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Blood, 1 November 2004, Vol. 104, No. 9, pp. 2667-2674.
Prepublished online as a Blood First Edition Paper on July 6, 2004; DOI 10.1182/blood-2004-03-0982.
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CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS
Myeloablative radiochemotherapy followed by autologous stem cell transplantation in first remission prolongs progression-free survival in follicular lymphoma: results of a prospective, randomized trial of the German Low-Grade Lymphoma Study Group
Georg Lenz,
Martin Dreyling,
Eva Schiegnitz,
Roswitha Forstpointner,
Hannes Wandt,
Mathias Freund,
Georg Hess,
Lorenz Truemper,
Volker Diehl,
Martin Kropff,
Michael Kneba,
Norbert Schmitz,
Bernd Metzner,
Markus Pfirrmann,
Michael Unterhalt, and
Wolfgang Hiddemann
From the Department of Internal Medicine III and the Department of Medical Informatics, Biometrics and Epidemiology, Ludwig-Maximilians University, Munich Grosshadern; Department of Hematology and Oncology, Klinikum Nord, Nuernberg; Department of Hematology and Oncology, University of Rostock; Department of Internal Medicine III, University Hospital Mainz; Department of Hematology and Oncology, Georg August University, Goettingen; Department of Internal Medicine I, University of Cologne; Department of Medicine, University of Muenster; Department of Internal Medicine II, University of Kiel; Department of Hematology, Allgemeines Krankenhaus St. Georg, Hamburg; and Department of Internal Medicine II, Klinikum Oldenburg, Germany.
Conventional chemotherapy has failed to substantially prolong survival for patients with advanced follicular lymphoma. To improve outcomes, the German Low-Grade Lymphoma Study Group (GLSG) initiated a randomized trial to compare the effect of potentially curative myeloablative radiochemotherapy followed by autologous stem cell transplantation (ASCT) with interferon- (IFN-) maintenance therapy in first remission. Three hundred seven patients (younger than 60 years) with follicular lymphoma were recruited into the trial from 130 institutions. After 2 cycles of cyclophosphamide-doxorubicin-vincristine-prednisone (CHOP) or mitoxantrone-chlorambucil-prednisone (MCP) induction chemotherapy, patients were randomly assigned to either the ASCT or the IFN- group. The respective therapy was started when patients achieved complete or partial remission after induction chemotherapy. Two hundred forty patients with follicular lymphoma are evaluable for the comparison of ASCT and IFN-. In patients who underwent ASCT, the 5-year progression-free survival (PFS) rate was 64.7%, and in the IFN- arm it was 33.3% (P < .0001). As expected, acute toxicity was higher in the ASCT group, but early mortality was below 2.5% in both study arms. In this randomized, multicenter trial, high-dose radiochemotherapy followed by ASCT significantly improved PFS compared with IFN- in patients with follicular lymphoma when applied as consolidation in first remission. Longer follow-up is necessary to determine the effect of ASCT on overall survival. (Blood. 2004;104:2667-2674)
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