Originally published as JCO Early Release 10.1200/JCO.2005.03.9313 on December 5 2005

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Phase II Study of Oral Fludarabine Phosphate in Relapsed Indolent B-Cell Non-Hodgkin's Lymphoma

From the Hematology and Stem Cell Transplantation Division and Clinical Laboratory Division, National Cancer Center Hospital; Research Center for Cancer Prevention and Screening, National Cancer Center; Department of Radiology, St Lukes International Hospital; Department of Pathology, Teikyo University Hospital; Department of Biostatistics/Epidemiology and Preventive Health Sciences, School of Health Sciences and Nursing, University of Tokyo, Tokyo; Departments of Hematology and Cell Therapy and Pathology and Molecular Diagnostics, Aichi Cancer Center Hospital, Nagoya; Department of Hematology and Oncology, Tokai University Hospital, Isehara; Department of Hematology and Rheumatology, Tohoku University Hospital, Sendai; Division of Oncology/Hematology and Diagnostic Radiology Division, National Cancer Center Hospital East, Kashiwa; Department of Hematology, Imamura Bun-in Hospital, Kagoshima; Department of Hematology, Kyoto Prefectural University of Medicine, Kyoto; and Nihon Schering K.K., Osaka, Japan.

Address reprint requests to Kensei Tobinai, MD, Hematology and Stem Cell Transplantation Division, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan, 104-0045; e-mail: ktobinai{at}ncc.go.jp

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.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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