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.
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.
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%).
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.
Clinicaltrials.gov Identifier: NCT03142334.
The oncologist. 2023 Aug 17 [Epub ahead of print]
Toni K Choueiri, Piotr Tomczak, Se Hoon Park, Balaji Venugopal, Stefan Symeonides, Jaroslav Hajek, Thomas Ferguson, Yen-Hwa Chang, Jae Lyun Lee, Naomi Haas, Piotr Sawrycki, Naveed Sarwar, Marine Gross-Goupil, Antoine Thiery-Vuillemin, Mauricio Mahave, Go Kimura, Rodolfo F Perini, Todd L Saretsky, Rituparna Bhattacharya, Lei Xu, Thomas Powles
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 Hematology and Oncology, Sungkyunkwan University Samsung Medical Center, Seoul, South Korea., Department of Medical Oncology, The Beatson West of Scotland Cancer Centre and University of Glasgow, Glasgow, UK., 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 Urology, Taipei Veterans General Hospital, Taipei, Taiwan., Department of Oncology, Asan Medical Center and University of Ulsan College of Medicine, Seoul, South Korea., Division of Hematology and Oncology, Abramson Cancer Center, Philadelphia, PA, USA., Chemotherapy Department, Wojewódzki Szpital Zespolony im. L. Rydygiera, Torun, Poland., Department of Surgery and Cancer, Imperial College Healthcare NHS Trust, London, 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, Fundación Arturo López Pérez FALP, Santiago, Chile., Department of Urology, Nippon Medical School Hospital, Tokyo, Japan., Merck & Co., Inc., Rahway, NJ, USA., Department of Oncology, Royal Free Hospital NHS Trust, University College London, London, UK.