IN-VIVO PURGING WITH HIGH-DOSE CYTARABINE FOLLOWED BY HIGH-DOSE CHEMORADIOTHERAPY AND REINFUSION OF UNPURGED BONE-MARROW FOR ADULT ACUTE MYELOGENOUS LEUKEMIA IN FIRST COMPLETE REMISSION

Purpose: To evaluate in a prospective study the efficacy of autologous bone marrow transplantation (BMT) in adult patients with acute myelog enous leukemia (AML) in first remission, using a single course of high -dose Cytarabine (HD Ara-C) consolidation therapy as in vivo purging. Patients and Methods: Sixty consecutive adult patients with AML in fir st complete remission (CR) were treated with HD Ara-C consolidation th erapy as a method of in vivo purging before marrow collection. High-do se therapy consisted of fractionated total-body irradiation (FTBI) 12 Gy, intravenous etoposide 60 mg/kg, and cyclophosphamide 75 mg/kg, fol lowed by reinfusion of cryopreserved marrow. Results: Sixty patients u nderwent consolidation treatment with HD Ara-C with the intent to trea t with autologous BMT. Sixteen patients were unable to proceed to auto logous BMT (10 patients relapsed, one died of sepsis, one developed ce rebellar toxicity, two had inadequate blood counts, and two refused). forty-four patients underwent autologous BMT and have a median follow- up time of 37 months (range, 14.7 to 68.7) for patients who are alive with no relapse. The cumulative probability of disease-free survival ( DFS) at 24 months in the intent-to-treat group is 49% (95% confidence interval [CI], 37% to 62%) and in those who actually underwent autolog ous BMT is 61% (95% CI, 46% to 74%). The probability of relapse was 44 % (95% CI, 31%, to 58%) and 33% (95% CI, 20% to 49%) for the intent-to -treat and autologous BMT patients, respectively. Conclusion: This app roach offers a relatively high DFS rate to adult patients with AML in first CR. The results of this study are similar to those achieved with allogeneic BMT. (C) 1996 by American Society of Clinical Oncology.