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: Francesco Zaja, Michael Mian, Stefano Volpetti, Carlo Visco, Cinzia Sissa, Ilaria Nichele, Monica Castelli, Achille Ambrosetti, Simona Puglisi, Renato Fanin, Sergio Cortelazzo, Giovanni Pizzolo, Livio Trentin, Francesco Rodeghiero, Rossella Paolini, Paolo Vivaldi, Rosaria Sancetta, Miriam Isola, Gianpietro Semenzato
• Journal: American journal of hematology (Am J Hematol) Vol. 88 Issue 11 Pg. 955-60 (Nov 2013) ISSN: 1096-8652 [Electronic] United States
• PMID: 23861234 (Publication Type: Journal Article, Multicenter Study)
• Copyright: Copyright © 2013 Wiley Periodicals, Inc.

Chemical References

• Antibodies, Monoclonal, Murine-Derived
• Antineoplastic Agents
• Antineoplastic Agents, Alkylating
• Nitrogen Mustard Compounds
• Rituximab
• Bendamustine Hydrochloride

Topics

• Adult
• Aged
• Aged, 80 and over
• Antibodies, Monoclonal, Murine-Derived (administration & dosage, adverse effects, therapeutic use)
• Antineoplastic Agents (administration & dosage, adverse effects, therapeutic use)
• Antineoplastic Agents, Alkylating (adverse effects, therapeutic use)
• Antineoplastic Combined Chemotherapy Protocols (administration & dosage, adverse effects, therapeutic use)
• Bendamustine Hydrochloride
• Female
• Follow-Up Studies
• Humans
• Leukemia, Lymphocytic, Chronic, B-Cell (diagnosis, drug therapy, pathology, physiopathology)
• Male
• Middle Aged
• Neoplasm Staging
• Neutropenia (chemically induced)
• Nitrogen Mustard Compounds (administration & dosage, adverse effects, therapeutic use)
• Prognosis
• Reproducibility of Results
• Retrospective Studies
• Rituximab
• Survival Analysis