chemotherapy versus chemotherapy alone for first-line treatment of advanced oesophageal cancer (KEYNOTE-590): a randomised, placebo-controlled, phase 3 study - The Lancet
Advanced/Metastatic: First Line, squamous cell, HER2 Negative
- Lorenzen S et al. Cetuximab plus cisplatin-5-fluorouracil versus cisplatin-5-fluorouracil alone in first-line metastatic squamous cell carcinoma of the esophagus: a randomized phase II study of the Arbeitsgemeinschaft Internistische Onkologie. Ann Oncol. 2009; 20:1667-73.Cetuximab plus cisplatin–5-fluorouracil versus cisplatin–5-fluorouracil alone in first-line metastatic squamous cell carcinoma of the esophagus: a randomized phase II study of the Arbeitsgemeinschaft Internistische Onkologie - Annals of Oncology
- Lee SJ et al. Capecitabine in combination with either cisplatin or weekly paclitaxel as a first-line treatment for metastatic esophageal squamous cell carcinoma: a randomized phase II study. BMC Cancer. 2015; 15:693.Capecitabine in combination with either cisplatin or weekly paclitaxel as a first-line treatment for metastatic esophageal squamous cell carcinoma: a randomized phase II study | BMC Cancer | Full Text (biomedcentral.com)
- Sun JM et al. Pembrolizumab plus chemotherapy versus chemotherapy alone for first-line treatment of advanced oesophageal cancer (KEYNOTE-590): a randomised, placebo-controlled, phase 3 study. Lancet. 2021; 398:759-71.Pembrolizumab plus chemotherapy versus chemotherapy alone for first-line treatment of advanced oesophageal cancer (KEYNOTE-590): a randomised, placebo-controlled, phase 3 study - The Lancet
Advanced/Metastatic: Subsequent Therapy, adenocarcinoma or squamous cell, HER2 Negative
- Hironaka S et al. Randomized, open-label, phase III study comparing irinotecan with paclitaxel in patients with advanced gastric cancer without severe peritoneal metastasis after failure of prior combination chemotherapy using fluoropyrimidine plus platinum: WJOG 4007 trial. J Clin Oncol. 2013; 31:4438-44.Randomized, Open-Label, Phase III Study Comparing Irinotecan With Paclitaxel in Patients With Advanced Gastric Cancer Without Severe Peritoneal Metastasis After Failure of Prior Combination Chemotherapy Using Fluoropyrimidine Plus Platinum: WJOG 4007 Trial | Journal of Clinical Oncology (ascopubs.org)
- Ilson DH et al. Paclitaxel given by a weekly 1-h infusion in advanced esophageal cancer. Ann Oncol. 2007; 18:898-902.Paclitaxel given by a weekly 1-h infusion in advanced esophageal cancer - Annals of Oncology
- Muro K et al. A phase II study of single-agent docetaxel in patients with metastatic esophageal cancer. Ann Oncol. 2004; 15:955-9.A phase II study of single-agent docetaxel in patients with metastatic esophageal cancer - Annals of Oncology
- Ford HE et al. Docetaxel versus active symptom control for refractory oesophagogastric adenocarcinoma (COUGAR-02): an open-label, phase 3 randomised controlled trial. Lancet Oncol. 2014; 15:78-86.Docetaxel versus active symptom control for refractory oesophagogastric adenocarcinoma (COUGAR-02): an open-label, phase 3 randomised controlled trial - The Lancet Oncology
- Mizota et al. A retrospective comparison of docetaxel and paclitaxel for patients with advanced or recurrent esophageal cancer who previously received platinum-based chemotherapy. Oncology. 2011; 81:237-42.A Retrospective Comparison of Docetaxel and Paclitaxel for Patients with Advanced or Recurrent Esophageal Cancer Who Previously Received Platinum-Based Chemotherapy - Abstract - Oncology 2011, Vol. 81, No. 3-4 - Karger Publishers
- Thuss-Patience PC et al. Survival advantage for irinotecan versus best supportive care as second-line chemotherapy in gastric cancer--a randomised phase III study of the Arbeitsgemeinschaft Internistische Onkologie (AIO). Eur J Cancer. 2011; 47:2306-14.Survival advantage for irinotecan versus best supportive care as second-line chemotherapy in gastric cancer – A randomised phase III study of the Arbeitsgemeinschaft Internistische Onkologie (AIO) - European Journal of Cancer (ejcancer.com)
- Wilke H et al. Ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (RAINBOW): a double-blind, randomised phase 3 trial. Lancet Oncol. 2014; 15:1224-35.Ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (RAINBOW): a double-blind, randomised phase 3 trial - The Lancet Oncology
- Marabelle A et al. Efficacy of Pembrolizumab in Patients with Noncolorectal High Microsatellite Instability/Mismatch Repair-Deficient Cancer: Results From the Phase II KEYNOTE-158 Study. J Clin Oncol. 2020; 38:1-10.Efficacy of Pembrolizumab in Patients With Noncolorectal High Microsatellite Instability/Mismatch Repair–Deficient Cancer: Results From the Phase II KEYNOTE-158 Study | Journal of Clinical Oncology (ascopubs.org)
- Shitara K et al. Trifluridine/tipiracil versus placebo in patients with heavily pretreated metastatic gastric cancer (TAGS): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2018; 19:1437-48.Trifluridine/tipiracil versus placebo in patients with heavily pretreated metastatic gastric cancer (TAGS): a randomised, double-blind, placebo-controlled, phase 3 trial - The Lancet Oncology
- Fuchs CS et al. Ramucirumab monotherapy for previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (REGARD): an international, randomised, multicentre, placebo-controlled, phase 3 trial. Lancet. 2014; 383:31-9.Ramucirumab monotherapy for previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (REGARD): an international, randomised, multicentre, placebo-controlled, phase 3 trial - The Lancet
- Kojima T et al. Randomized phase III KEYNOTE-181 study of pembrolizumab versus chemotherapy in advanced esophageal cancer. J Clin Oncol. 2020; 38:4138-48.Randomized Phase III KEYNOTE-181 Study of Pembrolizumab Versus Chemotherapy in Advanced Esophageal Cancer | Journal of Clinical Oncology (ascopubs.org)
- Kato K et al. Nivolumab versus chemotherapy in patients with advanced oesophageal squamous cell carcinoma refractory or intolerant to previous chemotherapy (ATTRACTION-3): a multicentre, randomised, open-label, phase 3 trial. Lancet Oncol. 2019; 20:1506-1517.Nivolumab versus chemotherapy in patients with advanced oesophageal squamous cell carcinoma refractory or intolerant to previous chemotherapy (ATTRACTION-3): a multicentre, randomised, open-label, phase 3 trial - The Lancet Oncology
Follicular B-cell Lymphoma Pathways:
First Line: Grade 1-2
|
*Use of preferred oncology medication products may be required for coverage. Refer to Cigna’s Drug and Biologic Coverage Policy 1403 for additional criteria.
