Umbrella strategy with systemic and intraperitoneal chemotherapy versus systemic chemotherapy in patients with advanced gastric cancer: a multicenter, randomized Phase III clinical trial
Yang Yang , Jia Wei , Juan Du , Zhengyun Zou , Rongfu Wei , Fenglin Zhang , Weisheng Shen , Xiyan Lu , Sanyuan Sun , Xiaoqin Li , Chunlan Nie , Gang Chen , Lixia Yu , Hanqing Qian , Yan Yang , Qin Liu , Jie Shen , Lifeng Wang , Yajun Xing , Fangbo Cui , Jianmin Shi , Lei Xi , Lichun Deng , Xiangmin Cao , Qing Zhu , Yuan Yuan , Meilian Cheng , Hui Xu , Ling Yuan , Miaomiao Guo , Meng Wang , Changyan Gao , Xiaoping Qian , Wenxian Guan , Baorui Liu
Clinical Cancer Bulletin ›› 2023, Vol. 2 ›› Issue (1) : 3
Umbrella strategy with systemic and intraperitoneal chemotherapy versus systemic chemotherapy in patients with advanced gastric cancer: a multicenter, randomized Phase III clinical trial
We have developed a tridirectional regimen combining intraperitoneal, intravenous, and oral chemotherapy as a treatment for patients with advanced gastric cancer and individualized these chemotherapeutics according to mRNA expression. This multicenter Phase III umbrella study compared the efficacy and safety of individualized tridirectional intraperitoneal and systemic chemotherapy with that of standard systemic chemotherapy.
BRCA1/TOPO1 mRNA expression was examined in all enrolled patients. The patients were then randomized in a ratio of 3:1 to an individualized arm and a control arm. Patients in the control arm received systemic intravenous/oral chemotherapy, whereas those in the individualized arm received sensitive chemotherapeutics selected from oxaliplatin/cisplatin/docetaxel/irinotecan/S-1 according to their BRCA1/TOPO1 mRNA expression and received individualized tridirectional intraperitoneal/intravenous/oral chemotherapy. The primary endpoint was progression-free survival and the secondary endpoints were response rate, overall survival, and safety.
Overall, 233 of 240 patients enrolled between August 2014 and December 2016 were included in the efficacy analysis. Baseline patient characteristics were balanced between the two arms. The objective response rate was 33.9% in the control arm and 49.1% in the individualized arm (P = 0.039). In the control and individualized arms, median progression-free survival was 5.9 months and 8.0 months, respectively (hazard ratio 0.521, 95% confidence interval 0.362–0.750, P = 0.0005) and median overall survival was 13.5 months and 16.4 months, respectively (hazard ratio 0.684, 95% confidence interval 0.474–0.988, P = 0.0430). Both regimens were tolerable.
The primary analysis demonstrated the statistical superiority of this tridirectional individualized regimen and suggests that this regimen has clinical efficacy in patients with advanced gastric cancer.
Chinese Clinical Trial Registry (chictr.org.cn) Identifier: ChiCTR-IPR-15006201.
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