title: Rituximab monotherapy with eight weekly infusions for relapsed or refractory patients with indolent B cell non-Hodgkin lymphoma mostly pretreated with rituximab: a multicenter phase II study.
abstract: Information regarding rituximab monotherapy with eight weekly infusions for relapsed or refractory indolent B cell non-Hodgkin lymphoma (B-NHL), in particular for patients pretreated with rituximab, is limited. To evaluate the efficacy and safety of eight doses of rituximab monotherapy, 52 patients with relapsed or refractory indolent B-NHL were enrolled in the present study. Forty of 45 eligible patients (89%) had follicular lymphoma and 24 (53%) were at intermediate or high risk group according to the Follicular Lymphoma International Prognostic Index. The median number of prior chemotherapy regimens was 1 (range 1-7). At the median follow-up of 12.2 months, the overall response rate (ORR), complete response rate (%CR), and median progression-free survival (PFS) were 69% (95% confidence interval [CI] 53%-82%), 47% (95% CI 32%-62%), and 15.6 months (95% CI 10.6- months), respectively. In the 33 patients pretreated with rituximab, the ORR, %CR, and median PFS were inferior compared with values for the 12 patients who had not received rituximab previously (64%vs 83% for ORR; 39%vs 67% for %CR; and 13.8 vs 17.5 months for median PFS, respectively). All mild-to-moderate infusion-related toxicities were reversible. Grade 3/4 non-hematologic adverse events occurred in six of the 52 patients. Two patients developed Grade 4 late-onset neutropenia and a decrease (>50%) in serum immunoglobulin was observed in six patients. In conclusion, rituximab monotherapy with eight weekly infusions is effective in relapsed patients with indolent B-NHL, with acceptable toxicities, including in patients pretreated with rituximab; however, careful monitoring is recommended for infections associated with late-onset neutropenia and hypogammaglobulinemia. (University Hospital Medical Information Network no. UMIN000002974.)
authors.affiliation: Department of Hematology, and Hematopoietic Stem Cell Transplantation, National Cancer Center Hospital, Tokyo, Japan. ktobinai@ncc.go.jp
authors.forename: Kensei
authors.initials: K
authors.lastname: Tobinai
authors.forename: Tadahiko
authors.initials: T
authors.lastname: Igarashi
authors.forename: Kuniaki
authors.initials: K
authors.lastname: Itoh
authors.forename: Mitsutoshi
authors.initials: M
authors.lastname: Kurosawa
authors.forename: Hirokazu
authors.initials: H
authors.lastname: Nagai
authors.forename: Akira
authors.initials: A
authors.lastname: Hiraoka
authors.forename: Tomohiro
authors.initials: T
authors.lastname: Kinoshita
authors.forename: Naokuni
authors.initials: N
authors.lastname: Uike
authors.forename: Michinori
authors.initials: M
authors.lastname: Ogura
authors.forename: Shigeru
authors.initials: S
authors.lastname: Nawano
authors.forename: Shigeo
authors.initials: S
authors.lastname: Mori
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Ohashi
mesh_terms: D000328:Adult; D000368:Aged; D058846:Antibodies, Monoclonal, Murine-Derived / Q000009:adverse effects / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D016393:Lymphoma, B-Cell / Q000188:drug therapy*; D008875:Middle Aged; D012008:Recurrence; D019233:Retreatment; D000069283:Rituximab
chemical_list: D058846:Antibodies, Monoclonal, Murine-Derived; D000970:Antineoplastic Agents; D000069283:Rituximab