A phase II study of bendamustine in combination with rituximab as initial treatment for patients with indolent non-follicular non-Hodgkin lymphoma

Abstract

The purpose of this phase 2 study was to determine the activity and safety of six cycles of bendamustine and eight rituximab (RB) as first-line treatment of adult patients with advanced stage non-follicular indolent non-Hodgkin lymphomas (INFL). The primary end-point was the complete response rate (CRR) with expected CRR of 75%. Sixty-nine patients were enrolled; median age was 65 years (45–75), 65% were male, 93% of patients had stage IV disease. Complete and overall response rates were 48% (95% CI = 35.6–60.2) and 86% (CI = 75.0–92.8). The most common grade 3/4 adverse events were neutropenia (43%), thrombocytopenia (7%) and anemia (4%); whereas the rate of febrile neutropenia was very low (3%). At a median follow-up of 22 months (1–43 months), 2-year progression-free survival was 89% (CI = 79–95) and 2-year overall survival was 96% (CI = 87–99). RB combination is active and well tolerated in patients with advanced stage previously untreated INFL.

Keywords:

• Bendamustine
• chemotherapy
• indolent non-follicular lymphomas
• rituximab

Acknowledgements

We gratefully acknowledge Mundipharma Pharmaceuticals srl Italia for providing a contribution consisting of drug supply (bendamustine) and a financial support to the study.

Potential conflict of interest

Stefano Luminari has received personal fees from Pfizer and serves in an advisory role for Roche, Celgene and Teva outside the submitted work. Luca Arcaini has received personal fees from Mundipharma and serves in an advisory role for Roche, Celgene and Gilead outside the submitted work. Antonello Pinto has received personal fees from Roche, Celgene, Takeda and Mundipharma and has received non-financial support from Mundipharma, outside the submitted work. Disclosure forms provided by the authors are available with the full text of this article at www.informahealthcare.com/lal