Lacave A, Wils J, Bleiberg H, Diaz-Rubio E, Duez N, Dalesio O
J Clin Oncol. 1987 Sep;5(9):1387-93. doi: 10.1200/JCO.1987.5.9.1387.
In a prospective phase III multicenter trial, 189 patients with advanced measurable and nonmeasurable gastric cancer were randomized to receive 5-fluorouracil (5-FU) combined with Adriamycin (FA) or FA plus methyl-CCNU (MeFA). The response rate in patients with measurable disease was 10% (three of 29), and 18% (five of 28), respectively. No difference in the duration of survival was detected (P = .14; log rank test). Median survivals were 21 and 32 weeks, respectively. Toxicity was moderate, but there have been two toxic deaths among the patients who received FA. Because of the low response rate and the short survival, neither regimen can be recommended for the treatment of advanced gastric cancer.
在一项前瞻性III期多中心试验中，189例晚期可测量和不可测量的胃癌患者被随机分为两组，分别接受5-氟尿嘧啶（5-FU）联合阿霉素（FA）或FA加甲基环己亚硝脲（MeFA）治疗。可测量疾病患者的缓解率分别为10%（29例中的3例）和18%（28例中的5例）。未检测到生存时间的差异（P = 0.14；对数秩检验）。中位生存期分别为21周和32周。毒性为中度，但接受FA治疗的患者中有2例因毒性死亡。由于缓解率低和生存期短，两种方案均不推荐用于晚期胃癌的治疗。
