Loehrer P J, Harry D, Chlebowski R T
Department of Medicine, Indiana University School of Medicine.
Invest New Drugs. 1994;12(1):57-63. doi: 10.1007/BF00873238.
From January, 1985, through January, 1987, 165 patients with advanced gastric cancer were randomized to receive epirubicin (E) alone (90 mg/m2 day 1), 5-Fluorouracil (5-FU) alone (500 mg/m2 days 1-5), or the combination of E (90 mg/m2 day 1) and 5-FU (400 mg/m2 days 1-5). Courses were repeated every four weeks. Patients were stratified by extent (locally advanced vs. metastatic), evaluability (measurable vs. nonmeasurable) and by history of prior radiotherapy (yes vs. no). Randomization to single arm epirubicin was stopped after 26 patients were enrolled. Objective responses occurred in only 1/16 (6%) of the patients treated with E alone, 1/40 (5%) with 5-FU alone and 4/33 (12%) with both 5-FU and E. There were no significant differences in all eligible patients with respect to time to progression or overall survival in the three treatment arms. Toxicity was primarily hematologic and more pronounced in the combination arm. Neither 5-FU alone, epirubicin alone, or the combination have a major impact in the treatment of gastric carcinoma.
从1985年1月至1987年1月，165例晚期胃癌患者被随机分组，分别接受单纯表柔比星（E）治疗（第1天90mg/m²）、单纯5-氟尿嘧啶（5-FU）治疗（第1 - 5天500mg/m²）或表柔比星（第1天90mg/m²）与5-氟尿嘧啶（第1 - 5天400mg/m²）联合治疗。每四周重复疗程。患者按病变范围（局部晚期与转移性）、可评估性（可测量与不可测量）以及既往放疗史（有与无）进行分层。在纳入26例患者后，停止了单臂表柔比星的随机分组。单纯接受E治疗的患者中仅1/16（6%）出现客观缓解，单纯接受5-FU治疗的患者中为1/40（5%），接受5-FU与E联合治疗的患者中为4/33（12%）。在所有符合条件的患者中，三个治疗组在疾病进展时间或总生存期方面无显著差异。毒性主要为血液学毒性，联合治疗组更为明显。单独使用5-FU、单独使用表柔比星或联合治疗对胃癌治疗均无重大影响。
