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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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CLINICAL TRIALS AND OBSERVATIONS
Rituximab combined with chemotherapy and interferon in follicular lymphoma patients: results of the GELA-GOELAMS FL2000 study
Gilles Salles1,
Nicolas Mounier2,
Sophie de Guibert3,
Franck Morschhauser4,
Chantal Doyen5,
Jean-François Rossi6,
Corinne Haioun7,
Pauline Brice8,
Béatrice Mahé9,
Reda Bouabdallah10,
Bruno Audhuy11,
Christophe Ferme12,
Caroline Dartigeas13,
Pierre Feugier14,
Catherine Sebban15,
Luc Xerri10, and
Charles Foussard16
1 Hospices Civils de Lyon and Université Lyon 1, Lyon, France;
2 Centre Hospitalier Universitaire de Nice, Nice, France;
3 Centre Hospitalier Universitaire de Rennes, Rennes, France;
4 Centre Hospitalier Universitaire de Lille, Lille, France;
5 Cliniques Universitaires (UCL) de Mont-Godinne, Yvoir, Belgium;
6 Centre Hospitalier Universitaire de Montpellier, Montpellier, France;
7 Hôpital Henri-Mondor, Assistance Publique-Hopitaux de Paris and Université Paris XII, Paris, France;
8 Hôpital Saint-Louis, Assistance Publique-Hopitaux de Paris, Paris, France;
9 Centre Hospitalier Universitaire de Nantes, Nantes, France;
10 Institut Paoli Calmettes, Marseille, Marseille, France;
11 Centre Hospitalier (CH) de Colmar, Colmar, France;
12 Institut Gustave Roussy, Villejuif, France;
13 Centre Hospitalier Universitaire de Tours, Tours, France;
14 Centre Hospitalier Universitaire de Nancy, Nancy, France;
15 Centre Léon Bérard, Lyon, France; and
16 Centre Hospitalier Universitaire d'Angers, d'Angers, France
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 rituximab and interferon for the same time period (R-CHVP+I arm). After a median follow-up of 5 years, event-free survival estimates were, respectively, 37% (95% confidence interval [CI], 29%-44%) and 53% (95% CI, 45%-60%) in the CHVP+I and R-CHVP+I arm (P = .001). Five-year overall survival estimates were not statistically different in the CHVP+I (79%; 95% CI, 72%-84%) and R-CHVP+I (84%; 95% CI, 78%-84%) arms. In a multivariate regression analysis, event-free survival was significantly influenced by both the Follicular Lymphoma International Prognostic Index score (hazard ratio = 2.08; 95% CI, 1.6%-2.8%) and the treatment arm (hazard ratio = 0.59; 95% CI, 0.44%-0.78%). With a 5-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 registered at the National Institutes of Health website as no. NCT00136552
[ClinicalTrials.gov]
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