Wils J A, Klein H O, Wagener D J, Bleiberg H, Reis H, Korsten F, Conroy T, Fickers M, Leyvraz S, Buyse M
Laurentius Hospital, Roermond, The Netherlands.
J Clin Oncol. 1991 May;9(5):827-31. doi: 10.1200/JCO.1991.9.5.827.
In a prospective phase III multicenter trial, 213 patients with advanced measurable or nonmeasurable gastric cancer were randomized to receive methotrexate (MTX), fluorouracil (5-FU), and Adriamycin (doxorubicin; Farmitalia Carlo Erba, Milan, Italy) (FAMTX) or 5-FU, Adriamycin, and mitomycin (FAM). The results show a significantly superior response rate (41% v 9% [P less than .0001]), and survival (median, 42 weeks v 29 weeks [P = .004]) for FAMTX. There was a cumulative thrombocytopenia in FAM and not in FAMTX. The FAMTX protocol should be the reference treatment in future clinical trials that seek to improve the therapeutic outcome in advanced gastric cancer.
在一项前瞻性III期多中心试验中，213例晚期可测量或不可测量的胃癌患者被随机分组，分别接受甲氨蝶呤（MTX）、氟尿嘧啶（5-FU）和阿霉素（多柔比星；意大利米兰法玛西亚卡洛·埃巴公司）（FAMTX）或5-FU、阿霉素和丝裂霉素（FAM）治疗。结果显示，FAMTX的缓解率（41%对9%[P<0.0001]）和生存率（中位数，42周对29周[P = 0.004]）显著更高。FAM组出现累积性血小板减少，而FAMTX组未出现。在未来旨在改善晚期胃癌治疗效果的临床试验中，FAMTX方案应作为参考治疗方案。
