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Phase II Study of Oral Vinorelbine in First-Line Advanced Breast Cancer Chemotherapy

From the Hospices Civils de Lyon, Department of Medical Oncology and EA 643, Université Claude Bernard Lyon I, France; Centre François Baclesse, Caen, France; Cancer Research Center MAS of Russia, Moscow, Russia; Centre Eugène Marquis, Rennes, France; Hôpital Bretonneau, Tours, France; and Institut de Recherche Pierre Fabre, Castres, France.

Address reprint requests to Véronique Trillet-Lenoir, PhD, MD, Centre Hospitalíer Lyon-Sud, 69495 Pierre Bénite Cedex, France; email: veronique.trillet-lenoir{at}chu-lyon.fr.

Purpose: A phase II trial was performed to evaluate the efficacy, tolerance, and pharmacokinetic profiles of oral vinorelbine (Navelbine). Oral Navelbine (NVB; Pierre Fabre Médicament, Boulogne, France) was given as first-line chemotherapy for locally advanced or metastatic breast carcinoma (ABC).

Patients and Methods: Sixty-four patients were entered to receive oral NVB on a weekly basis for a total of 8 weeks unless progression or toxicity occurred. Oral NVB was given at 60 mg/m² weekly for the first three administrations and was increased to 80 mg/m² for the subsequent administrations if there was no grade 4 neutropenia or no more than one episode of grade 3 neutropenia. Patients with objective response or stable disease continued treatment up to a total of 12 weeks or more.

Results: Fifty-eight evaluable patients were included in our study. Four patients (6.9%) had complete responses, and 14 (24.1%) had partial responses, for an overall response rate of 31% (95% CI, 19% to 43%). Median progression-free survival was 17.4 weeks. Median overall survival is not yet reached. There were no treatment-related deaths. The main toxicity was neutropenia: grade 4 in 17.2% of the patients, and 1.8% of administrations and associated clinical serious events in 4 patients (6.2%). Grade 3 and 4 nausea and/or vomiting were noted in 3.1% and 4.6% of the patients, respectively. Only one patient developed grade 3 neuroconstipation. An analysis of Quality of Life Questionnaire C30 forms revealed no significant alteration between baseline and weeks 8 and 16 in global quality of life.

Conclusion: Oral NVB at this schedule is an effective and well-tolerated agent in the treatment of ABC and offers a promising alternative to the intravenous route. Combination studies are ongoing.

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