Evaluation of daunorubicin (NSC-82151) and methotrexate (NSC-740) in combination as a remission maintenance regimen in the treatment of acute leukemia.

The addition of a single monthy dose of daunorubicin (25 mg/m given intravenously) to the maximum tolerated dose of methotrexate (25 mg/m/dose given orally twice weekly) was evaluated as a maintenance regimen in 0 children with acute lymphoblastic leukemia. Seven patients who were nonevaluable were excluded from the study; 31 patients received methotrexate alone and 32 patients received a combination of methotrezate and daunorubicin. There was no significant difference between the distribution of remission times for the two maintenance regimens (medians of 147 and 162 days, respectively). For patients with only one previous remission, the median length of remission in this study was significantly shorter than that of the original remission time. Despite the known myelosuppressive effects of both agents, daunorubicin did not cause additional toxicity nor did it interfere with the scheduled methotrexate therapy. Although the addition of daunorubicin to methotrexate does not appear to be beneficial in the treatment of acute leukemia, this combination could be evaluated in other cancers in which both agents are known to be effective.