BACKGROUND: In the phase 3 KEYNOTE-426 (NCT02853331) trial, pembrolizumab + axitinib demonstrated improvement in overall survival, progression-free survival, and objective response rate over sunitinib monotherapy for advanced renal cell carcinoma (RCC). OBJECTIVE: To evaluate health-related quality of life (HRQoL) in KEYNOTE-426. DESIGN, SETTING, AND PARTICIPANTS: A total of 861 patients were randomly assigned to receive pembrolizumab + axitinib (n = 432) or sunitinib (n = 429). HRQoL data were available for 429 patients treated with pembrolizumab + axitinib and 423 patients treated with sunitinib. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: HRQoL end points were measured using the European Organisation for the Research and Treatment of Cancer Core (EORTC) Quality of Life Questionnaire (QLQ-C30), EQ-5D visual analog rating scale (VAS), and Functional Assessment of Cancer Therapy Kidney Cancer Symptom Index-Disease-Related Symptoms (FKSI-DRS) questionnaires. RESULTS AND LIMITATIONS: Better or not different overall improvement rates from baseline between pembrolizumab + axitinib and sunitinib were observed for the FKSI-DRS (-0.79% improvement vs sunitinib; 95% confidence interval [CI] -7.2 to 5.6), QLQ-C30 (7.5% improvement vs sunitinib; 95% CI 1.0-14), and EQ-5D VAS (9.9% improvement vs sunitinib; 95% CI 3.2-17). For time to confirmed deterioration (TTcD) and time to first deterioration (TTfD), no differences were observed between arms for the QLQ-C30 (TTcD hazard ratio [HR] 1.0; 95% CI 0.82-1.3; TTfD HR 0.82; 95% CI 0.69-0.97) and EQ-5D VAS (TTcD HR 1.1; 95% CI 0.87-1.3; TTfD HR 0.98; 95% CI 0.83-1.2). TTfD was not different between treatment arms (HR 1.1; 95% CI 0.95-1.3) for the FKSI-DRS, but TTcD favored sunitinib (HR 1.4; 95% CI 1.1-1.7). Patients were assessed during the off-treatment period for sunitinib, which may have underestimated the negative impact of sunitinib on HRQoL. CONCLUSIONS: Overall, patient-reported outcome scales showed that results between the pembrolizumab + axitinib and sunitinib arms were not different, with the exception of TTcD by the FKSI-DRS. PATIENT SUMMARY: Compared with sunitinib, pembrolizumab + axitinib delays disease progression and extends survival, while HRQoL outcomes were not different between groups.

Adelaide and Meath Hospital University College Dublin Dublin Ireland

Barts Health and the Royal Free NHS Trusts Barts Cancer Institute London UK; Queen Mary University of London London UK

Bell Land General Hospital Osaka Japan

Central Clinical Hospital With Outpatient Clinic Moscow Russia

Centre Antoine Lacassagne Université Côte d'Azur Nice France

Centre Hospitalier de l'Université de Montréal Montréal QC Canada

CHU de Québec and Université Laval Quebec City QC Canada

Department of Urology Eberhard Karls University of Tübingen Tübingen Germany

Dnipro State Medical University Dnipro Ukraine

Fox Chase Cancer Center Philadelphia PA USA

Georgetown Lombardi Comprehensive Cancer Center Washington DC USA

Hospital de Clínicas de Porto Alegre Porto Alegre Brazil

Merck and Co Inc Rahway NJ USA

MSD UK London UK

Palacký University Olomouc Medical School and Teaching Hospital Olomouc Czech Republic

Russian Scientific Center of Roentgen Radiology Moscow Russia

Sumy State University Sumy Regional Oncology Center Sumy Ukraine

The Christie NHS Foundation Trust Manchester UK

Vanderbilt University Medical Center Nashville TN USA

Eur Urol. 2022 Dec;82(6):e174-e175. doi: 10.1016/j.eururo.2022.08.038. PubMed

Citace poskytuje Crossref.org

Real-World Primary Resistance to First-Line Immune-Based Combinations in Patients with Advanced Renal Cell Carcinoma (ARON-1)

Zobrazit více v PubMed

ClinicalTrials.gov
NCT02853331