Highlights
- •Until now, only three prospective trials showed the safety and efficacy of bendamustine–rituximab (BR) in previously untreated patients with chronic lymphocytic leukaemia (CLL).
- •The present study is the first to assess safety and efficacy of BR in a large cohort of patients with untreated CLL, outside of controlled clinical trials.
- •The results of our BR ‘real-life’ experience study are in good agreement with those obtained in three prospective primary studies, although some differences in terms of safety were evident. Thus, it seems that BR also achieves similar results in terms of outcome end-points in previously untreated CLL patients outside of controlled clinical trials.
Abstract
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 multicenter
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, 43–86 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.
Keywords
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Article info
Publication history
Published online: April 27, 2016
Accepted:
March 14,
2016
Received in revised form:
March 6,
2016
Received:
January 12,
2016
Identification
Copyright
© 2016 Elsevier Ltd. All rights reserved.
