We performed an observational study on the efficacy of ben-damustine and rituximab (BR) as first salvage regimen in chronic lymphocytic leukemia (CLL). In an intention-to-treat analysis including 237 patients, the median progression-free survival (PFS) was 25 months. The presence of del(17p), unmutated IGHV and advanced stage were associated with a shorter PFS at multivariate analysis. The median time-to-next treatment was 31.3 months. Front-line treatment with a chemoimmunotherapy regimen was the only predictive factor for a shorter time to next treatment at multivariate analysis. The median overall survival (OS) was 74.5 months. Advanced disease stage (i.e. Rai stage III-IV or Binet stage C) and resistant disease were the only parameters significantly associated with a shorter OS. Grade 3-5 infections were recorded in 6.3% of patients. A matched-adjusted indirect comparison with ibrutinib given second-line within Named Patient Programs in the United Kingdom and in Italy was carried out with OS as objective end point. When restricting the analysis to patients with intact 17p who had received chemoimmunotherapy in first line, there was no difference in OS between patients treated with ibrutinib (63% alive at 36 months) and patients treated with BR (74.4% alive at 36 months). BR is an efficacious first salvage regimen in CLL in a real-life population, including the elderly and unfit patients. BR and ibrutinib may be equally effective in terms of OS when used as first salvage treatment in patients without 17p deletion.

Department of Hematology Hospital Clinic Institut Investigacions Biomèdiques August Pi i Sunyer Barcelona Spain

Department of Hematology University Hospital Hradec Kralove Czech Republic

Division of Experimental Oncology IRCCS San Raffaele Scientific Institute and Vita Salute San Raffaele University Milan Italy

Haematology Department University Hospital National Health Service Trust Southampton UK

Hematology and Cellular Therapy Ospedale C e G Mazzoni Ascoli Piceno Italy

Hematology and Clinical Immunology Department of Medicine University of Padua Italy

Hematology and Transplant Unit San Maurizio Hospital Azienda Sanitaria dell'Alto Adige Bolzano Italy

Hematology Department Fondazione IRCCS Istituto Nazionale Tumori Milano Italy

Hematology Department of Biomedical Sciences and Hematology Sapienza University Rome Italy

Hematology Department of Cell Therapy and Hematology University Hospital Verona Italy

Hematology Department of Medical Sciences St Anna University Hospital Ferrara Italy

Hematology DIMECS e Dipartimento Oncologico Università del Piemonte Orientale Amedeo Avogadro Novara Italy

Hematology Niguarda Cancer Center ASST Grande Ospedale Metropolitano Niguarda Milan Italy

Hematology San Bortolo Hospital Vicenza Italy

Hematology San Carlo Hospital Potenza Italy

Hematology Unit A Pugliese Hospital Azienda Ospedaliera Pugliese Ciaccio Catanzaro Italy

Hematology Unit Arcispedale S Maria Nuova Reggio Emilia Italy

Hematology Unit Azienda Universitaria Ospedaliera Policlinico Vittorio Emanuele Catania Italy

Hematology Unit Careggi Hospital Florence Italy

Hematology Unit Città della Salute e della Scienza University of Turin Italy

Hematology Unit Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico University of Milan Italy

Hematology Unit Fondazione IRCCS Policlinico San Matteo Pavia Italy

Hematology Unit Hospital Universitario 12 de Octubre Madrid Spain

Hematology Unit Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori IRCCS Meldola Italy

Hematology Unit University Hospital Modena Italy

Hematology Università Cattolica del Sacro Cuore Policlinico A Gemelli Rome Italy

Hematology University Hospital IBSAL and CIBERONC Salamanca Spain

Hematology University Hospital Parma Italy

Hospital Costa del Sol Marbella Málaga Spain

Hospital de la Santa Creu i Sant Pau Barcellona Spain

Italian Group for Adult Hematologic Diseases Data Center and Health Outcomes Research Unit Rome Italy

Norwich Medical School UK

Oncology Unit Cardinal Massaia Hospital Asti Italy

Oxford University Hospitals NHS Foundation Trust UK

UK CLL Forum Cambridge University Hospitals NHS Foundation Trust UK

UK CLL Forum Oxford University Hospitals NHS Foundation Trust UK

University Hospitals of Leicester NHS Trust UK

Haematologica. 2018 Jul;103(7):1096-1098. doi: 10.3324/haematol.2018.196014. PubMed

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