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Blood, 1 April 2005, Vol. 105, No. 7, pp. 2677-2684.
Prepublished online as a Blood First Edition Paper on December 9, 2004; DOI 10.1182/blood-2004-10-3883.


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CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS

Early consolidation by myeloablative radiochemotherapy followed by autologous stem cell transplantation in first remission significantly prolongs progression-free survival in mantle-cell lymphoma: results of a prospective randomized trial of the European MCL Network

Martin Dreyling, Georg Lenz, Eva Hoster, Achiel Van Hoof, Christian Gisselbrecht, Rudolf Schmits, Bernd Metzner, Lorenz Truemper, Marcel Reiser, Hjalmar Steinhauer, Jean-Michel Boiron, Marc A. Boogaerts, Ali Aldaoud, Vittorio Silingardi, Hanneke C. Kluin-Nelemans, Joerg Hasford, Reza Parwaresch, Michael Unterhalt, and Wolfgang Hiddemann

From the Department of Internal Medicine III, Ludwig-Maximilians University, Munich, Germany; Department of Medical Informatics, Biometrics and Epidemiology (IBE), Ludwig-Maximilians University, Munich, Germany; Department of Hematology, Hopital St-Jan, Brugge, Belgium; Department of Hematology, Hopital Saint Louis, Paris, France; Department of Hematology and Oncology, University of Saarland, Homburg/Saar, Germany; Department of Internal Medicine II, Klinikum Oldenburg, Germany; Department of Hematology and Oncology, Georg August University, Goettingen, Germany; Department of Internal Medicine I, University of Cologne, Germany; Department of Internal Medicine II, Carl-Thiem Klinikum, Cottbus, Germany; Haut-Leveque Hospital, University of Bordeaux, France; Department of Hematology, University Hospital Gasthuisberg, Leuven, Belgium; Praxis für Hämatologie/Onkologie, Leipzig, Germany; Department of Medical Oncology, University of Modena, Italy; Department of Hematology, University Medical Center Groningen, Groningen, The Netherlands; and Department of Hematopathology, University of Kiel, Germany.

Mantle-cell lymphoma (MCL) is characterized by poor prognosis with a median survival of only 3 to 4 years. To improve clinical outcome, the European MCL Network initiated a randomized trial comparing consolidation with myeloablative radiochemotherapy followed by autologous stem cell transplantation (ASCT) to {alpha}-interferon maintenance (IFN{alpha}) in first remission. Patients 65 years of age or younger with advanced-stage MCL were assigned to ASCT or IFN{alpha} after achievement of complete or partial remission by a cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP)–like induction therapy. According to the International Prognostic Index (IPI), 43% of patients had a low-risk, 41% a low-intermediate, 11% a high-intermediate, and 6% a high-risk profile. Sixty-two of 122 patients proceeded to ASCT and 60 received IFN{alpha}. Patients in the ASCT arm experienced a significantly longer progression-free survival (PFS) with a median of 39 months compared with 17 months for patients in the IFN{alpha} arm (P = .0108). The 3-year overall survival (OS) was 83% after ASCT versus 77% in the IFN group (P = .18). Early consolidation by myeloablative radiochemotherapy followed by ASCT is feasible and results in a significant prolongation of PFS in advanced-stage MCL. Longer follow-up is needed to determine the effect on OS.


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