Bendamustine plus rituximab for previously untreated patients with indolent B-cell non-Hodgkin lymphoma or mantle cell lymphoma: a multicenter Phase II ... View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2017-04

AUTHORS

Michinori Ogura, Kenichi Ishizawa, Dai Maruyama, Naokuni Uike, Kiyoshi Ando, Koji Izutsu, Yasuhito Terui, Yoshitaka Imaizumi, Kunihiro Tsukasaki, Kenshi Suzuki, Tohru Izumi, Kensuke Usuki, Tomohiro Kinoshita, Masafumi Taniwaki, Nobuhiko Uoshima, Junji Suzumiya, Mitsutoshi Kurosawa, Hirokazu Nagai, Toshiki Uchida, Noriko Fukuhara, Ilseung Choi, Ken Ohmachi, Go Yamamoto, Kensei Tobinai, For the Japanese Bendamustine Lymphoma Study Group

ABSTRACT

A Phase II, multicenter clinical trial of bendamustine plus rituximab (BR) regimen was conducted in previously untreated patients with high-tumor-burden indolent B-cell non-Hodgkin lymphoma (B-NHL) and previously untreated elderly patients with mantle cell lymphoma (MCL) in Japan. Bendamustine 90 mg/m2/day on days 1 and 2, as well as rituximab 375 mg/m2 on day 1 were administered intravenously up to six cycles. The primary endpoint was the complete response (CR) rate as assessed by the International Workshop Response Criteria (1999). Sixty-nine patients (59 with indolent B-NHL and 10 with MCL) were treated. The median number of delivered cycles was six (range 1-6). The CR rates were 67.8% [95% confidence interval (CI) 54.4-79.4%] and 70.0% (95% CI 34.8-93.3%) for indolent B-NHL and MCL, respectively. Estimated progression-free survival at 30 months was 72.1% (95% CI 58.5-82.0%) in indolent B-NHL and was 67.5% (95% CI 29.1-88.2%) in MCL. Major grade 3/4 toxicities were hematologic and included lymphopenia (97%), CD4 lymphopenia (91%), neutropenia (86%), and leukopenia (83%). No treatment-related death was found. The BR regimen showed high efficacy as evidenced by the expected CR rate and durable response, as well as an acceptable safety profile for the study populations. More... »

PAGES

470-477

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s12185-016-2146-4

DOI

http://dx.doi.org/10.1007/s12185-016-2146-4

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1053131460

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/27900638


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