title: Phase II study of oral fludarabine phosphate in relapsed indolent B-Cell non-Hodgkin's lymphoma.
abstract: OBJECTIVE
  Although intravenous (IV) fludarabine phosphate is effective against indolent B-cell non-Hodgkin's lymphoma (B-NHL), IV administration for 3 to 5 consecutive days is inconvenient in an outpatient setting. To assess the efficacy and toxicity of oral fludarabine phosphate in patients with indolent B-NHL, we conducted a multicenter phase II study.
  
  
  METHODS
  Patients with relapsed indolent B-NHL received fludarabine phosphate tablets orally once daily on days 1 through 5 every 28 days for three to six cycles. The efficacy was separately analyzed in a mantle-cell lymphoma (MCL) cohort and indolent B-NHL except for MCL (IL) cohort. The primary end point was the overall response rate (ORR).
  
  
  RESULTS
  Fifty-two patients, including 46 in the IL cohort (41 with follicular lymphoma) and six in the MCL cohort, were registered, and all patients were eligible. Forty-one patients (79%) had received rituximab as prior therapy. In the IL cohort, the ORR and complete response rate were 65% (30 of 46 patients; 95% CI, 50% to 79%) and 30% (14 of 46 patients; 95% CI, 18% to 46%), respectively. One of six patients with MCL achieved a partial response. The median times to treatment failure for the 46 patients in the IL cohort and for the six patients in the MCL cohort were 8.6 and 6.1 months, respectively. Hematologic toxicities, including grade 4 neutropenia (37%), were the most frequent toxicities, and nonhematologic toxicities were mild.
  
  
  CONCLUSIONS
  Oral fludarabine phosphate is highly effective in patients with relapsed indolent B-NHL who have mostly been pretreated with rituximab and is more convenient than the IV formulation.
authors.affiliation: Hematology and Stem Cell Transplantation Division, National Cancer Center Hospital, Tokyo, 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: Yoshiaki
authors.initials: Y
authors.lastname: Ogawa
authors.forename: Ken-ichi
authors.initials: K
authors.lastname: Ishizawa
authors.forename: Hironobu
authors.initials: H
authors.lastname: Minami
authors.forename: Atae
authors.initials: A
authors.lastname: Utsunomiya
authors.forename: Masafumi
authors.initials: M
authors.lastname: Taniwaki
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: Taku
authors.initials: T
authors.lastname: Seriu
authors.forename: Tomomitsu
authors.initials: T
authors.lastname: Hotta
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D016393:Lymphoma, B-Cell / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D012008:Recurrence; D001084:Vidarabine Phosphate / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D000964:Antimetabolites, Antineoplastic; D001084:Vidarabine Phosphate; C042382:fludarabine phosphate