Efficacy, safety, and treatment feasibility of pembrolizumab plus lenvatinib in patients aged 75 years or older with advanced renal cell carcinoma: a Japanese multicenter retrospective study.

BACKGROUND

Pembrolizumab plus lenvatinib is a standard first-line treatment option for advanced renal cell carcinoma (RCC), but data focused on patients aged ≥ 75 years remain limited. We evaluated the efficacy, safety, and treatment feasibility of this regimen in a Japanese multicenter cohort.

METHODS

We retrospectively analyzed 170 patients with metastatic or unresectable RCC treated with first-line pembrolizumab plus lenvatinib. We compared those aged ≥ 75 years (n = 31) with those aged < 75 years (n = 139), assessing treatment exposure, treatment modifications, adverse events (AEs), best overall response, progression-free survival and overall survival.

RESULTS

The older patients more commonly received a reduced starting dose of lenvatinib (P = 0.02) and schedule modification (19% vs. 6%, P = 0.03). However, the number of lenvatinib dose reductions, final lenvatinib dose, and treatment duration were similar between the groups. There was no significant difference in any-grade AEs, grade ≥ 3 AEs, corticosteroid use for immune-related AEs, or AE-related treatment discontinuation. The objective response rate was 77% in patients aged ≥ 75 years and 65% in those aged < 75 years (P = 0.20). Progression-free survival and overall survival were also comparable (P = 0.92 and P = 0.58, respectively), and age ≥ 75 years was not associated with progression-free survival or overall survival in multivariable analysis.

CONCLUSIONS

Our results suggest that pembrolizumab plus lenvatinib can be feasibly administered to selected patients aged ≥ 75 years through individualized dose attenuation and schedule modification without an apparent loss of efficacy or increase in severe toxicity.