吉西他滨加卡铂与依托泊苷加卡铂治疗晚期食管癌的对照试验

A comparing trial of gemcitabine plus carboplatin versus etoposide plus carboplatin in treatment of patients with advanced esophageal cancer

目的:观察吉西他滨+卡铂与依托泊苷+卡铂治疗晚期食管癌的疗效和不良反应。方法:可评价疗效的晚期食管癌病人分为治疗组和对照组。治疗组36例,吉西他滨,d 1,8,1 000 mg·m^(-2)静脉滴注;卡铂,d 1,300 mg·m^(-2);21 d为一个周期。对照组35例,依托泊苷,d 1,2,3,100 mg·m^(-2)静脉滴注;卡铂,d 1,300 mg·m^(-2);21 d为一个周期。比较2组的疗效和不良反应。结果:治疗组和对照组的有效率分别为39％和31％(P=0．511),临床获益率分别为78％和54％(P=0．036),平均肿瘤进展时间分别为(5．8±s 1．7)mo和(5．2±1．8)mo(P=0．871),1年生存率分别为61％和49％(P=0．288)。2组主要不良反应为骨髓抑制和胃肠道反应,治疗有效的病人进食困难和胸痛均缓解。结论:吉西他滨+卡铂治疗晚期食管癌疗效确切,临床获益率高,病人耐受性好,为晚期食管癌的治疗提供了一种新的选择。

AIM： To evaluate the difference of efficacies and adverse reactions in advanced esophageal cancer patients treated with gemcitabine plus carboplatin versus etoposide plus carboplatin. METHODS： Eligible patients were randomly assigned to PG （gemcitabine ＋ carboplatin） group （n = 36） and PE （etoposide ＋ carboplatin） group （it = 35）. PG group was treated individually with gemcitabine 1 000 mg·m^-2 iv drip on d 1 and 8, and carboplatin 300 mg·m^-2 iv drip on d 1; PE group individually was treated with etoposide 100 mg·m^-2 iv drip on d 1, 2 and 3, and carboplatin 300 mg·m^-2 iv drip on d 1. Both groups pursued 21 d as a cycle. The response rate, clinical benefit rate, time to progression （TTP）, one-year survival, and side effects were observed and compared. RESULTS： The response rates, clinical benefit rates, mean TTP, one year survival rates were 39 % vs 31% （P=0.511）, 78%vs54% （P=0.036）, （5.8±s 1.7） movs （5.2±1.8） mo （P= 0.871）, and 61% vs 49 % （P = 0.288） in the PG and PE groups, respectively. The major adverse reactions were inhibition Of bone marrow and digestive tract reaction, with no statistical difference between the two groups. Dysphagia and chest pain were decreased in the responding patients. CONCLUSION： Good efficacy and tolerability of the PG regimen offer a new candidate for treating advanced esophageal cancer.