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 |
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| Affiliation: | 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 |
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| Abstract: | BackgroundThis 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 methodsFour 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).ResultsAt 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.ConclusionThe type of induction therapy (ACVBP or ACE) did not significantly affect overall survival at a median 51 months’ follow-up. |
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