Yazarlar : Vellenga E, van Putten W, Ossenkoppele GJ, Verdonck LF, Theobald M, Cornelissen JJ, Huijgens PC, Maertens J, Gratwohl A, Schaafsma R, Schanz U, Graux C, Schouten HC, Ferrant A, Bargetzi M, Fey MF, Löwenberg B.

Yayın : Blood.

Yayın Yılı : 2011

Pubmed Linki : http://www.ncbi.nlm.nih.gov/pubmed/21951683

Konu : Kemik İliği Nakli

Literatür İçeriği :  

Abstract

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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