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

• Published in: International journal of hematology Vol. 101; no. 6; pp. 554 - 562
• Main Authors: 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
• Format: Journal Article
• Language: English
• Published: Tokyo Springer Japan 01-06-2015; Springer Nature B.V
• Subjects: Adult; Aged; Antineoplastic Agents - administration & dosage; Antineoplastic Agents - adverse effects; Antineoplastic Agents - therapeutic use; Antineoplastic Combined Chemotherapy Protocols - administration & dosage; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; B-Lymphocytes - drug effects; B-Lymphocytes - pathology; Bendamustine Hydrochloride - adverse effects; Bendamustine Hydrochloride - therapeutic use; Drug Administration Schedule; Female; Hematology; Hodgkin's disease; Humans; Immunotherapy; Leukopenia; Leukopenia - chemically induced; Lymphocytes B; Lymphoma; Lymphoma, B-Cell - drug therapy; Lymphoma, B-Cell - pathology; Lymphoma, Mantle-Cell - drug therapy; Lymphoma, Mantle-Cell - pathology; Male; Mantle cell lymphoma; Medicine; Medicine & Public Health; Middle Aged; Mucosal-associated lymphoid tissue; Myelosuppression; Neoplasm Recurrence, Local - drug therapy; Neoplasm Recurrence, Local - pathology; Neutropenia; Neutropenia - chemically induced; Non-Hodgkin's lymphoma; Oncology; Original Article; Patients; Response rates; Rituximab; Rituximab - administration & dosage; Rituximab - adverse effects; Rituximab - therapeutic use; Toxicity; Treatment Outcome; Young Adult; Rituximab; Indolent B-cell lymphoma; Bendamustine; Refractory/relapsed; Mantle cell lymphoma
• ISSN: 0925-5710; 1865-3774
• DOI: 10.1007/s12185-015-1767-3

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.