Autologous peripheral blood stem cell transplantation for acute myeloid leukemia

Blood - Tập 118 - Trang 6037-6042 - 2011
Edo Vellenga1, Wim van Putten2, Gert J. Ossenkoppele3, Leo F. Verdonck4, Matthias Theobald5, Jan J. Cornelissen6, Peter C. Huijgens3, Johan Maertens7, Alois Gratwohl8, Ron Schaafsma9, Urs Schanz10, Carlos Graux11, Harry C. Schouten12, Augustin Ferrant13, Mario Bargetzi14, Martin F. Fey15, Bob Löwenberg6
1Department of Hematology, University of Groningen and University Medical Center Groningen, Groningen, The Netherlands
2Hovon Data Center and Department of Trials and Statistics, Erasmus University Medical Center Rotterdam, Rotterdam, The Netherlands
3Department of Hematology, VU University Medical Center Amsterdam, Amsterdam, The Netherlands
4University Medical Center Utrecht, Utrecht, The Netherlands
5Department of Internal Medicine III, University Hospital Mainz, Mainz, Germany
6Department of Hematology, Erasmus University Medical Center Rotterdam, Rotterdam, The Netherlands;
7University Hospital Gasthuisberg, Leuven, Belgium
8University Hospital-Basel, Basel, Switzerland
9Medisch Spectrum Twente, Enschede, The Netherlands
10Division of Hematology, University Hospital Zürich, Zürich, Switzerland
11UCL, MT-Godinne, Yvoir, Belgium
12University Medical Center Maastricht, Maastricht, The Netherlands
13Hospital St Luc, Bruxelles, Belgium
14Center of Hematology/Oncology and Transfusion Medicine Kantonsspittal Aarau, Switzerland
15Department of Medical Oncology, University and Inselspital, Berne, Switzerland

Tóm tắt

Abstract We report the results of a prospective, randomized phase 3 trial evaluating autologous peripheral blood stem cell transplantation (ASCT) versus intensive consolidation chemotherapy in newly diagnosed AML patients in complete remission (CR1). Patients with AML (16-60 years) in CR1 after 2 cycles of intensive chemotherapy and not eligible for allogeneic SCT were randomized between intensive chemotherapy with etoposide and mitoxantrone or ASCT ater high-dose cyclophosphamide and busulfan. Of patients randomized (chemotherapy, n = 259; ASCT, n = 258), more than 90% received their assigned treatment. The 2 groups were comparable with regard to prognostic factors. The ASCT group showed a markedly reduced relapse rate (58% vs 70%, P = .02) and better relapse-free survival at 5 years (38% vs 29%, P = .065, hazard ratio = 0.82; 95% confidence interval, 0.66-1.1) with nonrelapse mortality of 4% versus 1% in the chemotherapy arm (P = .02). Overall survival was similar (44% vs 41% at 5 years, P = .86) because of 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 postremission therapy but similar survival because more relapsing patients on the chemotherapy arm were salvaged with a late transplantation for relapse. This trial is registered at www.trialregister.nl as #NTR230 and #NTR291.

Tài liệu tham khảo

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Blood

Tập 118

6037-6042

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