Autologous peripheral blood stem cell transplantation for acute myeloid leukemia

Edo Vellenga; Wim van Putten; Gert Jan Ossenkoppele; Leo F. Verdonck; Matthias Theobald; Jan J. Cornelissen; Peter C. Huijgens; Johan Maertens; Alois Gratwohl; M Ron Schaafsma; Urs Schanz; Carlos Graux; Harry C. Schouten; Augustin Ferrant; Mario Bargetzi; Martin F. Fey; Bob Lowenberg

doi:10.1182/blood-2011-07-370247

Autologous peripheral blood stem cell transplantation for acute myeloid leukemia

Edo Vellenga^*, Wim van Putten, Gert Jan Ossenkoppele, Leo F. Verdonck, Matthias Theobald, Jan J. Cornelissen, Peter C. Huijgens, Johan Maertens, Alois Gratwohl, M Ron Schaafsma, Urs Schanz, Carlos Graux, Harry C. Schouten, Augustin Ferrant, Mario Bargetzi, Martin F. Fey, Bob Lowenberg

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

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. (Blood. 2011;118(23):6037-6042)

Original language	English
Pages (from-to)	6037-6042
Journal	Blood
Volume	118
Issue number	23
DOIs	https://doi.org/10.1182/blood-2011-07-370247
Publication status	Published - 1 Dec 2011

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10.1182/blood-2011-07-370247

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Vellenga, E., van Putten, W., Ossenkoppele, G. J., Verdonck, L. F., Theobald, M., Cornelissen, J. J., Huijgens, P. C., Maertens, J., Gratwohl, A., Schaafsma, M. R., Schanz, U., Graux, C., Schouten, H. C., Ferrant, A., Bargetzi, M., Fey, M. F., & Lowenberg, B. (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

@article{9848ba8d3d0d423f8747465838e0f1ee,

title = "Autologous peripheral blood stem cell transplantation for acute myeloid leukemia",

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. (Blood. 2011;118(23):6037-6042)",

author = "Edo Vellenga and {van Putten}, Wim and Ossenkoppele, {Gert Jan} and Verdonck, {Leo F.} and Matthias Theobald and Cornelissen, {Jan J.} and Huijgens, {Peter C.} and Johan Maertens and Alois Gratwohl and Schaafsma, {M Ron} and Urs Schanz and Carlos Graux and Schouten, {Harry C.} and Augustin Ferrant and Mario Bargetzi and Fey, {Martin F.} and Bob Lowenberg",

year = "2011",

month = dec,

day = "1",

doi = "10.1182/blood-2011-07-370247",

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Vellenga, E, van Putten, W, Ossenkoppele, GJ, Verdonck, LF, Theobald, M, Cornelissen, JJ, Huijgens, PC, Maertens, J, Gratwohl, A, Schaafsma, MR, Schanz, U, Graux, C, Schouten, HC, Ferrant, A, Bargetzi, M, Fey, MF & Lowenberg, B 2011, 'Autologous peripheral blood stem cell transplantation for acute myeloid leukemia', Blood, vol. 118, no. 23, pp. 6037-6042. https://doi.org/10.1182/blood-2011-07-370247

TY - JOUR

T1 - Autologous peripheral blood stem cell transplantation for acute myeloid leukemia

AU - Vellenga, Edo

AU - van Putten, Wim

AU - Ossenkoppele, Gert Jan

AU - Verdonck, Leo F.

AU - Theobald, Matthias

AU - Cornelissen, Jan J.

AU - Huijgens, Peter C.

AU - Maertens, Johan

AU - Gratwohl, Alois

AU - Schaafsma, M Ron

AU - Schanz, Urs

AU - Graux, Carlos

AU - Schouten, Harry C.

AU - Ferrant, Augustin

AU - Bargetzi, Mario

AU - Fey, Martin F.

AU - Lowenberg, Bob

PY - 2011/12/1

Y1 - 2011/12/1

N2 - 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. (Blood. 2011;118(23):6037-6042)

AB - 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. (Blood. 2011;118(23):6037-6042)

U2 - 10.1182/blood-2011-07-370247

DO - 10.1182/blood-2011-07-370247

M3 - Article

C2 - 21951683

SN - 0006-4971

VL - 118

SP - 6037

EP - 6042

JO - Blood

JF - Blood

IS - 23

ER -