KEY TAKEAWAYS
- The phase 3 KEYNOTE-426 (NCT02853331) trial compared pembrolizumab and axitinib combination therapy with sunitinib monotherapy in patients with advanced RCC.
- The primary aim was to assess health-related quality of life (HRQoL) in the context of the KEYNOTE-426 study.
- A cohort of 861 patients were randomly allocated to receive either pembrolizumab + axitinib (n = 432) or sunitinib (n = 429).
- No significant differences in overall improvement rates from baseline were observed between the pembrolizumab + axitinib and sunitinib treatments for the FKSI-DRS.
- The time to disease progression did not exhibit any significant difference between the treatment groups (hazard ratio 1.1; 95% confidence interval [CI] 0.95-1.3)
- Patient-reported outcome scales indicated no discernible differences in outcomes between pembrolizumab + axitinib.
The phase 3 KEYNOTE-426 (NCT02853331) trial results indicate that the combination of pembrolizumab and axitinib exhibited enhanced overall survival and progression-free survival, and objective response rate in comparison to sunitinib monotherapy for patients with advanced renal cell carcinoma (RCC). To assess health-related quality of life (HRQoL) in the context of the KEYNOTE-426 study. A cohort of 861 subjects were randomly allocated to receive either pembrolizumab + axitinib (n = 432) or sunitinib (n = 429). Health-related quality of life (HRQoL) information was obtainable for 429 individuals who received pembrolizumab + axitinib and 423 who received sunitinib. 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 were utilized to measure HRQoL endpoints. No significant differences in overall improvement rates from baseline were observed between the pembrolizumab + axitinib and sunitinib treatments for the FKSI-DRS, QLQ-C30, and EQ-5D VAS assessments.
The FKSI-DRS showed a slight decrease of 0.79% improvement compared to sunitinib, with a 95% confidence interval of -7.2 to 5.6. The QLQ-C30 showed a 7.5% improvement compared to sunitinib, with a 95% confidence interval of 1.0-14. The EQ-5D VAS showed a 9.9% improvement compared to sunitinib, with a 95% confidence interval of 3.2-17. There were no discernible distinctions between the arms for the QLQ-C30 and EQ-5D VAS regarding time to confirmed deterioration (TTcD) and time to first deterioration (TTfD). The TTcD hazard ratio (HR) was 1.0 with a 95% confidence interval (CI) of 0.82-1.3 for QLQ-C30 and 1.1 with a 95% CI of 0.87-1.3 for EQ-5D VAS. The TTfD HR was 0.82 with a 95% CI of 0.69-0.97 for QLQ-C30 and 0.98 with a 95% CI of 0.83-1.2 for EQ-5D VAS. The time to disease progression did not exhibit any significant difference between the treatment groups (hazard ratio [HR] 1.1; 95% confidence interval [CI] 0.95-1.3) as per the Functional Assessment of Cancer Therapy–Disease-Related Symptoms (FKSI-DRS) scale. However, the time to treatment failure favored sunitinib (HR 1.4; 95% CI 1.1-1.7) as per the same scale. During the off-treatment interval for sunitinib, patients were evaluated, potentially leading to an underestimation of the adverse effects of sunitinib on HRQoL. In general, the patient-reported outcome scales indicated no discernible differences in outcomes between the pembrolizumab + axitinib and sunitinib groups, except for the TTcD as measured by the FKSI-DRS.
Source:https://pubmed.ncbi.nlm.nih.gov/35843776/
Clinical Trail:https://clinicaltrials.gov/ct2/show/NCT02853331
Ciccarese C, Iacovelli R. Uncertainty Persists Regarding the Role of Immunotherapy for Treatment of Metastatic Renal Cell Carcinoma with Favourable Prognosis. Eur Urol. 2023 Feb;83(2):e45-e46. doi: 10.1016/j.eururo.2022.10.026. Epub 2022 Nov 26. PMID: 36446673.
