Academic Journal
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
العنوان: | 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 |
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المؤلفون: | 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 |
المصدر: | Signal Transduction and Targeted Therapy, Vol 9, Iss 1, Pp 1-10 (2024) |
بيانات النشر: | Nature Publishing Group, 2024. |
سنة النشر: | 2024 |
المجموعة: | LCC:Medicine LCC:Biology (General) |
مصطلحات موضوعية: | Medicine, Biology (General), QH301-705.5 |
الوصف: | 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. |
نوع الوثيقة: | article |
وصف الملف: | electronic resource |
اللغة: | English |
تدمد: | 2059-3635 |
Relation: | https://doaj.org/toc/2059-3635 |
DOI: | 10.1038/s41392-024-01788-2 |
URL الوصول: | https://doaj.org/article/2291e0ba14894e5bb2ec30a9d2eba1bf |
رقم الانضمام: | edsdoj.2291e0ba14894e5bb2ec30a9d2eba1bf |
قاعدة البيانات: | Directory of Open Access Journals |
تدمد: | 20593635 |
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DOI: | 10.1038/s41392-024-01788-2 |