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Activity of Oral Fludarabine Phosphate in Previously Treated Chronic Lymphocytic Leukemia

From the University Hospital, Leuven; St Jan Hospital, Brugge; and Hôpital Erasme, Brussels, Belgium; Royal Marsden Hospital, London; and Addenbrookes Hospital, Cambridge, United Kingdom; London Regional Cancer Center, London, Ontario, Canada; Ospedale Niguarda Ca’Granda, Milan; and Institute of Hematology "Seràgnoli," Bologna, Italy; Hôpital Pitié-Salpêtrière, Paris, France; Hospital Clinic i Provincial, Barcelona, Spain; and Schering AG, Berlin, Germany.

Address reprint requests to Marc Boogaerts, MD, PhD, Department of Hematology, University Hospital, U.Z. Gasthuisberg, Herestraat 49, B-2000 Leuven, Belgium; email: marc.boogaerts{at}uz.kuleuven.ac.be

PURPOSE: A prospective, multicenter, open-label phase II clinical trial was conducted to assess the efficacy and safety of oral fludarabine phosphate. Reference to an historical group of patients treated with the intravenous (IV) formulation allowed the investigators to compare the two formulations.

PATIENTS AND METHODS: Efficacy was assessed using the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) and National Cancer Institute (NCI) criteria for complete remission (CR), partial remission (PR), stable disease, or disease progression. Safety monitoring included World Health Organization (WHO) toxicity grading for all adverse events.

RESULTS: Seventy-eight (96.3%) of 81 recruited patients with previously treated B-cell chronic lymphocytic leukemia (CLL) received 10-mg tablets of fludarabine phosphate to a dose of 40 mg/m²/d for 5 days, repeated every 4 weeks, for a total of six to eight cycles. According to IWCLL criteria, the overall remission rate was 46.2% (CR, 20.5%; PR, 25.6%). The comparative figures using NCI criteria were 51.3% (CR, 17.9%; PR, 33.3%). Overall, 30 incidents of severe adverse events were reported for 22 patients. WHO grade 3 or grade 4 hematologic toxicities included granulocytopenia (53.8%), leukocytopenia (28.2%), thrombocytopenia (25.6%), and anemia (24.4%). Gastrointestinal adverse events were more common with the oral formulation than previously reported with IV fludarabine phosphate. However, these events were generally mild to moderate.

CONCLUSION: This study demonstrates that oral fludarabine phosphate has similar clinical efficacy to the IV formulation and a safety profile that is both predictable and essentially similar to that of the IV formulation.

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