An analysis published in the European Association of Urology showed that in patients with advanced renal cell carcinoma, the combination of pembrolizumab (Keytruda) and axitinib (Inlyta) had comparable health-related quality of life (HRQOL) outcomes compared with sunitinib (Sutent), except for results from the Functional Assessment of Cancer Therapy Kidney Cancer Symptom Index-Related Symptom (FKSI-DRS) questionnaire.1
The focus of the analysis was to determine the HRQOL of patients who were enrolled on the phase 3 KEYNOTE-426 trial (NCT02853331) and treated with either pembrolizumab and axitinib or sunitinib. Results from the FKSI-DRS questionnaire highlighted a –0.79% (95% CI, –7.2 to 5.6) improvement in the pembrolizumab plus axitinib arm vs the sunitinib. Moreover, the Quality of Life Questionnaire (QLQ-C30) identified an improvement of 7.5% (95% CI, 1.0-14.0) in the pembrolizumab arm compared with the sunitinib arm, and the EQ-5D visual analog rating scale identified a 9.9% (95% CI, 3.2-17.0) improvement favoring the pembrolizumab combination.
A total of 861 patients enrolled on the KEYNOTE-426 trial, of whom 432 were randomly assigned to the pembrolizumab arm and 429 were assigned to the sunitinib arm. At least 1 questionnaire was completed by 429 patients in the pembrolizumab arm and 423 in the sunitinib arm for the QLQ-C30 and EQ-5D questionnaires, and 429 vs 422 patients, respectively filled out the FKSI-DRS survey. At 30 weeks, the last time point for completion and compliance rates were 60% in the pembrolizumab arm and 80% in the sunitinib arm. Over time, completion rates for the QLQ-C30 decreased because of treatment discontinuation from disease progression, intolerable toxicity, physician or participant withdrawal, or death. Compliance and completion rates for FKSI-DRS and EQ-5D were similar to QLQ-C30.
No meaningful difference in least square mean scores was noted at week 30 between the pembrolizumab and sunitinib arms for FKSI-DRS (–0.53; 95% CI, –1.1 to –0.07), QLQ-C30 (–1.7; 95% CI, –4.3 to 0.90), and EQ-5D (–1.5; 95% CI, –4.0 to 1.0). Additionally, the empirical mean change from baseline to week 30 being measured through QLQ-C30 GHS/QOL and subscales were stable for the pembrolizumab group, with the exception of diarrhea which declined over time vs the consistent decline in the sunitinib arm. Despite the diarrhea highlighting a decline over time in the pembrolizumab arm, there was no difference in incidence between the combination and sunitinib groups when adjusted for exposure (9.3% vs 8.2%).
Via the constrained longitudinal data analysis, the least square mean (LSM) changes from baseline to week 150 did not show any significant changes between the pembrolizumab arm and sunitinib arm in the FKSI-DRS questionnaire (LSM, 0.00; 95% CI, –0.39 to 0.40) or EQ-5D (LSM, 1.5; 95% CI, –0.25 to 3.2). However, LSM was higher in the pembrolizumab arm vs the sunitinib arm for QLQ-C30 GHS/QOL (LSM, 2.1; 95% CI, 0.36-3.9).
The median time from randomization to the database cutoff date was 31 months. For the FKSI-DRS, the median time to confirmed deterioration was 25 months for the pembrolizumab arm and was not reached in the sunitinib arm (HR, 1.4; 95% CI, 1.1-1.7). Similar times were observed for the QLQ-C30 at 15 months vs 13 months (HR, 1.0; 95% CI, 0.82-1.3), and 8.3 months vs 10 months (HR, 1.1; 95% CI, 0.87-1.3) for EQ-5D for pembrolizumab vs sunitinib, respectively. For FKSI-DRS, the median time to the first deterioration was 2.8 months vs 2.6 months (HR, 1.1; 95% CI, 0.95-1.3), 3.0 months vs 2.3 months for QLQ-C30 (HR, 0.82; 95% CI, 0.69-0.97), and 2.2 months vs 2.3 months for EQ-5D (HR, 0.98; 95% CI, 0.83-1.2).
1. Bedke J, Rini BI, Plimack ER, et al. Health-related quality of life analysis from KEYNOTE-426: pembrolizumab plus axitinib versus sunitinib for advanced renal cell carcinoma. Eur Urol. Published online July 14, 2022. doi:10.1016/j.eururo.2022.06.009