Annals of Oncology 12:1677-1681, 2001
© 2001 European Society for Medical Oncology
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Oral vinorelbine: Feasibility and safety profile
1Department of Pneuinology, Centre Hospitalier Universitaire Minjoz Besançon, France
2Medical Oncology Unit and EA 643. Lyon I University and Centre Hospitalier Lyon-Sud Pierre Bénite, France
3Medical University of Gdansk Poland
4Hopital Fleyriat, Bourg en Bresse France
5 Hospital of Lung Diseases Poznan, Poland
6Bretonneau Hospital Tours, France
7Rydygier Hospital Crakow, Poland
8Institut Bergonie Bordeaux
9Hospital General Belfort
10Centre François Baclesse Caen, France
V. Trillet-Lenoir. MD, Medical Oncology Unit, Centre Hospitalier Lyon-Sud, 69495 Pierre Bénite Cedex, France, E-mail veronique.trillet-lenoir{at}chu-lyon.fr
Background: Patient preference as well as concerns and difficulties with intravenous access and pharmaco-economic issues have driven the development of oral vinorelbine.
Patients and methods: Four phase II studies were conducted in chemotherapy-naive non-small-cell lung cancer (NSCLC) and as first-line chemotherapy of advanced breast cancer (ABC). As recommended in the phase I dose-finding study, the first step used a weekly dose of 80 mg/m2. This regimen was associated with an excessive rate of early deaths (10%) due to complicated neutropenia and led to discontinuation of the first two studies. In a second step, the dose of 60 mg/m2/week was given for the first three courses and subsequently increased to 80 mg/m2/week, in the absence of severe neutropenia.
Results: One hundred and thirty eight patients (76 with NSCLC and 62 with ABC) received this regimen, of whom only five were unable to undergo dose escalation. The incidence of febrile neutropenia and neutropenic sepsis were low (2.9 and 3.6%, respectively). Although severe events were uncommon, nausea/vomiting and diarrhoea were frequent and primary prophylaxis with antiemetics should be recommended.
Conclusions: Overall, the safety profile of oral vinorelbine at 60 mg/m2/week for the first three courses with escalation to 80 mg/m2 is qualitatively comparable to that of i.v. vinorelbine at standard doses. Similarly to i.v. chemotherapy, close haematological monitoring is necessary.
advanced breast cancer, non-small-cell lung cancer, oral vinorelbine, safety profile
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