References
First Line: Grade 1-2
- Hiddemann W et al. Immunochemotherapy with obinutuzumab or rituximab for previously untreated follicular lymphoma in the GALLIUM study: influence of chemotherapy on efficacy and safety. J Clin Oncol. 2018; 36:2395-404.Immunochemotherapy With Obinutuzumab or Rituximab for Previously Untreated Follicular Lymphoma in the GALLIUM Study: Influence of Chemotherapy on Efficacy and Safety | Journal of Clinical Oncology (ascopubs.org)
- Czuczman MS et al. Treatment of patients with low-grade B-cell lymphoma with the combination of chimeric anti-CD20 monoclonal antibody and CHOP chemotherapy. J Clin Oncol. 1999; 17:268-76. Treatment of Patients With Low-Grade B-Cell Lymphoma With the Combination of Chimeric Anti-CD20 Monoclonal Antibody and CHOP Chemotherapy | Journal of Clinical Oncology (ascopubs.org)
- Hiddemann W et al. Frontline therapy with rituximab added to the combination of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) significantly improves the outcome for patients with advanced-stage follicular lymphoma compared with therapy with CHOP alone: results of a prospective randomized study of the German Low-Grade Lymphoma Study Group. Blood. 2005; 106:3725-32.Frontline therapy with rituximab added to the combination of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) significantly improves the outcome for patients with advanced-stage follicular lymphoma compared with therapy with CHOP alone: results of a prospective randomized study of the German Low-Grade Lymphoma Study Group | Blood | American Society of Hematology (ashpublications.org)
- Rummel MJ et al. Bendamustine plus rituximab versus CHOP plus rituximab as first-line treatment for patients with indolent and mantle-cell lymphomas: an open-label, multicentre, randomised, phase 3 non-inferiority trial. Lancet. 2013; 381:1203- 10.Bendamustine plus rituximab versus CHOP plus rituximab as first-line treatment for patients with indolent and mantle-cell lymphomas: an open-label, multicentre, randomised, phase 3 non-inferiority trial - The Lancet
- Flinn IW et al. Randomized trial of bendamustine-rituximab or R-CHOP/R-CVP in first-line treatment of indolent NHL or MCL: the BRIGHT study. Blood. 2014; 123:2944-52.Randomized trial of bendamustine-rituximab or R-CHOP/R-CVP in first-line treatment of indolent NHL or MCL: the BRIGHT study | Blood | American Society of Hematology (ashpublications.org)
- Marcus R et al. Phase III study of R-CVP compared with cyclophosphamide, vincristine, and prednisone alone in patients with previously untreated advanced follicular lymphoma. J Clin Oncol. 2008; 26:4579-86Phase III Study of R-CVP Compared With Cyclophosphamide, Vincristine, and Prednisone Alone in Patients With Previously Untreated Advanced Follicular Lymphoma | Journal of Clinical Oncology (ascopubs.org)
Head and Neck Cancer Pathways:
Advanced Disease: Definitive Chemoradiation
|
References
Advanced Disease: Definitive Chemoradiation
- Bernier J, Domenge C, Ozsahin M, et al. Postoperative irradiation with or without concomitant chemotherapy for locally advanced head and neck cancer. N Engl J Med. 2004; 350:1945-52.Postoperative Irradiation with or without Concomitant Chemotherapy for Locally Advanced Head and Neck Cancer | NEJM
- Chitapanarux I et al. Chemoradiation comparing cisplatin versus carboplatin in locally advanced nasopharyngeal cancer: randomised, non-inferiority, open trial. Eur J Cancer. 2007; 43:1399-406.Chemoradiation comparing cisplatin versus carboplatin in locally advanced nasopharyngeal cancer: Randomised, non-inferiority, open trial - European Journal of Cancer (ejcancer.com)
- Kiyota N et al. Phase II/III trial of post-operative chemoradiotherapy comparing 3-weekly cisplatin with weekly cisplatin in high-risk patients with squamous cell carcinoma of head and neck (JCOG1008). J Clin Oncol. 2020; 38:abstract 6502Phase II/III trial of post-operative chemoradiotherapy comparing 3-weekly cisplatin with weekly cisplatin in high-risk patients with squamous cell carcinoma of head and neck (JCOG1008). | Journal of Clinical Oncology (ascopubs.org)
- Clark JI et al. Phase II evaluation of paclitaxel in combination with carboplatin in advanced head and neck carcinoma. Cancer. 2001; 92:2334-40.Phase II evaluation of paclitaxel in combination with carboplatin in advanced head and neck carcinoma - PubMed (nih.gov)
- Gebre-Medhin M et al. ARTSCAN III: A Randomized Phase III Study Comparing Chemoradiotherapy With Cisplatin Versus Cetuximab in Patients With Locoregionally Advanced Head and Neck Squamous Cell Cancer. J Clin Oncol. 2021; 39:38-47.ARTSCAN III: A Randomized Phase III Study Comparing Chemoradiotherapy With Cisplatin Versus Cetuximab in Patients With Locoregionally Advanced Head and Neck Squamous Cell Cancer | Journal of Clinical Oncology (ascopubs.org)
Hepatocellular Carcinoma Pathways:
Metastatic/unresectable disease: First line
|
Metastatic/unresectable disease: Subsequent therapy
|
*Use of preferred oncology medication products may be required for coverage. Refer to Cigna’s Drug and Biologic Coverage Policy 1403 for additional criteria.
References
Metastatic disease: First line
- Llovet JM, Ricci S, Mazzaferro V, et al. Sorafenib in advanced hepatocellular carcinoma. N Eng J Med 2008; 359:378-90.Sorafenib in Advanced Hepatocellular Carcinoma | NEJM
- Kudo M et al. Lenvatinib versus sorafenib in first-line treatment of patients with unresectable hepatocellular carcinoma: a randomised phase 3 non-inferiority trial. Lancet. 2018; 391:1163-73.Lenvatinib versus sorafenib in first-line treatment of patients with unresectable hepatocellular carcinoma: a randomised phase 3 non-inferiority trial - The Lancet
- Finn RS et al. Atezolizumab plus bevacizumab in unresectable hepatocellular carcinoma. N Eng J Med 2020; 382:1894- 905.Atezolizumab plus Bevacizumab in Unresectable Hepatocellular Carcinoma | NEJM
- Yau T et al. CheckMate 459: a randomized, multi-center phase III study of nivolumab (NIVO) vs sorafenib (SOR) as first-line treatment in patients with advanced hepatocellular carcinoma (aHCC). Ann Oncol. 2019; 30:v874-v5.CheckMate 459: A randomized, multi-center phase III study of nivolumab (NIVO) vs sorafenib (SOR) as first-line (1L) treatment in patients (pts) with advanced hepatocellular carcinoma (aHCC) - ScienceDirect
Metastatic disease: Subsequent therapy
- Bruix J et al. Regorafenib for patients with hepatocellular carcinoma who progressed on sorafenib treatment (RESORCE): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2017; 389:56-66.References in Regorafenib for patients with hepatocellular carcinoma who progressed on sorafenib treatment (RESORCE): a randomised, double-blind, placebo-controlled, phase 3 trial - The Lancet
- Abou-Alfa GK et al. Cabozantinib in patients with advanced and progressing hepatocellular carcinoma. N Eng J Med 2018; 379:54-63.Cabozantinib in Patients with Advanced and Progressing Hepatocellular Carcinoma | NEJM
- Zhu AX et al. REACH-2: a randomized, double-blind, placebo-controlled phase 3 study of ramucirumab versus placebo as second-line treatment in patients with advanced hepatocellular carcinoma (HCC) and elevated baseline alpha-fetoprotein (AFP) following firstline sorafenib. J Clin Oncol. 2018; 36: abstract 4003.REACH-2: A randomized, double-blind, placebo-controlled phase 3 study of ramucirumab versus placebo as second-line treatment in patients with advanced hepatocellular carcinoma (HCC) and elevated baseline alpha-fetoprotein (AFP) following first-line sorafenib. | Journal of Clinical Oncology (ascopubs.org)
- Crocenzi TS et al. Nivolumab (nivo) in sorafenib (sor)-naive and-experienced pts with advanced hepatocellular carcinoma (HCC): CheckMate 040 study. J Clin Oncol. 2017; 35: abstract 4013.Nivolumab (nivo) in sorafenib (sor)-naive and -experienced pts with advanced hepatocellular carcinoma (HCC): CheckMate 040 study. | Journal of Clinical Oncology (ascopubs.org)
Hodgkin’s Lymphoma Pathways:
Stage III/IV classical Hodgkin’s lymphoma
|
References
