title: High anti-lymphoma activity of bendamustine/mitoxantrone/rituximab in rituximab pretreated relapsed or refractory indolent lymphomas and mantle cell lymphomas. A multicenter phase II study of the German Low Grade Lymphoma Study Group (GLSG).
abstract: On the basis of a preceding phase I study, the current trial explored bendamustine in combination with mitoxantrone and rituximab (BMR) in patients with stage III/IV relapsed or refractory indolent lymphomas and mantle cell lymphoma (MCL) with or without prior rituximab containing chemo-immunotherapy (R-chemo) treatment. Therapy consisted of bendamustine 90 mg/m(2) days 1 + 2, mitoxantrone 10 mg/m(2) day 1, rituximab 375 mg/m(2) day 8. Treatment was repeated on day 29 for a total of four cycles. Between 3 April and 04 July, 57 patients were recruited from 24 participating institutions, 39% of whom had received prior R-chemo therapy. Median age was 66 years (40 - 83). Lymphoma subtypes were 29 follicular (FL), 18 MCL, and 10 other indolent lymphomas. The overall response rate (ORR) was 89% with 35% CR and 54% PR. ORR in R-chemo pretreated patients was 76% (38% CR, 38% PR). After a median observation time of 27 months (1 - 43), the estimated median progression free survival is 19 months. The 2 year overall survival is 60% for patients with FL and MCL. Treatment related toxicities of grade 3/4 comprised a reversible myelosuppression (10% anemia, 78% leukocytopenia, 46% granulocytopenia, 16% thrombocytopenia). However, unexpected hospitalisations were necessary after 4% of BMR-application only. BMR is a very effective new outpatient immuno-chemotherapy with low toxicity for patients with relapsed/refractory FL, MCL and other indolent lymphomas.
authors.affiliation: Praxisklinik for Hematology and Oncology, Koblenz, Germany.
authors.forename: Rudolf
authors.initials: R
authors.lastname: Weide
authors.forename: Georg
authors.initials: G
authors.lastname: Hess
authors.forename: Hubert
authors.initials: H
authors.lastname: Köppler
authors.forename: Jochen
authors.initials: J
authors.lastname: Heymanns
authors.forename: Jörg
authors.initials: J
authors.lastname: Thomalla
authors.forename: Ali
authors.initials: A
authors.lastname: Aldaoud
authors.forename: Christoph
authors.initials: C
authors.lastname: Losem
authors.forename: Stefan
authors.initials: S
authors.lastname: Schmitz
authors.forename: Ursula
authors.initials: U
authors.lastname: Haak
authors.forename: Christoph
authors.initials: C
authors.lastname: Huber
authors.forename: Michael
authors.initials: M
authors.lastname: Unterhalt
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Hiddemann
authors.forename: Martin
authors.initials: M
authors.lastname: Dreyling
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 / Q000627:therapeutic use* / Q000633:toxicity; D000069461:Bendamustine Hydrochloride; D005260:Female; D006801:Humans; D008224:Lymphoma, Follicular / Q000150:complications / Q000188:drug therapy / Q000401:mortality; D020522:Lymphoma, Mantle-Cell / Q000188:drug therapy*; D008228:Lymphoma, Non-Hodgkin / Q000150:complications / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D008942:Mitoxantrone / Q000008:administration & dosage; D009588:Nitrogen Mustard Compounds / Q000008:administration & dosage*; D012074:Remission Induction; D000069283:Rituximab; D016879:Salvage Therapy / Q000379:methods; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D058846:Antibodies, Monoclonal, Murine-Derived; D009588:Nitrogen Mustard Compounds; D000069283:Rituximab; D000069461:Bendamustine Hydrochloride; D008942:Mitoxantrone