DX方案与DF方案治疗老年进展期胃癌的对比研究

Therapeutic outcomes of Docetaxel combined with capecitabine regimen versus docetaxel combined with 5-fluorouracil and leucovorin regimen for elderly patients with advanced gastric cancer

目的比较多烯紫杉醇联合卡培他滨（DX）方案与多烯紫杉醇联合5-氟尿嘧啶/亚叶酸钙（DF）方案治疗老年进展期胃癌的临床疗效及安全性。方法 96例患者随机分为治疗组和对照组。治疗组（DX组）49例,应用多烯紫杉醇联合卡培他滨方案化疗：多烯紫杉醇60mg/m2,静脉滴注1h,第1天;卡培他滨1 000mg/m2,口服,2次/日,第1~14天。对照组（DF组）47例,应用多烯紫杉醇联合5-氟尿嘧啶/亚叶酸钙方案化疗：多烯紫杉醇60mg/m2,静脉滴注1h,第1天;亚叶酸钙200mg/m2,静脉滴注2h后予5-氟尿嘧啶500mg/m2,持续静脉输注22h,第1~5天;两组均3周为1周期。2周期后评价疗效。随访观察疾病进展时间和生存期。结果DX组总有效率42.86%,DF组总有效率31.91%,差异无统计学意义（P〉0.05）;DX组、DF组疾病控制率分别为79.59%、63.83%,两组相比差异无统计学意义（P〉0.05）;DX组体力状况Karnofsky评分明显高于DF组（P〈0.05）。DX组手足综合征发生率明显高于DF组（P〈0.05）,而Ⅲ/Ⅳ度中性粒细胞下降发生率则明显低于DF组（P〈0.05）。结论多烯紫杉醇联合卡培他滨方案疗效肯定、不良反应易耐受,是老年进展期胃癌较理想的化疗方案,值得临床进一步研究。

Objective To compare the efficacy and safety of docetaxel plus capecitabine（DX）regimen and docetaxel combined with 5-fluorouracil/leucovorin calcium（DF）regimen in the treatment of elderly patients with advanced gastric cancer（AGC）. Methods A total of 96 elderly patients with AGC were randomly divided into an observation and a control group.The observation group（DX group,n =49）received DX regimen chemotherapy with docetaxel 60 mg/m2,intravenous drip（1h）,day l;oral capecitabine 1000 mg/m2,twice daily,day 1to14.The control group（DF group,n=47）received DF chemotherapy with docetaxel 60mg/m2,intravenous drip（1h）,day l;leucovorin calcium 200mg/m2,intravenous drip（2h）,followed by 5-fluorouracil 500mg/m2,continuous intravenous infusion（22h）,day 1to 5.The two regimens were repeated every 21 days.The efficacy and toxicity were evaluated after two cycles.The time to progression（TTP）and survival time（ST）were observed and recorded. Results The response rate（RR）of the DX group was 42.86% while the DF group was 31.91%,there was no significant difference in two groups（P〉0.05）.The disease control rate（DCR）of the DX group and the DF group was 79.59% and 63.83%,respectively,group paired comparison showed no statistical difference（P 〉0.05）.But the Karnofsky scores of the DX group was higher than that of the DF group（P〈0.05）.The incidence of hand-foot syndrome of the DX group was more than that of the DF group（P〈0.05）.And the incidence of III/IV degree of bone marrow suppression in DX group was obviously lower than that of the DF group（P〈0.05）. Conclusion Docetaxel combined with capecitabine regimen is an effective,safe and well-tolerated regimen for elderly patients with advanced gastric cancer.It was considerable regimen in the treatment of elderly patients with advanced gastric cancer.It was worthy of further clinical study.