Stage III/IV classical Hodgkin’s lymphoma
- Gordon LI et al. Randomized phase III trial of ABVD versus Stanford V with or without radiation therapy in locally extensive and advanced-stage Hodgkin lymphoma: an intergroup study coordinated by the Eastern Cooperative Oncology Group (E2496). J Clin Oncol. 2013; 31:684-91.Randomized Phase III Trial of ABVD Versus Stanford V With or Without Radiation Therapy in Locally Extensive and Advanced-Stage Hodgkin Lymphoma: An Intergroup Study Coordinated by the Eastern Cooperative Oncology Group (E2496) | Journal of Clinical Oncology (ascopubs.org)
- Johnson P et al. Adapted treatment guided by interim PET-CT scan in advanced Hodgkin's lymphoma. N Eng J Med 2016; 1:2419-29.Adapted Treatment Guided by Interim PET-CT Scan in Advanced Hodgkin’s Lymphoma | NEJM
- Straus et al. Brentuximab vedotin with chemotherapy for stage III/IV classical Hodgkin lymphoma: 3-year update of the ECHELON-1 study. Blood. 2020; 135:735-42.Brentuximab vedotin with chemotherapy for stage III/IV classical Hodgkin lymphoma: 3-year update of the ECHELON-1 study | Blood | American Society of Hematology (ashpublications.org)
Kidney Cancer Pathways:
First line: Good risk
|
References
First line: Good risk
- Motzer RJ et al. Pazopanib versus sunitinib in metastatic renal-cell carcinoma. N Eng J Med 2013; 1:722-31.Pazopanib versus Sunitinib in Metastatic Renal-Cell Carcinoma | NEJM
- Motzer RJ, Tannir NM, McDermott DF, et al. Nivolumab plus ipilimumab versus sunitinib in advanced renal-cell carcinoma. N Eng J Med 2018; 378:1277-129021.Nivolumab plus Ipilimumab versus Sunitinib in Advanced Renal-Cell Carcinoma | NEJM
- Motzer RJ et al. Avelumab plus axitinib versus sunitinib for advanced renal-cell carcinoma. N Eng J Med 2019; 380:1103-15.Avelumab plus Axitinib versus Sunitinib for Advanced Renal-Cell Carcinoma | NEJM
- Motzer RJ et al. Lenvatinib plus Pembrolizumab or Everolimus for Advanced Renal Cell Carcinoma. N Eng J Med 2021; 384:1289-1300.Lenvatinib plus Pembrolizumab or Everolimus for Advanced Renal Cell Carcinoma | NEJM
- Choueiri TK et al. Nivolumab + cabozantinib vs sunitinib in first-line treatment for advanced renal cell carcinoma: First results from the randomized phase III CheckMate 9ER trial. Ann Oncol. 2020; 31:S1159.696O_PR Nivolumab + cabozantinib vs sunitinib in first-line treatment for advanced renal cell carcinoma: First results from the randomized phase III CheckMate 9ER trial - Annals of Oncology
- Rini BI et al. Pembrolizumab plus axitinib versus sunitinib for advanced renal-cell carcinoma. N Eng J Med 2019; 380:1116-27.Pembrolizumab plus Axitinib versus Sunitinib for Advanced Renal-Cell Carcinoma | NEJM
First line: Intermediate/poor risk
- Motzer RJ, Tannir NM, McDermott DF, et al. Nivolumab plus ipilimumab versus sunitinib in advanced renal-cell carcinoma. N Eng J Med 2018; 378:1277-129021.Nivolumab plus Ipilimumab versus Sunitinib in Advanced Renal-Cell Carcinoma | NEJM
- Motzer RJ et al. Lenvatinib plus Pembrolizumab or Everolimus for Advanced Renal Cell Carcinoma. N Eng J Med 2021; 384:1289-1300.Lenvatinib plus Pembrolizumab or Everolimus for Advanced Renal Cell Carcinoma | NEJM
- Choueiri TK et al. Nivolumab + cabozantinib vs sunitinib in first-line treatment for advanced renal cell carcinoma: First results from the randomized phase III CheckMate 9ER trial. Ann Oncol. 2020; 31:S1159.696O_PR Nivolumab + cabozantinib vs sunitinib in first-line treatment for advanced renal cell carcinoma: First results from the randomized phase III CheckMate 9ER trial - Annals of Oncology
- Rini BI et al. Pembrolizumab plus axitinib versus sunitinib for advanced renal-cell carcinoma. N Eng J Med 2019; 380:1116-27.Pembrolizumab plus Axitinib versus Sunitinib for Advanced Renal-Cell Carcinoma | NEJM
- Choueiri TK et al. Cabozantinib versus sunitinib as initial targeted therapy for patients with metastatic renal cell carcinoma of poor or intermediate risk: the Alliance A031203 CABOSUN trial. J Clin Oncol. 2017; 35:591-7.Cabozantinib Versus Sunitinib As Initial Targeted Therapy for Patients With Metastatic Renal Cell Carcinoma of Poor or Intermediate Risk: The Alliance A031203 CABOSUN Trial | Journal of Clinical Oncology (ascopubs.org)
Lung Cancer: Non-small Cell Lung Cancer Pathways:
Advanced/Metastatic: First line, nonsquamous, PD-L1 ≥ 50%, no actionable mutations
|
Advanced/Metastatic: First line, squamous, PD-L1 ≥ 50%, no actionable mutations
|
Metastatic: First line, nonsquamous, PD-L1 <50%, no driver mutation
|
Metastatic: First line, squamous, PD-L1 <50%, no driver mutation
|
Metastatic: Subsequent Therapy, nonsquamous, no actionable mutations
|
Metastatic: Subsequent Therapy, squamous, no actionable mutations
|
References
Advanced/Metastatic: First line, squamous or nonsquamous, PD-L1 ≥ 50%, no actionable mutations
- Reck M et al. Pembrolizumab versus chemotherapy for PD-L1-positive non-small-cell lung cancer. N Eng J Med 2016; 375:1823-33.Pembrolizumab versus Chemotherapy for PD-L1–Positive Non–Small-Cell Lung Cancer | NEJM
- Reck M et al. Five-year outcomes with pembrolizumab versus chemotherapy for metastatic non-small-cell lung cancer with PD-L1 tumor proportion score >= 50. J Clin Oncol. 2021; 39:2339-49.Five-Year Outcomes With Pembrolizumab Versus Chemotherapy for Metastatic Non–Small-Cell Lung Cancer With PD-L1 Tumor Proportion Score ≥ 50% | Journal of Clinical Oncology (ascopubs.org)
- Herbst RS et al. Atezolizumab for First-Line Treatment of PD-L1-Selected Patients with NSCLC. N Eng J Med 2020 Oct 1; 383:1328-1339.Atezolizumab for First-Line Treatment of PD-L1–Selected Patients with NSCLC | NEJM
- Spigel D et al. IMpower110: interim overall survival (OS) analysis of a phase III study of atezolizumab (atezo) vs platinum-based chemotherapy (chemo) as first-line (1L) treatment (tx) in PD-L1-selected NSCLC. Ann Oncol. 2019; 30(Suppl 5):v915.IMpower110: Interim overall survival (OS) analysis of a phase III study of atezolizumab (atezo) vs platinum-based chemotherapy (chemo) as first-line (1L) treatment (tx) in PD-L1–selected NSCLC - Annals of Oncology
- Sezer A et al. Cemiplimab monotherapy for first-line treatment of advanced non-small-cell lung cancer with PD-L1 of at least 50%: a multicentre, open-label, global, phase 3, randomised, controlled trial. Lancet. 2021; 397:592-604.Cemiplimab monotherapy for first-line treatment of advanced non-small-cell lung cancer with PD-L1 of at least 50%: a multicentre, open-label, global, phase 3, randomised, controlled trial - The Lancet
Metastatic: First line, squamous or nonsquamous, PD-L1 <50%, no driver mutation
- Gandhi L et al. Pembrolizumab plus Chemotherapy in Metastatic Non–Small-Cell Lung Cancer. N Eng J Med 2018; 378:2078-92.Pembrolizumab plus Chemotherapy in Metastatic Non–Small-Cell Lung Cancer | NEJM
- Gadgeel S, Rodriguez-Abreu D, Speranza G, et al. Updated Analysis From KEYNOTE-189: Pembrolizumab or Placebo Plus Pemetrexed and Platinum for Previously Untreated Metastatic Nonsquamous Non–Small-Cell Lung Cancer. J Clin Oncol. 2020; 38:1505-17.Updated Analysis From KEYNOTE-189: Pembrolizumab or Placebo Plus Pemetrexed and Platinum for Previously Untreated Metastatic Nonsquamous Non–Small-Cell Lung Cancer | Journal of Clinical Oncology (ascopubs.org)
- Paz-Ares L, Luft A, Vicente D et al. Pembrolizumab plus Chemotherapy for Squamous Non–Small-Cell Lung Cancer. N Eng J Med. 2018; 379:2040-51.Pembrolizumab plus Chemotherapy for Squamous Non–Small-Cell Lung Cancer | NEJM
- Socinski M et al. Atezolizumab for First-Line Treatment of Metastatic Nonsquamous NSCLC. N Eng J Med 2018; 378:2288-2301.Atezolizumab for First-Line Treatment of Metastatic Nonsquamous NSCLC | NEJM
- West H et al. Atezolizumab in combination with carboplatin plus nab-paclitaxel chemotherapy compared with chemotherapy alone as first-line treatment for metastatic non-squamous non-small-cell lung cancer (IMpower130): a multicentre, randomised, open-label, phase 3 trial. Lancet Oncol. 2019; 20:924-37.Atezolizumab in combination with carboplatin plus nab-paclitaxel chemotherapy compared with chemotherapy alone as first-line treatment for metastatic non-squamous non-small-cell lung cancer (IMpower130): a multicentre, randomised, open-label, phase 3 trial - The Lancet Oncology
