Phase II study of oral fludarabine phosphate in relapsed indolent B-Cell non-Hodgkin's lymphoma.
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.
Tobinai
Kensei
K
Hematology and Stem Cell Transplantation Division, National Cancer Center Hospital, Tokyo, Japan. ktobinai@ncc.go.jp
Watanabe
Takashi
T
Ogura
Michinori
M
Morishima
Yasuo
Y
Ogawa
Yoshiaki
Y
Ishizawa
Ken-ichi
K
Minami
Hironobu
H
Utsunomiya
Atae
A
Taniwaki
Masafumi
M
Terauchi
Takashi
T
Nawano
Shigeru
S
Matsusako
Masaki
M
Matsuno
Yoshihiro
Y
Nakamura
Shigeo
S
Mori
Shigeo
S
Ohashi
Yasuo
Y
Hayashi
Masaki
M
Seriu
Taku
T
Hotta
Tomomitsu
T
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
D000964:Antimetabolites, Antineoplastic; D001084:Vidarabine Phosphate; C042382:fludarabine phosphate