BACKGROUND: In patients with renal cell carcinoma (RCC) enrolled in the phase III KEYNOTE-564 trial (NCT03142334), disease-free survival (DFS) following nephrectomy was prolonged with use of adjuvant pembrolizumab therapy versus placebo. Patient-reported outcomes (PROs) provide an important measure of health-related quality of life (HRQoL) and can complement efficacy and safety results. PATIENTS AND METHODS: In KEYNOTE-564, 994 patients were randomly assigned to receive pembrolizumab 200 mg (n = 496) or placebo (n = 498) intravenously every 3 weeks for ≤17 cycles. Patients who received ≥1 dose of treatment and completed ≥1 HRQoL assessment were included in this analysis. HRQoL end points were assessed using the EORTC QLQ-C30, FKSI-DRS, and EQ VAS. Prespecified and exploratory PRO end points were mean change from baseline in EORTC QLQ-C30 GHS/QoL score, EORTC QLQ-C30 physical function subscale score, and FKSI-DRS score. RESULTS: No clinically meaningful difference in least squares mean scores for pembrolizumab versus placebo were observed at week 52 for EORTC QLQ-C30 GHS/QoL (-2.5; 95% CI -5.2 to 0.1), EORTC QLQ-C30 physical functioning (-0.87; 95% CI -2.7 to 1.0), and FKSI-DRS (-0.7; 95% CI -1.2 to -0.1). Most PRO scores remained stable or improved for the EORTC QLQ-C30 GHS/QoL (pembrolizumab, 54.3%; placebo, 67.5%), EORTC QLQ-C30 physical functioning (pembrolizumab, 64.7%; placebo, 68.8%), and FKSI-DRS (pembrolizumab, 58.2%; placebo, 66.3%). CONCLUSIONS: Adjuvant treatment with pembrolizumab did not result in deterioration of HRQoL. These findings together with the safety and efficacy findings support adjuvant pembrolizumab treatment following nephrectomy. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT03142334.

Chemotherapy Department Wojewódzki Szpital Zespolony im L Rydygiera Torun Poland

Department of Hematology and Oncology Sungkyunkwan University Samsung Medical Center Seoul South Korea

Department of Medical Oncology Edinburgh Cancer Centre NHS Lothian Institute of Genetics and Cancer University of Edinburgh Edinburgh UK

Department of Medical Oncology Fakultní Nemocnice Ostrava Ostrava Czech Republic

Department of Medical Oncology Fiona Stanley Hospital Perth Western Australia Australia

Department of Medical Oncology Lank Center for Genitourinary Oncology at Dana Farber Cancer Institute Brigham and Women's Hospital and Harvard Medical School Boston MA USA

Department of Medical Oncology Poznan University of Medical Sciences Poznan Poland

Department of Medical Oncology The Beatson West of Scotland Cancer Centre and University of Glasgow Glasgow UK

Department of Medical Oncology University Hospital Bordeaux Hôpital Saint André Bordeaux France

Department of Medical Oncology University Hospital Jean Minjoz Besançon France

Department of Oncology Asan Medical Center and University of Ulsan College of Medicine Seoul South Korea

Department of Oncology Fundación Arturo López Pérez FALP Santiago Chile

Department of Oncology Royal Free Hospital NHS Trust University College London London UK

Department of Surgery and Cancer Imperial College Healthcare NHS Trust London UK

Department of Urology Nippon Medical School Hospital Tokyo Japan

Department of Urology Taipei Veterans General Hospital Taipei Taiwan

Division of Hematology and Oncology Abramson Cancer Center Philadelphia PA USA

Merck and Co Inc Rahway NJ USA

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ClinicalTrials.gov
NCT03142334