- Hellmann MD et al. Nivolumab plus ipilimumab in advanced non-small-cell lung cancer. N Eng J Med 2019; 381:2020-31.Nivolumab plus Ipilimumab in Advanced Non–Small-Cell Lung Cancer | NEJM
- Paz-Ares L et al. First-line nivolumab plus ipilimumab combined with two cycles of chemotherapy in patients with non-small-cell lung cancer (CheckMate 9LA): an international, randomised, open-label, phase 3 trial. Lancet Oncol. 2021; 22:198-211.First-line nivolumab plus ipilimumab combined with two cycles of chemotherapy in patients with non-small-cell lung cancer (CheckMate 9LA): an international, randomised, open-label, phase 3 trial - The Lancet Oncology
- Jotte R et al. Atezolizumab in Combination with Carboplatin and Nab-Paclitaxel in Advanced Squamous NSCLC (IMpower131): Results From a Randomized Phase III Trial. J Thorac Oncol. 2020 Aug; 15:1351-1360.Atezolizumab in Combination With Carboplatin and Nab-Paclitaxel in Advanced Squamous NSCLC (IMpower131): Results From a Randomized Phase III Trial - Journal of Thoracic Oncology (jto.org)
Metastatic: Subsequent Therapy, squamous or nonsquamous, no actionable mutation
- Herbst RS, Baas P, Kim DW, et al. Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomised controlled trial. Lancet. 2016; 387:1540-50.Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomised controlled trial - The Lancet
- Herbst RS et al. Long-term outcomes and retreatment among patients with previously treated, programmed death-ligand 1-positive, advanced non-small-cell lung cancer in the KEYNOTE-010 study. J Clin Oncol. 2020; 38:1580-90.Long-Term Outcomes and Retreatment Among Patients With Previously Treated, Programmed Death-Ligand 1‒Positive, Advanced Non‒Small-Cell Lung Cancer in the KEYNOTE-010 Study | Journal of Clinical Oncology (ascopubs.org)
- Herbst RS et al. Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomised controlled trial. Lancet. 2016; 387:1540-50.Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomised controlled trial - The Lancet
- Borghaei H et al. Nivolumab versus docetaxel in advanced nonsquamous non-small-cell lung cancer. N Eng J Med 2015; 373:1627-39.Nivolumab versus Docetaxel in Advanced Nonsquamous Non–Small-Cell Lung Cancer | NEJM
- Vokes EE et al. Nivolumab versus docetaxel in previously treated advanced non-small-cell lung cancer (CheckMate 017 and CheckMate 057): 3-year update and outcomes in patients with liver metastases. Ann Oncol. 2018; 29:959-65.Nivolumab versus docetaxel in previously treated advanced non-small-cell lung cancer (CheckMate 017 and CheckMate 057): 3-year update and outcomes in patients with liver metastases - Annals of Oncology
- Brahmer J, et al. Nivolumab versus docetaxel in advanced squamous-cell non-small-cell lung cancer. N Eng J Med 2015; 373:123-35.Nivolumab versus Docetaxel in Advanced Squamous-Cell Non–Small-Cell Lung Cancer | NEJM
- Rittmeyer A et al. Atezolizumab versus docetaxel in patients with previously treated non-small-cell lung cancer (OAK): a phase 3, open-label, multicentre randomised controlled trial. Lancet. 2017; 389:255-65.Atezolizumab versus docetaxel in patients with previously treated non-small-cell lung cancer (OAK): a phase 3, open-label, multicentre randomised controlled trial - The Lancet
- Hanna N et al. Randomized phase III trial of pemetrexed versus docetaxel in patients with non-small-cell lung cancer previously treated with chemotherapy. J Clin Oncol. 2004; 22:1589-97.Randomized Phase III Trial of Pemetrexed Versus Docetaxel in Patients With Non–Small-Cell Lung Cancer Previously Treated With Chemotherapy | Journal of Clinical Oncology (ascopubs.org)
- Fossella FV et al. Randomized phase III trial of docetaxel versus vinorelbine or ifosfamide in patients with advanced non-small-cell lung cancer previously treated with platinum-containing chemotherapy regimens. The TAX 320 Non-Small Cell Lung Cancer Study Group. J Clin Oncol. 2000 Jun; 18:2354-62.Randomized Phase III Trial of Docetaxel Versus Vinorelbine or Ifosfamide in Patients With Advanced Non–Small-Cell Lung Cancer Previously Treated With Platinum-Containing Chemotherapy Regimens | Journal of Clinical Oncology (ascopubs.org)
- Anderson H et al. Gemcitabine plus best supportive care (BSC) vs BSC in inoperable non-small cell lung cancer--a randomized trial with quality of life as the primary outcome. UK NSCLC Gemcitabine Group. Non-Small Cell Lung Cancer. British Journal of Cancer. 2000; 83:447-53.Gemcitabine plus best supportive care (BSC) vs BSC in inoperable non-small cell lung cancer – a randomized trial with quality of life as the primary outcome | British Journal of Cancer (nature.com)
- Garon EB et al. Ramucirumab plus docetaxel versus placebo plus docetaxel for second-line treatment of stage IV non-small-cell lung cancer after disease progression on platinum-based therapy (REVEL): a multicentre, doubleblind, randomised phase 3 trial. Lancet. 2014; 384:665-73.Ramucirumab plus docetaxel versus placebo plus docetaxel for second-line treatment of stage IV non-small-cell lung cancer after disease progression on platinum-based therapy (REVEL): a multicentre, double-blind, randomised phase 3 trial - The Lancet
Lung Cancer: Small Cell Lung Cancer Pathways:
Limited Stage Disease
|
Extensive Stage Disease: First Line
|
Extensive Stage Disease: Subsequent Therapy
|
References
Limited Stage Disease
- Turrisi AT et al. Twice-daily compared with once-daily thoracic radiotherapy in limited small-cell lung cancer treated concurrently with cisplatin and etoposide. N Engl J Med. 1999; 340:265-71.Twice-Daily Compared with Once-Daily Thoracic Radiotherapy in Limited Small-Cell Lung Cancer Treated Concurrently with Cisplatin and Etoposide | NEJM
- Faivre-Finn C et al. Concurrent once-daily versus twice-daily chemoradiotherapy in patients with limited-stage small-cell lung cancer (CONVERT): an open-label, phase 3, randomised, superiority trial. Lancet Oncol. 2017; 18:1116-25.Concurrent once-daily versus twice-daily chemoradiotherapy in patients with limited-stage small-cell lung cancer (CONVERT): an open-label, phase 3, randomised, superiority trial - The Lancet Oncology
- Okamoto H et al. Phase II study of area under the plasma-concentration-versus-time curve-based carboplatin plus standarddose intravenous etoposide in elderly patients with small-cell lung cancer. J Clin Oncol. 1999; 17:3540-5Phase II Study of Area Under the Plasma-Concentration-Versus-Time Curve–Based Carboplatin Plus Standard-Dose Intravenous Etoposide in Elderly Patients With Small-Cell Lung Cancer | Journal of Clinical Oncology (ascopubs.org)
- Skarlos DV et al. Randomized comparison of early versus late hyperfractionated thoracic irradiation concurrently with chemotherapy in limited disease small-cell lung cancer: a randomized phase II study of the Hellenic Cooperative Oncology Group (HeCOG). Ann Oncol. 2001; 12: 1231-8.Randomized comparison of early versus late hyperfractionated thoracic irradiation concurrently with chemotherapy in limited disease small-cell lung cancer: A randomized phase II study of the Hellenic Cooperative Oncology Group (HeCOG) - Annals of Oncology
Extensive Stage Disease: First Line
- Hanna N et al. Randomized phase III trial comparing irinotecan/cisplatin with etoposide/cisplatin in patients with previously untreated extensive-stage disease small-cell lung cancer. J Clin Oncol. 2006; 24:2038-43.Randomized Phase III Trial Comparing Irinotecan/Cisplatin With Etoposide/Cisplatin in Patients With Previously Untreated Extensive-Stage Disease Small-Cell Lung Cancer | Journal of Clinical Oncology (ascopubs.org)
- Noda K et al. Irinotecan plus cisplatin compared with etoposide plus cisplatin for extensive small-cell lung cancer. N Engl J Med. 2002; 346:85-91.Irinotecan plus Cisplatin Compared with Etoposide plus Cisplatin for Extensive Small-Cell Lung Cancer | NEJM
