晚期胃癌一线化疗后卡培他滨维持治疗的疗效和安全性

Efficacy and safety of capecitabine maintenance therapy following first-line chemotherapy in patients with advanced gastric cancer

目的观察卡培他滨在晚期胃癌一线化疗后维持治疗的疗效和不良反应。方法 280例晚期胃癌患者经FOLFOX4方案(奥沙利铂+氟尿嘧啶+亚叶酸钙,6~9个周期)或XELOX方案(奥沙利铂+卡培他滨,4~6个周期)一线化疗后,疗效评价无疾病进展的172例患者,按照患者意愿分为维持组63例(卡培他滨维持治疗,1 000 mg/m2,每天2次,d1~14,每3周重复)和观察组109例。结果 FOLFOX4方案组和XELOX方案组的疾病控制率分别为64.4%(85/132)和65.5%(97/148),两者比较,差异无统计学意义(P=0.95)。XELOX方案的患者入维持组的比例高于FOLFOX4方案患者(P=0.009)。中位无进展生存期维持组为10.7个月(95%CI:9.6~11.8个月),观察组为7.3个月(95%CI:6.9~7.6个月,P<0.01)。中位生存期维持组优于观察组,分别为18.3个月(95%CI:17.5~19.0个月)和15.0个月(95%CI:14.5~15.5个月,P<0.01)。维持组常见不良反应为血液学和胃肠道毒性,以1~2级多见。结论卡培他滨作为晚期胃癌一线化疗后维持治疗延长PFS和OS,耐受性良好。

Objective To evaluate the efficacy and safety of capecitabine maintenance therapy following first-line chemotherapy in patients with advanced gastric cancer. Methods This study enrolled 172 cases who were evaluated as ＂ without disease progression＂ from 280 advanced gastric cancer patients after first-line chemotherapy of FOLFOX4 regimen（ oxaliplatin ＋ fluorouracil ＋ leucovorin） for 6 - 9 cycles or XELOX regimen（ oxaliplatin ＋ capecitabine） for 4 - 6 cycles.According to patients＇ decision,63 cases participated in the capecitabine maintenance group（ 1 000 mg/m^2,twice per day d1-14,every 3 weeks） and 109 cases participated in the observation group. Results The disease control rate was 64. 4%（ 85/132） in the patients treated by FOLFOX4 regimen and 65. 5%（ 97/148） in those treated by XELOX regimen（ P =0. 95）. Notably,the percentage of patients in the capecitabine maintenance group was higher in those treated by XELOX regimen than that in those treated by FOLFOX4 regimen（ P = 0. 009）. In the maintenance group,the median progression free survival time was 10. 7 months（ 95% CI： 9. 6-11. 8 months）,which was longer than that of the observation group（ 7. 3 months,95% CI： 6. 9-7. 6 months,P 0. 01）. Moreover,the median overall survival rate was also higher in the maintenance group（ 18. 3 months,95% CI： 17. 5-19. 0 months）,as compared with the observation group（ 15. 0 months,95%CI： 14. 5-15. 5 months,P 0. 01）. The most common adverse reactions in the maintenance group were grades 1-2 hematological and gastrointestinal toxicity. Conclusion Capecitabine maintenance therapy can prolong progression free survival and overall survival,with tolerant adverse reactions,in patients with advanced gastric cancer after first-line chemotherapy.