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.
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.


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.


CONCLUSIONS
The type of induction therapy (ACVBP or ACE) did not significantly affect overall survival at a median 51 months' follow-up.
Haioun
C
C
Service d'Hématologie Clinique, Centre Hospitalier Universitaire, Groupe Hospitalier Henri Mondor-Chenevier, Assistance Publique-Hôpitaux de Paris et Université Paris XII, Créteil, France. corinne.haioun@hmn.aphp.fr
Mounier
N
N
Emile
J F
JF
Ranta
D
D
Coiffier
B
B
Tilly
H
H
Récher
C
C
Fermé
C
C
Gabarre
J
J
Herbrecht
R
R
Morchhauser
F
F
Gisselbrecht
C
C
D000293:Adolescent; D000328:Adult; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D058846:Antibodies, Monoclonal, Murine-Derived; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001761:Bleomycin / Q000627:therapeutic use; D003131:Combined Modality Therapy; D003520:Cyclophosphamide / Q000627:therapeutic use; D004317:Doxorubicin / Q000627:therapeutic use; D005260:Female; D018380:Hematopoietic Stem Cell Transplantation; D006801:Humans; D016403:Lymphoma, Large B-Cell, Diffuse / Q000188:drug therapy* / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D011241:Prednisone / Q000627:therapeutic use; D000069283:Rituximab; D019172:Transplantation Conditioning; D014182:Transplantation, Autologous; D016896:Treatment Outcome; D014751:Vindesine / Q000627:therapeutic use; D055815:Young Adult
D000911:Antibodies, Monoclonal; D058846:Antibodies, Monoclonal, Murine-Derived; D000970:Antineoplastic Agents; D001761:Bleomycin; D000069283:Rituximab; D004317:Doxorubicin; D003520:Cyclophosphamide; D014751:Vindesine; D011241:Prednisone