학술논문
XELOX (capecitabine plus oxaliplatin) plus bevacizumab (anti-VEGF-A antibody) with or without adoptive cell immunotherapy in the treatment of patients with previously untreated metastatic colorectal cancer: a multicenter, open-label, randomized, controlled, phase 3 trial
Document Type
article
Author
Qiu-Zhong Pan; Jing-Jing Zhao; Liang Liu; Dong-Sheng Zhang; Li-Ping Wang; Wen-Wei Hu; De-Sheng Weng; Xiang Xu; Yi-Zhuo Li; Yan Tang; Wei-Hong Zhang; Jie-Yao Li; Xiao Zheng; Qi-Jing Wang; Yong-Qiang Li; Tong Xiang; Li Zhou; Shuang-Ning Yang; Chen Wu; Rong-Xing Huang; Jia He; Wei-Jiao Du; Lu-Jun Chen; Yue-Na Wu; Bin Xu; Qiong Shen; Yi Zhang; Jing-Ting Jiang; Xiu-Bao Ren; Jian-Chuan Xia
Source
Signal Transduction and Targeted Therapy, Vol 9, Iss 1, Pp 1-10 (2024)
Subject
Language
English
ISSN
2059-3635
Abstract
Abstract Fluoropyrimidine-based combination chemotherapy plus targeted therapy is the standard initial treatment for unresectable metastatic colorectal cancer (mCRC), but the prognosis remains poor. This phase 3 trial (ClinicalTrials.gov: NCT03950154) assessed the efficacy and adverse events (AEs) of the combination of PD-1 blockade-activated DC-CIK (PD1-T) cells with XELOX plus bevacizumab as a first-line therapy in patients with mCRC. A total of 202 participants were enrolled and randomly assigned in a 1:1 ratio to receive either first-line XELOX plus bevacizumab (the control group, n = 102) or the same regimen plus autologous PD1-T cell immunotherapy (the immunotherapy group, n = 100) every 21 days for up to 6 cycles, followed by maintenance treatment with capecitabine and bevacizumab. The main endpoint of the trial was progression-free survival (PFS). The median follow-up was 19.5 months. Median PFS was 14.8 months (95% CI, 11.6–18.0) for the immunotherapy group compared with 9.9 months (8.0–11.8) for the control group (hazard ratio [HR], 0.60 [95% CI, 0.40–0.88]; p = 0.009). Median overall survival (OS) was not reached for the immunotherapy group and 25.6 months (95% CI, 18.3–32.8) for the control group (HR, 0.57 [95% CI, 0.33–0.98]; p = 0.043). Grade 3 or higher AEs occurred in 20.0% of patients in the immunotherapy group and 23.5% in the control groups, with no toxicity-associated deaths reported. The addition of PD1-T cells to first-line XELOX plus bevacizumab demonstrates significant clinical improvement of PFS and OS with well tolerability in patients with previously untreated mCRC.