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Blood, 15 December 2008, Vol. 112, No. 13, pp. 4824-4831.
Prepublished online as a Blood First Edition Paper on September 17, 2008; DOI 10.1182/blood-2008-04-153189.
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Submitted April 21, 2008
Accepted August 16, 2008
Rituximab combined with chemotherapy and interferon in follicular lymphoma patients: results of the GELA-GOELAMS FL2000 study
Gilles Salles*, Nicolas Mounier, Sophie de Guibert, Franck Morschhauser, Chantal Doyen, Jean-Francois Rossi, Corinne Haioun, Pauline Brice, Beatrice Mahe, Reda Bouabdallah, Bruno Audhuy, Christophe Ferme, Caroline Dartigeas, Pierre Feugier, Catherine Sebban, Luc Xerri, and Charles Foussard
Hospices Civils de Lyon, UMR CNRS 5239, Pierre-Bénite, France
CHU de Nice, Nice, France
CHU de Rennes, Rennes, France
CHU de Lille, Lille, France
UCL- Mont-Godinne, Mont-Godinne, Belgium
CHU de Montpellier, Montpelllier, France
Hopital Henri-Mondor - AP-HP, Universite Paris XII, Creteil, France
Hopital Saint Louis - AP-HP, Paris, France
CHU de Nantes, Nantes, France
Institut Paoli-Calmettes, Marseille, France
CH de Colmar, Colmar, France
Institut Gustave Roussy, Villejuif, France
CHU de Tours, Tours, France
CHU de Nancy, Nancy, France
Centre Leon Berard, Lyon, France
CHU d'Angers, Angers, France
* Corresponding author; email: gilles.salles{at}chu-lyon.fr.
The FL2000 study was undertaken to evaluate the combination of the anti-CD20 monoclonal antibody rituximab with chemotherapy plus interferon in the first line treatment of follicular lymphoma patients with a high tumor burden. Patients were randomly assigned to receive either 12 courses of the chemotherapy regimen CHVP (cyclophosphamide, adriamycin, etoposide and prednisolone) plus interferon- 2a (CHVP+I arm) over 18 months or 6 courses of the same chemotherapy regimen combined with 6 infusions of 375 mg/m2 of rituximab and interferon for the same time period (R-CHVP+I arm). After a median follow-up of five years, event-free survival estimates were respectively 37% [95% C.I. 29 - 44] and 53% [95% C.I. 45 - 60] in the CHVP+I and R-CHVP+I arm (P=.0004). Five years overall survival estimates were not statistically different in the CHVP+I (79%) [95% C.I. 72 - 84]) and R-CHVP+I (84% [95% C.I. 78 - 84]) arms. In a multivariate regression analysis, event free survival was significantly influenced by both the Follicular Lymphoma International Prognostic Index (FLIPI) score (HR=2.08; 95% C.I. [1.6 - 2.8]) and the treatment arm (HR=0.59; 95% C.I. [0.44 - 0.78]). With a five year follow-up, the combination of rituximab with CHVP+I provides superior disease control in follicular lymphoma patients despite a shorter duration of chemotherapy. This study's clinical trial was deposited on the National Institute of Health website (NCT00136552)

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