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.

Abstract

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.

• Authors: C Haioun, N Mounier, J F Emile, D Ranta, B Coiffier, H Tilly, C Récher, C Fermé, J Gabarre, R Herbrecht, F Morchhauser, C Gisselbrecht
• Journal: Annals of oncology : official journal of the European Society for Medical Oncology (Ann Oncol) Vol. 20 Issue 12 Pg. 1985-92 (Dec 2009) ISSN: 1569-8041 [Electronic] England
• PMID: 19567453 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antibodies, Monoclonal
• Antibodies, Monoclonal, Murine-Derived
• Antineoplastic Agents
• Bleomycin
• Rituximab
• Doxorubicin
• Cyclophosphamide
• Vindesine
• Prednisone

Topics

• Adolescent
• Adult
• Antibodies, Monoclonal (therapeutic use)
• Antibodies, Monoclonal, Murine-Derived
• Antineoplastic Agents (therapeutic use)
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Bleomycin (therapeutic use)
• Combined Modality Therapy
• Cyclophosphamide (therapeutic use)
• Doxorubicin (therapeutic use)
• Female
• Hematopoietic Stem Cell Transplantation
• Humans
• Lymphoma, Large B-Cell, Diffuse (drug therapy, surgery)
• Male
• Middle Aged
• Prednisone (therapeutic use)
• Rituximab
• Transplantation Conditioning
• Transplantation, Autologous
• Treatment Outcome
• Vindesine (therapeutic use)
• Young Adult