EFFICACY OF DAUNORUBICIN IN THE THERAPY OF ADULT ACUTE LYMPHOCYTIC-LEUKEMIA - A PROSPECTIVE RANDOMIZED TRIAL BY CANCER AND LEUKEMIA GROUP-B

  • 1 January 1984
    • journal article
    • research article
    • Vol. 64  (1) , 267-274
Abstract
The efficacy of the addition of intensive therapy with daunorubicin (45 mg/m2 i.v. on days 1, 2, 3) to an induction program consisting of vincristine, prednisone, and L-asparaginase was assessed in 177 previously untreated adults (.gtoreq. 20 yr of age) with acute lymphocytic leukemia (ALL). A complete response [CR] was observed in 38/46 patients (83%) treated with daunorubicin, compared to 25/53 (47%) induced with vincristine, prednisone and L-asparaginase alone (P = 0.003). The high response rate attributable to the use of the anthracycline was confirmed by the nonrandomized treatment of 78 subsequent patients, in whom a CR rate of 76% was attained. A common program for CNS therapy and for maintenance therapy was employed in 103 patients achieving CR. Maintenance consisted of cycles of 6-mercaptopurine (6-MP) and methotrexate with periodic reinforcement with vincristine and prednisone. Maintenance therapy was minimally toxic. The average duration of CR was 15 mo. and was not affected by the induction program employed. Approximately 25% of responders are projected to remain in continuing CR for 36 mo. The failure of the daunorubicin-containing programs to produce a higher percentage of long-term survivors, despite the higher CR rates achieved, was thought to be due to the use of a maintenance program that was weak in intensity and dependent on reinforcement with vincristine and prednisone. The results support the concept of an intensive, rather than a conservative, chemotherapeutic approach as the most appropriate strategy for the treatment of adult ALL.