title: Maintenance therapy with rituximab leads to a significant prolongation of response duration after salvage therapy with a combination of rituximab, fludarabine, cyclophosphamide, and mitoxantrone (R-FCM) in patients with recurring and refractory follicular and mantle cell lymphomas: Results of a prospective randomized study of the German Low Grade Lymphoma Study Group (GLSG).
abstract: In follicular lymphoma (FL) and mantle cell lymphoma (MCL) the monoclonal antibody rituximab (R) improves the prognosis when combined with chemotherapy. The present study investigated R-maintenance after R-chemotherapy. Patients with recurring or refractory FL and MCL were randomized to 4 courses of fludarabine, cyclophosphamide, and mitoxantrone (FCM) alone or combined with R (R-FCM). Responding patients underwent a second randomization for R-maintenance comprising 2 further courses of 4-times-weekly doses of R after 3 and 9 months. The first randomization was stopped after 147 patients, when R-FCM revealed a significantly better outcome. All subsequent patients received R-FCM. Of the 176 patients who are currently evaluable (as of October 2005), 138 received R-FCM for remission induction. Response duration was significantly prolonged by R-maintenance after R-FCM, with the median not being reached in this evaluation versus an estimated median of 16 months (P = .001). This beneficial effect was also observed when analyzing FL (P = .035) and MCL (P = .049) separately. Hence, R-maintenance is effective after salvage with R-chemotherapy and significantly prolongs response duration in patients with recurring or refractory FL or MCL.
authors.affiliation: Department of Internal Medicine III, University of Munich, Grosshadern Marchioninistr. 15, 81377 München, Germany.
authors.forename: Roswitha
authors.initials: R
authors.lastname: Forstpointner
authors.forename: Michael
authors.initials: M
authors.lastname: Unterhalt
authors.forename: Martin
authors.initials: M
authors.lastname: Dreyling
authors.forename: Hans-Peter
authors.initials: HP
authors.lastname: Böck
authors.forename: Roland
authors.initials: R
authors.lastname: Repp
authors.forename: Hannes
authors.initials: H
authors.lastname: Wandt
authors.forename: Christiane
authors.initials: C
authors.lastname: Pott
authors.forename: John F
authors.initials: JF
authors.lastname: Seymour
authors.forename: Bernd
authors.initials: B
authors.lastname: Metzner
authors.forename: Annette
authors.initials: A
authors.lastname: Hänel
authors.forename: Tanja
authors.initials: T
authors.lastname: Lehmann
authors.forename: Frank
authors.initials: F
authors.lastname: Hartmann
authors.forename: Hermann
authors.initials: H
authors.lastname: Einsele
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Hiddemann
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000008:administration & dosage; D058846:Antibodies, Monoclonal, Murine-Derived; D000971:Antineoplastic Combined Chemotherapy Protocols; D003520:Cyclophosphamide / Q000008:administration & dosage; D018572:Disease-Free Survival; D005260:Female; D005858:Germany; D006801:Humans; D008224:Lymphoma, Follicular / Q000188:drug therapy* / Q000401:mortality; D020522:Lymphoma, Mantle-Cell / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D008942:Mitoxantrone / Q000008:administration & dosage; D011446:Prospective Studies; D012008:Recurrence; D012074:Remission Induction; D000069283:Rituximab; D016879:Salvage Therapy / Q000379:methods; D015996:Survival Rate; D014740:Vidarabine / Q000008:administration & dosage / Q000031:analogs & derivatives
chemical_list: D000911:Antibodies, Monoclonal; D058846:Antibodies, Monoclonal, Murine-Derived; D000069283:Rituximab; D003520:Cyclophosphamide; D008942:Mitoxantrone; D014740:Vidarabine; C024352:fludarabine