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前瞻性、随机对照的方法评价小剂量顺铂联合5-氟脲嘧啶与ELF方案治疗晚期胃癌的疗效 被引量:7

Prospective Randomized Trial in the Evaluation of Combinated Chemotherapy of Low-dose Cisplatin and 5-fluorouracil Versus ELF Chemotherapy in Advanced Cancer
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摘要 目的:前瞻性、随机对照的方法分析比较小剂量顺铂联合5-氟脲嘧啶持续静脉滴注(L-FP)与ELF方案治疗不能切除或复发和转移的晚期胃癌病人的疗效。方法:49例晚期胃癌患者随机分入L-FP组(试验组)24例和ELF组(对照组)25例。试验组:CDDP3.5mg/m2,每周1~5天,连续4周,5-FU300mg/m2,持续静脉滴注24小时,连续4周,休息2周,共治疗2个周期。对照组:LV200mg/d静脉滴注1小时,Vp-16100mg/d静脉滴注4小时,5-FU500mg/m2静脉滴注,第1~5天,3周为一周期,共治疗2~3个周期。结果:试验组24例中,可评价疗效23例,完全缓解(CR)3例,部分缓解(PR)9例;对照组25例中,22例可评价疗效,完全缓解(CR)1例,部分缓解(PR)7例,实验组和对照组有效率分别为52.2%和31.9%(P=0.167)。两组肿瘤中位缓解时间、中位进展时间、中位生存时间分别为5.5月、7.0月、9.0月和4.0月、5.5月、7.0月。1年生存率分别为30.4%和13.6%,经Log-rank检验具有统计学意义(P=0.032)。不良反应:试验组Ⅲ度以上副作用发生率:恶心、呕吐12.5%,白细胞减少4.2%,中性粒细胞减少8.3%,血小板降低4.2%,对照组恶心、呕吐16.0%,白细胞减少12.0%,中性粒细胞减少12.0%,血小板降低4.0%。结论:小剂量顺铂联合5-氟脲嘧啶持续静脉滴注(L-FP)治疗晚期胃癌疗效好,毒副反应可耐受。 Objective: Objective: The results of a prospectively randomized study from comparison of the combined treatment of low- dose of CDDP and protracted venous infusion of Fluorouracil (L- FP) with the combination of Etoposide, Leucovorin and Fluorouracil (ELF) in advanced gastric cancer were reported. Patients and Methods: Forty nine patients with adennocarcinoma received randomizedly either L- FP (CDDP3.5mg/m^2/d, d1 - 5/w and PVI 5 - FU300mg/m^2/d, 4week) or ELF (Etoposide 100mg/d, d1-3, Leucovorin 200mg/d, d1-5, Fluorouracil 500mg/m2/d, d1-5, every 3 weeks) and analyzed their for survials, response, and toxicities were analyzed. Results: The over- all response rate was 52.2% with L- FP and 31.9% with ELF ( P = 0,167), Toxicity was both tolerable, and there were no toxic death. The median response duration, the median time to progression, the median survival time was 5.5, 7.0, 9.0 months with L - PF and 4.0, 5.5, 7.0 months with ELF. 1 - year suvival rates was 30.4% and 13.6%, respectively. The difference was statistically significant between the two groups with respect to over - all survial ( P = 0.032). Conclusion: This study demonstrated that the L - FP was superior to ELF in advanced gastric cancer, and the toxicity was tolerable,
出处 《华西医学》 CAS 2005年第3期440-442,共3页 West China Medical Journal
关键词 小剂量顺铂 5-氟脲嘧啶 亚叶酸钙 足叶乙甙 晚期胃癌 化疗 CDDP Fluorouracil Etoposide Leucovorin advanced gastric cancer chemotherapy
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