J Natl Cancer Inst. 1988 Sep 7;80(13):1011-5. doi: 10.1093/jnci/80.13.1011.
The Gastrointestinal Tumor Study Group compared three regimens in a controlled prospectively randomized trial for the treatment of patients with advanced gastric cancer. All regimens contained 5-fluorouracil and doxorubicin (FA) but differed in the third drug: semustine (Me), triazinate (T), or cisplatin (P). FAT produced significantly superior overall survival (P less than .01) compared to FAMe. One-year survival rate for the FAT regimen was 30% compared to 15% for the FAMe regimen, and median survival times were 30 versus 24 weeks, respectively. The FAP regimen demonstrated a similar survival advantage compared to the FAMe regimen. The improved survival was observed despite decreased 5-fluorouracil and doxorubicin dosages for patients on the FAT and FAP arms. Severe toxicity rates were 42% for FAT, 69% for FAP, and 62% for FAMe. The FAT regimen produced significantly less hematologic toxicity than either FAP or FAMe, while mild neurotoxicity was the limiting toxicity of cisplatin in this study. Two classes of drugs, without known risks of potentially fatal long-term toxic effects, appear to be effective substitutes for long-acting alkylating agents such as Me or mitomycin in the treatment of advanced gastric cancer. These findings identify new approaches to therapy for this common disease.
胃肠道肿瘤研究组在一项前瞻性对照随机试验中，比较了三种治疗晚期胃癌患者的方案。所有方案都含有5-氟尿嘧啶和阿霉素（FA），但第三种药物不同：司莫司汀（Me）、三嗪咪唑胺（T）或顺铂（P）。与FAME方案相比，FAT方案的总生存期显著更长（P<0.01）。FAT方案的一年生存率为30%，而FAME方案为15%，中位生存期分别为30周和24周。与FAME方案相比，FAP方案也显示出类似的生存优势。尽管FAT组和FAP组患者的5-氟尿嘧啶和阿霉素剂量降低，但仍观察到生存期有所改善。FAT方案的严重毒性发生率为42%，FAP方案为69%，FAME方案为62%。FAT方案产生的血液学毒性明显低于FAP或FAME方案，而轻度神经毒性是本研究中顺铂的剂量限制性毒性。两类无已知潜在致命长期毒性风险的药物，似乎可有效替代长效烷化剂如Me或丝裂霉素用于晚期胃癌的治疗。这些发现为这种常见疾病确定了新的治疗方法。
