Tong Gangling, Li Shuluan, Lin Lin, He Lirui, Wang Li, Lv Guoqing, Zheng Ruinian, Wang Shubin
Department of Oncology, Peking University Shenzhen Hospital, Shenzhen, Guangdong 518036, People's Republic of China.
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Shenzhen, Guangdong 518116, People's Republic of China.
Cancer Manag Res. 2020 Apr 8;12:2481-2489. doi: 10.2147/CMAR.S239420. eCollection 2020.
The aim of this study was to evaluate the efficacy and safety of trastuzumab, combined with the FLOT regimen, in the perioperative treatment of resectable HER-2-positive advanced gastric cancer.
Overall, 45 patients were divided into two groups; 29 patients in the experimental group were treated with trastuzumab combined with FLOT and 16 patients in the control group were treated with FLOT alone. The primary endpoint was objective response rate (ORR), and the secondary endpoints were disease control rate (DCR), tumor regression grade (TRG), surgical margin, side effects, and overall survival.
In the experimental and control groups, ORR was 72.4% and 43.8% (=0.226), DCR was 89.7% and 87.5%, R0 resection rate was 96.5% and 93.7%, total/subtotal tumor regression grade was 17.2% and 6.3%, partial tumor regression grade was 27.6% and 18.7% (=0.468), and 2-year survival rate was 78.1% and 73.9% (=0.932), respectively. The common side effects were agranulocytosis and vomiting. There was no significant difference between the two groups.
Trastuzumab combined with FLOT has a good curative effect and safety profile in the perioperative treatment of patients with resectable HER-2-positive advanced gastric cancer. In addition, trastuzumab + FLOT had the same result as FLOT alone, as there was no significant benefit with the addition of T in the group studied.
本研究旨在评估曲妥珠单抗联合FLOT方案在可切除的HER-2阳性晚期胃癌围手术期治疗中的疗效和安全性。
总共45例患者被分为两组；实验组29例患者接受曲妥珠单抗联合FLOT治疗，对照组16例患者仅接受FLOT治疗。主要终点为客观缓解率（ORR），次要终点为疾病控制率（DCR）、肿瘤退缩分级（TRG）、手术切缘、副作用和总生存期。
实验组和对照组的ORR分别为72.4%和43.8%（P=0.226），DCR分别为89.7%和87.5%，R0切除率分别为96.5%和93.7%，肿瘤完全/部分退缩分级分别为17.2%和6.3%，部分肿瘤退缩分级分别为27.6%和18.7%（P=0.468），2年生存率分别为78.1%和73.9%（P=0.932）。常见的副作用为粒细胞缺乏症和呕吐。两组之间无显著差异。
曲妥珠单抗联合FLOT在可切除的HER-2阳性晚期胃癌患者围手术期治疗中具有良好的疗效和安全性。此外，曲妥珠单抗+FLOT与单独使用FLOT的结果相同，因为在所研究的组中添加曲妥珠单抗没有显著益处。
