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.

Authors

Shimpei Yamashita, Takeshi Yamasaki, Kosuke Ueda, Ryotaro Tomida, Shingo Toyoda, Hiroaki Iwamoto, Makito Miyake, Ikko Tomisaki, Shuichi Morizane, Yasuo Kohjimoto

Published in

International journal of clinical oncology. Jun 30, 2026. Epub Jun 30, 2026.

Abstract

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.
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.
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.
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.

PMID:
42377813
Bibliographic data and abstract were imported from PubMed on 30 Jun 2026.

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