替吉奥胶囊联合奥沙利铂治疗进展期胃癌的临床研究

Study of S-1 and Oxaliplatin combination chemotherapy in patients with advanced gastric cancer

目的评价替吉奥胶囊联合奥沙利铂治疗进展期胃癌的疗效及毒副反应。方法收集我院65例经病理证实的不可手术切除的进展期胃癌患者,具有可评价的肿瘤病灶。随机分为研究组和对照组,根据RESIST疗效评估标准,评价客观疗效;采用NCI-CTC 3.0的标准评价不良反应。结果两组患者均完成治疗,且具有可评价病灶。研究组33例患者中,CR 2例(6.1%),PR 15例(45.5%),SD 10例(30.3%),PD 6例(18.2%);有效率为51.6%,疾病控制率为81.8%;中位无进展生存期8.1个月,中位生存期13.4个月。研究组32例患者中,CR 1例(3.1%),PR7例(21.9%),SD 14例(43.7%),PD 8例(31.3%);有效率为25.0%,疾病控制率为68.7%;中位缓解期5.8个月,中位生存期8.5个月。奥沙利铂联合替吉奥联合化疗组缓解率较替吉奥单药组更高,差异有统计学意义(P=0.028,<0.05)。两组不良反应主要是恶心呕吐、中性粒细胞减少、腹泻及胆碱能综合征,主要为1或2级,经对症处理后好转,无毒性相关死亡病例。结论替吉奥胶囊联合奥沙利铂治疗进展期胃癌是安全有效的,且给药方便,值得临床推广应用及进一步研究。

Objective To evaluate the clinical effects and adverse events of S-1 and Oxaliplatin combination chemotherapy in patients with advanced gastric cancer. Methods 65 patients with unresectable advanced gastric cancer and pathologically confirmed as adenocarcinoma by pathological diagnosis,having assessable focus were selected and randomly assigned to clinical trial group who were received S-1 and Oxaliplatin combination chemotherapy and control group who were received oral S-1. According to RESIST evaluation criteria for evaluating the objective response,using NCI-CTC 3.0 criteria evaluated the adverse reactions. Results All of the 65 cases were completed the whole plan were assessed with informed consent. In the study group 33 cases,the complete response rate（CR）,partial response rate（PR）,stable disease rate（SD） and progressive disease rate（PR） were 6.1%,45. 5%,30.3%,18.2%,respectively. The median time to progression（TTP） was 8.1 months,median survival time was 13.4 months. In the control group 32 cases,the complete response rate（CR）,partial response rate（PR）,stable disease rate（SD） and progressive disease rate（PR） were 3.1%,21.9%,43.7%,31.3%,respectively. The median time to progression（TTP） was 5.8 months,median survival time was 8.5 months. There is a significantly statistic difference between the two groups of the response rate（P=0.028,〈0.05） Adverse events mainly included nausea and vomiting,neutropenia,diarrhea,cholinergic syndrome and others. These events were mostly grade 1 or 2. All treatment-related toxicities resolved. There was no toxicity-related dead case. Conclusion S-1 and oxaliplatin combination chemotherapy is highly active against advanced gastric cancer and can be given safely and conveniently with proper management of adverse events. Further studies of this combination are warranted.