- Niell HB et al. Randomized phase III intergroup trial of etoposide and cisplatin with or without paclitaxel and granulocyte colony-stimulating factor in patients with extensive-stage small-cell lung cancer: Cancer and Leukemia Group B Trial 9732. J Clin Oncol. 2005; 23:3752-9.Randomized Phase III Intergroup Trial of Etoposide and Cisplatin With or Without Paclitaxel and Granulocyte Colony-Stimulating Factor in Patients With Extensive-Stage Small-Cell Lung Cancer: Cancer and Leukemia Group B Trial 9732 | Journal of Clinical Oncology (ascopubs.org)
- Paz-Ares L et al. Durvalumab plus platinum-etoposide versus platinum-etoposide in first-line treatment of extensive-stage small-cell lung cancer (CASPIAN): a randomised, controlled, open-label, phase 3 trial. Lancet. 2019; 394:1929-39.Durvalumab plus platinum–etoposide versus platinum–etoposide in first-line treatment of extensive-stage small-cell lung cancer (CASPIAN): a randomised, controlled, open-label, phase 3 trial - The Lancet
- Horn L et al. First-line atezolizumab plus chemotherapy in extensive-stage small-cell lung cancer. N Engl J Med. 2018; 379:2220-9.First-Line Atezolizumab plus Chemotherapy in Extensive-Stage Small-Cell Lung Cancer | NEJM
- Schmittel A et al. A randomized phase II trial of irinotecan plus carboplatin versus etoposide plus carboplatin treatment in patients with extended disease small-cell lung cancer. Ann Oncol. 2006; 17:663-7.A randomized phase II trial of irinotecan plus carboplatin versus etoposide plus carboplatin treatment in patients with extended disease small-cell lung cancer (annalsofoncology.org)
- Schmittel A et al. A German multicenter, randomized phase III trial comparing irinotecan–carboplatin with etoposide–carboplatin as first-line therapy for extensive-disease small-cell lung cancer. Ann Oncol. 2011; 22:1798-1804.A German multicenter, randomized phase III trial comparing irinotecan–carboplatin with etoposide–carboplatin as first-line therapy for extensive-disease small-cell lung cancer - Annals of Oncology
Extensive Stage Disease: Subsequent Therapy
- Von Pawel J et al. Topotecan versus cyclophosphamide, doxorubicin, and vincristine for the treatment of recurrent small-cell lung cancer. J Clin Oncol. 1999; 17:658-67.Topotecan Versus Cyclophosphamide, Doxorubicin, and Vincristine for the Treatment of Recurrent Small-Cell Lung Cancer | Journal of Clinical Oncology (ascopubs.org)
- O'Brien ME et al. Phase III trial comparing supportive care alone with supportive care with oral topotecan in patients with relapsed small-cell lung cancer. J Clin Oncol. 2006; 24:5441-7.Phase III Trial Comparing Supportive Care Alone With Supportive Care With Oral Topotecan in Patients With Relapsed Small-Cell Lung Cancer | Journal of Clinical Oncology (ascopubs.org)
- Eckardt JR et al. Phase III study of oral compared with intravenous topotecan as second-line therapy in small-cell lung cancer. J Clin Oncol. 2007; 25:2086-92.Phase III Study of Oral Compared With Intravenous Topotecan As Second-Line Therapy in Small-Cell Lung Cancer | Journal of Clinical Oncology (ascopubs.org)
- Trigo J et al. Lurbinectedin as second-line treatment for patients with small-cell lung cancer: a single-arm, open-label, phase 2 basket trial. Lancet Oncol. 2020; 21:645-54.Lurbinectedin as second-line treatment for patients with small-cell lung cancer: a single-arm, open-label, phase 2 basket trial - The Lancet Oncology
- Antonia SJ et al. Nivolumab alone and nivolumab plus ipilimumab in recurrent small-cell lung cancer (CheckMate 032): a multicentre, open-label, phase 1/2 trial. Lancet Oncol. 2016; 17:883-95.Nivolumab alone and nivolumab plus ipilimumab in recurrent small-cell lung cancer (CheckMate 032): a multicentre, open-label, phase 1/2 trial - The Lancet Oncology
- Ready NE et al. Nivolumab monotherapy and nivolumab plus ipilimumab in recurrent small cell lung cancer: results from the CheckMate 032 randomized cohort. J Thorac Oncol. 2020; 15:426-35.Nivolumab Monotherapy and Nivolumab Plus Ipilimumab in Recurrent Small Cell Lung Cancer: Results From the CheckMate 032 Randomized Cohort - Journal of Thoracic Oncology (jto.org)
- Owonikoko T.K. et al. Nivolumab (nivo) plus ipilimumab (ipi), nivo, or placebo (pbo) as maintenance therapy in patients (pts) with extensive disease small cell lung cancer (ED-SCLC) after first-line (1L) platinum-based chemotherapy (chemo): Results from the double-blind, randomized phase III CheckMate 451 study. 2019; 30:1177.Nivolumab (nivo) plus ipilimumab (ipi), nivo, or placebo (pbo) as maintenance therapy in patients (pts) with extensive disease small cell lung cancer (ED-SCLC) after first-line (1L) platinum-based chemotherapy (chemo): Results from the double-blind, randomized phase III CheckMate 451 study - Annals of Oncology
- Rudin CM et al. Pembrolizumab or placebo plus etoposide and platinum as first-line therapy for extensive-stage small-cell lung cancer: randomized, double-blind, phase III KEYNOTE-604 study. J Clin Oncol. 2020; 38:2369-79.Pembrolizumab or Placebo Plus Etoposide and Platinum as First-Line Therapy for Extensive-Stage Small-Cell Lung Cancer: Randomized, Double-Blind, Phase III KEYNOTE-604 Study | Journal of Clinical Oncology (ascopubs.org)
Melanoma Pathways:
Metastatic: First line BRAF mutation (+)
|
Metastatic: First line, BRAF mutation (-)
|
References
Metastatic: First line therapy BRAF mutated
- Larkin J, Ascierto PA, Dreno B, et al. Combined vemurafenib and cobimetinib in BRAF-mutated melanoma. N Engl J Med. 2014; 371(20):1867-76.Combined Vemurafenib and Cobimetinib in BRAF-Mutated Melanoma | NEJM
- Ascierto PA, McArthur GA, Dreno B, et al. Cobimetinib combined with vemurafenib in advanced BRAF(V600)-mutant melanoma (coBRIM): updated efficacy results from a randomised, double-blind, phase 3 trial. Lancet Oncol. 2016; 17(9):1248-60.Cobimetinib combined with vemurafenib in advanced BRAFV600-mutant melanoma (coBRIM): updated efficacy results from a randomised, double-blind, phase 3 trial - The Lancet Oncology
- Long GV, Stroyakovskiy D, Gogas H, et al. Dabrafenib and trametinib versus dabrafenib and placebo for Val600 BRAF-mutant melanoma: a multicentre, double-blind, phase 3 randomised controlled trial. Lancet. 2015; 386(9992):444-51.Dabrafenib and trametinib versus dabrafenib and placebo for Val600 BRAF-mutant melanoma: a multicentre, double-blind, phase 3 randomised controlled trial - The Lancet
- Long GV, Flaherty KT, Stroyakovskiy D, et al. Dabrafenib plus trametinib versus dabrafenib monotherapy in patients with metastatic BRAF V600E/Kmutant melanoma: long-term survival and safety analysis of a phase 3 study. Ann Oncol. 2017; 28:1631-9.Dabrafenib plus trametinib versus dabrafenib monotherapy in patients with metastatic BRAF V600E/K-mutant melanoma: long-term survival and safety analysis of a phase 3 study - Annals of Oncology
- Robert C, Karaszewska B, Schachter J, et al. Improved overall survival in melanoma with combined dabrafenib and trametinib. N Engl J Med. 2015; 372(1):30-9.Improved Overall Survival in Melanoma with Combined Dabrafenib and Trametinib | NEJM
- Dummer R, Ascierto PA, Gogas HJ, et al. Encorafenib plus binimetinib versus vemurafenib or encorafenib in patients with BRAF-mutant melanoma (COLUMBUS): a multicentre, open-label, randomised phase 3 trial. Lancet Oncol. 2018; 19(5):603-15.Encorafenib plus binimetinib versus vemurafenib or encorafenib in patients with BRAF-mutant melanoma (COLUMBUS): a multicentre, open-label, randomised phase 3 trial - The Lancet Oncology
Metastatic: No prior immunotherapy
- Robert C, Schachter J, Long GV, et al. Pembrolizumab versus ipilimumab in advanced melanoma. N Engl J Med. 2015; 372(26):2521-32.Pembrolizumab versus Ipilimumab in Advanced Melanoma | NEJM
- Schachter J, Ribas A, Long GV, et al. Pembrolizumab versus ipilimumab for advanced melanoma: final overall survival results of a multicentre, randomised, open-label phase 3 study (KEYNOTE-006). Lancet. 2017; 390(10105):1853-62.Pembrolizumab versus ipilimumab for advanced melanoma: final overall survival results of a multicentre, randomised, open-label phase 3 study (KEYNOTE-006) - The Lancet
