替吉奥联合奥沙利铂与改良FOLFOX6方案一线治疗进展期胃癌的随机对照研究

Randomized controlled trial on S-1 combined with oxaliplatin and modified FOLFOX6 in the first-line therapy of advanced gastric cancer

目的比较国产替吉奥联合奥沙利铂方案(SOX)与改良FOLFOX6方案(mFOLFOX6)一线治疗局部晚期或转移性胃癌的近期疗效、远期生存及安全性。方法 40例进展期胃癌患者随机分为A、B组,A组采用SOX联合化疗方案,B组采用mFOLFOX6方案。2组患者均接受至少2周期化疗,每2周期评判1次近期疗效。结果 A组客观有效率、疾病控制率、中位疾病进展时间、中位生存期、1年生存率分别为45.0%、80.0%、6.0个月、15.0个月和45.0%;B组分别为40.0%、90.0%、5.5个月、11.0个月和35.0%。2组客观有效率及生存期无显著差异。2组不良反应均为血液系统毒性、恶心/呕吐和外周神经毒性,A组不良反应整体略轻微,但无显著性差异。结论氟尿嘧啶类药物联合奥沙利铂一线治疗进展期胃癌有较好的近期和远期疗效;替吉奥口服与氟尿嘧啶静脉化疗在疗效上无显著差异,不良反应均可耐受,可根据患者个体状况选择应用。

Objective To compare the nearterm therapeutic effect, long - term survival and safety of homemade S- 1 combined with oxaliplatin （SOX） and modified FOLFOX6 （mFOLFOX6） in the first - line therapy of local advanced or metastatic gastric cancer. Methods Forty patients with advanced gastric cancer were randomly divided into group A and group B. Group A adopted SOX combined with chemotherapy, while group B was applied with mFOLFOX6. Patients in both groups received at least two cycles of chemotherapy, and the nearterm therapeutic effects were evaluated once every two weeks. Results The objective response rate （ORR）, disease control rate （DCR）, median time to progression （mTTP）, median overall survival （mOS） and one - year survival rate of group A were 45.0 %, 80.0 %, 6.0 months, 15.0 months and 45.0 %, respectively, whereas those of group B were 40.0 %, 90.0 %, 5.5 months, 11.0 months and 35.0 %. There were no significant differences between ORR and OS of the two groups. The adverse reactions of both groups included hematologic toxicity, nausea/vomiting and peripheral nerve toxicity, and those of group A were milder on the whole, but there were no marked differences. Conclusion Fluorouracil - like drugs combined with oxaliplatin have better short - term and long - term therapeutic effects in the firstline treatment of advanced gastric cancer. The therapeutic effects of orallytaken S- 1 and fluomuracil intravenous chemotherapy have no conspicuous difference, and both adverse reactions can be tolerated, so they can be selected for application according to individual condition.