吉西他滨联合顺铂治疗晚期食管癌的临床观察

Clinical analysis of gemcitabine combined with cisplatin in the treatment of advanced esophageal carcinoma

目的:比较吉西他滨联合顺铂(GP方案)或氟尿嘧啶联合顺铂(PF方案)治疗晚期食管癌的疗效和不良反应。方法:2006年10月-2008年10月,48例Ⅲ～Ⅳ期初治晚期食管癌患者随机接受GP方案(24例)或PF方案(24例)化疗,3周为1个化疗周期,每2个周期评价1次疗效和不良反应,完成4～6个化疗周期后评价近期疗效,并进行随访。观察中位生存时间(median survival time,MST)以及1、2和3年生存率。结果:GP组有效率为70.8%(17/24),高于PF组的41.7%(10/24),差异有统计学意义(P=0.042)。两组的主要不良反应均为骨髓抑制和胃肠系统不良反应。GP组和PF组Ⅲ～Ⅳ度白细胞减少发生率分别为37.5%(9/24)和16.7%(4/24),Ⅲ～Ⅳ度血小板减少发生率分别为29.2%(7/24)和8.3%(2/24),Ⅲ度恶心和呕吐的发生率分别为20.8%(5/24)和33.3%(8/24),两组差异均无统计学意义(P>0.05)。未见Ⅳ度胃肠系统不良反应和Ⅱ～Ⅳ度肝肾功能损害。GP组的MST为22.6个月(95%可信区间:12.8～32.4个月),PF组的MST为11.5个月(95%可信区间:9.3～13.7个月),差异有统计学意义(P<0.05)。GP组的1年生存率高于PF组(75.0%和45.8%,P=0.039),2年和3年生存率与PF组的差异无统计学意义(GP组:31.0%和8.3%;PF组:25.0%和4.2%)(P>0.05)。结论:GP方案治疗晚期食管癌的近期疗效和生存获益均优于PF方案,患者耐受良好。

Objective： To compare the clinical response and toxicities between GP （gemcitabine combined with cisplatin） and PF （cisplatin combined with fluorouracil） regimens in patients with primary advanced esophageal carcinoma. Methods： Forty-eight patients with stages Ⅲ-Ⅳ advanced esophageal cancer randomly received GP regimen （n = 24） or PF regimen （n = 24） every three weeks. The clinical response and toxicities were evaluated every two cycles, and the short-term response was evaluated after completion of 4-6 cycles of chemotherapy. MST （median survival time） and one-, two- and three-year survival rates were calculated. Results： The overall response rate of GP regimen was significantly higher than that of PF regimen [70.8% （17/24） vs 41.7% （10/24）, P = 0.042]. The most common toxicities were myelosuppression and gastrointestinal reactions in the two groups. The proportions of patients experienced grades Ⅲ-Ⅳ neutropenia and thrombocytopenia between GP group and PF group were 37.5% （9/24） and 16.7% （4/24） （P 〉 0.05）, and 29.2% （7/24） and 8.3% （2/24） （P 〉 0.05）, respectively. Grade Ⅲ nausea and vomiting was observed in 5 （20.8%） patients in GP group and 8 （33.3%） patients in PF group （P 〉 0.05）. Grade Ⅳ gastrointestinal reactions and grades Ⅱ-Ⅳ hepatic and renal failure were not observed in this study period. The MST of the GP group and the PF group were 22.6 （95% confidence interval： 12.8-32.4） and 11.5 （95% confidence interval： 9.3-13.7） months, respectively （P 〈 0.05）. The one-year survival rate of the patients receiving GP regimen was 75.0%, which was higher than that of the patients receiving PF regimen （45.8%, P = 0.039）. However, the two- and three-year survival rates were not significantly higher in the GP group than in the PF group （31.0% vs 8.3%; 25.0% vs 4.2%; P 〉 0.05）.Conclusion： GP regimen is superior to PF regimen in short-term response and long-term survival benefit for patients with advanced esophageal carcinoma, and the toxicities are tolerable.