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Annals of Oncology Advance Access published online on September 9, 2007
Annals of Oncology, doi:10.1093/annonc/mdm372
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© 2007 European Society for Medical Oncology

Optimizing clinical care of patients with metastatic breast cancer: a new oral vinorelbine plus trastuzumab combination

C Catania1,*, M Medici1, E Magni1, E Munzone1, D Cardinale2, L Adamoli1, G Sanna1, I Minchella1, D Radice3, A Goldhirsch4 and F Nolè1

1 Division of Medical Oncology, Unit for Medical Care
2 Division of Cardiology
3 Division of Biostatistics and Epidemiology
4 Department of Medicine, European Institute of Oncology, Milan, Italy

* Correspondence to: Dr C. Catania, Unit for Medical Care, Division of Medical Oncology, European Institute of Oncology, Milan 20141, Italy. Tel: +39-02-57489482; Fax: +39-02-57489581; E-mail: chiara.catania{at}ieo.it

Background: Trastuzumab (T) combined with i.v. vinorelbine (i.v.VNR) is an active regimen for patients with advanced breast cancer (ABC). In order to further improve quality of life of patients undergoing treatment for ABC, a new regimen using oral vinorelbine (oVNR) (d1 + d3) plus q3wks T was tested (ToVNR).

Patients and methods: Thirty-nine patients with ABC, human epidermal growth factor receptor 2/neu 3+ or FISH positive received 288 treatment cycles with T 6 mg/kg (loading dose, 8 mg/kg) on d1 and oVNR 55 mg/m2 on d1 + d3, q3wks until disease progression or unacceptable toxicity.

Results: Thirty-seven patients and 286 treatment cycles were evaluated (two patients were lost to follow-up). Treatment was very well tolerated. Two patients had complete response (CR), 14 partial response (PR), 17 stable disease (SD) and four disease progression (PD) (overall response rate: 43%). Clinical benefit rate (CR + PR + SD >24 months) was 73%. Median time to progression was 8.9 months (range 2–27) and median duration of response was 10.9 months (range 2–27).

Conclusions: The ToVNR combination is active and very well tolerated. It favorably compares with the combination of T and weekly i.v. administered VNR, allowing a more convenient once every three weeks hospital admission and leaving patients and care providers free from the unpleasant effect of i.v.VNR.

Received for publication November 28, 2006. Revision received April 20, 2007. Revision received June 25, 2007. Accepted for publication June 28, 2007.


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