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- Title
Phase II and pharmacological study of oral paclitaxel (Paxoral) plus ciclosporin in anthracycline-pretreated metastatic breast cancer.
- Authors
Helgason, H. H.; Kruijtzer, C. M. F.; Huitema, A. D. R.; Marcus, S. G.; ten Bokkel Huinink, W. W.; Schot, M. E.; Schornagel, J. H.; Beijnen, J. H.; Schellens, J. H. M.
- Abstract
Paclitaxel is an important chemotherapeutic agent for breast cancer. Paclitaxel has high affinity for the P-glycoprotein (P-gp) (drug efflux pump) in the gastrointestinal tract causing low and variable oral bioavailability. Previously, we demonstrated that oral paclitaxel plus the P-gp inhibitor cyclosporin (CsA) is safe and results in adequate exposure to paclitaxel. This study evaluates the activity, toxicity and pharmacokinetics of paclitaxel combined with CsA in breast cancer patients. Patients with measurable metastatic breast cancer were given oral paclitaxel 90 mg m-2 combined with CsA 10 mg kg-1 (30 min prior to each paclitaxel administration) twice on one day, each week. Twenty-nine patients with a median age of 50 years were entered. All patients had received prior treatments, 25 had received prior anthracycline-containing chemotherapy and 19 had three or more metastatic sites. Total number of weekly administrations was 442 (median: 15/patient) and dose intensity of 97 mg m-2 week-1. Most patients needed treatment delay and 17 patients needed dose reductions. In intention to treat analysis, the overall response rate was 52%, the median time to progression was 6.5 months and overall survival was 16 months. The pharmacokinetics revealed moderate inter- and low intrapatient variability. Weekly oral paclitaxel, combined with CsA, is active in patients with advanced breast cancer.
- Subjects
BREAST cancer treatment; ANTINEOPLASTIC antibiotics; PACLITAXEL; P-glycoprotein; PHARMACOKINETICS; RESEARCH; ANTHRACYCLINES; CLINICAL trials; ORAL drug administration; RESEARCH methodology; METASTASIS; ANTINEOPLASTIC agents; PROGNOSIS; MEDICAL cooperation; EVALUATION research; CYCLOSPORINE; TREATMENT effectiveness; DRUG administration; COMPARATIVE studies; SURVIVAL analysis (Biometry); BREAST tumors
- Publication
British Journal of Cancer, 2006, Vol 95, Issue 7, p794
- ISSN
0007-0920
- Publication type
journal article
- DOI
10.1038/sj.bjc.6603332