Dataset Information

Patient-Reported Outcomes in KEYNOTE-564: Adjuvant Pembrolizumab Versus Placebo for Renal Cell Carcinoma.

ABSTRACT:

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.

SUBMITTER: Choueiri TK

PROVIDER: S-EPMC10836324 | biostudies-literature | 2024 Feb

REPOSITORIES: biostudies-literature

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Publications

Patient-Reported Outcomes in KEYNOTE-564: Adjuvant Pembrolizumab Versus Placebo for Renal Cell Carcinoma.

Choueiri Toni K TK Tomczak Piotr P Park Se Hoon SH Venugopal Balaji B Symeonides Stefan S Hajek Jaroslav J Ferguson Thomas T Chang Yen-Hwa YH Lee Jae Lyun JL Haas Naomi N Sawrycki Piotr P Sarwar Naveed N Gross-Goupil Marine M Thiery-Vuillemin Antoine A Mahave Mauricio M Kimura Go G Perini Rodolfo F RF Saretsky Todd L TL Bhattacharya Rituparna R Xu Lei L Powles Thomas T

The oncologist 20240201 2

<h4>Background</h4>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.<h4>Patients and methods</h4>In KEYNOTE-564, 994 patients were randomly assigned to receive pembrolizuma ...[more]

PMID: 37589219

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Dataset Information

Patient-Reported Outcomes in KEYNOTE-564: Adjuvant Pembrolizumab Versus Placebo for Renal Cell Carcinoma.

Background

Patients and methods

Results

Conclusions

Trial registration

Publications

Patient-Reported Outcomes in KEYNOTE-564: Adjuvant Pembrolizumab Versus Placebo for Renal Cell Carcinoma.

Similar Datasets

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