title: 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.
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(2)) for two consecutive days and R (375 mg/m(2)) 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.
authors.affiliation: Department of Internal medicine, Tokyo Dental College Ichikawa General Hospital, 5-11-13 Sugano, Ichikawa, Chiba, 272-8513, Japan, kmatumoto1123@gmail.com.
authors.forename: Kimihiro
authors.initials: K
authors.lastname: Matsumoto
authors.forename: Nobuyuki
authors.initials: N
authors.lastname: Takayama
authors.forename: Yoshinobu
authors.initials: Y
authors.lastname: Aisa
authors.forename: Hironori
authors.initials: H
authors.lastname: Ueno
authors.forename: Masao
authors.initials: M
authors.lastname: Hagihara
authors.forename: Kentaro
authors.initials: K
authors.lastname: Watanabe
authors.forename: Aya
authors.initials: A
authors.lastname: Nakaya
authors.forename: Kenko
authors.initials: K
authors.lastname: Chen
authors.forename: Takayuki
authors.initials: T
authors.lastname: Shimizu
authors.forename: Yuiko
authors.initials: Y
authors.lastname: Tsukada
authors.forename: Yuji
authors.initials: Y
authors.lastname: Yamada
authors.forename: Tomonori
authors.initials: T
authors.lastname: Nakazato
authors.forename: Akaru
authors.initials: A
authors.lastname: Ishida
authors.forename: Yoshitaka
authors.initials: Y
authors.lastname: Miyakawa
authors.forename: Kenji
authors.initials: K
authors.lastname: Yokoyama
authors.forename: Hideaki
authors.initials: H
authors.lastname: Nakajima
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Masuda
authors.forename: Takahiro
authors.initials: T
authors.lastname: Yano
authors.forename: Shinichiro
authors.initials: S
authors.lastname: Okamoto
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001402:B-Lymphocytes / Q000187:drug effects / Q000473:pathology; D000069461:Bendamustine Hydrochloride / Q000009:adverse effects / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007970:Leukopenia / Q000139:chemically induced; D016393:Lymphoma, B-Cell / Q000188:drug therapy* / Q000473:pathology; D020522:Lymphoma, Mantle-Cell / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000473:pathology; D009503:Neutropenia / Q000139:chemically induced; D000069283:Rituximab / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents; D000069283:Rituximab; D000069461:Bendamustine Hydrochloride