Outside of controlled clinical trials, bendamustine plus rituximab is also effective and safe for the treatment of treatment-naïve patients with chronic lymphocytic leukemia (CLL), a study published in the European Journal of Cancer has shown.1

Because only 3 prospective clinical trials have demonstrated the efficacy and safety of bendamustine plus rituximab in previously untreated patients with CLL, researchers sought to evaluate the safety and efficacy of the chemoimmunotherapy regimen in a large cohort of patients in a “real-life” experience study.

For the retrospective study, researchers analyzed data from 279 patients with progressive CLL who received at least 1 cycle of front-line bendamustine plus rituximab treatment. Their median age was 70 years, 62.4% were male and 35.8% had Binet stage C. Of the 192 cases with fluorescent in situ hybridization analysis results available, 10.9% had del(11q) and 9.4% had del(17p).

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Results showed that the overall response rate was 86.4% and 28% of patients achieved complete remission. Patients with del(17q), specifically, had an overall response rate of 66.7%.

Researchers found that at a median follow-up of 24 months, the 2-year progression-free survival rate was 69.9%.

The study also demonstrated a Cumulative Illness Rating Scale (CIRS) score of 7 or higher, immunoglobulin heavy-chain variable-region (IGHV) unmutated status, del(17p), and a bendamustine-rituximab dose intensity less than 80% were independently associated with shorter progression-free survival.

In terms of safety, 25.9%, 15.4%, and 15.1% of patients experienced grade 3 or 4 neutropenia, thrombocytopenia, and anemia, respectively. Nearly 9% of patients reported severe infections.

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“The results of our bendamustine-rituximab ‘real-life’ experience study are in good agreement with those obtained in 3 prospective primary studies, although some differences in terms of safety were evident,” the authors concluded. “Thus, it seems that bendamustine-rituximab also achieves similar results in terms of outcome end-points in previously untreated CLL patients outside of controlled clinical trials.”


  1. Gentile M, Zirlik K, Ciolli S, et al. Combination of bendamustine and rituximab as front-line therapy for patients with chronic lymphocytic leukaemia: multicenter, retrospective clinical practice experience with 279 cases outside of controlled clinical trials. Eur J Cancer. 2016;60:154-165.