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This article was written by Massimo Gentile from the UOC Ematologia, Ospendale Annunziata in Italy along with co-authors from various other centers; and published in the European Journal of Cancer in June 2016. The article describes clinical data results from a retrospective, multicenter study in a cohort of patients (n=279) with progressive Chronic Lymphocytic Leukemia (CLL) from 33 centers (29 Italian, 3 Israeli and 1 German) across Europe. Patients were administered at least 1 cycle of bendamustine–rituximab (BR) as front line therapy during the period 2008–2014. The primary and secondary objectives of the study were to determine safety and efficacy of BR as frontline therapy and to establish the progression free survival (PFS) and overall survival (OS) respectively. These objectives were evaluated on the intention to treat (ITT) population which included all patients receiving at least 1 cycle of BR. Other biological parameters on overall response rate [ORR, complete response (CR), partial response (PR)] were also assessed and recorded according to the CLL (IWCLL) 2008 criteria.
Although the combination of fludarabine, cyclophosphamide and rituximab (FCR) represents the gold standard front line therapy for young and fit patients with CLL; BR has shown to be a suitable alternative especially for elderly and fit patients. The results of this retrospective study are also in good agreement with the results obtained in three other prospective primary studies [GCLLSG phase II and II trials and the MABLE trial (NCT01056510)]. BR has shown to achieve similar outcome end-points in previously untreated CLL patients outside of controlled clinical trials.
The full article can be found here
Combination of bendamustine and rituximab as frontline therapy for patients with chronic lymphocytic leukaemia: multicenter, retrospective clinical practice experience with 279 cases outside of controlled clinical trials
Recently, encouraging results in terms of safety and efficacy have been obtained using bendamustine-rituximab (BR) in untreated chronic lymphocytic leukaemia (CLL) patients enrolled in a phase II study. Here, we report a retrospective international multicentre study of CLL patients treated with BR as front-line therapy. The cohort included 279 patients with progressive CLL from 33 centers (29 Italian, 3 Israeli and 1 German) who received at least 1 cycle of BR as first-line treatment during the 2008-2014 period. The primary objective of this study was to evaluate the efficacy and safety of BR administered as front-line therapy, outside of controlled clinical trials. Median age was 70 years (range, 43e86 years); 62.4% were males and 35.8% had Binet stage C. Forty-two patients (15.2%) were unfit (cumulative illness rating scale [CIRS] score _7), and 140 (50.2%) had creatinine clearance _70 ml/min. Fluorescent in situ hybridisation analysis, available for 192 cases, showed that 21 (10.9%) had del11q and 18 (9.4%) del17p. The overall response rate (ORR) was 86.4%, with a complete remission rate of 28%. Patients with del17p had an ORR of 66.7%. After median follow-up of 24 months, the 2-year progression-free survival (PFS) was 69.9%; CIRS _7, immunoglobulin heavy-chain variable-region (IGHV) unmutated status, del17p and BR dose intensity <80% were independently associated with shorter PFS. Grade III or IV neutropenia, thrombocytopenia, and anaemia were observed in 25.9%, 15.4%, and 15.1% of patients, respectively. Twenty-four patients (8.6%) had severe infections. BR is also an effective and safe regimen for untreated CLL patients, outside of controlled clinical trials.
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