JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL

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 Haioun, N Mounier, J F Emile, D Ranta, B Coiffier, H Tilly, C Récher, C Fermé, J Gabarre, R Herbrecht, F Morchhauser, C Gisselbrecht
Annals of Oncology: Official Journal of the European Society for Medical Oncology 2009, 20 (12): 1985-92
19567453

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.

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