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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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Submitted March 15, 2004
Accepted June 16, 2004

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 (GLSG)

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*

Department of Internal Medicine III, Ludwig-Maximilians University, Munich Grosshadern, Germany
Department of Internal Medicine III, Ludwig-Maximilians University, Munich Grosshadern, Germany; Department of Medical Informatics, Biometrics and Epidemiology (IBE), Ludwig-Maximilians University, Munich Grosshadern, Germany
Department of Hematology and Oncology, Klinikum Nord, Nuernberg, Germany
Department of Hematology and Oncology, University of Rostock, Rostock, Germany
Department of Internal Medicine III, University Hospital Mainz, Mainz, Germany
Department of Hematology and Oncology, Georg August University, Goettingen, Germany
Department of Internal Medicine I, University of Cologne, Cologne, Germany
Department of Medicine, University of Muenster, Muenster, Germany
Department of Internal Medicine II, University of Kiel, Kiel, Germany
Department of Hematology, Allgemeines Krankenhaus St. Georg, Hamburg, Germany
Department of Internal Medicine II, Klinikum Oldenburg, Oldenburg, Germany
Department of Medical Informatics, Biometrics and Epidemiology (IBE), Ludwig-Maximilians University, Munich Grosshadern, Germany

* Corresponding author; email: wolfgang.hiddemann{at}med.uni-muenchen.de.

In advanced follicular lymphoma conventional chemotherapy has failed to substantially prolong survival. To improve the outcome, the German Low-Grade Lymphoma Study Group (GLSG) initiated a randomized trial, comparing the effect of a potentially curative myeloablative radiochemotherapy followed by autologous stem cell transplantation (ASCT) to A-interferon maintenance (IFNA) in first remission. 307 patients (younger than 60 years) with follicular lymphoma from 130 institutions were recruited into this trial. After two cycles of a CHOP-like induction chemotherapy, patients were randomly assigned to either ASCT or IFNA. The respective therapy was started when patients achieved a complete or partial remission after induction chemotherapy. 240 patients with follicular lymphoma are evaluable for the comparison of ASCT vs. IFN. In patients receiving ASCT, the five-year progression-free survival (PFS) was 64.7% as compared to 33.3% in the IFNA arm (p < 0.0001). As expected, acute toxicity was higher in the ASCT group, however early mortality was below 2.5% in both study arms. In this randomized multicenter trial, high-dose radiochemotherapy followed by ASCT significantly improved the PFS in comparison to IFNA in patients with follicular lymphoma when applied as consolidation in first remission. Longer follow-up is necessary to determine the effect of ASCT on the overall survival.


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