title: Rituximab maintenance after first-line therapy with rituximab, fludarabine, cyclophosphamide, and mitoxantrone (R-FCM) for chronic lymphocytic leukemia.
abstract: 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.
authors.affiliation: Department of Hematology, University Hospital Vall d'Hebron, Universitat Autonoma, Barcelona, Spain;
authors.forename: Pau
authors.initials: P
authors.lastname: Abrisqueta
authors.forename: Neus
authors.initials: N
authors.lastname: Villamor
authors.forename: María José
authors.initials: MJ
authors.lastname: Terol
authors.forename: Eva
authors.initials: E
authors.lastname: González-Barca
authors.forename: Marcos
authors.initials: M
authors.lastname: González
authors.forename: Christelle
authors.initials: C
authors.lastname: Ferrà
authors.forename: Eugenia
authors.initials: E
authors.lastname: Abella
authors.forename: Julio
authors.initials: J
authors.lastname: Delgado
authors.forename: Jose A
authors.initials: JA
authors.lastname: García-Marco
authors.forename: Yolanda
authors.initials: Y
authors.lastname: González
authors.forename: Felix
authors.initials: F
authors.lastname: Carbonell
authors.forename: Secundino
authors.initials: S
authors.lastname: Ferrer
authors.forename: Encarna
authors.initials: E
authors.lastname: Monzó
authors.forename: Isidro
authors.initials: I
authors.lastname: Jarque
authors.forename: Ana
authors.initials: A
authors.lastname: Muntañola
authors.forename: Mireia
authors.initials: M
authors.lastname: Constants
authors.forename: Lourdes
authors.initials: L
authors.lastname: Escoda
authors.forename: Xavier
authors.initials: X
authors.lastname: Calvo
authors.forename: Sabela
authors.initials: S
authors.lastname: Bobillo
authors.forename: José Bruno
authors.initials: JB
authors.lastname: Montoro
authors.forename: Emili
authors.initials: E
authors.lastname: Montserrat
authors.forename: Francesc
authors.initials: F
authors.lastname: Bosch
mesh_terms: D000368:Aged; D058846:Antibodies, Monoclonal, Murine-Derived / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D019540:Area Under Curve; D003520:Cyclophosphamide / Q000008:administration & dosage; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D015451:Leukemia, Lymphocytic, Chronic, B-Cell / Q000188:drug therapy* / Q000378:metabolism; D060046:Maintenance Chemotherapy; D008297:Male; D008875:Middle Aged; D008942:Mitoxantrone / Q000008:administration & dosage; D009503:Neutropenia / Q000139:chemically induced; D011446:Prospective Studies; D012074:Remission Induction; D000069283:Rituximab; D013921:Thrombocytopenia / Q000139:chemically induced; D016896:Treatment Outcome; D014740:Vidarabine / Q000008:administration & dosage / Q000031:analogs & derivatives
chemical_list: D058846:Antibodies, Monoclonal, Murine-Derived; D000069283:Rituximab; D003520:Cyclophosphamide; D008942:Mitoxantrone; D014740:Vidarabine; C024352:fludarabine