替吉奥联合奥沙利铂治疗复发、转移性胃癌的临床观察

Clinical evaluation of tegafur-gimeracil-oteracil potassium combined with oxaliplatin for recurrent and metastatic gastric cancer

目的评估替吉奥(S-1)联合奥沙利铂化疗方案治疗复发、转移性胃癌患者的疗效及不良反应。方法选择2007年4月至2011年6月本院收治的复发、转移性胃癌患者,共38例,随机分为替吉奥联合奥沙利铂治疗组(n=19)和顺铂联合氟尿嘧啶对照组(n=19),所有患者均至少接受2个疗程化疗。参照实体瘤疗效评价标准(RECIST),通过治疗后部分缓解(PR)、病情稳定(SD)和病情进展(PD)情况,以及疾病进展时间(TTP)和中位生存时间(MST)等评估疗效,并观察不良反应。结果治疗组8例为PR,6例为SD,5例为PD,有效率为42.10%,疾病控制率为73.68%,TTP为8.3个月,MST为10.7个月;对照组6例为PR,5例为SD,8例为PD,有效率为31.58%,疾病控制率为57.59%,TPP为7.1个月,MST为8.2个月。两组间有效率、疾病控制率、TTP及MST差异均具有统计学意义(P<0.05)。两组患者主要不良反应为骨髓抑制、胃肠道反应及外周神经毒性,治疗组Ⅲ/Ⅳ级不良反应发生率显著低于对照组(8.5%对17.6%,P<0.05)。结论替吉奥联合奥沙利铂化疗方案治疗复发、转移性胃癌,临床获益率较高,不良反应较轻,患者耐受良好。

Objective To investigate the clinical efficacy and adverse reactions of tegafur-gimeracil-oteracil potassium （S-l） combined with oxaliplatin in the treatment of recurrent and metastatic gastric cancer. Methods Patients with recurrent and metastatic gastric carcinoma were randomly divided into S-1 plus oxaliplatin treatment group （n=19） and 5-fluorouracil plus cisplatin control group （n=19）. All patients received at least two cycle therapy. Then observed partial response （PR）, stable disease （SD） and progressive disease （PD） in patients according to Response Evaluation Criteria in Solid Tumors （RECIST）, included time to progression （TTP）, median survival time （MST） and adverse reactions. Results In treatment group, there were 8 cases reached PR, 6 cases SD, and 5 cases PD, the rate of effectiveness was 42.10%, the clinical beneficial response was 73.68%, TPP and MST were 8.3 and 10.7 months. However, in control group, there were 6 cases reached PR, 5 cases SD, 8 cases PD. The rate of effectiveness was 31.58%, the clinical beneficial response was 57.59%, TPP and MST were 7.1 and 8.2 months. There was obvious difference between each group. The major toxicities included myelosuppression, gastrointestinal reaction and peripheral nerve toxicity, the incidence of III/1V leukocyte reduction in treatment group were lower than those in control group （8.5% vs 17.6%, P〈0.05）. Conclusion S-1 plus oxaliplatin chemotherapy regimen could achieve better clinical benefit and with mild adverse reactions in the treatment of recurrent and metastatic gastric cancer.