A randomized clinical trial of remission induction,consolidation, and chemo-immunotherapy maintenance in adult acute myeloblastic leukemia

Summary The Southeastern Cancer Study Group conducted a randomized clinical trial in acute myeloblastic leukemia and the blastic phase of chronic myelocytic leukemia to compare: Two induction programs (Schedule A) cytosine arabinoside and 6-thioguanine or (Schedule B) cytosine arabinoside, 6-thioguanine and daunorubicin; two consolidation programs (Schedule C) continuation of induction programs at a reduced dose or (Schedule D) a combination of cyclophosphamide, methotrexate and vincristine; and two maintenance programs — (Schedule E) 1 month of BCG, followed by methotrexate or (Schedule F) methotrexate. Over a 3 year period 372 patients were entered and 295 were judged evaluable. None of 11 patients with blastic phase of chronic myelocytic leukemia responded. There were no significant differences between the schedules in the number of patients with acute myeloblastic leukemia achieving complete remissions (37%, Schedule A vs. 41% Schedule B). The relapse rates on consolidation were similar (43%, Schedule C and 39%, Schedule D). BCG significantly prolonged the duration of first remission following consolidation (P<0.05) from 13.0–23.9 weeks. Survival was not significantly prolonged (92.7 weeks vs. 71.7 weeks). There were no serious complications from BCG therapy.Contributors. The following members of the Southeastern Cancer Study Group participated in this study: John T. Carpenter, John R. Durant, Richard Gams, William J. Hammack, George A. Omura, Gayle Roberts, University of Alabama School of Medicine, Birmingham, Alabama; Harold Silberman, Donald S. Miller, Duke University School of Medicine, Durham, North Carolina; William B. Kremer, Durham Veterans Administration Hospital, Durham, North Carolina; Evert A. Bruckner, Lawrence E. Cooper, Charles C. Corley, Joseph E. Hardison, Charles M. Huguley, Jr., James Keller, Mason G. Robertson, John D. Schmale, Charles Vogel, W. R. Vogler, William H. Whaley, E. F. Winton, Emory University School of Medicine, Atlanta, Georgia; Chan Kon Chin, Guy Faguet, Claude-Starr Wright, Medical College of Georgia, Augusta, Georgia; Y. S. Ahn, Howard E. Lessner, University of Miami School of Medicine, Miami, Florida; Dov Gorshein, Scott Murphy, Presbyterian University of Pennsylvania Medical Center, Philadelphia, Pennsylvania; William E. Barry, Sharon P. Fischer, Rosaline R. Joseph, Richard V. Smalley, Temple University School of Medicine, Philadelphia, Pennsylvania; Virgil Loeb, Jr., Cary Presant, Edward Reinhard, Shabbir H. Safdar, Washington University School of Medicine, St. Louis, Missouri; Norman Maldonado, Enrique Velez-Garcia, University of Puerto Rico School of Medicine, San Juan, Puerto Rico; S. A. Gregory, William H. Knospe, Rush-Presbyterian-St. Luke's Medical Center, Chicago, Illinois; Stephen Krauss, University of Tennessee Memorial Research Center, Knoxville, Tennessee; Karl Tornyos, New Orleans Veterans Hospital, New Orleans, Louisiana; W. B. Forman, R. W. Kellermeyer, A. Rassiga, Case Western Reserve University School of Medicine, Cleveland, Ohio; William R. Arrowsmith, George Porter, Donald M. Samples, Ochsner Clinic, New Orleans, Louisiana; Lois W. Dow, Charles L. Neely, University of Tennessee School of Medicine, Memphis, Tennessee; G. O. Broun, Jr., St. Louis University School of Medicine, St. Louis, Missouri