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

Kimihiro Matsumoto, Nobuyuki Takayama, Yoshinobu Aisa, Hironori Ueno, Masao Hagihara, Kentaro Watanabe, Aya Nakaya, Kenko Chen, Takayuki Shimizu, Yuiko Tsukada, Yuji Yamada, Tomonori Nakazato, Akaru Ishida, Yoshitaka Miyakawa, Kenji Yokoyama, Hideaki Nakajima, Yoshihiro Masuda, Takahiro Yano, Shinichiro Okamoto

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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/m<sup>2</sup>) for two consecutive days and R (375 mg/m<sup>2</sup>) 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.

Original languageEnglish
Pages (from-to)554-562
Number of pages9
JournalInternational Journal of Hematology
Volume101
Issue number6
DOIs
Publication statusPublished - 2015 Jun 11

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Mantle-Cell Lymphoma
B-Cell Lymphoma
Non-Hodgkin's Lymphoma
Marginal Zone B-Cell Lymphoma
Follicular Lymphoma
Leukopenia
Neutropenia
Appointments and Schedules
Bendamustine Hydrochloride
Rituximab
Safety
Incidence
Therapeutics
Infection

Keywords

  • Bendamustine
  • Indolent B-cell lymphoma
  • Mantle cell lymphoma
  • Refractory/relapsed
  • Rituximab

ASJC Scopus subject areas

  • Hematology

Cite this

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. / Matsumoto, Kimihiro; Takayama, Nobuyuki; Aisa, Yoshinobu; Ueno, Hironori; Hagihara, Masao; Watanabe, Kentaro; Nakaya, Aya; Chen, Kenko; Shimizu, Takayuki; Tsukada, Yuiko; Yamada, Yuji; Nakazato, Tomonori; Ishida, Akaru; Miyakawa, Yoshitaka; Yokoyama, Kenji; Nakajima, Hideaki; Masuda, Yoshihiro; Yano, Takahiro; Okamoto, Shinichiro.

In: International Journal of Hematology, Vol. 101, No. 6, 11.06.2015, p. 554-562.

Research output: Contribution to journalArticle

Matsumoto, K, Takayama, N, Aisa, Y, Ueno, H, Hagihara, M, Watanabe, K, Nakaya, A, Chen, K, Shimizu, T, Tsukada, Y, Yamada, Y, Nakazato, T, Ishida, A, Miyakawa, Y, Yokoyama, K, Nakajima, H, Masuda, Y, Yano, T & Okamoto, S 2015, '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', International Journal of Hematology, vol. 101, no. 6, pp. 554-562. https://doi.org/10.1007/s12185-015-1767-3
Matsumoto, Kimihiro ; Takayama, Nobuyuki ; Aisa, Yoshinobu ; Ueno, Hironori ; Hagihara, Masao ; Watanabe, Kentaro ; Nakaya, Aya ; Chen, Kenko ; Shimizu, Takayuki ; Tsukada, Yuiko ; Yamada, Yuji ; Nakazato, Tomonori ; Ishida, Akaru ; Miyakawa, Yoshitaka ; Yokoyama, Kenji ; Nakajima, Hideaki ; Masuda, Yoshihiro ; Yano, Takahiro ; Okamoto, Shinichiro. / 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. In: International Journal of Hematology. 2015 ; Vol. 101, No. 6. pp. 554-562.
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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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AU - Matsumoto, Kimihiro

AU - Takayama, Nobuyuki

AU - Aisa, Yoshinobu

AU - Ueno, Hironori

AU - Hagihara, Masao

AU - Watanabe, Kentaro

AU - Nakaya, Aya

AU - Chen, Kenko

AU - Shimizu, Takayuki

AU - Tsukada, Yuiko

AU - Yamada, Yuji

AU - Nakazato, Tomonori

AU - Ishida, Akaru

AU - Miyakawa, Yoshitaka

AU - Yokoyama, Kenji

AU - Nakajima, Hideaki

AU - Masuda, Yoshihiro

AU - Yano, Takahiro

AU - Okamoto, Shinichiro

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N2 - 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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