VI Autologous Bone Marrow Transplantation.pdf - Blog Science ...

pts). The other 56 pts are too early/no summary form sent so far. The median
duration of follow-up is 2.5 years. It is important to underline that the time from
CR to start of the last step of treatment was shorter for the IC arm (median: 10
wks, range: 2-32) than for ABMT (median: 13 wks, range 7-49), or allo-BMT (median:
15 wks, range 4-48).
Out of the 581 pts who achieved a CR, 283 are alive in ist CR. The major
cause of failure was relapse, observed in 217 pts (191 BM relapse, 5 CNS relapse,
11 BM + CNS and 10 other types of relapse). In addition 81 pts died in 1st CR, 27
of the 119 pts who completed an allo-BMT, 9 in the ABMT arm, 7 in the second
intensive consolidation arm, and 38 among the 209 patients not allografted and
not randomized for toxicity or refusal.
Presently, the actuarial DFS for allo-BMT is 51 % ± 10.4, and for pts randomized
42% + 9 % (p= 0.78). There is a trend for a better DFS of pts randomized for
ABMT (50 % ± 11.2) than for IC (31 % +11.4) but the difference is yet not significant
(log rank p = 0.08) (Fig. 1). However, the overall survival following CR of
the 2 randomized arms is practically identical (59 % +11.6 for ABMT and 54 % +
14 % for IC) (Fig. 2). The overall survival of pts allografted is also identical at 3
yrs (56 %), despite a higher early mortality for allo-BMT. The overall survival of
871 registered and évaluable pts is 37 % + 4.4 at 4 yrs, and the survival following
CR51%±5.8.
DISCUSSION
These preliminary results confirm that intensive post-CR treatment for adult
AML of relatively young age groups (the median age of our pts is 33 yrs, range
14-59 yrs) provides 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 one consolidation
then 6 courses of semi-intensive maintenance following CR, the DFS was
23 % at 4 yrs
; it 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 to ABMT confirm the results of pilot studies or the EBMT registry (3
'
4)
; they are equivalent to alio-ABMT, and could be considered as having a better
therapeutic index since there is less related morbidity and treatment-related
mortality with ABMT than with allo-BMT. Our results contradict those from recent
prospective studies that showed a superiority of allo-BMT over ABMT but
were based on smaller 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 evident when 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 to ABMT during 1st CR. A salvage ABMT at
relapse or 2nd CR following intensive consolidation could be considered as a
suitable therapeutic option. Other observations could influence the choice of
treatment in AML: there is no difference for DFS in the ABMT arm between the
8 SIXTH INTERNATIONAL SYMPOSIUM ON AUTOLOGOUS BONE MARROW TRANSPLANTATION