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

Abstract

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. © 2011 Blackwell Publishing Ltd.