title: Japanese phase II study of 90Y-ibritumomab tiuxetan in patients with relapsed or refractory indolent B-cell lymphoma.
abstract: There is no data about the efficacy and safety of radioimmunotherapy with 90Y-ibritumomab tiuxetan in patients with relapsed or refractory indolent B-cell lymphoma pretreated with rituximab-containing chemotherapy. We focused on this in a Japanese phase II study. Radioimmunotherapy with 90Y-ibritumomab tiuxetan (11.1 and 14.8 MBq) was evaluated in patients with 100-149x10(9) and >150x10(9) platelets/L, respectively. The primary endpoint was the overall response rate. Forty patients were treated with 90Y-ibritumomab tiuxetan (18 with 11.1 MBq/kg and 22 with 14.8 MBq/kg). Thirty-five patients (88%) had been pretreated with rituximab, including 27 (68%) pretreated with rituximab-containing chemotherapy. The overall response rate was 83% (33/40; 95% confidence interval, 67-93%), and the complete response rate was 68% (27/40; 95% confidence interval, 51-81%). The overall response rates in patients pretreated with rituximab-containing chemotherapy and rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) were 83% (19/23) and 94% (17/18), respectively. The median progression-free survival time of the 40 patients who received 90Y-ibritumomab tiuxetan was 9.6 months. Toxicity was primarily hematological and mostly transient. No grade 4 non-hematological toxicity was observed. In conclusion, radioimmunotherapy with 90Y-ibritumomab tiuxetan is safe and highly effective in patients with relapsed or refractory indolent B-cell lymphoma, including those pretreated with rituximab-containing chemotherapy. (ClinicalTrials.gov number NCT00220285).
authors.affiliation: Hematology and Stem Cell Transplantation Division, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, and School of Medicine, Keio University, Tokyo, 104-0045, Japan. ktobinai@ncc.go.jp
authors.forename: Kensei
authors.initials: K
authors.lastname: Tobinai
authors.forename: Takashi
authors.initials: T
authors.lastname: Watanabe
authors.forename: Michinori
authors.initials: M
authors.lastname: Ogura
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Morishima
authors.forename: Tomomitsu
authors.initials: T
authors.lastname: Hotta
authors.forename: Kenichi
authors.initials: K
authors.lastname: Ishizawa
authors.forename: Kuniaki
authors.initials: K
authors.lastname: Itoh
authors.forename: Shin-ichiro
authors.initials: S
authors.lastname: Okamoto
authors.forename: Masafumi
authors.initials: M
authors.lastname: Taniwaki
authors.forename: Norifumi
authors.initials: N
authors.lastname: Tsukamoto
authors.forename: Hirokazu
authors.initials: H
authors.lastname: Okumura
authors.forename: Takashi
authors.initials: T
authors.lastname: Terauchi
authors.forename: Shigeru
authors.initials: S
authors.lastname: Nawano
authors.forename: Masaki
authors.initials: M
authors.lastname: Matsusako
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Matsuno
authors.forename: Shigeo
authors.initials: S
authors.lastname: Nakamura
authors.forename: Shigeo
authors.initials: S
authors.lastname: Mori
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Ohashi
authors.forename: Masaki
authors.initials: M
authors.lastname: Hayashi
authors.forename: Keigo
authors.initials: K
authors.lastname: Endo
mesh_terms: D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D016393:Lymphoma, B-Cell / Q000532:radiotherapy*; D008297:Male; D008875:Middle Aged; D016499:Radioimmunotherapy / Q000009:adverse effects; D012008:Recurrence; D015021:Yttrium Radioisotopes / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000911:Antibodies, Monoclonal; D015021:Yttrium Radioisotopes; C422802:ibritumomab tiuxetan