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A Randomized Clinical Trial of Daunorubicin and a Combination of Prednisone, Vincristine, 6-Mercaptopurine, and Methotrexate in Adult Acute Nonlymphocytic Leukemia¹

Medical Section, National Cancer Institute, Baltimore Cancer Research Center, Baltimore, Maryland 21211

Twenty-two adult patients with acute nonlymphocytic leukemia received daunorubicin, and 21 received a combination of prednisone, vincristine, 6-mercaptopurine, and methotrexate in a randomized study. The single agent was superior to the combination in inducing complete remission (50 versus 28%). In addition, patients who completely responded to daunorubicin did so in a median of 19 days, whereas the median time to complete response with the combination of prednisone, vincristine, 6-mercaptopurine, and methotrexate was 64 days. Deaths during therapy were fewer with daunorubicin than with the combination of prednisone, vincristine, 6-mercaptopurine, and methotrexate (36%, as compared to 52%). Daunorubicin is a highly effective drug in the treatment of adults with acute nonlymphocytic leukemia.

¹ This paper was presented in part at the Tenth International Cancer Congress, Houston, Texas, May 22 to 29, 1970.

² To whom requests for reprints may be addressed, at 3100 Wyman Park Drive, Baltimore, Md. 21211.

Received 1/20/72. Accepted 6/ 8/72.