One hundred and forty-six previously untreated patients with advanced gastric cancer were assigned at random to therapy with the following regimens: 1) Methyl CCNU alone; 2) Methyl CCNU with cyclophosphamide induction; 3) 5-fluorouracil (5-FU) + methyl CCNU; and 4) 5-FU + methyl CCNU with cyclophosphamide induction. Cyclophosphamide induction produced an objective response rate of only 8%. In addition, it added to hematologic toxicity and detracted from the therapeutic activity of subsequent treatment. Methyl CCNU was relatively ineffective therapy with an overall objective response rate of 8%. The response rate to 5-FU + methyl CCNU without cyclophosphamide induction was 40% and this was significantly superior to all other regimens. The survival time of all patients treated with 5-FU + methyl CCNU was significantly superior to that of all patients treated with methyl CCNU alone.
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