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Annals of Oncology 12:1683-1691, 2001
© 2001 European Society for Medical Oncology

research-article

Phase I and pharmacokinetic study of weekly oral therapy with vinorelbine in patients with advanced breast cancer (ABC)

J. Bonneterre1,, B. Chevalier2, C. Focan3, L. Mauriac4 and M. Piccart5

1Centre Oscar Lambret Lille
2Centre Henri Becquerel Rouen, France
3Centre Hospitaher Sant-Joseph Espérance Liège, Belgium
4Institut Bergonie Bordeaux, France
5Institut Jules Bordet Bruxelles, Belgium

J. Bonneterre, MD. PhD., Centre Oscar Lambret, 1 rue Frederic Combemale, 59020 Lille cedex

Background: A phase I dose-escalation study of a new formulation of oral vinorelbine was conducted to determine the maximum tolerated dose (MTD) of a once weekly regimen and preliminary pharmacokinetic profile in patients with advanced breast cancer (ABC). Twenty-six patients were treated at dose levels ranging from 60 to 100 mg/m2/week. Pharmacokinetics was assessed during the first administration.

Patients and methods: All patients had histologically confirmed locally advanced or metastatic breast cancer and had received no more than two prior chemotherapy regimens for ABC.

Results: The MTD was 100 mg/m2/week due to the occurrence of dose-limiting neutropenia, nausea/vomiting and constipation in five of six patients. Toxicities at 80 mg/m2/week were manageable, neutropenia being the main toxicity (grade 3–4 seen in 10 of 13 patients). Nausea, vomiting and diarrhoea were common but rarely severe. Vinorelbine was rapidly absorbed with maximum blood concentration (Cmax) of 103.8 ± 41.6 ng-ml–1 observed 1.2 ± 0.8 hours (Tmax) after administration of 80 mg/m2. Pharmacokinetic exposure increased linearly with dose. Area under the concentration-time curve (AUC) and concentration measured 24 hours after drug intake (C24h) were significantly correlated with depletion of neutrophils. Objective tumour responses were reported in 6 of the 14 evaluable patients treated at doses ≥. 80 mg/m2/week.

Conclusion: The safety profile of oral vinorelbine appears comparable to that of intravenous dosing. The recommended phase II dose is 80 mg/m2/week and requires regular monitoring of neutrophil counts.

advanced breast cancer, oral vinorelbine, phase I, recommended dose


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