title: Bendamustine plus rituximab for previously untreated patients with indolent B-cell non-Hodgkin lymphoma or mantle cell lymphoma: a multicenter Phase II clinical trial in Japan.
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/m2on 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.
authors.affiliation: Department of Hematology and Oncology, Nagoya Daini Red Cross Hospital, Nagoya, Japan. mi-ogura@naa.att.ne.jp.|Department of Hematology, Tokai Central Hospital, 4-6-2 Higashijimacho, Sohara, Kakamigahara, Gifu, 504-8601, Japan. mi-ogura@naa.att.ne.jp.
authors.forename: Michinori
authors.initials: M
authors.lastname: Ogura
authors.affiliation: Department of Hematology and Rheumatology, Tohoku University Graduate School of Medicine, Sendai, Japan.
authors.forename: Kenichi
authors.initials: K
authors.lastname: Ishizawa
authors.affiliation: Department of Hematology, National Cancer Center Hospital, Tokyo, Japan.
authors.forename: Dai
authors.initials: D
authors.lastname: Maruyama
authors.affiliation: Department of Hematology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.
authors.forename: Naokuni
authors.initials: N
authors.lastname: Uike
authors.affiliation: Department of Hematology and Oncology, Tokai University Hospital, Isehara, Japan.
authors.forename: Kiyoshi
authors.initials: K
authors.lastname: Ando
authors.affiliation: Department of Hematology, Toranomon Hospital, Tokyo, Japan.
authors.forename: Koji
authors.initials: K
authors.lastname: Izutsu
authors.affiliation: Department of Hematology Oncology, The Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan.
authors.forename: Yasuhito
authors.initials: Y
authors.lastname: Terui
authors.affiliation: Department of Hematology, Nagasaki University Hospital, Nagasaki, Japan.
authors.forename: Yoshitaka
authors.initials: Y
authors.lastname: Imaizumi
authors.affiliation: Department of Hematology, National Cancer Center Hospital East, Kashiwa, Japan.
authors.forename: Kunihiro
authors.initials: K
authors.lastname: Tsukasaki
authors.affiliation: Department of Hematology, Japanese Red Cross Medical Center, Tokyo, Japan.
authors.forename: Kenshi
authors.initials: K
authors.lastname: Suzuki
authors.affiliation: Division of Hematology, Tochigi Cancer Center, Utsunomiya, Japan.
authors.forename: Tohru
authors.initials: T
authors.lastname: Izumi
authors.affiliation: Department of Hematology, NTT Medical Center Tokyo, Tokyo, Japan.
authors.forename: Kensuke
authors.initials: K
authors.lastname: Usuki
authors.affiliation: Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan.
authors.forename: Tomohiro
authors.initials: T
authors.lastname: Kinoshita
authors.affiliation: Division of Hematology and Oncology, Kyoto Prefectural University of Medicine, Kyoto, Japan.
authors.forename: Masafumi
authors.initials: M
authors.lastname: Taniwaki
authors.affiliation: Department of Hematology, Matsushita Memorial Hospital, Moriguchi, Japan.
authors.forename: Nobuhiko
authors.initials: N
authors.lastname: Uoshima
authors.affiliation: Department of Oncology/Hematology, School of Medicine, Shimane University, Izumo, Japan.
authors.forename: Junji
authors.initials: J
authors.lastname: Suzumiya
authors.affiliation: Department of Hematology, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan.
authors.forename: Mitsutoshi
authors.initials: M
authors.lastname: Kurosawa
authors.affiliation: Department of Hematology, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.
authors.forename: Hirokazu
authors.initials: H
authors.lastname: Nagai
authors.affiliation: Department of Hematology and Oncology, Nagoya Daini Red Cross Hospital, Nagoya, Japan.
authors.forename: Toshiki
authors.initials: T
authors.lastname: Uchida
authors.affiliation: Department of Hematology and Rheumatology, Tohoku University Graduate School of Medicine, Sendai, Japan.
authors.forename: Noriko
authors.initials: N
authors.lastname: Fukuhara
authors.affiliation: Department of Hematology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.
authors.forename: Ilseung
authors.initials: I
authors.lastname: Choi
authors.affiliation: Department of Hematology and Oncology, Tokai University Hospital, Isehara, Japan.
authors.forename: Ken
authors.initials: K
authors.lastname: Ohmachi
authors.affiliation: Department of Hematology, Toranomon Hospital, Tokyo, Japan.
authors.forename: Go
authors.initials: G
authors.lastname: Yamamoto
authors.affiliation: Department of Hematology, National Cancer Center Hospital, Tokyo, Japan.
authors.forename: Kensei
authors.initials: K
authors.lastname: Tobinai
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000069461:Bendamustine Hydrochloride / Q000008:administration & dosage*; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D007564:Japan; D007970:Leukopenia / Q000139:chemically induced; D016393:Lymphoma, B-Cell / Q000150:complications / Q000188:drug therapy* / Q000401:mortality; D020522:Lymphoma, Mantle-Cell / Q000150:complications / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D012074:Remission Induction; D000069283:Rituximab / Q000008:administration & dosage*
chemical_list: D000069283:Rituximab; D000069461:Bendamustine Hydrochloride
keywords: Bendamustine; First-line therapy; Indolent B-cell non-Hodgkin lymphoma; Mantle cell lymphoma; Rituximab