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      Pembrolizumab as Second-Line Therapy for Advanced Urothelial Carcinoma.

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          Abstract

          Patients with advanced urothelial carcinoma that progresses after platinum-based chemotherapy have a poor prognosis and limited treatment options.

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          Most cited references9

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          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.

          Luciano José María De Santis, Joaquim Bellmunt, Graham Mead … (2012)
          This is the first randomized phase II/III trial comparing two carboplatin-based chemotherapy regimens in patients with urothelial cancer who are ineligible ("unfit") for cisplatin chemotherapy.
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            Safety and activity of pembrolizumab in patients with locally advanced or metastatic urothelial cancer (KEYNOTE-012): a non-randomised, open-label, phase 1b study.

            Elizabeth R Plimack, Joaquim Bellmunt, Shilpa Gupta … (2017)
            PD-1 and its ligands are expressed in urothelial cancer, and findings have shown that inhibition of the PD-1 pathway has clinical benefit. We aimed to assess the safety and activity of an anti-PD-1 antibody pembrolizumab in patients with locally advanced or metastatic urothelial cancer.
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              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 platinum-based chemotherapy.

              J Bellmunt, R Fougeray, J.E. Rosenberg … (2013)
              To compare long-term, updated overall survival (OS) of patients with advanced transitional cell carcinoma of the urothelium (TCCU) treated with vinflunine plus best supportive care (BSC) or BSC alone, after failure of platinum-based chemotherapy. Three hundred and seventy patients were randomly assigned in a phase III trial and allocated (2:1) to vinflunine (320 or 280 mg/m(2)) plus BSC or BSC alone. The first report (Bellmunt J, Theodore C, Demkov T et al. Phase III trial of vinflunine plus best supportive care compared with best supportive care alone after a platinumcontaining regimen in patients with advanced transitional cell carcinoma of the urothelial tract. J Clin Oncol 2009; 27(27): 4454-4461) had a median follow-up of 22.1 m and the current report has a follow-up of 45.4 m. Three hundred and fifty-two patients had died (censoring rate 5%). In the intention-to-treat (ITT) population, the median OS was 6.9 m and 4.6 m for vinflunine plus BSC versus BSC alone, respectively (n.s.). In multivariate Cox analysis, the addition of vinflunine was independently correlated with improved survival (HR: 0.719; 95% CI:0.570-0.906, P = 0.0052). In the eligible population, the median OS in both the arms was 6.9 and 4.3 m, respectively (HR: 0.78; 95% CI:0.61-0.96; P = 0.0227), indicating an estimated 22% reduction in the risk of death. The updated OS data confirm the positive treatment effect of vinflunine on survival that was previously reported. These results are consistent over time and confirm that vinflunine is a valuable option for second-line treatment in patients with advanced TCCU after failure of platinum-based regimens.
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                Author and article information

                Journal
                Journal ID (iso-abbrev): N. Engl. J. Med.
                Title: The New England journal of medicine
                Publisher: New England Journal of Medicine (NEJM/MMS)
                ISSN (Electronic): 1533-4406
                ISSN (Print): 0028-4793
                Publication date (Electronic): March 16 2017
                Volume: 376
                Issue: 11
                Affiliations
                [1 ] From Dana-Farber Cancer Institute, Boston (J.B., T.K.C.); Parc de Salut Mar, Hospital del Mar Medical Research Institute, Barcelona (J.B.), and Fundación Instituto Valenciano de Oncología, Valencia (M.A.C.) - both in Spain; Erasmus MC Cancer Institute, Rotterdam (R.W.), and Radboud University Medical Center, Nijmegen (W.G.) - both in the Netherlands; Abramson Cancer Center, University of Pennsylvania, Philadelphia (D.J.V.); Centre Hospitalier Universitaire de Québec-Université Laval, Quebec, QC, Canada (Y.F.); Asan Medical Center and University of Ulsan College of Medicine, Seoul, South Korea (J.-L.L.); the University of California, San Francisco, San Francisco (L.F.); Comprehensive Cancer Centers of Nevada, Las Vegas (N.J.V.); Smilow Cancer Hospital, Yale University, New Haven, CT (D.P.P.); Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (A.N.); Westmead Hospital and Macquarie University, Sydney (H.G.); the University of Southern California Norris Comprehensive Cancer Center and Hospital, Los Angeles (D.I.Q.); Hôpital Saint-Louis, Paris (S.C.); San Camillo and Forlanini Hospitals, Rome (C.N.S.); Merck, Kenilworth, NJ (Y.M., C.H.P., R.F.P.); and Memorial Sloan Kettering Cancer Center, New York (D.F.B.).
                Article
                DOI: 10.1056/NEJMoa1613683
                PubMed ID: 28212060
                SO-VID: 448dc8a4-6081-4e21-ae12-ec3be68a52fb
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