Zhang Zhan-Dong, Kong Ye, Yang Wei, Zhang Bin, Zhang Yong-Lei, Ma Er-Min, Liu Hong-Xing, Chen Xiao-Bin, Hua Ya-Wei
Department of General Surgery, Affiliated Tumor Hospital of Zhengzhou University, Henan Cancer Hospital, 127 Dongming Road, Zhengzhou 45008, China.
World J Surg Oncol. 2014 Apr 23;12:115. doi: 10.1186/1477-7819-12-115.
The prognosis of patients with advanced gastric cancer is poor. The goal of this study was to evaluate the efficacy and safety of combination therapy of cetuximab and S-1 combined with oxaliplatin (SOX) in Chinese patients with advanced gastric cancer.
For patients in the experimental group (cetuximab in combination with SOX (Ce-SOX), 30 patients), once-weekly cetuximab (400 mg/m2 at the first infusion then 250 mg/m2 every week) was administered. For patients in both the control (SOX alone, 26 patients) and experimental groups, oxaliplatin (100 mg/m2) was administered intravenously on day 1, while S-1 (80 mg/m2/day) was given orally twice daily for 14 days. The endpoints of this study included progression-free survival, response rate, and disease-control rate.
There was no statistically significant difference in response rate between the Ce-SOX and SOX groups (54.8% versus 44%, P=0.225). The difference in disease-control rate was also statistically insignificant between the two groups (87.1% versus 76%, P=0.162). Median progression-free survival in the Ce-SOX group was significantly higher than that in the SOX group (12.8 versus 10.1 months, P=0.007). The median overall survival of the Ce-SOX group and SOX group was 14.0 and 12.2 months, respectively (P=0.043). The one-year survival rate for the Ce-SOX group was 57% compared to 40% in the SOX group. There was no statistical difference in the grade 3 or 4 adverse effects between the two groups.
These findings suggest that the cetuximab combined with SOX regimen is feasible and shows promising efficacy with tolerable adverse effects in Chinese patients with advanced gastric cancer.
晚期胃癌患者的预后较差。本研究的目的是评估西妥昔单抗与S-1联合奥沙利铂（SOX）的联合疗法对中国晚期胃癌患者的疗效和安全性。
对于实验组患者（西妥昔单抗联合SOX（Ce-SOX），30例），给予每周一次的西妥昔单抗（首次输注剂量为400mg/m²，随后每周250mg/m²）。对于对照组（单纯SOX，26例）和实验组患者，奥沙利铂（100mg/m²）于第1天静脉给药，而S-1（80mg/m²/天）每日口服两次，共14天。本研究的终点包括无进展生存期、缓解率和疾病控制率。
Ce-SOX组和SOX组的缓解率无统计学显著差异（54.8%对44%，P=0.225）。两组的疾病控制率差异也无统计学意义（87.1%对76%，P=0.162）。Ce-SOX组的中位无进展生存期显著高于SOX组（12.8个月对10.1个月，P=0.007）。Ce-SOX组和SOX组的中位总生存期分别为14.0个月和12.2个月（P=0.043）。Ce-SOX组的一年生存率为57%，而SOX组为40%。两组3级或4级不良反应无统计学差异。
这些结果表明，西妥昔单抗联合SOX方案是可行的，并且在晚期胃癌中国患者中显示出有前景的疗效和可耐受的不良反应。
