title: Phase II study of bendamustine combined with rituximab in relapsed/refractory mantle cell lymphoma: efficacy, tolerability, and safety findings.
abstract: In most cases of relapsed/refractory mantle cell lymphoma (MCL), patients respond to salvage therapy, though typically responses are partial and/or transient followed by disease progression, even with newer agents (e.g., ibrutinib). In this multicenter, open-label, single-arm, phase II study, patients with relapsed/refractory non-blastoid MCL received bendamustine 90 mg/m(2) (days 1 and 2) and rituximab 375 mg/m(2) (day 1) for 6 planned 28-day cycles. Functional imaging with 18-fluoro-2-deoxy-D-glucose positron emission tomography/computed tomography (18F-FDG PET/CT) was conducted at baseline and after cycle 6. Forty-five patients were enrolled (median age, 70 years; 82 % stage IV disease; median number of prior chemotherapies, 2 [range, 1-4]), showing an overall response rate (ORR; primary efficacy measure) of 82 % (complete response [CR], 40 %; partial response, 42 %). In the 32 patients with complete 18F-FDG PET/CT data, 75 % achieved a complete metabolic response. Median duration of response was 1.6 years, 1-year progression-free survival was 67 %, and 3-year overall survival was 55 %. Main non-hematologic adverse events were nausea (69 %), fatigue (56 %), decreased appetite (42 %), constipation (38 %), diarrhea (36 %), vomiting (36 %), and decreased weight (31 %). Grade 3/4 neutropenia and lymphopenia occurred in 44 and 89 % of patients, respectively. ORR and CR rate compared favorably with single-agent ibrutinib (ORR, 67 %; CR, 23 %); bendamustine-rituximab is an effective therapy with manageable toxicity in relapsed/refractory MCL.
authors.affiliation: Department of Medicine, Elm and Carlton Streets, Roswell Park Cancer Institute, Buffalo, NY, 14263, USA. docczucz@gmail.com.
authors.forename: Myron S
authors.initials: MS
authors.lastname: Czuczman
authors.affiliation: Lymphoma Division, Hackensack University Medical Center, Hackensack, NJ, 07601, USA.
authors.forename: A
authors.initials: A
authors.lastname: Goy
authors.affiliation: Department of Nuclear Medicine, Roswell Park Cancer Institute, Buffalo, NY, 14263, USA.
authors.forename: D
authors.initials: D
authors.lastname: Lamonica
authors.affiliation: Department of Nuclear Medicine, Roswell Park Cancer Institute, Buffalo, NY, 14263, USA.|University of Texas Medical Branch at Galveston, Galveston, TX, 77555, USA.
authors.forename: D A
authors.initials: DA
authors.lastname: Graf
authors.affiliation: Teva Branded Pharmaceutical Products R&D, Inc., Frazer, PA, 19355, USA.
authors.forename: M C
authors.initials: MC
authors.lastname: Munteanu
authors.affiliation: Department of Medicine, The Ottawa Hospital, General Campus, K1H 8L6, Ottawa, Canada.
authors.forename: R H
authors.initials: RH
authors.lastname: van der Jagt
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D000069461:Bendamustine Hydrochloride / Q000008:administration & dosage / Q000009:adverse effects; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D020522:Lymphoma, Mantle-Cell / Q000188:drug therapy* / Q000401:mortality*; D008297:Male; D008875:Middle Aged; D012008:Recurrence; D000069283:Rituximab / Q000008:administration & dosage / Q000009:adverse effects; D015996:Survival Rate; D013997:Time Factors
chemical_list: D000069283:Rituximab; D000069461:Bendamustine Hydrochloride
keywords: 18F-FDG PET/CT; Bendamustine; Mantle cell lymphoma; Refractory; Relapsed; Rituximab