替吉奥联合奥沙利铂一线治疗晚期食管癌的临床观察

A phase Ⅱ trial of S-1 plus oxaliplatin as first-line chemotherapy for advanced esophageal carcinoma

目的 本研究旨在评价替吉奥（S-1）联合奥沙利铂（SOX方案）一线治疗晚期食管癌的临床疗效和毒副反应。方法 SOX方案一线治疗35例食管癌患者。具体用法：替吉奥胶囊60mg,早晚餐后30min口服,连服14d;奥沙利铂130mg/m2加人5%葡萄糖液500m L中静脉滴注3h,第1天;21d为一周期,每2周期按WHO疗效标准评价疗效,所有患者至少接受2周期化疗。结果 35例患者共接受113个周期的化疗,所有患者均可评价疗效。35例患者中无完全缓解病例,部分缓解17例（48.57%）,稳定5例（14.29%）,进展13例（37.14%）,总有效率为62.86%,中位疾病进展时间187d,中位生存时间287d。最常见的不良反应为胃肠道反应及血液系统毒性,Ⅲ~Ⅳ级恶心/呕吐发生率为8.57%,Ⅲ~Ⅳ级粒细胞减少、Ⅲ~Ⅳ级血小板减少、Ⅲ~Ⅳ级贫血的发生率分别为8.57%,5.71%,5.71%;黏膜炎及腹泻多数为轻度,Ⅲ级毒性均为1例,经对症治疗后均可缓解;神经系统毒性较轻微,主要为Ⅰ级,无Ⅲ级以上外周神经毒性发生;肝毒性主要表现为ALT升高,但毒性较轻微,无Ⅱ级以上肝毒性。结论 替吉奥联合奥沙利铂方案一线治疗晚期食管癌疗效满意、毒性较低,值得临床应用及进一步大样本、多中心研究。

Objective This study was to evaluate the efficacy and toxicity of SOX regimen as first-line chemotherapy for advanced esophageal carcinoma （AEC） patients. Met!rods Thirty-five patients with pathologically confirmed AEC were entered into the study. They .received S-1 （60rag, bid, days 1 to 14） and oxaliplatin （130mg/m2, day 1） every 3 weeks. Treatment efficacy was evaluated every six weeks based on the WHO standard. All patients received at least two cycles of therapy. Results Patients received a total of 113 cycles of treatment, and all were evaluable for efficacy and toxicity. The overall response rate was 62.86% . No complete response （CR） was achieved, 17 （48.57%） achieved partial responses （PRs）, 5 （14.29%） had stable disease （SD）, and 13 had progression disease （PD）. The median time to progression （TTP） was 187 days and the median survival time （MST） was 287 days. Hematologic toxicity included 3 cases （8.57 % ） of grade Ⅲ- IV neutropenia, and two cases of grade Ⅲ - IV thrombocytopenia. The main non-hematologic toxicity included three cases of grade Ⅲ nausea/vomiting （8.57 % ）. Conclusion SOX regimen is effective and well tolerated as first-line chemotherapy for AEC patients.