Department of Medical Oncology, People's Hospital of Xinjiang, Urumqi, People's Republic of China.
Onco Targets Ther. 2013 Jul 25;6:925-9. doi: 10.2147/OTT.S46487. Print 2013.
We aimed to evaluate the efficacy and safety of combination therapy of Endostar (recombinant human endostatin) and S-1 combined with oxaliplatin (SOX) in patients with advanced gastric cancer.
In this randomized, controlled trial, 165 late-stage gastric cancer patients were assigned to the experimental arm with Endostar in combination with SOX (80 patients) and the control arm with SOX alone (85 patients). The end points of this study included progression-free survival, response rate, and disease-control rate.
There was no statistically significant difference in response rate between the experimental arm and the control arm (53.8% vs 42.4%, P=0.188). The difference in disease-control rate was also statistically insignificant between the two arms (85.0% vs 72.9%, P=0.188). Progression-free survival in the experimental arm was significantly higher than that in the control arm (15.0 months vs 12.0 months, P=0.0001). Common adverse events included immunosuppression, gastrointestinal distress, and neuropathy. There was no statistical difference in the incidences of adverse events.
Combination therapy of Endostar and SOX provides therapeutic benefits to advanced gastric cancer patients, with tolerable adverse effects.
我们旨在评估恩度（重组人血管内皮抑制素）联合替吉奥（S-1）加奥沙利铂（SOX）方案治疗晚期胃癌的疗效和安全性。
在这项随机对照试验中，165 例晚期胃癌患者被分配到恩度联合 SOX 组（80 例）和 SOX 单药组（85 例）。该研究的终点包括无进展生存期、缓解率和疾病控制率。
实验组和对照组的缓解率无统计学差异（53.8%比 42.4%，P=0.188）。两组疾病控制率的差异也无统计学意义（85.0%比 72.9%，P=0.188）。实验组的无进展生存期明显长于对照组（15.0 个月比 12.0 个月，P=0.0001）。常见的不良反应包括免疫抑制、胃肠道不适和神经病变。不良反应的发生率无统计学差异。
恩度联合 SOX 方案为晚期胃癌患者提供了治疗益处，且不良反应可耐受。
