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A phase II study of bendamustine plus rituximab in Japanese patients with relapsed or refractory indolent B-cell non-Hodgkin lymphoma and mantle cell lymphoma previously treated with rituximab: BRB study

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Abstract

To evaluate the efficacy and safety of a combined regimen of bendamustine (B) and rituximab (R) in Japanese patients with relapsed/refractory (r/r) indolent B-cell non-Hodgkin lymphomas (B-NHLs) and mantle cell lymphoma (MCL). Patients aged 20–79 years with pathologically confirmed B-NHLs or MCL, which were r/r after 1–2 R-containing regimens, were included in this study. The BR regimen consisted of B (90 mg/m2) for two consecutive days and R (375 mg/m2) on day 1, 2, or 3. The course was repeated every 4 weeks for up to four cycles. Fifty-three patients were enrolled in this study and analyzed. The diagnosis included follicular lymphoma (FL) (77 %), mucosa-associated lymphoid tissue lymphoma (13 %) and others (10 %). Forty-seven (90 %) patients completed four cycles of treatment as per schedule. Best overall response rate (ORR) and complete response rate (CRR) was 94 and 71 %, respectively (for FL, ORR 95 % and CRR 80 %). The treatment was well tolerated and the primary toxicity was myelosuppression; the incidence of grade 3/4 leukopenia and neutropenia were 42 and 40 %, respectively. There were no grade 5 toxicities. The BR regimen is safe in Japanese patients with r/r indolent B-NHLs and MCL, and is effective for those with r/r indolent B-NHLs. For the evaluation of late toxicity, especially infection, longer follow-up of this cohort is needed.

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Acknowledgments

The authors thank to the patients who participated in this multicenter study, and to the following collaborators who have substantially contributed to data acquisition: Norihide Sato, Hideo Uchida, Takahide Kikuchi, Akihiro Yokoyama, Saigen Boku, Hiroshi Murakami, Taku Kikuchi, Eri Matsuki, Jo Ishizawa, Tomoki Ueda, and Takehiko Mori. We also thank the staffs at the Keio Center for Clinical Research for their technical assistance in data management.

Conflict of interest

Authors have no conflict of interests to declare. Dr. Shinichiro Okamoto received research fund from Eisai Co., Ltd. in 2010, not relevant to this work.

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Authors and Affiliations

  1. Department of Internal medicine, Tokyo Dental College Ichikawa General Hospital, 5-11-13 Sugano, Ichikawa, Chiba, 272-8513, Japan

    Kimihiro Matsumoto & Aya Nakaya

  2. Second Department of Internal medicine, Kyorin University School of Medicine, Tokyo, Japan

    Nobuyuki Takayama

  3. Department of Hematology, Yokohama Municipal Citizen’s Hospital, Yokohama, Japan

    Yoshinobu Aisa & Tomonori Nakazato

  4. Department of Hematology, National Hospital Organization Tokyo Medical Center, Tokyo, Japan

    Hironori Ueno & Takahiro Yano

  5. Department of Hematology, Eiju General Hospital, Tokyo, Japan

    Masao Hagihara

  6. Department of Hematology, Tokyo Saiseikai Central Hospital, Tokyo, Japan

    Kentaro Watanabe & Yuiko Tsukada

  7. Department of Internal medicine, Keiyu Hospital, Yokohama, Japan

    Kenko Chen

  8. Division of Hematology, Department of Internal medicine, Keio University School of Medicine, Tokyo, Japan

    Takayuki Shimizu, Yoshitaka Miyakawa, Kenji Yokoyama, Hideaki Nakajima & Shinichiro Okamoto

  9. Division of General Internal Medicine, Department of Medicine, Kawasaki Municipal Kawasaki Hospital, Kawasaki, Japan

    Yuji Yamada

  10. Department of Internal Medicine, Tachikawa Hospital Federation of National Public Service Personnel Mutual Aid Associations, Tokyo, Japan

    Akaru Ishida

  11. Department of Hematology, Saiseikai Utsunomiya Hospital, Utsunomiya, Japan

    Yoshihiro Masuda

Authors
  1. Kimihiro Matsumoto
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  2. Nobuyuki Takayama
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  8. Kenko Chen
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  9. Takayuki Shimizu
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  13. Akaru Ishida
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  14. Yoshitaka Miyakawa
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  15. Kenji Yokoyama
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  16. Hideaki Nakajima
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  17. Yoshihiro Masuda
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  18. Takahiro Yano
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  19. Shinichiro Okamoto
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Keio BRB Study Group

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Correspondence to Kimihiro Matsumoto.

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Matsumoto, K., Takayama, N., Aisa, Y. et al. A phase II study of bendamustine plus rituximab in Japanese patients with relapsed or refractory indolent B-cell non-Hodgkin lymphoma and mantle cell lymphoma previously treated with rituximab: BRB study. Int J Hematol 101, 554–562 (2015). https://doi.org/10.1007/s12185-015-1767-3

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  • DOI: https://doi.org/10.1007/s12185-015-1767-3

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