Health-related quality of life (HRQoL) of pembrolizumab (pembro) vs chemotherapy (chemo) for previously treated advanced urothelial cancer (UC) in KEYNOTE-045 - Abstract
Methods:
The EORTC QLQ-C30 HRQoL instrument was administered electronically at cycles 1–4, then every 2 cycles for up to 1 y and 30 d after discontinuation. The key HRQoL end points were 1) change from baseline to wk 15 and 2) time to deterioration (TTD) (defined as ≥10-point decrease from baseline) in the QLQ-C30 global health status/QoL score. HRQoL was assessed in patients (pts) who received ≥1 dose of assigned study treatment and completed ≥1 HRQoL instrument (N = 520). Score change from baseline was compared using a constrained longitudinal data analysis model. TTD was compared using a stratified log-rank test and Cox proportional hazards model.
Results:
Baseline global health status/QoL scores were similar between arms. HRQoL compliance at wk 15 was 88% for both arms. From baseline to wk 15, scores were stable for pembro (n = 266) (least squares [LS] mean +0.75 [95% CI –2.34 to +3.83]) but worsened for chemo (n = 254) (LS mean –8.30 [95% CI –11.76 to –4.83]); the difference in LS means between arms was 9.05 (95% CI 4.61-13.48; nominal 2-sided P< 0.001). At wk 15, pts without PD had improved scores with pembro but worsened scores with chemo (LS mean +5.97 vs –4.31), while pts with PD had less worsening with pembro (LS mean –3.54 vs –13.95). TTD was prolonged with pembro (HR 0.70; 95% CI 0.55-0.90; nominal 1-sided P = 0.002; median 3.5 mo vs 2.2 mo). Rates of improvement (defined as ≥10-point increase from baseline) at wk 15 were 31.2% with pembro and 22.0% with chemo; rates of deterioration were 28.9% and 40.6%, respectively.
Conclusions:
Pembro was associated with substantially better HRQoL for a longer duration than investigator-choice chemo in pts with previously treated advanced UC. Along with superior OS, these data support pembro as a new standard-of-care in this population.
Author(s): Ronald De Wit, Dean F. Bajorin, Joaquim Bellmunt, Yves Fradet, Jae-Lyun Lee, Lawrence Fong, Nicholas J. Vogelzang, Miguel Ángel Climent, Daniel Peter Petrylak, Toni K. Choueiri, Andrea Necchi, Winald R. Gerritsen, Howard Gurney, David I. Quinn, Stephane Culine, Cora N. Sternberg, Yabing Mai, Haojie Li, Rodolfo F. Perini, David J. Vaughn
Institution(s): Erasmus MC Cancer Institute, Rotterdam, Netherlands; Memorial Sloan-Kettering Cancer Center, New York, NY; Dana-Farber Cancer Institute, Boston, MA; CHU de Québec-Université Laval, Québec, QC, Canada; Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea; University of California, San Francisco, San Francisco, CA; Comprehensive Cancer Centers of Nevada, Las Vegas, NV; Fundación Instituto Valenciano de Oncología, Valencia, Spain; Smilow Cancer Hospital, New Haven, CT; Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy; Radboud University Nijmegen Medical Center, Nijmegen, Netherlands; Westmead Hospital and Macquarie University, Sydney, Australia; University of Southern California Norris Comprehensive Cancer Center and Hospital, Los Angeles, CA; Hôpital Saint-Louis - AP-HP, Paris, France; San Camillo Forlanini Hospital, Rome, Italy; Merck & Co., Inc., Kenilworth, NJ; Abramson Cancer Center, Philadelphia, PA
Clinical trial information: NCT02256436
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