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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 efficacy and side effects of gemcitabine plus cisplatin (GP regimen) or fluorouracil plus cisplatin (PF regimen) in the treatment of advanced esophageal cancer. Methods: From October 2006 to October 2008, 48 patients with advanced stage Ⅲ-Ⅳ advanced esophageal cancer were randomly divided into GP regimen (24 cases) and PF regimen (24 cases), with 3 cycles of 1 chemotherapy cycle. Each 2 A cycle of evaluation of the efficacy and adverse reactions, completed 4 to 6 cycles of chemotherapy after the evaluation of the short-term efficacy and follow-up. The median survival time (MST), 1, 2 and 3 year survival rates were observed. Results: The effective rate of GP group was 70.8% (17/24), which was higher than that of PF group (41.7%, 10/24). The difference was statistically significant (P = 0.042). The main adverse reactions in both groups were bone marrow suppression and gastrointestinal adverse reactions. The incidence of grade Ⅲ ~ Ⅳ leukopenia in GP group and PF group were 37.5% (9/24) and 16.7% (4/24), respectively. The incidence of grade Ⅲ ~ Ⅳ thrombocytopenia was 29.2% (7/24) and 8.3% The rates of% (2/24), Ⅲ ° nausea and vomiting were 20.8% (5/24) and 33.3% (8/24), respectively. There was no significant difference between the two groups (P> 0.05). No grade IV gastrointestinal adverse reactions and grade Ⅱ ~ Ⅳ liver and kidney dysfunction. The MST in the GP group was 22.6 months (95% confidence interval: 12.8 to 32.4 months), and the MST in the PF group was 11.5 months (95% confidence interval: 9.3 to 13.7 months) with statistically significant differences P <0.05). The 1-year survival rates in GP group were higher than those in PF group (75.0% vs 45.8%, P = 0.039). There was no significant difference in 2-year and 3-year survival between PF group and GP group (GP: 31.0% vs 8.3% Group: 25.0% and 4.2%) (P> 0.05). Conclusion: The GP regimen in the treatment of advanced esophageal cancer has better curative effect and survival benefit than PF regimen. The patients are well tolerated.