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- Title
Three-year outcomes of preoperative chemoradiotherapy plus nivolumab in microsatellite stable and microsatellite instability-high locally advanced rectal cancer.
- Authors
Tsukada, Yuichiro; Bando, Hideaki; Inamori, Koji; Wakabayashi, Masashi; Togashi, Yosuke; Koyama, Shohei; Kotani, Daisuke; Yuki, Satoshi; Komatsu, Yoshito; Homma, Shigenori; Taketomi, Akinobu; Uemura, Mamoru; Kato, Takeshi; Fukui, Makoto; Nakamura, Naoki; Kojima, Motohiro; Kawachi, Hiroshi; Kirsch, Richard; Yoshida, Tsutomu; Sato, Akihiro
- Abstract
Background: Preoperative chemoradiotherapy (CRT) followed by surgery is the standard treatment for locally advanced rectal cancer (LARC). We reported the short-term outcomes of the VOLTAGE trial that investigated the safety and efficacy of preoperative CRT followed by nivolumab and surgery. Here, we present the 3-year outcomes of this trial. Methods: Thirty-nine patients with microsatellite stable (MSS) LARC and five patients with microsatellite instability-high (MSI-H) LARC underwent CRT (50.4 Gy) followed by five doses of nivolumab (240 mg) and surgery. The 3-year relapse-free survival (RFS), overall survival (OS), and associations with biomarkers were evaluated. Results: The 3-year RFS rates in patients with MSS and MSI-H were 79.5% and 100%, respectively, and the 3-year OS rates were 97.4% and 100%, respectively. Of the MSS patients, those with pre-CRT PD-L1 positivity, pre-CRT high CD8 + T cell/effector regulatory T cell (eTreg) ratio, pre-CRT high expression of Ki-67, CTLA-4, and PD-1 had a trend toward better 3-year RFS than those without. Conclusions: Three-year outcomes of patients with MSI-H were better than those of patients with MSS. PD-L1 positivity, elevated CD8/eTreg ratio, and high expression of Ki-67, CTLA-4, and PD-1 could be positive predictors of prognosis in patients with MSS. Clinical trial registration: ClinicalTrials.gov Identifier: NCT02948348.
- Publication
British Journal of Cancer, 2024, Vol 131, Issue 2, p283
- ISSN
0007-0920
- Publication type
Article
- DOI
10.1038/s41416-024-02730-7