title: Re-treatment of relapsed indolent B-cell lymphoma with rituximab.
abstract: The purpose of this study was to investigate the toxicity and the efficacy of re-treatment with rituximab, a chimeric mouse human anti-CD20 monoclonal antibody, in relapsed patients with indolent B-cell non-Hodgkin's lymphoma (NHL) who responded to rituximab in the previous phase I or phase II study. Thirteen patients with relapsed B-cell NHL, each of whom was confirmed to have Revised European-American Lymphoma Classification type II, 1-6 histology (indolent B-NHL), enrolled in this re-treatment study. All were re-treated with rituximab at 375 mg/m2 weekly for 4 consecutive weeks. Rituximab re-treatment was well tolerated with no grade 3/4 nonhematological toxicities, similar to that of the initial treatment. No patients developed detectable human anti-chimeric antibody. Partial responses were observed in 5 of 13 patients (38%; 95% confidence interval [CI], 14% to 68%); 6 patients showed stable disease and 2 showed progressive disease. Overall survival rate was 93% at 19 months of median follow-up after rituximab re-treatment. Median progression-free survival (PFS) after the re-treatment was 5.1 months (95% CI, 4.1 to 5.6 months), and the median PFS after the initial treatment was 8.2 months (95%CI, 5.9 to 11.3 months). Although rituximab re-treatment induced prolonged depletion of normal peripheral blood B cells in all patients, no significant decrease in serum immunoglobulin or complement level was observed. In conclusion, rituximab re-treatment was well tolerated, and it may produce a prolonged PFS in some patients with indolent B-cell NHL who showed initial response to rituximab.
authors.affiliation: Hematology and Oncology, National Cancer Center Hospital East, Kashiwa, Japan.
authors.forename: T
authors.initials: T
authors.lastname: Igarashi
authors.forename: T
authors.initials: T
authors.lastname: Ohtsu
authors.forename: H
authors.initials: H
authors.lastname: Fujii
authors.forename: Y
authors.initials: Y
authors.lastname: Sasaki
authors.forename: Y
authors.initials: Y
authors.lastname: Morishima
authors.forename: M
authors.initials: M
authors.lastname: Ogura
authors.forename: Y
authors.initials: Y
authors.lastname: Kagami
authors.forename: T
authors.initials: T
authors.lastname: Kinoshita
authors.forename: M
authors.initials: M
authors.lastname: Kasai
authors.forename: Y
authors.initials: Y
authors.lastname: Kiyama
authors.forename: Y
authors.initials: Y
authors.lastname: Kobayashi
authors.forename: K
authors.initials: K
authors.lastname: Tobinai
mesh_terms: D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000633:toxicity; D058846:Antibodies, Monoclonal, Murine-Derived; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000633:toxicity; D001402:B-Lymphocytes / Q000166:cytology; D003165:Complement System Proteins / Q000032:analysis; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D007136:Immunoglobulins / Q000097:blood; D007239:Infections / Q000209:etiology; D018655:Lymphocyte Count; D016393:Lymphoma, B-Cell / Q000150:complications / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D012008:Recurrence; D000069283:Rituximab; D013601:T-Lymphocytes / Q000166:cytology; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D058846:Antibodies, Monoclonal, Murine-Derived; D000970:Antineoplastic Agents; D007136:Immunoglobulins; D000069283:Rituximab; D003165:Complement System Proteins