Triazinate and platinum efficacy in combination with 5-fluorouracil and doxorubicin: results of a three-arm randomized trial in metastatic gastric cancer. Gastrointestinal Tumor Study Group.

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.