Autologous peripheral blood stem cell transplantation for acute myeloid leukemia.
(2011) Blood — Vol. 118, n° 23, p. 6037-6042 (2011)
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- Authors
- et. al.
- 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.
- Affiliations
Citations
Vellenga, E., van Putten, W., Ossenkoppele, G. J., Verdonck, L. F., Theobald, M., Cornelissen, J. J., Huijgens, P. C., Maertens, J., Gratwohl, A., Schaafsma, R., Schanz, U., Graux, C., Schouten, H. C., Ferrant, A., Bargetzi, M., Fey, M. F., Löwenberg, B., & et al. (2011). Autologous peripheral blood stem cell transplantation for acute myeloid leukemia. Blood, 118(23), 6037-6042. https://doi.org/10.1182/blood-2011-07-370247 (Original work published 2011)