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Annals of Oncology Advance Access published online on November 7, 2005
Annals of Oncology, doi:10.1093/annonc/mdj069
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© 2005 European Society for Medical Oncology
Received August 22, 2005
Accepted October 4, 2005

original article

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

Y. Ogawa 1*, T. Hotta 1, K. Tobinai 2, T. Watanabe 2, Y. Sasaki 3, H. Minami 3, Y. Morishima 4, M. Ogura 4, and T. Seriu 5

1 Department of Hematology and Oncology, Tokai University School of Medicine, Isehara
2 Hematology Division, National Cancer Center Hospital, Tokyo
3 Division of Oncology and Hematology, National Cancer Center Hospital East, Kashiwa
4 Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya
5 Nihon Schering K.K., Osaka, Japan

* To whom correspondence should be addressed.
Y. Ogawa, E-mail: yoshioga{at}is.icc.u-tokai.ac.jp


  Abstract

Background: The primary objective of this study was to investigate the tolerability, efficacy and pharmacokinetic profile of oral fludarabine phosphate in relapsed patients with indolent B-cell non-Hodgkin's lymphoma (B-NHL).

Patients and methods: Patients received fludarabine phosphate orally for 5 days, for a total of one to three cycles. Tolerability was assessed using the National Cancer Institute Common Toxicity Criteria. Efficacy was assessed using the International Workshop Criteria for NHL. Pharmacokinetic samples were taken on day 1 and day 5 of the first treatment cycle.

Results: Twelve patients were enrolled. One patient at 40 mg/m2/day developed grade 4 hyperuricemia. At 50 mg/m2/day, one patient developed grade 3 febrile neutropenia and grade 4 leukopenia, and another patient showed lasting grade 4 neutropenia. Most common toxicities included grade 3 or 4 lymphopenia (83%), leukopenia (50%) and neutropenia (50%). All the toxicities were reversible. The overall response rate was 67%. The AUC0-24h values on day 5 indicated a dose-dependent increase in systemically available 2-fluoro-arabinofuranosyl-adenine (2F-ara-A).

Conclusions: Oral fludarabine phosphate is safe and effective for relapsed patients with indolent B-NHL. The dose of 40 mg/m2/day is recommended for a following pivotal phase II study.

Keywords: fludarabine phosphate; indolent B-cell non-Hodgkin's lymphoma; oral; pharmacokinetic.
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