Patient-reported outcomes in KEYNOTE-564: adjuvant pembrolizumab versus placebo for renal cell carcinoma

Toni K. Choueiri*, Piotr Tomczak, Se Hoon Park, Balaji Venugopal, Stefan N Symeonides, Jaroslav Hajek, Thomas Ferguson, Yen-Hwa Chang, Jae Lyun Lee, Naomi Haas, Piotr Sawrycki, Naveed Sarwar, Marine Gross-Goupil, Antoine Thiery-Vuillemin, Mauricio Maheve, Go Kimura, Rodolfo F. Perini, Todd L. Saretsky, Rituparna Bhattacharya, Lei XuThomas Powles

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

Abstract / Description of output

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 endpoints were assessed using the EORTC QLQ-C30, FKSI-DRS, and EQ VAS. Prespecified and exploratory PRO endpoints 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: Identifier: NCT03142334
Original languageEnglish
JournalThe Oncologist
Publication statusPublished - 17 Aug 2023

Keywords / Materials (for Non-textual outputs)

  • renal cell carcinoma
  • health-related quality of life
  • nephrectomy
  • pembrolizumab


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