Aggressive conventional chemotherapy compared with high-dose chemotherapy with autologous haemopoietic stem-cell transplantation for relapsed chemosensitive Hodgkin's disease

A randomised trial

Norbert Schmitz, Beate Pfistner, Michael Sextro, Markus Sieber, Angelo M. Carella, Matthias Haenel, Friederike Boissevain, Reinhart Zschaber, Peter Müller, Hartmut Kirchner, Andreas Lohri, Susanne Decker, Bettina Koch, Dirk Hasenclever, Anthony H. Goldstone, Volker Diehl

Research output: Contribution to journalArticle

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Abstract

Background: High-dose chemotherapy followed by transplantation of autologous haemopoietic stem cells (BEAM-HSCT) is frequently used to treat patients with relapsed Hodgkin's disease. We aimed to compare this treatment with conventional aggressive chemotherapy without stem-cell transplantation (Dexa-BEAM). Methods: 161 patients between 16 and 60 years of age with relapsed Hodgkin's disease were randomly assigned two cycles of Dexa-BEAM (dexamethasone and carmustine, etoposide, cytarabine, and melphalan) and either two further courses of Dexa-BEAM or high-dose BEAM and transplantation of haemopoietic stem cells. Only patients with chemosensitive disease (complete or partial remission after two courses of Dexa-BEAM) proceeded to further treatment. The primary endpoint was freedom from treatment failure for patients with chemosensitive disease. Analysis was per protocol. Findings: 17 patients were excluded from the study after randomisation (ten given Dexa-BEAM and seven given BEAM-HSCT). Median follow-up was 39 months (IQR 3-78). Freedom from treatment failure at 3 years was significantly better for patients given BEAM-HSCT (55%) than for those on Dexa-BEAM (34%; difference -21%, 95% CI -39.87 to -2.13; p=0.019). Overall survival of patients given either treatment did not differ significantly. Interpretation: High-dose BEAM and transplantation of haemopoietic stem cells improves freedom from treatment failure in patients with chemosensitive first relapse of Hodgkin's disease irrespective of length of initial remission.

Original languageEnglish
Pages (from-to)2065-2071
Number of pages7
JournalLancet
Volume359
Issue number9323
DOIs
Publication statusPublished - Jun 15 2002

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Stem Cell Transplantation
Hodgkin Disease
Drug Therapy
Treatment Failure
Carmustine
Melphalan
Autologous Transplantation
Cytarabine
Etoposide
Random Allocation
Dexamethasone
Stem Cells
Therapeutics
Recurrence
Survival

ASJC Scopus subject areas

  • Medicine(all)

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Aggressive conventional chemotherapy compared with high-dose chemotherapy with autologous haemopoietic stem-cell transplantation for relapsed chemosensitive Hodgkin's disease : A randomised trial. / Schmitz, Norbert; Pfistner, Beate; Sextro, Michael; Sieber, Markus; Carella, Angelo M.; Haenel, Matthias; Boissevain, Friederike; Zschaber, Reinhart; Müller, Peter; Kirchner, Hartmut; Lohri, Andreas; Decker, Susanne; Koch, Bettina; Hasenclever, Dirk; Goldstone, Anthony H.; Diehl, Volker.

In: Lancet, Vol. 359, No. 9323, 15.06.2002, p. 2065-2071.

Research output: Contribution to journalArticle

Schmitz, N, Pfistner, B, Sextro, M, Sieber, M, Carella, AM, Haenel, M, Boissevain, F, Zschaber, R, Müller, P, Kirchner, H, Lohri, A, Decker, S, Koch, B, Hasenclever, D, Goldstone, AH & Diehl, V 2002, 'Aggressive conventional chemotherapy compared with high-dose chemotherapy with autologous haemopoietic stem-cell transplantation for relapsed chemosensitive Hodgkin's disease: A randomised trial', Lancet, vol. 359, no. 9323, pp. 2065-2071. https://doi.org/10.1016/S0140-6736(02)08938-9
Schmitz, Norbert ; Pfistner, Beate ; Sextro, Michael ; Sieber, Markus ; Carella, Angelo M. ; Haenel, Matthias ; Boissevain, Friederike ; Zschaber, Reinhart ; Müller, Peter ; Kirchner, Hartmut ; Lohri, Andreas ; Decker, Susanne ; Koch, Bettina ; Hasenclever, Dirk ; Goldstone, Anthony H. ; Diehl, Volker. / Aggressive conventional chemotherapy compared with high-dose chemotherapy with autologous haemopoietic stem-cell transplantation for relapsed chemosensitive Hodgkin's disease : A randomised trial. In: Lancet. 2002 ; Vol. 359, No. 9323. pp. 2065-2071.
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abstract = "Background: High-dose chemotherapy followed by transplantation of autologous haemopoietic stem cells (BEAM-HSCT) is frequently used to treat patients with relapsed Hodgkin's disease. We aimed to compare this treatment with conventional aggressive chemotherapy without stem-cell transplantation (Dexa-BEAM). Methods: 161 patients between 16 and 60 years of age with relapsed Hodgkin's disease were randomly assigned two cycles of Dexa-BEAM (dexamethasone and carmustine, etoposide, cytarabine, and melphalan) and either two further courses of Dexa-BEAM or high-dose BEAM and transplantation of haemopoietic stem cells. Only patients with chemosensitive disease (complete or partial remission after two courses of Dexa-BEAM) proceeded to further treatment. The primary endpoint was freedom from treatment failure for patients with chemosensitive disease. Analysis was per protocol. Findings: 17 patients were excluded from the study after randomisation (ten given Dexa-BEAM and seven given BEAM-HSCT). Median follow-up was 39 months (IQR 3-78). Freedom from treatment failure at 3 years was significantly better for patients given BEAM-HSCT (55{\%}) than for those on Dexa-BEAM (34{\%}; difference -21{\%}, 95{\%} CI -39.87 to -2.13; p=0.019). Overall survival of patients given either treatment did not differ significantly. Interpretation: High-dose BEAM and transplantation of haemopoietic stem cells improves freedom from treatment failure in patients with chemosensitive first relapse of Hodgkin's disease irrespective of length of initial remission.",
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T1 - Aggressive conventional chemotherapy compared with high-dose chemotherapy with autologous haemopoietic stem-cell transplantation for relapsed chemosensitive Hodgkin's disease