- Robert C, Ribas A, Schachter J, et al. Pembrolizumab versus ipilimumab in advanced melanoma (KEYNOTE-006): post-hoc 5-year results from an openlabel, multicentre, randomised, controlled, phase 3 study. Lancet Oncol. 2019; 20(9):1239-51.Pembrolizumab versus ipilimumab in advanced melanoma (KEYNOTE-006): post-hoc 5-year results from an open-label, multicentre, randomised, controlled, phase 3 study - The Lancet Oncology
- Larkin J, Chiarion-Sileni V, Gonzalez R, et al. Combined nivolumab and ipilimumab or monotherapy in untreated melanoma. N Engl J Med. 2015; 373(1):23-34.Combined Nivolumab and Ipilimumab or Monotherapy in Untreated Melanoma | NEJM
- Hodi FS, Chiarion-Sileni V, Gonzalez R, et al. Nivolumab plus ipilimumab or nivolumab alone versus ipilimumab alone in advanced melanoma (CheckMate 067): 4-year outcomes of a multicentre, randomised, phase 3 trial. Lancet Oncol. 2018; 19(11):1480-92.Nivolumab plus ipilimumab or nivolumab alone versus ipilimumab alone in advanced melanoma (CheckMate 067): 4-year outcomes of a multicentre, randomised, phase 3 trial - The Lancet Oncology
- Larkin J, Chiarion-Sileni V, Gonzalez R, et al. Five-year survival with combined nivolumab and ipilimumab in advanced melanoma. N Engl J Med. 2019; 381(16):1535-46.Five-Year Survival with Combined Nivolumab and Ipilimumab in Advanced Melanoma | NEJM
- Tawbi H et al. Relatlimab and Nivolumab versus Nivolumab in Untreated Advanced Melanoma. N Eng J Med. 2022; 386:24-34.Relatlimab and Nivolumab versus Nivolumab in Untreated Advanced Melanoma | NEJM
Multiple Myeloma Pathways:
First line: Transplant eligible
|
First line: Transplant ineligible
|
References
First line: Transplant eligible
- Roussel M, Lauwers-Cances V, Robillard N, et al. Front-line transplantation program with lenalidomide, bortezomib, and dexamethasone combination as induction and consolidation followed by lenalidomide maintenance in patients with multiple myeloma: a phase II study by the Intergroupe Francophone du Myelome. J Clin Oncol. 2014; 32(25):2712-7.Front-Line Transplantation Program With Lenalidomide, Bortezomib, and Dexamethasone Combination As Induction and Consolidation Followed by Lenalidomide Maintenance in Patients With Multiple Myeloma: A Phase II Study by the Intergroupe Francophone du Myélome | Journal of Clinical Oncology (ascopubs.org)
- Voorhees PM, Kaufman JL, Laubach J, et al. Daratumumab, lenalidomide, bortezomib, and dexamethasone for transplant-eligible newly diagnosed multiple myeloma: the GRIFFIN trial. Blood. 2020; 136(8):936-45.Daratumumab, lenalidomide, bortezomib, and dexamethasone for transplant-eligible newly diagnosed multiple myeloma: the GRIFFIN trial | Blood | American Society of Hematology (ashpublications.org)
- Kumar S, Flinn I, Richardson PG, et al. Randomized, multicenter, phase 2 study (EVOLUTION) of combinations of bortezomib, dexamethasone, cyclophosphamide, and lenalidomide in previously untreated multiple myeloma. Blood. 2012; 119(19):4375-82.Randomized, multicenter, phase 2 study (EVOLUTION) of combinations of bortezomib, dexamethasone, cyclophosphamide, and lenalidomide in previously untreated multiple myeloma | Blood | American Society of Hematology (ashpublications.org)
First line: Transplant ineligible
- Durie BG, Hoering A, Abidi MH, et al. Bortezomib with lenalidomide and dexamethasone versus lenalidomide and dexamethasone alone in patients with newly diagnosed myeloma without intent for immediate autologous stem-cell transplant (SWOG S0777): a randomised, open-label, phase 3 trial. Lancet. 2017; 389(10068):519-27.Bortezomib with lenalidomide and dexamethasone versus lenalidomide and dexamethasone alone in patients with newly diagnosed myeloma without intent for immediate autologous stem-cell transplant (SWOG S0777): a randomised, open-label, phase 3 trial - The Lancet
- Facon T, Kumar S, Plesner T, et al. Daratumumab plus lenalidomide and dexamethasone for untreated myeloma. N Engl J Med. 2019; 380(22):2104- 15.Oral ixazomib, lenalidomide, and dexamethasone for transplant-ineligible patients with newly diagnosed multiple myeloma | Blood | American Society of Hematology (ashpublications.org)Daratumumab plus Lenalidomide and Dexamethasone for Untreated Myeloma | NEJM
- Facon T, Venner CP, Bahlis NJ, et al. Oral ixazomib, lenalidomide, and dexamethasone for transplant-ineligible patients with newly diagnosed multiple myeloma. Blood. 2021; 137(26):3616-28.Oral ixazomib, lenalidomide, and dexamethasone for transplant-ineligible patients with newly diagnosed multiple myeloma | Blood | American Society of Hematology (ashpublications.org)
- Kumar SK, Jacobus SJ, Cohen AD, et al. Carfilzomib or bortezomib in combination with lenalidomide and dexamethasone for patients with newly diagnosed multiple myeloma without intention for immediate autologous stem-cell transplantation (ENDURANCE): a multicentre, open-label, phase 3, randomised, controlled trial. Lancet Oncol. 2020; 21(10):1317-30.Carfilzomib or bortezomib in combination with lenalidomide and dexamethasone for patients with newly diagnosed multiple myeloma without intention for immediate autologous stem-cell transplantation (ENDURANCE): a multicentre, open-label, phase 3, randomised, controlled trial - The Lancet Oncology
- Mateos MV, Dimopoulos MA, Cavo M, et al. Daratumumab plus bortezomib, melphalan, and prednisone for untreated myeloma. N Engl J Med. 2018; 378(6):518-28.Daratumumab plus Bortezomib, Melphalan, and Prednisone for Untreated Myeloma | NEJM
- Mateos MV, Cavo M, Blade J, et al. Overall survival with daratumumab, bortezomib, melphalan, and prednisone in newly diagnosed multiple myeloma (ALCYONE): a randomised, open-label, phase 3 trial. Lancet. 2020; 395(10218):132-41. Overall survival with daratumumab, bortezomib, melphalan, and prednisone in newly diagnosed multiple myeloma (ALCYONE): a randomised, open-label, phase 3 trial - The Lancet
Myelodysplastic Syndrome (MDS) Pathways:
IPSS-R: intermediate, high, very high, non-transplant candidate
|
References
IPSS-R: intermediate, high, very high, non-transplant candidate
- Fenaux P, Mufti GJ, Hellstrom-Lindberg E, et al. Efficacy of azacitidine compared with that of conventional care regimens in the treatment of higher-risk myelodysplastic syndromes: a randomised, open-label, phase III study. Lancet Oncol. 2009 Mar; 10(3):223-32.Efficacy of azacitidine compared with that of conventional care regimens in the treatment of higher-risk myelodysplastic syndromes: a randomised, open-label, phase III study - The Lancet Oncology
- Lübbert M, Suciu S, Baila L, et al. Low-dose decitabine versus best supportive care in elderly patients with intermediate- or high-risk myelodysplastic syndrome (MDS) ineligible for intensive chemotherapy: final results of the randomized phase III study of the European Organisation for Research and Treatment of Cancer Leukemia Group and the German MDS Study Group. J Clin Oncol. 2011 May 20; 29(15):1987-96. Low-Dose Decitabine Versus Best Supportive Care in Elderly Patients With Intermediate- or High-Risk Myelodysplastic Syndrome (MDS) Ineligible for Intensive Chemotherapy: Final Results of the Randomized Phase III Study of the European Organisation for Research and Treatment of Cancer Leukemia Group and the German MDS Study Group | Journal of Clinical Oncology (ascopubs.org)
- Garcia-Manero G, Griffiths EA, Steensma DP et al. Oral cedazuridine/decitabine for MDS and CMML: a phase 2 pharmacokinetic/pharmacodynamic randomized crossover study. Blood. 2020 Aug 6; 136(6):674-683.Oral cedazuridine/decitabine for MDS and CMML: a phase 2 pharmacokinetic/pharmacodynamic randomized crossover study | Blood | American Society of Hematology (ashpublications.org)
Neuroendocrine Cancer Pathways:
Poorly-differentiated, Large or Small Cell (Extrapulmonary)
|
References
Well-differentiated Grade ½, GI tract, Lung, and Thymus
