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2000
Volume 9, Issue 2
  • ISSN: 1574-8847
  • E-ISSN: 2212-3938

Abstract

Introduction: Previously, we demonstrated that oral docetaxel plus the P-glycoprotein (Pgp; ABCB1) inhibitor cyclosporin A (CsA) is safe and results in adequate exposure to docetaxel. This phase II study evaluates the anti-tumor activity, safety and pharmacokinetics of oral docetaxel in combination with CsA in women with advanced breast cancer. Materials and Methods: Patients with measurable advanced breast cancer were given one flat dose of 100 mg oral docetaxel, preceded by one single dose of 15 mg/kg CsA, weekly for 6 weeks in a cycle of 8 weeks. Pharmacokinetic monitoring of docetaxel and CsA was performed in week 1 and 9. Results: Thirty-three patients with a median age of 50 years were recruited. Thirty patients were evaluable for toxicity and twenty-six for response. All had received prior anthracycline treatment. The treatment was generally well tolerated with manageable toxicity although many patients needed a dose reduction, most commonly because of fatigue and uncomplicated neutropenia. The median treatment duration was 16 weeks (range 6 – 32). The overall response rate in evaluable patients was 42% (95% CI: 23 – 63) and the median overall survival was 12.2 months (8.4 – 23.1). The interpatient variability in the area under the curve of 100 mg orally administered docetaxel was moderate, respectively 49 and 30% in week 1 and 9. Conclusion: Weekly oral docetaxel, combined with the booster drug CsA, is an active and safe treatment in anthracycline pre-treated patients with advanced breast cancer.

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/content/journals/ccp/10.2174/1574884708666131111193403
2014-05-01
2025-05-22
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/content/journals/ccp/10.2174/1574884708666131111193403
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  • Article Type:
    Research Article
Keyword(s): Anti-tumor activity; cyclosporin A; oral docetaxel; P-glycoprotein; phase II; safety
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