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Leuk Lymphoma. 2016;57(4):880-7. doi: 10.3109/10428194.2015.1091934. Epub 2016 Feb 8.

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

Author information

1
a Department of Diagnostic , Clinical, and Public Health Medicine, University of Modena and Reggio Emilia , Modena , Italy ;
2
b Fondazione Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena , Milano , Italy ;
3
c Hematology, Città della Salute e della Scienza , Torino , Italy ;
4
d Division of Hematology , Spedali Civili , Brescia , Italy ;
5
e Division of Hematology , Sapienza University , Roma , Italy ;
6
f Azienda ospedaliera nazionale SS. Antonio e Biagio e Cesare Arrigo , Alessandria ;
7
g Department of Hematology Oncology , Fondazione IRCCS Policlinico San Matteo, University of Pavia , Pavia , Italy ;
8
h Azienda Ospedaliera Universitaria 'San Martino' , Genova , Italy ;
9
i Azienda Ospedaliera Ospedale Niguarda Ca' Granda , Milano , Italy ;
10
j UOSC di Ematologia Oncologica, Istituto Nazionale Tumori, Fondazione Pascale, IRCCS , Napoli , Italy ;
11
k Azienda ospedaliera Bianchi Melacrino Morelli , Reggio Calabria , Italy.

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

PMID:
26379040
DOI:
10.3109/10428194.2015.1091934
[Indexed for MEDLINE]

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