- Rinke A, Müller HH, Schade-Brittinger C, et al. Placebo-controlled, double-blind, prospective, randomized study on the effect of octreotide LAR in the control of tumor growth in patients with metastatic neuroendocrine midgut tumors: a report from the PROMID Study Group. J Clin Oncol. 2009 Oct 1; 27(28):4656-63.Placebo-Controlled, Double-Blind, Prospective, Randomized Study on the Effect of Octreotide LAR in the Control of Tumor Growth in Patients With Metastatic Neuroendocrine Midgut Tumors: A Report From the PROMID Study Group | Journal of Clinical Oncology (ascopubs.org)
- Caplin ME, Pavel M, Cwikla JB, et al. Lanreotide in Metastatic Enteropancreatic Neuroendocrine Tumors. N Engl J Med. 2014; 371:224-33.Lanreotide in Metastatic Enteropancreatic Neuroendocrine Tumors | NEJM
- Pavel ME, Baudin E, Öberg KE, et al. Efficacy of everolimus plus octreotide LAR in patients with advanced neuroendocrine tumor and carcinoid syndrome: final overall survival from the randomized, placebo-controlled phase 3 RADIANT-2 study. Ann Oncol. 2017 Jul 1; 28(7):1569-1575. Efficacy of everolimus plus octreotide LAR in patients with advanced neuroendocrine tumor and carcinoid syndrome: final overall survival from the randomized, placebo-controlled phase 3 RADIANT-2 study - Annals of Oncology
- O'Toole D, Ducreux M, Bommelaer G. et al. Treatment of carcinoid syndrome: a prospective crossover evaluation of lanreotide versus octreotide in terms of efficacy, patient acceptability, and tolerance. Cancer. 2000 Feb 15;88(4):770-6. Treatment of carcinoid syndrome - O'Toole - 2000 - Cancer - Wiley Online Library
Poorly-differentiated, Large or Small Cell (Extrapulmonary)
- Iwasa S, Morizane C, Okusaka T, et al. Cisplatin and etoposide as first-line chemotherapy for poorly differentiated neuroendocrine carcinoma of the hepatobiliary tract and pancreas. Jpn J Clin Oncol. 2010 Apr; 40(4):313-8.Cisplatin and Etoposide as First-line Chemotherapy for Poorly Differentiated Neuroendocrine Carcinoma of the Hepatobiliary Tract and Pancreas | Japanese Journal of Clinical Oncology | Oxford Academic (oup.com)
- Frizziero M, Spada F, Lamarca A, et al. Carboplatin in Combination with Oral or Intravenous Etoposide for Extra-Pulmonary, Poorly-Differentiated Neuroendocrine Carcinomas. Neuroendocrinology. 2019; 109(2):100-112.Carboplatin in Combination with Oral or Intravenous Etoposide for Extra-Pulmonary, Poorly-Differentiated Neuroendocrine Carcinomas - Abstract - Neuroendocrinology 2019, Vol. 109, No. 2 - Karger Publishers
- Hanna N et al. Randomized phase III trial comparing irinotecan/cisplatin with etoposide/cisplatin in patients with previously untreated extensive-stage disease small-cell lung cancer. J Clin Oncol. 2006; 24:2038-43.Randomized Phase III Trial Comparing Irinotecan/Cisplatin With Etoposide/Cisplatin in Patients With Previously Untreated Extensive-Stage Disease Small-Cell Lung Cancer | Journal of Clinical Oncology (ascopubs.org)
- Schmittel A et al. A German multicenter, randomized phase III trial comparing irinotecan–carboplatin with etoposide–carboplatin as first-line therapy for extensive-disease small-cell lung cancer. Ann Oncol. 2011; 22:1798-1804.A German multicenter, randomized phase III trial comparing irinotecan–carboplatin with etoposide–carboplatin as first-line therapy for extensive-disease small-cell lung cancer - Annals of Oncology
- Hadoux J, Malka D, Planchard D, et al. Post-first-line FOLFOX chemotherapy for grade 3 neuroendocrine carcinoma. Endocr Relat Cancer. 2015 Jun; 22(3):289-98.Post-first-line FOLFOX chemotherapy for grade 3 neuroendocrine carcinoma in: Endocrine-Related Cancer Volume 22 Issue 3 (2015) (bioscientifica.com)
- Hentic O, Hammel P, Couvelard A, et al. FOLFIRI regimen: an effective second-line chemotherapy after failure of etoposide-platinum combination in patients with neuroendocrine carcinomas grade 3. Endocr Relat Cancer. 2012 Nov 6; 19(6):751-7.FOLFIRI regimen: an effective second-line chemotherapy after failure of etoposide–platinum combination in patients with neuroendocrine carcinomas grade 3 in: Endocrine-Related Cancer Volume 19 Issue 6 (2012) (bioscientifica.com)
- Zhu J, Strosberg JR, Dropkin E, et al. Treatment of High-Grade Metastatic Pancreatic Neuroendocrine Carcinoma with FOLFIRINOX. J Gastrointest Cancer. 2015 Jun; 46(2):166-9.Treatment of High-Grade Metastatic Pancreatic Neuroendocrine Carcinoma with FOLFIRINOX | SpringerLink
- Rogowski W, Wachula E, Gorzelak A, et al. Capecitabine and temozolomide combination for treatment of high-grade, well-differentiated neuroendocrine tumour and poorly-differentiated neuroendocrine carcinoma - retrospective analysis. Endokrynol Pol. 2019; 70(4):313-317.Capecitabine and temozolomide combination for treatment of high-grade, well-differentiated neuroendocrine tumour and poorly-differentiated neuroendocrine carcinoma — retrospective analysis | Rogowski | Endokrynologia Polska (viamedica.pl)
- Klein O, Kee D, Markman B, et al. Immunotherapy of Ipilimumab and Nivolumab in Patients with Advanced Neuroendocrine Tumors: A Subgroup Analysis of the CA209-538 Clinical Trial for Rare Cancers. Clin Cancer Res. 2020 Sep 1; 26(17):4454-4459. Immunotherapy of Ipilimumab and Nivolumab in Patients with Advanced Neuroendocrine Tumors: A Subgroup Analysis of the CA209-538 Clinical Trial for Rare Cancers | Clinical Cancer Research | American Association for Cancer Research (aacrjournals.org)
- Marabelle A, Fakih M, Lopez J, et al. Association of tumour mutational burden with outcomes in patients with advanced solid tumours treated with pembrolizumab: prospective biomarker analysis of the multicohort, open-label, phase 2 KEYNOTE-158 study. Lancet Oncol. 2020 Oct; 21(10):1353-1365.Association of tumour mutational burden with outcomes in patients with advanced solid tumours treated with pembrolizumab: prospective biomarker analysis of the multicohort, open-label, phase 2 KEYNOTE-158 study - The Lancet Oncology
Ovarian Cancer Pathways:
Primary therapy: Stage II-IV
|
Recurrent disease, platinum sensitive
|
References
Primary therapy: Stage II-IV
- du Bois A, Luck HJ, Meier W, et al. A randomized clinical trial of cisplatin/paclitaxel versus carboplatin/paclitaxel as first-line treatment of ovarian cancer. J Natl Cancer Inst 2003; 95:1320 –30.Randomized Clinical Trial of Cisplatin/Paclitaxel Versus Carboplatin/Paclitaxel as First-Line Treatment of Ovarian Cancer | JNCI: Journal of the National Cancer Institute | Oxford Academic (oup.com)
- Bookman MA, Brady MF, McGuire WP, et al. Evaluation of new platinum-based treatment regimens in advanced-stage ovarian cancer: a phase III Trial of the Gynecologic Cancer Intergroup. J Clin Oncol. 2009; 27(9):1419-25.Evaluation of New Platinum-Based Treatment Regimens in Advanced-Stage Ovarian Cancer: A Phase III Trial of the Gynecologic Cancer InterGroup | Journal of Clinical Oncology (ascopubs.org)
- Perren T, Swart AM, Pfisterer J, et al. A Phase 3 Trial of Bevacizumab in Ovarian Cancer. N Eng J Med. 2011; 365:2484-96. A Phase 3 Trial of Bevacizumab in Ovarian Cancer | NEJM
- Oza AM, Cook AD, Pfisterer J, et al. Standard chemotherapy with or without bevacizumab for women with newly diagnosed ovarian cancer (ICON7): overall survival results of a phase 3 randomised trial. Lancet Oncol. 2015 Aug; 16(8):928-36. Standard chemotherapy with or without bevacizumab for women with newly diagnosed ovarian cancer (ICON7): overall survival results of a phase 3 randomised trial - The Lancet Oncology
- Burger RA, Brady MF, Bookman MA, et al. Incorporation of Bevacizumab in the Primary Treatment of Ovarian Cancer. N Eng J Med. 2011; 365:2473-83.Incorporation of Bevacizumab in the Primary Treatment of Ovarian Cancer (nejm.org)
- Tewari KS, Burger RA, Enserro D, et al. Final Overall Survival of a Randomized Trial of Bevacizumab for Primary Treatment of Ovarian Cancer. J Clin Oncol. 2019 Sep 10; 37(26):2317-28. Final Overall Survival of a Randomized Trial of Bevacizumab for Primary Treatment of Ovarian Cancer | Journal of Clinical Oncology (ascopubs.org)
Recurrent disease, platinum sensitive
