Early matched sibling hematopoietic-cell transplantation for adult AML in first remission using an age-adapted strategy: long-term results of a prospective GOELAMS study
Mené sur 832 patients français atteints d'une leucémie myéloïde aiguë, cet essai de phase III compare les effets à long terme (durée de suivi : 108 mois) de deux méthodes de conditionnement d'une allogrefffe de cellules souches hématopoïétiques en fonction de l'âge des patients
The GOELAMS LAM2001 phase III trial, involving 832 patients with acute myeloid leukemia (AML) (median: 46 years, range: 17-60) proposed HLA-identical sibling allograft of hematopoietic stem cells (HSCT) for all patients with an identified donor. The trial compared reduced intensity conditioning (RIC) for patients over 50 years of age (N=47) and myeloablative conditioning for younger patients (N=117). Bone marrow HSCT was performed in the younger patients, while the older ones received a consolidation course, followed by peripheral blood allo-HSCT using RIC. The incidence of grade II-IV aGVHD, was 51.9% (95% CI:42.1-61.8) and 11.3% (1.6-21.2) after myeloablative or RIC respectively (p<0.0001) and that of cGVHD 45.8% (95% CI: 34.8-56.7) and 41.7% (24.7-58.6) (NS). Cumulative incidence (CI) of non-relapse mortality at 108 months was 15.8% (95%CI: 9.8-23.2) for myeloablative, and 6.5% (0.2-16.2) for RIC (NS). CI of relapse at 108 months was 21.7% (95%CI: 13.9-28.6) and 28.6% (16.5-43.4) (NS). Overall survival at 108 months was 63.4% (95%CI: 54.6-72.2) and 65.8% (52.2-72.2) respectively after myeloablative or RIC (NS). RIC PBSC allo-HCT is prospectively feasible for patients aged between 51 and 60 without excess of relapse or non-relapse mortality and compares favorably with myeloablative marrow allo-HCT proposed to younger patients. This study was registered at http://clinicaltrials.gov/ct no NCT01015196.
Blood 2012