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J Clin Oncol. 2018 Jun 1;36(16):1579-1587. doi: 10.1200/JCO.2017.76.9562. Epub 2018 Mar 28.

Health-Related Quality-of-Life Analysis From KEYNOTE-045: A Phase III Study of Pembrolizumab Versus Chemotherapy for Previously Treated Advanced Urothelial Cancer.

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David J. Vaughn, Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA; Joaquim Bellmunt and Toni K. Choueiri, Dana-Farber Cancer Institute, Boston, MA; Yves Fradet, CHU de Québec-Université Laval, Quebec City, Quebec, Canada; Jae Lyun Lee, Asan Medical Center and University of Ulsan College of Medicine, Seoul, Republic of Korea; Lawrence Fong, University of California, San Francisco, San Francisco; David I. Quinn, University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA; Nicholas J. Vogelzang, Comprehensive Cancer Centers of Nevada, Las Vegas, NV; Miguel A. Climent, Fundación Instituto Valenciano de Oncología, Valencia, Spain; Daniel P. Petrylak, Smilow Cancer Hospital, Yale University, New Haven, CT; Andrea Necchi, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Istituto Nazionale dei Tumori, Milan; Cora N. Sternberg, San Camillo and Forlanini Hospitals, Rome, Italy; Winald Gerritsen, Radboud University Medical Center, Nijmegen; Ronald de Wit, Erasmus University Medical Center Cancer Institute, Rotterdam, the Netherlands; Howard Gurney, Westmead Hospital and Macquarie University, Sydney, New South Wales, Australia; Stephane Culine, Hôpital Saint-Louis, Paris, France; Yabing Mai, Haojie Li, and Rodolfo F. Perini, Merk & Co., Inc., Kenilworth, NJ; and Dean F. Bajorin, Memorial Sloan Kettering Cancer Center, New York, NY.


Purpose In the phase III KEYNOTE-045 study ( identifier: NCT02256436), pembrolizumab significantly prolonged overall survival compared with investigator's choice of chemotherapy in patients with previously treated advanced urothelial cancer. Here, we report the results of health-related quality-of-life (HRQoL) analyses from the KEYNOTE-045 trial. Patients and Methods Patients were randomly assigned 1:1 to pembrolizumab 200 mg or investigator's choice of docetaxel 75 mg/m2, paclitaxel 175 mg/m2, or vinflunine 320 mg/m2 administered intravenously every 3 weeks. Key prespecified HRQoL analyses were time to deterioration (TTD) and mean change from baseline to week 15 in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 global health status/quality-of-life score. Results Of 542 patients who were randomly assigned, 519 were included in HRQoL analyses (pembrolizumab, n = 266; chemotherapy, n = 253). HRQoL compliance was > 95% at baseline and approximately 88% at week 15 for both groups. Pembrolizumab prolonged TTD in global health status/quality-of-life score compared with chemotherapy (median, 3.5 months v 2.3 months; hazard ratio, 0.72; nominal one-sided P = .004). Mean (95% CI) change from baseline to week 15 in global health status/quality-of-life score was 0.69 (-2.40 to 3.77) with pembrolizumab and -8.36 (-11.84 to -4.89) with chemotherapy (mean difference, 9.05 points; 95% CI, 4.61 to 13.50; nominal two-sided P < .001). Conclusion Pembrolizumab prolonged TTD in HRQoL compared with chemotherapy. Patients who were treated with pembrolizumab had stable or improved global health status/quality of life, whereas those who were treated with investigator's choice of chemotherapy experienced declines in global health status/quality of life. Combined with efficacy and safety outcomes, these data support pembrolizumab as standard of care for patients with platinum-refractory advanced urothelial cancer.

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