Allogeneic transplantation as post-remission therapy for cytogenetically high-risk XXXX : landmark analysis from a single prospective multicenter trial.

@entity1 @entity3052
Background Allogeneic hematopoietic cell transplantation is considered the preferred post-remission therapy in @entity1 with @entity3052 cytogenetically defined as being at high risk. To substantiate evidence for allogeneic hematopoietic cell transplantation in first complete remission in these high-risk @entity1 we performed a landmark analysis within a single prospective multicenter treatment trial. DESIGN AND METHODS: By the time of analysis, 2,347 @entity1 had been accrued into the AMLCG 99 trial between 1999 - 2007. Out of this population, 243 @entity1 under 60 years old fulfilled the criteria for high-risk cytogenetics. Landmark analyses were performed with a control cohort, who remained in first complete remission at least the median time from complete remission to transplantation in the intervention group. RESULTS: After standardized induction therapy, 111 @entity1 under 60 years old achieved complete remission. A matched allogeneic donor was identified for 59 @entity1 (30 sibling donors, 29 unrelated donors). Fifty-five @entity1 received an allogeneic hematopoietic cell transplant after a median time of 88 days in first complete remission. Of the remaining 56 @entity1 , 21 relapsed within 90 days after achieving first complete remission and for 7 @entity1 with relevant comorbidities no donors search was initiated, leaving 28 @entity1 given conventional post-remission therapy as the control cohort. The median follow-up of surviving @entity1 was 60.4 months. @entity1 with an allogeneic donor had substantially better 5-year overall and relapse-free survival rates than the control group (48% versus 18%, P=0.004 and 39% versus 10%, P<0.001, respectively). A survival benefit from transplantation was evident regardless of donor type, age and monosomal karyotype. Conclusions Beyond evidence available for subgroups of high-risk @entity1 , the findings of this study establish in a broader manner that allogeneic hematopoietic cell transplantation is a preferable consolidation treatment for @entity1 with @entity3052 and high-risk cytogenetics. The study was registered at Clinicaltrials.gov as NCT00266136.
