Three-year outcomes of preoperative chemoradiotherapy plus nivolumab in microsatellite stable and microsatellite instability-high locally advanced rectal cancer

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发表日期：

2024年6月4日

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Yuichiro Tsukada,
Hideaki Bando,
Koji Inamori,
Masashi Wakabayashi,
Yosuke Togashi,
Shohei Koyama,
Daisuke Kotani,
Satoshi Yuki,
Yoshito Komatsu,
Shigenori Homma,
Akinobu Taketomi,
Mamoru Uemura,
Takeshi Kato,
Makoto Fukui,
Naoki Nakamura,
Motohiro Kojima,
Hiroshi Kawachi,
Richard Kirsch,
Tsutomu Yoshida,
Akihiro Sato,
Hiroyoshi Nishikawa,
Masaaki Ito,
Takayuki Yoshino

摘要

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.