The majority of adults with acute myelogenous leukemia (AML) and advanced myelodysplastic syndrome (MDS) will obtain remission (CR) with a cytarabine (ara-C) containing regimen. Unfortunately, a majority of responding patients will relapse and die of leukemia. Several strategies have been employed to reduce the relapse rate and thus increase the percentage of patients cured, including consolidation, intensification, and transplantation. Nevertheless, new strategies are required. We are reporting a novel maintenance strategy for patients who have completed their scheduled intensification with high-dose (HD) ara-C following CR. From 4/97 to 12/1999, 34 front-line patients (pts) with AML (23 pts) or MDS (11 pts) were continuously maintained with ara-C, 5 mg/SQ daily plus interferon-2b (IFN), 3 Megaunits/SQ 3 times per week, with no planned interruptions in therapy. For analysis, a historical control population was also selected (2 controls randomly selected per study pt) so that both control and study patients were treated within 2 years of each other (similar follow-up times); had remained in CR for a similar length of time as study patients when they started IFN+ara-C; required the same number of courses to complete remission (CR); had the same cytogenetic abnormalities and antecedent hématologie disorder (AHD) status, and were similar ages. CR was achieved with topotecan (T) plus HD ara-C, with (21/34) or without (9/34) cyclophosphamide (C). After achieving CR, both groups received a median of 4 courses of consolidation therapy with HD ara-C in combination with fludarabine, idarubicin, or T plus C. The study and control group were comparable in regard to age (median 58, range 20-77), AHD (53%), cytogenetics(diploid,41%;-5,-7, llq-,20%;inv 16,t(8;21), 15%; other, 24%), and weeks from diagnosis to entry on protocol (29). There was no difference in either CR duration or overall survival between the groups for the 70 week period after CR, encompassing approximately 55% of patients. After this period, the curves separate with the study patients doing better for both CR duration and survival over control, although the differences are not yet significant. No patient was dose increased and several patients were dose reduced because of IFN induced malaise or low blood counts. Longer follow-up will be needed to determine whether or not IFN and ara-C maintenance will prolong CR or increase survival in a subset of patients with AML or MDS.
|Original language||English (US)|
|Issue number||11 PART II|
|State||Published - Dec 1 2000|
ASJC Scopus subject areas
- Cell Biology