title: Phase II study of oral fludarabine in combination with rituximab for relapsed indolent B-cell non-Hodgkin lymphoma.
abstract: Oral fludarabine is more convenient than intravenous fludarabine in an outpatient setting. To assess the efficacy and toxicity of oral fludarabine in combination with rituximab in patients with relapsed indolent B-cell non-Hodgkin lymphoma (B-NHL), we conducted a multicenter phase II study. Patients with relapsed indolent B-NHL with two or fewer prior regimens and up to 16 doses of rituximab were eligible. Patients received 375 mg/m(2) rituximab on day 1, and 40 mg/m(2) oral fludarabine once daily on days 1 through 5 every 28 days for up to six cycles. The primary endpoint was the overall response rate. Forty-one patients were enrolled, including 38 (93%) with follicular lymphoma. Thirty-four patients (83%) had received rituximab as prior therapy. Twenty-seven patients (66%) completed the planned six cycles. Dose reduction of oral fludarabine was required in 17 patients (41%). The overall response rate was 76% (31 of 41 patients; 95% confidence interval, 60-88%) with a complete response rate of 68% (28 of 41 patients; 95% confidence interval, 52-82%). Median progression-free survival for the 41 patients was 19.7 months (95% confidence interval, 12.3-26.5 months). Hematological toxicities, including grade 4 neutropenia (68%), were the most frequent toxicities. Non-hematological toxicities were mild, except for one patient who died of Pneumocystis jiroveci pneumonia 4 months after the protocol treatment. In conclusion, oral fludarabine in combination with rituximab is a highly effective and convenient therapy for patients with relapsed indolent B-NHL who have mostly been pretreated with rituximab.
authors: Hematology and Stem Cell Transplantation Division, National Cancer Center Hospital, Tokyo, Japan. ktobinai@ncc.go.jp
authors: Kensei
authors: K
authors: Tobinai
authors: Ken-ichi
authors: K
authors: Ishizawa
authors: Michinori
authors: M
authors: Ogura
authors: Kuniaki
authors: K
authors: Itoh
authors: Yasuo
authors: Y
authors: Morishima
authors: Kiyoshi
authors: K
authors: Ando
authors: Masafumi
authors: M
authors: Taniwaki
authors: Takashi
authors: T
authors: Watanabe
authors: Joji
authors: J
authors: Yamamoto
authors: Toshiki
authors: T
authors: Uchida
authors: Masanobu
authors: M
authors: Nakata
authors: Takashi
authors: T
authors: Terauchi
authors: Shigeru
authors: S
authors: Nawano
authors: Masaki
authors: M
authors: Matsusako
authors: Masaki
authors: M
authors: Hayashi
authors: Tomomitsu
authors: T
authors: Hotta
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects; D058846:Antibodies, Monoclonal, Murine-Derived; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D016393:Lymphoma, B-Cell / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000401:mortality; D009367:Neoplasm Staging; D000069283:Rituximab; D016896:Treatment Outcome; D014740:Vidarabine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*
chemical_list: D000911:Antibodies, Monoclonal; D058846:Antibodies, Monoclonal, Murine-Derived; D000069283:Rituximab; D014740:Vidarabine; C024352:fludarabine