- Pfisterer J, Plante M, Vergote I, et al. Gemcitabine plus carboplatin compared with carboplatin in patients with platinum-sensitive recurrent ovarian cancer: an intergroup trial of the AGO-OVAR, the NCIC CTG, and the EORTC GCG. J Clin Oncol. 2006; 24(29):4699-707.Gemcitabine Plus Carboplatin Compared With Carboplatin in Patients With Platinum-Sensitive Recurrent Ovarian Cancer: An Intergroup Trial of the AGO-OVAR, the NCIC CTG, and the EORTC GCG | Journal of Clinical Oncology (ascopubs.org)
- Aghajanian C, Blank SV, Goff BA, et al. OCEANS: a randomized, double-blind, placebo-controlled phase III trial of chemotherapy with or without bevacizumab in patients with platinum-sensitive recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer. J Clin Oncol. 2012; 30(17):2039-45.OCEANS: A Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Chemotherapy With or Without Bevacizumab in Patients With Platinum-Sensitive Recurrent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer | Journal of Clinical Oncology (ascopubs.org)
- Aghajanian C, Goff B, Nycum LR, et al. Final overall survival and safety analysis of OCEANS, a phase 3 trial of chemotherapy with or without bevacizumab in patients with platinum-sensitive recurrent ovarian cancer. Gynecol Oncol. 2015; 139(1):10-6.Final overall survival and safety analysis of OCEANS, a phase 3 trial of chemotherapy with or without bevacizumab in patients with platinum-sensitive recurrent ovarian cancer - Gynecologic Oncology (gynecologiconcology-online.net)
- Wagner U, Marth C, Largillier R, et al. Final overall survival results of phase III GCIG CALYPSO trial of pegylated liposomal doxorubicin and carboplatin vs paclitaxel and carboplatin in platinum-sensitive ovarian cancer patients. British Journal of Cancer. 2012; 107(4):588-91.Final overall survival results of phase III GCIG CALYPSO trial of pegylated liposomal doxorubicin and carboplatin vs paclitaxel and carboplatin in platinum-sensitive ovarian cancer patients | British Journal of Cancer (nature.com)
- Coleman RL, Brady MF, Herzog TJ, et al. Bevacizumab and paclitaxel-carboplatin chemotherapy and secondary cytoreduction in recurrent, platinum-sensitive ovarian cancer (NRG Oncology/Gynecologic Oncology Group study GOG-0213): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2017 Jun; 18(6):779-791.Bevacizumab and paclitaxel–carboplatin chemotherapy and secondary cytoreduction in recurrent, platinum-sensitive ovarian cancer (NRG Oncology/Gynecologic Oncology Group study GOG-0213): a multicentre, open-label, randomised, phase 3 trial - The Lancet Oncology
- Pfisterer J, Shannon CM, Baumann K, et al. Bevacizumab and platinum-based combinations for recurrent ovarian cancer: a randomised, open-label, phase 3 trial. Lancet Oncol. 2020; 21(5):699-709.Bevacizumab and platinum-based combinations for recurrent ovarian cancer: a randomised, open-label, phase 3 trial - The Lancet Oncology
Pancreatic Cancer Pathways:
Neoadjuvant: Adenocarcinoma
|
||
Advanced/Metastatic: First line, adenocarcinoma
|
References
Neoadjuvant: Adenocarcinoma
- Katz MH, Shi Q, Ahmad SA, Herman JM, et al. Preoperative Modified FOLFIRINOX Treatment Followed by Capecitabine-Based Chemoradiation for Borderline Resectable Pancreatic Cancer: Alliance for Clinical Trials in Oncology Trial A021101. JAMA Surg. 2016 Aug 17; 151(8):e161137.Preoperative Modified FOLFIRINOX Treatment Followed by Capecitabine-Based Chemoradiation for Borderline Resectable Pancreatic Cancer: Alliance for Clinical Trials in Oncology Trial A021101 | Endocrine Surgery | JAMA Surgery | JAMA Network
- Murphy JE, Wo JY, Ryan DP, et al. Total Neoadjuvant Therapy With FOLFIRINOX Followed by Individualized Chemoradiotherapy for Borderline Resectable Pancreatic Adenocarcinoma: A Phase 2 Clinical Trial. JAMA Oncol.2018; 4(7):963–969.Total Neoadjuvant Therapy With FOLFIRINOX Followed by Individualized Chemoradiotherapy for Borderline Resectable Pancreatic Adenocarcinoma: A Phase 2 Clinical Trial | Gastroenterology | JAMA Oncology | JAMA Network
- O'Reilly EM, Lee JW, Zalupski M, et al. Randomized, multicenter, phase II trial of gemcitabine and cisplatin with or without veliparib in patients with pancreas adenocarcinoma and a germline BRCA/PALB2 mutation. J Clin Oncol 2020; 38:1378-88.Randomized, Multicenter, Phase II Trial of Gemcitabine and Cisplatin With or Without Veliparib in Patients With Pancreas Adenocarcinoma and a Germline BRCA/PALB2 Mutation | Journal of Clinical Oncology (ascopubs.org)
- Sohal DPS, Duong M, Ahmad SA, et al. Efficacy of Perioperative Chemotherapy for Resectable Pancreatic Adenocarcinoma: A Phase 2 Randomized Clinical Trial. JAMA Oncol. 2021; 7(3):421–427.Efficacy of Perioperative Chemotherapy for Resectable Pancreatic Adenocarcinoma: A Phase 2 Randomized Clinical Trial | Clinical Pharmacy and Pharmacology | JAMA Oncology | JAMA Network
Prostate Cancer Pathways:
Metastatic: Adenocarcinoma, Castration Resistant
|
Testicular Cancer Pathways:
First Line: Good Risk
|
First Line: Intermediate/Poor Risk
|
References
First Line: Good Risk
- Saxman SB, Finch D, Gonin R, et al. Long-term follow-up of a phase III study of three versus four cycles of bleomycin, etoposide, and cisplatin in favorable-prognosis germ-cell tumors: the Indian University experience. J Clin Oncol. 1998;16(2):702-6.Long-term follow-up of a phase III study of three versus four cycles of bleomycin, etoposide, and cisplatin in favorable-prognosis germ-cell tumors: the Indian University experience. | Journal of Clinical Oncology (ascopubs.org)
- Culine S, Kerbrat P, Kramar A, et al. Refining the optimal chemotherapy regimen for good-risk metastatic nonseminomatous germ-cell tumors: a randomized trial of the Genito-Urinary Group of the French Federation of Cancer Centers (GETUG T93BP). Ann Oncol. 2007 May; 18(5):917-24. Refining the optimal chemotherapy regimen for good-risk metastatic nonseminomatous germ-cell tumors: a randomized trial of the Genito-Urinary Group of the French Federation of Cancer Centers (GETUG T93BP) - Annals of Oncology
First Line: Intermediate/Poor Risk
- de Wit R, Stoter G, Sleijfer DT, et al. Four cycles of BEP vs four cycles of VIP in patients with intermediate-prognosis metastatic testicular non-seminoma: a randomized study of the EORTC Genitourinary Tract Cancer Cooperative Group. European Organization for Research and Treatment of Cancer. Br J Cancer. 1998 Sep; 78(6):828-32. Four cycles of BEP vs four cycles of VIP in patients with intermediate-prognosis metastatic testicular non-seminoma: a randomized study of the EORTC Genitourinary Tract Cancer Cooperative Group | British Journal of Cancer (nature.com)
- Culine S, Kramar A, Théodore C, et al. Randomized trial comparing bleomycin/etoposide/cisplatin with alternating cisplatin/cyclophosphamide/doxorubicin and vinblastine/bleomycin regimens of chemotherapy for patients with intermediate- and poor-risk metastatic nonseminomatous germ cell tumors: Genito-Urinary Group of the French Federation of Cancer Centers Trial T93MP. J Clin Oncol. 2008 Jan 20; 26(3):421-7.Randomized Trial Comparing Bleomycin/Etoposide/Cisplatin With Alternating Cisplatin/Cyclophosphamide/Doxorubicin and Vinblastine/Bleomycin Regimens of Chemotherapy for Patients With Intermediate- and Poor-Risk Metastatic Nonseminomatous Germ Cell Tumors: Genito-Urinary Group of the French Federation of Cancer Centers Trial T93MP | Journal of Clinical Oncology (ascopubs.org)
- Nichols CR, Catalano PJ, Crawford ED, et al. Randomized comparison of cisplatin and etoposide and either bleomycin or ifosfamide in treatment of advanced disseminated germ cell tumors: an Eastern Cooperative Oncology Group, Southwest Oncology Group, and Cancer and Leukemia Group B Study. J Clin Oncol. 1998 Apr; 16(4):1287-93.Randomized comparison of cisplatin and etoposide and either bleomycin or ifosfamide in treatment of advanced disseminated germ cell tumors: an Eastern Cooperative Oncology Group, Southwest Oncology Group, and Cancer and Leukemia Group B Study. | Journal of Clinical Oncology (ascopubs.org)