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Publications

Journal Article Ahead of print

PubMed: 42240722 DOI: 10.1007/s11523-026-01226-z

Real-World Outcomes of Adjuvant Pembrolizumab for Renal Cell Carcinoma: The Potential Role of PD-L1 as a Prognostic Biomarker.

Target Oncol

Authors: Hiroki Ishihara, Takayuki Nakayama, Hironori Fukuda, Nanaka Katsurayama, Yuki Nemoto, Shinsuke Mizoguchi, Hiroaki Shimmura, Yasunobu Hashimoto, Atsuko Seki, Kazuhiko Yoshida, Junpei Iizuka, Tsunenori Kondo, Yoji Nagashima, Toshio Takagi

Affiliations

  • Department of Urology, Saiseikai Kawaguchi General Hospital, 5-11-5 Nishikawaguchi, Kawaguchi, Saitama, Japan.
  • Department of Urology, Tokyo Women's Medical University, 8-1 Kawada-cho, Shinjuku-ku, Tokyo, Japan.
  • Department of Urology, Tokyo Women's Medical University, 8-1 Kawada-cho, Shinjuku-ku, Tokyo, Japan.
  • Department of Urology, Tokyo Women's Medical University Adachi Medical Center, 4-33-1 Kouhoku, Adachi-ku, Tokyo, Japan.
  • Department of Urology, Jyoban Hospital, Uenodai 57, Joban Kamiyunagayamachi, Iwaki, Fukushima, Japan.
  • Department of Urology, Saiseikai Kazo Hospital, 1680 Kamitakayanagi, Kazo, Saitama, Japan.

Abstract

BACKGROUND

Real-world data on adjuvant pembrolizumab after surgery for renal cell carcinoma (RCC) are limited.

OBJECTIVE

To clarify the real-world outcomes of adjuvant pembrolizumab for patients with RCC with a high risk of recurrence.

PATIENTS AND METHODS

We retrospectively evaluated the clinicopathological data of 53 patients who received pembrolizumab as an adjuvant therapy after curative surgery for RCC on the basis of the criteria of the KEYNOTE-564 trial. The efficacy and safety profiles were assessed. The potential of PD-L1 expression as a biomarker of recurrence was evaluated in 35 RCC samples using the combined positive score (CPS).

RESULTS

The median follow-up period was 18.9 months. On the basis of the KEYNOTE-564 criteria, 45 patients (85%) were categorized into the intermediate-to-high-risk group. A total of 11 patients (21%) experienced recurrence, with a 12-month disease-free survival (DFS) rate of 90.5%. Patients with high PD-L1 CPS (≥ 10) had a higher recurrence rate than those with low PD-L1 CPS (< 10) (44% versus 5%, p = 0.0130). DFS was shorter in patients with high PD-L1 expression than in those with low PD-L1 expression (median: 24.0 months versus not reached, p = 0.0116). Grade ≥ 3 adverse events occurred in 13 patients (25%), and treatment discontinuation was required in 11 patients (21%).

CONCLUSIONS

Adjuvant pembrolizumab exhibited feasible efficacy and manageable safety profiles for high-risk RCC in a real-world population. Further studies with longer follow-up periods and larger sample sizes are needed to confirm overall survival benefit, long-term toxicity, and the potential role of PD-L1 as a prognostic biomarker.

MeSH

Cells, Safety, Neoplasms, Carcinoma, Renal Cell, Biomarkers, Therapeutics