晚期胃癌卡培他滨或替吉奥维持治疗的临床研究

Clinical study of capecitabine or S-1 as maintenance treatment to patients with advanced gastric cancer

目的观察和比较晚期胃癌患者一线化疗后卡培他滨或替吉奥维持治疗的疗效及其不良反应。方法晚期胃癌患者一线化疗6个周期后,最终病情无进展的有123例,将其随机分为卡培他滨组(1 000 mg/m^2,每天2次,连续口服14 d,每21天为1个周期)或替吉奥组(体表面积≤1.25 m^2,40mg/次;体表面积1.25~1.5 m^2,50 mg/次;体表面积≥1.5 m^2,60 mg/次,每天2次,连续14 d,每21天为1个周期)和观察组(予最佳支持治疗)。维持化疗直至病情进展或患者出现化疗不耐受。结果卡培他滨组、替吉奥组的疾病控制率分别是70.7%、80.5%(P=0.304);两组的中位疾病进展时间分别为8.3和8.5个月,差异无统计学意义(P=0.448),但明显长于观察组的6.7个月(P<0.001)。维持化疗组的中位生存时间分别为15.3、15.7个月,差异无显著性(P=0.637),但优于观察组的12.8个月(P<0.05)。两组患者的不良反应主要有色素沉着、骨髓抑制、恶心呕吐以及手足综合征等,未出现治疗相关的死亡。结论卡培他滨和替吉奥在晚期胃癌的维持化疗中疗效相当,能够延长患者的生存时间,并且不良反应能耐受。

Objective To evaluate the efficacy and adverse effect caused by capecitabine compared with S-1 as maintenance treatment of patients with advanced gastric cancer（AGC）.Methods A total of 123 AGC patients who did not suffer disease progression after first-line chemotherapy were randomized into three groups.The capecitabine group（Cap）received maintenance chemotherapy with capecitabine（1 000 mg/m^2 twice daily for 14 days,21 days/cycle）,and the S-1 group（S1）received S-1（40,50,or 60 mg according to the body surface area and orally administered twice a day for 14 days,21 days/cycle）.The observation group was given the supportive treatment.Patients kept this chemotherapy regimens until disease progressed or with intolerant toxicity.Results The disease control rate was 70.7% in the Cap group and 80.5% in the S1 group（P=0.304）.The median time of progression was 8.3 months in the Cap group and 8.5 months in the S1 group（P=0.448）.Maintenance chemotherapy groups showed better responses in the treatment group than the observation group,which demonstrated a median progression of 6.7 months（P〈0.001）.The median overall survival time was 15.3 months in the Cap group and 15.7 months in the S1 group（P=0.637）.Maintenance chemotherapy groups showed better responses than the observation group,which demonstrated a median survival of 12.8 months（P〈0.05）.The main side effects included hyperpigmentation,bone marrow suppression,nausea and vomiting and hand-foot syndrome.No death occurred in relation to the therapy.Conclusion The effectiveness of capecitabine and S-1 as maintenance chemotherapy in AGC patients after the first-line chemotherapy are similar,and both can prolong the time of overall survival.And the adverse reactions can be tolerated.