T2 - A randomised trial

AU - Schmitz, Norbert

AU - Pfistner, Beate

AU - Sextro, Michael

AU - Sieber, Markus

AU - Carella, Angelo M.

AU - Haenel, Matthias

AU - Boissevain, Friederike

AU - Zschaber, Reinhart

AU - Müller, Peter

AU - Kirchner, Hartmut

AU - Lohri, Andreas

AU - Decker, Susanne

AU - Koch, Bettina

AU - Hasenclever, Dirk

AU - Goldstone, Anthony H.

AU - Diehl, Volker

PY - 2002/6/15

Y1 - 2002/6/15

N2 - Background: High-dose chemotherapy followed by transplantation of autologous haemopoietic stem cells (BEAM-HSCT) is frequently used to treat patients with relapsed Hodgkin's disease. We aimed to compare this treatment with conventional aggressive chemotherapy without stem-cell transplantation (Dexa-BEAM). Methods: 161 patients between 16 and 60 years of age with relapsed Hodgkin's disease were randomly assigned two cycles of Dexa-BEAM (dexamethasone and carmustine, etoposide, cytarabine, and melphalan) and either two further courses of Dexa-BEAM or high-dose BEAM and transplantation of haemopoietic stem cells. Only patients with chemosensitive disease (complete or partial remission after two courses of Dexa-BEAM) proceeded to further treatment. The primary endpoint was freedom from treatment failure for patients with chemosensitive disease. Analysis was per protocol. Findings: 17 patients were excluded from the study after randomisation (ten given Dexa-BEAM and seven given BEAM-HSCT). Median follow-up was 39 months (IQR 3-78). Freedom from treatment failure at 3 years was significantly better for patients given BEAM-HSCT (55%) than for those on Dexa-BEAM (34%; difference -21%, 95% CI -39.87 to -2.13; p=0.019). Overall survival of patients given either treatment did not differ significantly. Interpretation: High-dose BEAM and transplantation of haemopoietic stem cells improves freedom from treatment failure in patients with chemosensitive first relapse of Hodgkin's disease irrespective of length of initial remission.

AB - Background: High-dose chemotherapy followed by transplantation of autologous haemopoietic stem cells (BEAM-HSCT) is frequently used to treat patients with relapsed Hodgkin's disease. We aimed to compare this treatment with conventional aggressive chemotherapy without stem-cell transplantation (Dexa-BEAM). Methods: 161 patients between 16 and 60 years of age with relapsed Hodgkin's disease were randomly assigned two cycles of Dexa-BEAM (dexamethasone and carmustine, etoposide, cytarabine, and melphalan) and either two further courses of Dexa-BEAM or high-dose BEAM and transplantation of haemopoietic stem cells. Only patients with chemosensitive disease (complete or partial remission after two courses of Dexa-BEAM) proceeded to further treatment. The primary endpoint was freedom from treatment failure for patients with chemosensitive disease. Analysis was per protocol. Findings: 17 patients were excluded from the study after randomisation (ten given Dexa-BEAM and seven given BEAM-HSCT). Median follow-up was 39 months (IQR 3-78). Freedom from treatment failure at 3 years was significantly better for patients given BEAM-HSCT (55%) than for those on Dexa-BEAM (34%; difference -21%, 95% CI -39.87 to -2.13; p=0.019). Overall survival of patients given either treatment did not differ significantly. Interpretation: High-dose BEAM and transplantation of haemopoietic stem cells improves freedom from treatment failure in patients with chemosensitive first relapse of Hodgkin's disease irrespective of length of initial remission.

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