Randomized trial comparing epirubicin, cisplatin, and fluorouracil versus fluorouracil, doxorubicin, and methotrexate in advanced esophagogastric cancer
Randomized trial comparing epirubicin, cisplatin, and fluorouracil versus fluorouracil, doxorubicin, and methotrexate in advanced esophagogastric cancer
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DOI：
10.1200/jco.1997.15.1.261
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发表时间：
1997-01-01
影响因子：
45.3
通讯作者：
Meehan, M
中科院分区：
文献类型：
--
作者：
Webb, A;Cunningham, D;Meehan, M
目的：我们报告了一项前瞻性随机研究的结果，比较了表阿霉素、顺铂和长期静脉输注氟尿嘧啶（5-FU）（ECF方案）与5-FU、阿霉素和甲氨蝶呤（FAMTX）的标准组合在先前未经治疗的晚期食管胃癌患者中的应用。274例腺癌或未分化癌患者被随机分组，并分析生存率、肿瘤反应、毒性和生活质量（QL）。ECF组的总体缓解率为45%（95%置信区间[CI]，36%至54%），FAMTX组为21%（95% CI，13%至29%）（P = .0002）。毒性是可以忍受的，只有三个中毒死亡。FAMTX方案的血液学毒性和严重感染较ECF方案严重，而ECF方案的呕吐和脱发较FAMTX方案严重。ECF组的中位生存期为8.9个月，FAMTX组为5.7个月（P = 0.0009）; 1年时，ECF组36%（95%CI，27%至45%）和FAMTX组21%（95%CI，14%至29%）的患者存活。ECF组的中位无失败生存期为7.4个月，FAMTX组为3.4个月（P = 0.00006）。第24周时ECF的总体QL评分更好，但其余QL数据显示研究两组之间无差异。基于医院的成本分析的一个子集的患者是相似的，每个手臂，转化为一个增量成本为975美元每生命yeargained.Conclusion：ECF方案的结果在生存和反应的优势，可耐受的毒性，更好的QL和成本效益相比，FAMTX化疗。这种方案现在应该被认为是晚期食管胃癌的标准治疗。(C)1997年，美国临床肿瘤学会。
Purpose: We report the results of a prospectively randomized study that compared the combination of epirubicin, cisplatin, and protracted venous infusion fluorouracil (5-FU) (ECF regimen) with the standard combination of 5-FU, doxorubicin, and methotrexate (FAMTX) in previously untreated patients with advanced esophagogastric cancer.Patients and Methods: Two hundred seventy-four patients with adenocarcinoma or undifferentiated carcinoma were randomized and analyzed for survival, tumor response, toxicity, and quality of life (QL).Results: The overall response rate was 45% (95% confidence interval [CI], 36% to 54%) with ECF and 21% (95% CI, 13% to 29%) with FAMTX (P = .0002). Toxicity was tolerable and there were only three toxic deaths. The FAMTX regimen caused more hematologic toxicity and serious infections, but ECF caused more emesis and alopecia. The median survival duration was 8.9 months with ECF and 5.7 months with FAMTX (P = .0009); at 1 year, 36% (95% CI, 27% to 45%) of ECF and 21% (95% CI, 14% to 29%) of FAMTX patients were alive. The median failure-free survival duration was 7.4 months with ECF and 3.4 months with FAMTX (P = .00006). The global QL scores were better for ECF at 24 weeks, but the remaining QL data showed no differences between either arm of the study. Hospital-based cost analysis on a subset of patients was similar for each arm and translated into an increment cost of $975 per life-year gained.Conclusion: The ECF regimen results in a survival and response advantage, tolerable toxicity, better QL and cost-effectiveness compared with FAMTX chemotherapy. This regimen should now be considered the standard treatment for advanced esophagogastric cancer. (C) 1997 by American Society of Clinical Oncology.