Clin Cancer Res: A new treatment plan for locally advanced rectal cancer - preoperative chemoradiotherapy combined with nivolumab consolidation followed by radical surgery!

Preoperative chemoradiotherapy (CRT) plus surgical resection is the standard treatment for locally advanced rectal cancer (LARC)
.

Combining immune checkpoint inhibitors with radiation therapy may improve outcomes for these patients

This study evaluated the efficacy of preoperative chemoradiotherapy followed by nivolumab followed by surgery in patients with locally advanced rectal cancer
.

To evaluate the efficacy of preoperative chemoradiotherapy followed by nivolumab followed by surgery in patients with locally advanced rectal cancer
.

This is a Phase I-II clinical trial investigating the possibility of sequential use of preoperative chemoradiotherapy, 5 courses of nivolumab, and radical surgery in Phase I; in Phase II, evaluating Efficacy of this treatment regimen in patients with locally advanced rectal cancer with microsatellite stable (MSS) and microsatellite instability high (MSI-H)
.

Case complete remission rate in different groups of patients

Case complete remission rate in different groups of patients

In Phase I, 3 patients received fully planned preoperative chemoradiation and nivolumab (no dose adjustment); therefore, this regimen is recommended for Phase II
.

Pathological complete response rates in the MSS cohort and exploratory MSI-H cohort were 30% (11/37, 90% CI 18%-44%) and 60% (3/5), respectively

Pathological complete response rates in the MSS cohort and exploratory MSI-H cohort were 30% (11/37, 90% CI 18%-44%) and 60% (3/5), respectively

Changes in the ratio of CD8/eTreg cells during treatment

Changes in the ratio of CD8/eTreg cells during treatment

Among 24 MSS patients analyzed by flow cytometry in samples before chemoradiotherapy, the pathological complete response rate was 78 for patients with tumor-infiltrating CD8+ T cells/effector regulatory T cells (CD8/eTreg) ratios ≥2.
5 and <2.
5, respectively % (7/9) and 13% (2/15, p=0.
003)
.

Pathological complete response rates were 78% (7/9) and 13% (2/15, p=0.
003) in patients with tumor-infiltrating CD8+ T cells/effector regulatory T cells (CD8/eTreg) ratios ≥2.
5 and <2.
5, respectively
.

Pathological complete response rates were 78% (7/9) and 13% (2/15, p=0.

Consolidation therapy with nivolumab after preoperative chemoradiotherapy may improve the pathological complete response rate of locally advanced rectal cancer

Original source:

Original source:

Hideaki Bando, Yuichiro Tsukada, Koji Inamori, et al.

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