Clinical Study

British Journal of Cancer (2009) 101, 232–237. doi:10.1038/sj.bjc.6605156 www.bjcancer.com
Published online 7 July 2009

All-oral combination of oral vinorelbine and capecitabine as first-line chemotherapy in HER2-negative metastatic breast cancer: an International Phase II Trial

N Tubiana-Mathieu1, P Bougnoux2, D Becquart3, A Chan4, P-F Conte5, F Majois6, M Espie7, M Morand8, N Vaissiere8 and G Villanova8

  1. 1CHU Dupuytren, Limoges, France
  2. 2CHU Bretonneau, Tours, France
  3. 3AZ Middelheim, Antwerp, Belgium
  4. 4Mount Hospital and Royal Perth Hospital, Perth, Australia
  5. 5Policlinico di Modena, Modena, Italy
  6. 6Hopital Jolimont, Haine St Paul, Belgium
  7. 7Hopital St Louis, Paris, France
  8. 8Institut de Recherche Pierre Fabre, Boulogne-Billancourt, France

Correspondence: Dr N Tubiana-Mathieu, CHU Dupuytren, 2 avenue Martin Luther King, Limoges, Cedex 87042, France; E-mail: nicole.tubiana-mathieu@chu-limoges.fr

Received 4 March 2009; Revised 1 June 2009; Accepted 2 June 2009; Published online 7 July 2009.

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Abstract

Background:

  

This multicentre, international phase II trial evaluated the efficacy and safety profile of a first-line combination of oral vinorelbine plus capecitabine for women with metastatic breast cancer (MBC).

Methods:

  

Patients with measurable, HER2-negative disease received, as a first line in metastatic setting, 3-weekly cycles of oral vinorelbine 80 mg m-2 (after a first cycle at 60) on day 1 and day 8, plus capecitabine 1000 mg m-2 (750 if greater than or equal to65 years of age) twice daily, on days 1–14. Treatment was continued until progression or unacceptable toxicity.

Results:

  

A total of 55 patients were enrolled and 54 were treated (median age: 58.5 years). Most (78%) had visceral involvement and 63% had received earlier (neo)adjuvant chemotherapy. The objective response rate (RECIST) in 49 evaluable patients was 51% (95% confidence interval (CI), 36–66), including complete response in 4%. The clinical benefit rate (response or stable disease for greater than or equal to6 months) was 63% (95% CI, 48–77). The median duration of response was 7.2 months (95% CI, 6.4–10.2). After a median follow-up of 41 months, median progression-free survival was 8.4 months (95% CI, 5.8–9.7) and median overall survival was 29.2 months (95% CI, 18.2–40.1). Treatment-related adverse events were manageable, the main grade 3–4 toxicity was neutropaenia (49%); two patients experienced febrile neutropaenia and three patients had a neutropaenic infection (including one septic death). A particularly low rate of alopaecia was observed.

Conclusion:

  

These results show that the all-oral combination of oral vinorelbine and capecitabine is an effective and well-tolerated first-line regimen for MBC.

Keywords:

oral therapy, first-line chemotherapy, metastatic breast cancer, HER2 negative