title: Bendamustine in chronic lymphocytic leukemia: outcome according to different clinical and biological prognostic factors in the everyday clinical practice.
abstract: Bendamustine proved to be effective for the treatment of chronic lymphocytic leukemia (CLL). However, the relationship between its activity with clinico-biological prognosticators has been addressed only in few studies. We retrospectively evaluated the efficacy of bendamustine, in a real-life contest, on 142 patients, median age 70 years, median number of previous regimens 2 (0-8, 13% previously untreated). Bendamustine was administered for a median number of 4 cycles, in 84% of cases with rituximab. Overall (ORR) and complete response (CRR) rates were 68 and 16.5%, respectively. Multivariate analysis demonstrated a relationship between ORR and number of prior treatments (OR 0.25, 95% CI 0.08-0.71; P = 0.009), del(17p) (OR 0.10, 95% CI 0.03-0.32; P < 0.001) and concomitant rituximab (OR 4.37, 95% CI 1.12-17.04; P = 0.033). The estimated 1- and 2-years overall survival (OS) and progression free survival (PFS) rates were 76, 61, 51, and 26%, respectively. Previous sensitivity to fludarabine (HR 0.36, 95% CI 0.16-0.82), response to bendamustine (HR 0.21, 95% CI 0.10-0.45), and del(17p) (HR 2.18, 95% CI 1.002-4.74) had a prognostic significance in multivariate analysis for PFS, while the number of previous therapies (HR 3.48, 95% CI 1.29-9.38; P = 0.014), concomitant use of rituximab (HR 0.32, 95% CI 0.11-0.93) and response to bendamustine (HR 0.22, 95% CI 0.07-0.66) were significant for OS. Side effects included grade 3-4 neutropenia, infections, thrombocytopenia and anemia which occurred in 40, 14, 14, and 10% of patients, respectively. These results confirm the activity and safety of bendamustine and rituximab combination even in patients with unfavorable clinical and biological features excluding del(17p).
authors.affiliation: Clinica Ematologica, DISM, Azienda Ospedaliero Universitaria S. M. Misericordia, Udine, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Zaja
authors.forename: Michael
authors.initials: M
authors.lastname: Mian
authors.forename: Stefano
authors.initials: S
authors.lastname: Volpetti
authors.forename: Carlo
authors.initials: C
authors.lastname: Visco
authors.forename: Cinzia
authors.initials: C
authors.lastname: Sissa
authors.forename: Ilaria
authors.initials: I
authors.lastname: Nichele
authors.forename: Monica
authors.initials: M
authors.lastname: Castelli
authors.forename: Achille
authors.initials: A
authors.lastname: Ambrosetti
authors.forename: Simona
authors.initials: S
authors.lastname: Puglisi
authors.forename: Renato
authors.initials: R
authors.lastname: Fanin
authors.forename: Sergio
authors.initials: S
authors.lastname: Cortelazzo
authors.forename: Giovanni
authors.initials: G
authors.lastname: Pizzolo
authors.forename: Livio
authors.initials: L
authors.lastname: Trentin
authors.forename: Francesco
authors.initials: F
authors.lastname: Rodeghiero
authors.forename: Rossella
authors.initials: R
authors.lastname: Paolini
authors.forename: Paolo
authors.initials: P
authors.lastname: Vivaldi
authors.forename: Rosaria
authors.initials: R
authors.lastname: Sancetta
authors.forename: Miriam
authors.initials: M
authors.lastname: Isola
authors.forename: Gianpietro
authors.initials: G
authors.lastname: Semenzato
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D058846:Antibodies, Monoclonal, Murine-Derived / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D018906:Antineoplastic Agents, Alkylating / Q000009:adverse effects / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D000069461:Bendamustine Hydrochloride; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015451:Leukemia, Lymphocytic, Chronic, B-Cell / Q000175:diagnosis / Q000188:drug therapy* / Q000473:pathology / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D009503:Neutropenia / Q000139:chemically induced; D009588:Nitrogen Mustard Compounds / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011379:Prognosis; D015203:Reproducibility of Results; D012189:Retrospective Studies; D000069283:Rituximab; D016019:Survival Analysis
chemical_list: D058846:Antibodies, Monoclonal, Murine-Derived; D000970:Antineoplastic Agents; D018906:Antineoplastic Agents, Alkylating; D009588:Nitrogen Mustard Compounds; D000069283:Rituximab; D000069461:Bendamustine Hydrochloride