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著者: 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, German Hodgkin's Lymphoma Study Group, Lymphoma Working Party of the European Group for Blood and Marrow Transplantation
雑誌名: Lancet. 2002 Jun 15;359(9323):2065-71. doi: 10.1016/S0140-6736(02)08938-9.
Abstract/Text
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.
PMID 12086759 Lancet. 2002 Jun 15;359(9323):2065-71. doi: 10.1016/S0140-6736(02)08938-9.
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