Cancer. 1984 Jan 1;53(1):13-7. doi: 10.1002/1097-0142(19840101)53:1<13::aid-cncr2820530104>3.0.co;2-0.
Two hundred forty-one patients with unresectable gastric adenocarcinoma were entered, between December 1978 and March 1981, into a prospectively randomized comparison of three chemotherapy regimens to identify therapeutic activity and determine patient tolerability: (1) 5-fluorouracil plus Adriamycin (FA); (2) FA plus methyl-CCNU (FAMe); and (3) FA plus mitomycin C (FAMi). Patients were stratified by stage and performance status prior to randomization. Treatment groups were well balanced with respect to known prognostic discriminants. The primary endpoint to evaluate treatment effect was patient survival. Pair-wise comparisons using a proportional hazards model adjusted for stage and performance status documented a significant survival advantage for FAMe compared with FA (P less than 0.03). Toxicity was primarily hematologic and was seen more frequently in patients receiving FAMe. Further investigations of the FAMe regimen in the surgical adjuvant setting and combined with radiotherapy for patients with locally unresectable gastric cancer are under development.
1978年12月至1981年3月期间，241例无法切除的胃腺癌患者被纳入一项前瞻性随机对照试验，比较三种化疗方案，以确定治疗活性并评估患者耐受性：（1）5-氟尿嘧啶加阿霉素（FA）；（2）FA加甲基环己亚硝脲（FAMe）；（3）FA加丝裂霉素C（FAMi）。随机分组前，患者按分期和体能状态进行分层。各治疗组在已知的预后判别因素方面平衡良好。评估治疗效果的主要终点是患者生存率。使用调整了分期和体能状态的比例风险模型进行的两两比较表明，与FA相比，FAMe具有显著的生存优势（P<0.03）。毒性主要为血液学毒性，在接受FAMe治疗的患者中更常见。目前正在开展进一步研究，探索FAMe方案在手术辅助治疗中的应用，以及与局部无法切除的胃癌患者放疗联合使用的效果。
