نبذة مختصرة : We report the results of a prospective, randomized phase 3 trial evaluating the use of autologous peripheral blood stem cell transplantation (ASCT) vs. intensive consolidation chemotherapy in newly diagnosed AML patients in complete remission (CR1). Patients with AML between 16-60 yrs of age in CR1 after two cycles of intensive chemotherapy and not eligible for allogeneic SCT were randomized between intensive chemotherapy with etoposide and mitoxantrone or ASCT following high-dose cyclophosphamide and busulfan. Of patients randomized (chemotherapy n=259; ASCT n=258), more than 90% received their assigned treatment arm. The two groups were comparable as regards prognostic factors. The ASCT group showed a markedly reduced relapse rate (58% vs. 70%, p=0.02) and better relapse free survival (RFS) at five years (38% vs. 29%, p= 0.065, HR 0.82 (0.66-1.1) with non-relapse mortality of 4% vs. 1% in the chemotherapy arm (p=0.02). Overall survival (OS) was similar (44% vs. 41% at 5 years, p=0.86) due to more opportunities for salvage with second-line chemotherapy and stem cell transplantation in patients relapsing on the chemotherapy arm. This large study shows a relapse advantage for ASCT as post remission therapy but similar survival since more relapsing patients on the chemotherapy arm were salvaged with a late transplantation for relapse. This trial is registered at http://www.trialregister.nl as NTR230 and NTR291.
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