Phase I and pharmacokinetic study of oral fludarabine phosphate in relapsed indolent B-cell non-Hodgkin's lymphoma
| Autor: | T. Hotta, T. Seriu, Yasutsuna Sasaki, Takashi Watanabe, Kensei Tobinai, Yoshiaki Ogawa, Michinori Ogura, Hironobu Minami, Yasuo Morishima |
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| Rok vydání: | 2006 |
| Předmět: |
Male
Antimetabolites Antineoplastic medicine.medical_specialty Oral Fludarabine Phosphate Lymphoma B-Cell Administration Oral Neutropenia Gastroenterology Recurrence Fludarabine monophosphate hemic and lymphatic diseases Internal medicine medicine Humans Aged Leukopenia Dose-Response Relationship Drug business.industry Lymphoma Non-Hodgkin Hematology Middle Aged medicine.disease Non-Hodgkin's lymphoma Fludarabine Surgery Oncology Tolerability Female medicine.symptom business Vidarabine Phosphate Febrile neutropenia medicine.drug |
| Zdroj: | Annals of Oncology. 17:330-333 |
| ISSN: | 0923-7534 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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