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

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R. Harousseau reviewed the results of a prospective study organized by the<br />

GOELAM Group. 318 patients with newly diagnosed AML were registered and<br />

78 percent achieved CR. 56 underwent allo-BMT, 54 were randomized to intensive<br />

consolidation and 52 to the ABMT arm. At a median follow-up of 34<br />

months DFS appears similar between the chemotherapy and ABMT groups<br />

(48.7 vs 47.6 percent, respectively).<br />

Finally, J. Reiffers outlined results of a prospective trial on behalf of the<br />

French BGMT Group. After one consolidation, patients were randomized to<br />

ABMT or to maintenance chemotherapy. 204 patients were entered, 162<br />

achieved CR (80 percent) and 77 were randomized to maintenance (38) or<br />

ABMT (39). Actuarial DFS at 3 years was not significantly different: 48.3+8.5 percent<br />

for ABMT and 38.9+8.4 percent for the maintenance arm.<br />

A review of these trials indicates that several points deserve emphasis. First,<br />

the proportion of subjects registering at induction who were randomized to an<br />

ABMT arm is quite small and relatively consistent from trial to trial: from 12 to<br />

19 percent. This confirms the need to enter very large numbers of patients at the<br />

outset in order to address questions related to DFS after transplant. Second, although<br />

data are preliminary, there are no striking differences between conventional<br />

therapy or transplant, whether autologous or allogeneic. Longer followup<br />

will be required and may disclose the superiority of one type of treatment. In<br />

two of the 3 studies, the trend was in favor of ABMT over conventional intensive<br />

consolidation therapy. Unfortunately, one difficulty in conducting prospective<br />

trials over extended periods (4 to 5 years) is that previously unrecognized prognostic<br />

factors may be identified and found not to be controlled for in the study.<br />

Moreover, big improvements (>15 percent) in chemotherapy or ABMT in the<br />

interim, although unlikely to occur, could make the studies obsolete. One possibility<br />

here is that marrow purging will be shown to be of clinical benefit possibly<br />

from gene marking studies or analysis of marrow transplant registry data. Of<br />

relevance, C. Gorin provided an update on the EBMTG experience and indicated<br />

no benefit of marrow purging from an overall evaluation of 1483 transplants.<br />

However, a retrospective analysis identified a subgroup with AML CR-1<br />

that underwent marrow purging and had a reduced relapse rate and improved<br />

DFS. None of the prospective studies reviewed at the Symposium employed<br />

ABMT with purged autografts.<br />

Despite these potential limitations, the investigators who designed and conducted<br />

these trials should be complimented since the data generated are likely<br />

to lead to conclusions of greater validity than can be derived from single arm<br />

studies with small numbers of subjects. It will be very interesting to hear the final<br />

reports on these trials.<br />

248 SIXTH INTERNATIONAL SYMPOSIUM ON AUTOLOGOUS BONE MARROW TRANSPLANTATION

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