Allogeneic versus autologous bone marrow transplantation (BMT) versus intensive consolidation in acute myelogenous leukemia (AML) in first remission. An EORTC-Gimema phase IIi trial (AML8 A) . the EORTC Leukemia Cooperative Group and the GIMEMA Group
Zittoun, R.; Mandelli, F.; Willemze, R.; de Witte, T.; Tura, S.; Ferrini, P.R.; Stryckmans, P.; Gattringer, C.; Petti, M.C.; Solbu, G.
Leukemia 6(Suppl 2): 114-115
1992
ISSN/ISBN: 0887-6924 PMID: 1578909 Document Number: 3766
The preliminary results confirm that intensive postCR treatment allows in adult AML of relatively young age groups (the median age of our pts is 39 yrs, range 14-60 yrs) a better DFS and overall survival than those previously achieved with more conventional post-CR chemotherapy regimens : in the previous AML6 EORTC protocol for pts under 65 yrs old, who received 1 consolidation then 6 courses of semiintensive maintenance following CR, the DFS was 23 % at 4 yrs (7); its is 40 % in the present one. The results obtained with allo-BMT correspond to those published by transplant registries or achieved in prospective studies comparing this treatment with post-CR chemotherapy (8). Our study was intended to compare the 3 post-CR therapeutic options according to genetic chance (allo-BMT) or randomization (ABMT or IC), and on the basis of intention to treat. Presently the DFS of pts randomized for ABMT confirm the results of pilot studies or EBMT registry (3, 4); they are equivalent to allo-ABMT, and could be considered as having a better therapeutic index since there is less morbidity and treatment-realted mortality with ABMT than with allo-BMT. Our results contradict therefore those from recent prospective studies who showed a superiority of allo-BMT over ABMT but were based on small number of pts (9, 10). ABMT seems superior to our IC arm, but the difference for DFS is not - yet significant. However, the difference between the two randomized arms is no longer present when the overall survival is considered. This observation is explained in our series by the fact that pts relapsing in the IC arm are more easily reinduced in 2nd CR and had more salvage ABMT afterwards than pts randomized for ABMT during 1st CR. A salvage ABMT at time of relapse or 2nd CR following intensive consolidation could be considered therefore as a relevant therapeutic option. Other observations could influence the choice of treatment in AML : there is no difference for DFS in ABMT arm between the EORTC and the GIMEMA groups, despite two different conditioning regimens (CTX-TBI or BUCY). Further comparative studies of the 3 treatment options intended to evaluate the respective quality of life and cost-effectiveness could help at making optimum medical decision. In addition, progresses can be expected to increase the efficacy and reduce the toxicity of each of these 3 options.
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