Bendamustine with or without rituximab in the treatment of relapsed chronic lymphocytic leukaemia: An Italian retrospective study

Emilio Iannitto, Fortunato Morabito, Salvatrice Mancuso, Massimo Gentile, Antonella Montanini, Accursio Augello, Velia Bongarzoni, Alfonso D'Arco, Nicola Di Renzo, Rita Fazzi, Giovanni Franco, Roberto Marasca, Antonino Mulè, Maurizio Musso, Pellegrino Musto, Elsa Pennese, Andrea Piccin, Delia Rota-Scalabrini, Giuseppe Visani, Luigi Rigacci

Research output: Contribution to journalArticlepeer-review


To retrospectively assess the efficacy of bendamustine alone and with rituximab (R-B), 109 patients with relapsed chronic lymphocytic leukaemia (CLL) were enrolled in 24 Italian centres. The median age was 66years (range 39-85). Forty-three percent of patients had relapsed and 57% were resistant (median previous therapies=3; range 1-8). Twenty-two patients received bendamustine alone and 87 patients received R-B (median B dosage: 100mg/m2 per day, range 90-130mg/m2 per day). The overall response rate was 69·6% (complete response 28·6%; partial response 41%), and was significantly higher in patients treated with R-B (P=0·014) and in those responsive to the previous treatment (P=0·04). After a median follow-up of 7·9months (range 1-148), the median progression-free survival was 16months and the median duration of response was 13months. Median overall survival (OS) was 16·8months for the whole cohort; patients not responding to the treatment had a significantly worse outcome than those who attained a response (P=0·0001). In multivariate analysis, only resistant disease status at start of bendamustine treatment (HR 3·2, 95% CI 1·4-7·3, P=0·006) had an independent prognostic value for OS. Toxicity was manageable and mostly haematological. In conclusion, in our experience R-B was an effective and well-tolerated treatment for relapsed/refractory CLL patients, producing a remarkable high CR rate and mild toxicity.

Original languageEnglish
Pages (from-to)351-357
Number of pages7
JournalBritish Journal of Haematology
Issue number3
Publication statusPublished - May 2011


  • Antineoplastic agents
  • Bendamustine
  • Leukaemia
  • Relapsed chronic lymphocytic leukaemia
  • Rituximab

ASJC Scopus subject areas

  • Hematology


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