title: A phase II study of bendamustine in combination with rituximab as initial treatment for patients with indolent non-follicular non-Hodgkin lymphoma.
abstract: The purpose of this phase 2 study was to determine the activity and safety of six cycles of bendamustine and eight rituximab (RB) as first-line treatment of adult patients with advanced stage non-follicular indolent non-Hodgkin lymphomas (INFL). The primary end-point was the complete response rate (CRR) with expected CRR of 75%. Sixty-nine patients were enrolled; median age was 65 years (45-75), 65% were male, 93% of patients had stage IV disease. Complete and overall response rates were 48% (95% CI = 35.6-60.2) and 86% (CI = 75.0-92.8). The most common grade 3/4 adverse events were neutropenia (43%), thrombocytopenia (7%) and anemia (4%); whereas the rate of febrile neutropenia was very low (3%). At a median follow-up of 22 months (1-43 months), 2-year progression-free survival was 89% (CI = 79-95) and 2-year overall survival was 96% (CI = 87-99). RB combination is active and well tolerated in patients with advanced stage previously untreated INFL.
authors.affiliation: a Department of Diagnostic , Clinical, and Public Health Medicine, University of Modena and Reggio Emilia , Modena , Italy ;
authors.forename: Stefano
authors.initials: S
authors.lastname: Luminari
authors.affiliation: b Fondazione Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena , Milano , Italy ;
authors.forename: Maria
authors.initials: M
authors.lastname: Goldaniga
authors.affiliation: a Department of Diagnostic , Clinical, and Public Health Medicine, University of Modena and Reggio Emilia , Modena , Italy ;
authors.forename: Marina
authors.initials: M
authors.lastname: Cesaretti
authors.affiliation: c Hematology, Città della Salute e della Scienza , Torino , Italy ;
authors.forename: Lorella
authors.initials: L
authors.lastname: Orsucci
authors.affiliation: d Division of Hematology , Spedali Civili , Brescia , Italy ;
authors.forename: Alessandra
authors.initials: A
authors.lastname: Tucci
authors.affiliation: e Division of Hematology , Sapienza University , Roma , Italy ;
authors.forename: Alessandro
authors.initials: A
authors.lastname: Pulsoni
authors.affiliation: f Azienda ospedaliera nazionale SS. Antonio e Biagio e Cesare Arrigo , Alessandria ;
authors.forename: Flavia
authors.initials: F
authors.lastname: Salvi
authors.affiliation: g Department of Hematology Oncology , Fondazione IRCCS Policlinico San Matteo, University of Pavia , Pavia , Italy ;
authors.forename: Luca
authors.initials: L
authors.lastname: Arcaini
authors.affiliation: h Azienda Ospedaliera Universitaria 'San Martino' , Genova , Italy ;
authors.forename: Angelo Michele
authors.initials: AM
authors.lastname: Carella
authors.affiliation: i Azienda Ospedaliera Ospedale Niguarda Ca' Granda , Milano , Italy ;
authors.forename: Alessandra
authors.initials: A
authors.lastname: Tedeschi
authors.affiliation: j UOSC di Ematologia Oncologica, Istituto Nazionale Tumori, Fondazione Pascale, IRCCS , Napoli , Italy ;
authors.forename: Antonello
authors.initials: A
authors.lastname: Pinto
authors.affiliation: k Azienda ospedaliera Bianchi Melacrino Morelli , Reggio Calabria , Italy.
authors.forename: Caterina
authors.initials: C
authors.lastname: Stelitano
authors.affiliation: b Fondazione Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena , Milano , Italy ;
authors.forename: Luca
authors.initials: L
authors.lastname: Baldini
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000069461:Bendamustine Hydrochloride / Q000008:administration & dosage; D001853:Bone Marrow / Q000473:pathology; D018450:Disease Progression; D005260:Female; D006801:Humans; D008228:Lymphoma, Non-Hodgkin / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D012074:Remission Induction; D000069283:Rituximab / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D000069283:Rituximab; D000069461:Bendamustine Hydrochloride
keywords: Bendamustine; chemotherapy; indolent non-follicular lymphomas; rituximab