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Publications

Journal Article Ahead of print

PubMed: 42847603 DOI: 10.1093/jjco/hyag173

Prognostic impact of lenvatinib dose intensity in previously untreated patients with advanced renal cell carcinoma receiving lenvatinib plus pembrolizumab.

Jpn J Clin Oncol

Authors: Koichi Nishimura, Hiroki Ishihara, Katsurayama Nanaka, Takayuki Nakayama, Hironori Fukuda, Kazuhiko Yoshida, Yasunobu Hashimoto, Junpei Iizuka, Tsunenori Kondo, Toshio Takagi

Affiliations

  • Department of Urology, Tokyo Women's Medical University Adachi Medical Center, 4-33-1 Kohoku, Adachi-ku, Tokyo, Japan.
  • Department of Urology, Tokyo Women's Medical University, 8-1, Kawada-cho, Shinjuku-ku, Tokyo, Japan.
  • Department of Urology, Saiseikai Kawaguchi General Hospital, Saitama, 5-11-5 Nishikawaguchi, Kawaguchi, Saitama Japan.
  • Department of Urology, Tokyo Women's Medical University Adachi Medical Center, 4-33-1 Kohoku, Adachi-ku, Tokyo, Japan. Department of Urology, Tokyo Women's Medical University, 8-1, Kawada-cho, Shinjuku-ku, Tokyo, Japan.

Abstract

BACKGROUND

Lenvatinib plus pembrolizumab is the standard of care as first-line systemic therapy for advanced renal cell carcinoma (RCC). However, the prognostic impact of the relative dose intensity (RDI) of lenvatinib remains unclear.

METHODS

Clinical data from 54 patients with advanced RCC who received lenvatinib plus pembrolizumab as first-line therapy were retrospectively evaluated. The RDI of lenvatinib within the initial 3 months (3m-RDI) was calculated, and tumor response and survival were compared according to 3m-RDI.

RESULT

The 3m-RDI threshold was set at 70%, which was significantly associated with objective response during treatment. Patients with a high 3m-RDI (≥70%) had a higher objective response rate (ORR) than those with a low 3m-RDI (<70%) (69% vs. 36%, P = .014).Multivariable analysis identified 3m-RDI ≥70% as an independent predictor of higher ORR (odds ratio: 5.25, 95% CI: 1.55-20.36, P = .007). Among patients with synchronous metastasis (n = 24), patients with a high 3m-RDI had higher ORR (62% vs. 18%, P = .028) and longer progression-free survival (median: not reached vs. 4.8 months, P = .035) than those with a low 3m-RDI.

CONCLUSIONS

Lenvatinib with 3m-RDI ≥70% may be a useful early treatment-related marker associated with clinical outcomes during first-line lenvatinib plus pembrolizumab for advanced RCC.

MeSH

Cells, Neoplasms, Carcinoma, Renal Cell, Immunotherapy, Drug-Related Side Effects And Adverse Reactions, Immune Checkpoint Inhibitors, Kidney Neoplasms, Therapeutics