Phase II study of oral fludarabine phosphate in relapsed indolent B-cell non-Hodgkin's lymphoma

Kensei Tobinai, Takashi Watanabe, Michinori Ogura, Yasuo Morishima, Yoshiaki Ogawa, Ken Ichi Ishizawa, Hironobu Minami, Atae Utsunomiya, Masafumi Taniwaki, Takashi Terauchi, Shigeru Nawano, Masaki Matsusako, Yoshihiro Matsuno, Shigeo Nakamura, Shigeo Mori, Yasuo Ohashi, Masaki Hayashi, Taku Seriu, Tomomitsu Hotta

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    34 Citations (Scopus)


    Purpose: 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. Patients and 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. Conclusion: 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.

    Original languageEnglish
    Pages (from-to)174-180
    Number of pages7
    JournalJournal of Clinical Oncology
    Issue number1
    Publication statusPublished - 2006 Jan 1

    ASJC Scopus subject areas

    • Oncology
    • Cancer Research


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