Pembrolizumab as second-line therapy for advanced urothelial carcinoma

New England Journal of Medicine

Volumn 376, Issue 11, 2017, Pages 1015-1026

  Bellmunt, J ^a,b   De Wit, R ^d   Vaughn, D J ^f   Fradet, Y ^g   Lee, J L ^h   Fong, L ⁱ   Vogelzang, N J ^j   Climent, M A ^c   Petrylak, D P ^k   Choueiri, T K ^a   Necchi, A ^l   Gerritsen, W ^e   Gurney, H ^m   Quinn, D I ⁿ   Culine, S ^o   Sternberg, C N ^p   Mai, Y ^q   Poehlein, C H ^q   Perini, R F ^q   Bajorin, D F ^r  

^a DANA FARBER CANCER INSTITUTE   (United States)

^b HOSPITAL DEL MAR   (Spain)

^c INSTITUTO VALENCIANO DE ONCOLOGÍA   (Spain)

^d ERASMUS MC CANCER INSTITUTE   (Netherlands)

^e RADBOUD UNIVERSITY MEDICAL CENTER   (Netherlands)

^f UNIVERSITY OF PENNSYLVANIA   (United States)

^g LAVAL UNIVERSITY   (Canada)

^h University of Ulsan College of Medicine   (South Korea)

ⁱ UNIVERSITY OF CALIFORNIA   (United States)

^j Department of Hematology Oncology   (United States)

^k YALE UNIVERSITY   (United States)

^l NATIONAL CANCER INSTITUTE   (Italy)

^m MACQUARIE UNIVERSITY   (Australia)

ⁿ UNIVERSITY OF SOUTHERN CALIFORNIA   (United States)

^o SAINT LOUIS HOSPITAL   (France)

^p SAN CAMILLO FORLANINI HOSPITAL   (Italy)

^q MERCK RESEARCH LABORATORIES   (United States)

^r MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

CARBOPLATIN; CISPLATIN; DOCETAXEL; PACLITAXEL; PEMBROLIZUMAB; PROGRAMMED DEATH 1 LIGAND 1; VINFLUNINE; ANTINEOPLASTIC AGENT; MONOCLONAL ANTIBODY; PDCD1 PROTEIN, HUMAN; PLATINUM DERIVATIVE; PROGRAMMED DEATH 1 RECEPTOR; TAXOID; VINBLASTINE;

ADULT; ADVANCED CANCER; AGED; ARTICLE; CANCER GROWTH; CANCER PROGNOSIS; CANCER RECURRENCE; CANCER SURVIVAL; DRUG EFFICACY; DRUG FATALITY; DRUG RESPONSE; DRUG WITHDRAWAL; FEMALE; HAZARD RATIO; HUMAN; INTENTION TO TREAT ANALYSIS; LIVER METASTASIS; MAJOR CLINICAL STUDY; MALE; OVERALL SURVIVAL; PHASE 3 CLINICAL TRIAL; PROGRESSION FREE SURVIVAL; PROTEIN EXPRESSION; SURVIVAL TIME; TRANSITIONAL CELL CARCINOMA; VERY ELDERLY; ANALOGS AND DERIVATIVES; ANTAGONISTS AND INHIBITORS; CLINICAL TRIAL; CONTROLLED STUDY; IMMUNOLOGY; MIDDLE AGED; MULTICENTER STUDY; PATHOLOGY; RANDOMIZED CONTROLLED TRIAL; SURVIVAL ANALYSIS; TUMOR RECURRENCE; UROLOGIC NEOPLASMS; UROTHELIUM;

ADULT; AGED; AGED, 80 AND OVER; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTINEOPLASTIC AGENTS; FEMALE; HUMANS; MALE; MIDDLE AGED; NEOPLASM RECURRENCE, LOCAL; PACLITAXEL; PLATINUM COMPOUNDS; PROGRAMMED CELL DEATH 1 RECEPTOR; SURVIVAL ANALYSIS; TAXOIDS; UROLOGIC NEOPLASMS; UROTHELIUM; VINBLASTINE;

EID: 85015755043     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMoa1613683     Document Type: Article

References (24)

1. Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin 2015; 65: 87-108.
2. De Santis M, Bellmunt J, Mead G, 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: 191-9.
3. Seront E, Machiels JP. Molecular biology and targeted therapies for urothelial carcinoma. Cancer Treat Rev 2015; 41: 341-53.
4. Oing C, Rink M, Oechsle K, Seidel C, von Amsberg G, Bokemeyer C. Second line chemotherapy for advanced and metastatic urothelial carcinoma: vinflunine and beyond-A comprehensive review of the current literature. J Urol 2016; 195: 254-63.
5. Raggi D, Miceli R, Sonpavde G, et al. Second-line single-Agent versus doublet chemotherapy as salvage therapy for metastatic urothelial cancer: a systematic review and meta-Analysis. Ann Oncol 2016; 27: 49-61.
6. Bellmunt J, Théodore C, Demkov T, et al. Phase III trial of vinflunine plus best supportive care compared with best supportive care alone after a platinum-containing regimen in patients with advanced transitional cell carcinoma of the urothelial tract. J Clin Oncol 2009; 27: 4454-61.
7. Bellmunt J, Fougeray R, Rosenberg JE, et al. Long-term survival results of a randomized phase III trial of vinflunine plus best supportive care versus best supportive care alone in advanced urothelial carcinoma patients after failure of platinumbased chemotherapy. Ann Oncol 2013; 24: 1466-72.
8. Zhang T, Xie J, Arai S, et al. The efficacy and safety of anti-PD-1/PD-L1 antibodies for treatment of advanced or refractory cancers: a meta-Analysis. Oncotarget 2016; 7: 73068-79.
9. Plimack ER, Bellmunt J, Gupta S, et al. Safety and activity of pembrolizumab in patients with locally advanced or metastatic urothelial cancer (KEYNOTE-012): a non-randomised, open-label, phase 1b study. Lancet Oncol 2017 January 9 (Epub ahead of print).
10. Rosenberg JE, Hoffman-Censits J, Powles T, et al. Atezolizumab in patients with locally advanced and metastatic urothelial carcinoma who have progressed following treatment with platinum-based chemotherapy: a single-Arm, multicentre, phase 2 trial. Lancet 2016; 387: 1909-20.
11. Sharma P, Callahan MK, Bono P, et al. Nivolumab monotherapy in recurrent metastatic urothelial carcinoma (CheckMate 032): a multicentre, open-label, two-stage, multi-Arm, phase 1/2 trial. Lancet Oncol 2016; 17: 1590-8.
12. Balar AV, Bellmunt J, O'Donnell PH, et al. First-line pembrolizumab in cisplatin-ineligible unresectable or metastatic urothelial cancer: interim results for KEYNOTE-052. Ann Oncol 2016; 27: Suppl 6. abstract.
13. Massard C, Gordon MS, Sharma S, et al. Safety and efficacy of durvalumab (MEDI4736), an anti-programmed cell death ligand-1 immune checkpoint inhibitor, in patients with advanced urothelial bladder cancer. J Clin Oncol 2016; 34: 3119-25.
14. Apolo AB, Infante JR, Hamid O, et al. Avelumab (MSB0010718C; anti-PD-L1) in patients with metastatic urothelial carcinoma from the JAVELIN solid tumor phase 1b trial: analysis of safety, clinical activity, and PD-L1 expression. J Clin Oncol 2016; 34: Suppl. abstract.
15. Eisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer 2009; 45: 228-47.
16. Bellmunt J, Choueiri TK, Fougeray R, et al. Prognostic factors in patients with advanced transitional cell carcinoma of the urothelial tract experiencing treatment failure with platinum-containing regimens. J Clin Oncol 2010; 28: 1850-5.
17. Sonpavde G, Pond GR, Fougeray R, et al. Time from prior chemotherapy enhances prognostic risk grouping in the second-line setting of advanced urothelial carcinoma: a retrospective analysis of pooled, prospective phase 2 trials. Eur Urol 2013; 63: 717-23.
18. Yang Y, Pang Z, Ding N, et al. The efficacy and potential predictive factors of PD-1/PD-L1 blockades in epithelial carcinoma patients: a systematic review and meta analysis. Oncotarget 2016; 7: 74350-61.
19. Jamieson NB, Maker AV. Gene-expression profiling to predict responsiveness to immunotherapy. Cancer Gene Ther 2016 November 11 (Epub ahead of print).
20. Motzer RJ, Escudier B, McDermott DF, et al. Nivolumab versus everolimus in advanced renal-cell carcinoma. N Engl J Med 2015; 373: 1803-13.
21. Borghaei H, Paz-Ares L, Horn L, et al. Nivolumab versus docetaxel in advanced nonsquamous non-small-cell lung cancer. N Engl J Med 2015; 373: 1627-39.
22. Herbst RS, Baas P, Kim DW, et al. Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced nonsmall-cell lung cancer (KEYNOTE-010): a randomised controlled trial. Lancet 2016; 387: 1540-50.
23. Barlesi F, Park K, Ciardiello F, et al. Primary analysis from OAK, a randomized phase III study comparing atezolizumab with docetaxel in 2L/3L NSCLC. Ann Oncol 2016; 27: Suppl 6. abstract.
24. Ferris RL, Blumenschein G Jr, Fayette J, et al. Nivolumab for recurrent squamouscell carcinoma of the head and neck. N Engl J Med 2016; 375: 1856-67.