Rituximab maintenance after first-line therapy with rituximab, fludarabine, cyclophosphamide, and mitoxantrone (R-FCM) for chronic lymphocytic leukemia

Pau Abrisqueta, Neus Villamor, María José Terol, Eva González-Barca, Marcos González, Christelle Ferrà, Eugenia Abella, Julio Delgado, Jose A. García-Marco, Yolanda González, Felix Carbonell, Secundino Ferrer, Encarna Monzó, Isidro Jarque, Ana Muntañola, Mireia Constants, Lourdes Escoda, Xavier Calvo, Sabela Bobillo, José Bruno MontoroEmili Montserrat, Francesc Bosch

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Abstract

© 2013 by The American Society of Hematology. The effectiveness of rituximab maintenance therapy in the treatment of chronic lymphocytic leukemia has been investigated in a phase 2 clinical trial that included an initial treatment with rituximab 500 mg/m2 on day 1 (375 mg/m2 the first cycle), fludarabine 25 mg/m2 on days 1 to 3, cyclophosphamide 200 mg/m2 on days 1 to 3, and mitoxantrone 6 mg/m2 on day 1 (R-FCM), for 6 cycles, followed by a maintenance phase with rituximab 375 mg/m2 every 3 months for 2 years. Sixty-seven patients having achieved complete response (CR) or partial response (PR) with R-FCM were given maintenance therapy. At the end of maintenance, 40.6% of patients were in CR with negative minimal residual disease (MRD), 40.6% were in CR MRD-positive, 4.8% remained in PR, and 14% were considered failures. Six of 29 patients (21%) who were in CR MRD-positive or in PR after R-FCM improved their response upon rituximab maintenance. The 4-year progression-free survival (PFS) and overall survival rates were 74.8% and 93.7%, respectively. MRD status after R-FCM induction was the strongest predictor of PFS. Maintenance with rituximab after R-FCM improved the quality of the response, particularly in patients MRD-positive after initial treatment, and obtained a prolonged PFS. This trial was registered at www.clinicaltrialsregister.eu as identifier #2005-001569-33.
Original languageEnglish
Pages (from-to)3951-3959
JournalBlood
Volume122
Issue number24
DOIs
Publication statusPublished - 1 Jan 2013

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    Abrisqueta, P., Villamor, N., Terol, M. J., González-Barca, E., González, M., Ferrà, C., Abella, E., Delgado, J., García-Marco, J. A., González, Y., Carbonell, F., Ferrer, S., Monzó, E., Jarque, I., Muntañola, A., Constants, M., Escoda, L., Calvo, X., Bobillo, S., ... Bosch, F. (2013). Rituximab maintenance after first-line therapy with rituximab, fludarabine, cyclophosphamide, and mitoxantrone (R-FCM) for chronic lymphocytic leukemia. Blood, 122(24), 3951-3959. https://doi.org/10.1182/blood-2013-05-502773