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

Stefano Luminari, Maria Cecilia Goldaniga, Marina Cesaretti, L. Orsucci, Alessandra Tucci, Alessandro Pulsoni, Flavia Salvi, Luca Arcaini, Angelo Michele Carella, Alessandra Tedeschi, Antonio Pinto, Caterina Stelitano, Luca Baldini

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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.

Original languageEnglish
Pages (from-to)880-887
Number of pages8
JournalLeukemia and Lymphoma
Volume57
Issue number4
DOIs
Publication statusPublished - Apr 2 2016

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Keywords

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

ASJC Scopus subject areas

  • Hematology
  • Oncology
  • Cancer Research

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