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Related Experiment Videos

Oral fludarabine.

Greg L Plosker1, David P Figgitt

  • 1Adis International Limited, Auckland, New Zealand. demail@adis.co.nz

Drugs
|October 4, 2003
PubMed
Summary
This summary is machine-generated.

A new oral formulation of fludarabine offers an effective treatment option for relapsed or refractory B-cell chronic lymphocytic leukemia (CLL). Oral fludarabine demonstrates comparable efficacy and tolerability to its intravenous counterpart.

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Area of Science:

  • Oncology
  • Pharmacology
  • Hematology

Background:

  • Fludarabine is a key antimetabolite antineoplastic agent for hematological malignancies, especially B-cell chronic lymphocytic leukemia (CLL).
  • An oral formulation of fludarabine is now available in Europe for patients with relapsed or refractory B-cell CLL.
  • This oral form represents the first purine analogue available for clinical use in B-cell CLL.

Purpose of the Study:

  • To evaluate the clinical efficacy and tolerability of a new oral fludarabine formulation.
  • To compare the efficacy of oral fludarabine with historical data from intravenous fludarabine treatment in B-cell CLL.

Main Methods:

  • A Phase II study involving 78 patients with previously treated B-cell CLL.
  • Treatment consisted of six to eight cycles of oral fludarabine (40 mg/m²/day for 5 days every 28 days).

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  • Pharmacokinetic data indicated similar systemic exposure between oral (40 mg/m²/day) and intravenous (25 mg/m²/day) fludarabine.

    • Main Results:

    • The overall response rate for oral fludarabine was 46.2% (20.5% complete response, 25.6% partial response) or 51.3% (17.9% CR, 33.3% PR).
    • These response rates were comparable to a historical control group treated with intravenous fludarabine (48% overall response rate).
    • The most frequent adverse effect was myelosuppression (WHO grade 3 or 4); infections and gastrointestinal disturbances were common but usually mild to moderate.

    Conclusions:

    • Oral fludarabine provides similar clinical efficacy to intravenous fludarabine for previously treated B-cell CLL.
    • The tolerability profile of oral fludarabine is comparable to the intravenous formulation.
    • Oral fludarabine offers a convenient new treatment option for patients with relapsed or refractory B-cell CLL.