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Annals of Oncology Advance Access published online on June 30, 2009
Annals of Oncology, doi:10.1093/annonc/mdp237
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© The Author 2009. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oxfordjournals.org

Rituximab versus observation after high-dose consolidative first-line chemotherapy with autologous stem-cell transplantation in patients with poor-risk diffuse large B-cell lymphoma

C. Haioun1,*, N. Mounier2, J. F. Emile3, D. Ranta4, B. Coiffier5, H. Tilly6, C. Récher7, C. Fermé8, J. Gabarre9, R. Herbrecht10, F. Morchhauser11 and C. Gisselbrecht12

1 Service d'Hématologie Clinique, Centre Hospitalier Universitaire, Groupe Hospitalier Henri Mondor-Chenevier, Assistance Publique-Hôpitaux de Paris et Université Paris XII, Créteil
2 Service d'Onco-Hématologie, Centre Hospitalier Universitaire Archet 1, Nice
3 Service de Pathologie, Hôpital Ambroise Paré, Assistance Publique-Hôpitaux de Paris, Paris
4 Service d'Hématologie et de Médecine Interne, Centre Hospitalier Universitaire Nancy-Brabois, Vandoeuvre les Nancy
5 Service d'Hématologie, Hôpital Lyon Sud, Hospices Civils de Lyon, Pierre Bénite
6 Département d'Hématologie, Centre Henri Becquerel, Rouen
7 Service d'Hématologie, Centre Hospitalier Universitaire Purpan, Toulouse
8 Service d'Hématologie, Institut Gustave Roussy, Villejuif
9 Service d'Hématologie Clinique, Groupe Hospitalier Pitié-Salpêtrière, Assistance Publique-Hôpitaux de Paris, Paris
10 Département d'Hématologie et d'Oncologie, Centre Hospitalier Universitaire de Strasbourg, Strasbourg
11 Service des Maladies du Sang, Centre Hospitalier Universitaire de Lille, Lille
12 Service d'Hémato-Oncologie Adulte, Hôpital Saint Louis, Assistance Publique-Hôpitaux de Paris, Paris, France

* Correspondence to: Dr C. Haioun, Service d'Hématologie Clinique, Hôpital H. Mondor, 51, Avenue du Maréchal de Lattre de Tassigny, 94010 Créteil, France. Tel: +33-1-49-81-20-51; Fax: +33-1-49-81-20-67; E-mail: corinne.haioun{at}hmn.aphp.fr

Background: This study compared the induction regimens doxorubicin, cyclophosphamide and etoposide (ACE) with doxorubicin, cyclophosphamide, vincristine, bleomycin and prednisone (ACVBP) before high-dose therapy (HDT) followed by autologous stem-cell transplantation (ASCT) for patients with poor-risk diffuse large B-cell lymphoma (DLBCL). A second randomisation compared rituximab with observation post-ASCT.

Materials and methods: Four hundred and seventy-six patients <60 years old with newly diagnosed CD20+ DLBCL were randomised to induction with ACE or ACVBP. Three hundred and thirty responders received HDT followed by ASCT. After ASCT, 269 patients were re-randomised to receive either maintenance rituximab or observation alone. Randomisation was stratified by the quality of response to ASCT. The primary end point of this study was event-free survival (EFS).

Results: At a median of 4 years’ follow-up from the second randomisation, there was a trend (P = 0.1) towards increased EFS for patients who received rituximab compared with observation.

Conclusion: The type of induction therapy (ACVBP or ACE) did not significantly affect overall survival at a median 51 months’ follow-up.

autologous transplantation, diffuse large B-cell lymphoma, poor-risk lymphoma, rituximab

Received for publication March 18, 2009. Accepted for publication March 20, 2009.


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