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Blood, 15 February 2007, Vol. 109, No. 4, pp. 1395-1400.
Prepublished online as a Blood First Edition Paper on October 12, 2006; DOI 10.1182/blood-2006-05-021907.


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CLINICAL TRIALS AND OBSERVATIONS

Prospective feasibility analysis of reduced-intensity conditioning (RIC) regimens for hematopoietic stem cell transplantation (HSCT) in elderly patients with acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS)

Elihu Estey1, Marcos de Lima2, Raoul Tibes1, Sherry Pierce1, Hagop Kantarjian1, Richard Champlin2, and Sergio Giralt2

Departments of1 Leukemia and 2 Blood and Marrow Transplantation, The University of Texas M. D. Anderson Cancer Center, Houston, TX

To prospectively assess the applicability of reduced-intensity conditioning hematopoietic stem cell transplantation (RIC-HSCT), we wrote a protocol in which all untreated patients 50 years or older with acute myeloid leukemia (AML) and unfavorable cytogenetics would be evaluated during induction for a possible RIC-HSCT in first complete remission (CR1). Ninety-nine of 259 patients entered CR. Fifty-three of the 99 were seen by the Transplant Service with the remainder not seen because of illness, lack/unavailability of siblings, refusal, or, primarily, unclear reasons (21 patients). A donor was identified for 26 patients (21 sibling, 5 unrelated) with RIC-HSCT performed in 14 (13 sibling). Results in consulted patients suggested that 50% or fewer of the 85 patients who did not undergo transplantation were potential transplant candidates. We attempted to find one or more chemotherapy pair-mates for each patient who underwent transplantation based on cytogenetics, age, and a relapse-free survival (RFS) time that was more than or equal to the time from CR1 to RIC-HSCT in the patient who underwent transplantation. Thirty-two of the 39 matches favored (longer RFS) RIC-HSCT and 7, chemotherapy. The probability that the corresponding beta distribution was different than expected (ie, that RIC-HSCT was superior) was 0.99 (P = .004). Results were similar with respect to survival. While RIC-HSCT thus seems of interest, methods are needed to extend its applicability.


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