Feasibility and Safety of Maintenance Therapy in the Treatment of Acute Myeloid Leukemia

Abstract

Brief Abstract In this study, we present data about the feasibility and safety of a prolonged monthly myelosuppressive maintenance therapy as a postremission therapy for acute myeloid leukemia after induction and induction-type consolidation. Maintenance therapy could be started in 57% of CR patients assigned to maintenance and completed in 14%. Full Abstract Introduction We have previously shown that a prolonged monthly myelosuppressive chemotherapy proved superior to high-dose cytarabine consolidation therapy ( J Clin Oncol 2003; 21:4496) after induction therapy and induction-type consolidation therapy. In this study, feasibility and safety of this approach was evaluated in the AMLCG 1999 trial. Patients and Methods 827 patients with a CR before May 2005 were either randomized up front to receive maintenance therapy ( Results Out of the 827 patients, 326 patients (39%) did not receive maintenance therapy due to allogeneic (63; 7.6%) or autologous (6; 0.7%) stem cell transplantation (SCT); early relapse (126; 15.3%); withdrawal of consent (19; 2.3%); medical reasons other than relapse (60; 7.3%); other reasons not classified (9; 1.1%); or death in remission (43; 5.2%). In 30 patients (3.6%), the application of maintenance therapy cannot be followed due to loss of follow-up or incomplete documentation. For the remaining 471 patients (57.0%) with a documented start of the maintenance therapy, the median number of maintenance courses applied was 6 (first to third quartile: 2–16) over a median duration from achievement of CR of 10 months (first to third quartile: 5–24). A dose reduction was necessary in all patients. Out of the 471 patients who started maintenance, therapy was terminated early in 348 patients (73.9%) due to an allogeneic SCT in first CR (7 patients; 1.5%); relapse (205; 43.5%); withdrawal of consent (21; 4.5%); medical reasons other than relapse (89; 18.9%); other reasons not classified (17; 3.6%), loss of follow-up or incomplete documentation (55; 11.7%); and death in CR (8; 1.7%). 69 patients (14.4%) completed maintenance for 3 years. Conclusion These results show that a prolonged monthly myelosuppressive maintenance therapy as part of a postremission therapy in AML is feasible and safe.