1. ¹Mount Hospital and Royal Perth Hospital, Perth, Australia
2. ²Hospital Clinico San Carlos, Madrid, Spain
3. ³Klinikum Grosshadern, München, Germany
4. ⁴Instituto Catala d'Oncologia, Hospitalet de Llobregat, Barcelona, Spain
5. ⁵Instituto Valenciano de Oncologia, Valencia, Spain
6. ⁶Oncology Department, Medical University and Regional Cancer Centre, Bialystok, Poland
7. ⁷Medical School, Tampere University Central Hospital, Pikonlinna, Finland
8. ⁸Klinikum Universität München, München, Germany
9. ⁹Peripheral General Hospital Iraklion, Stavrakia and Voutes, Iraklion, Greece
10. ¹⁰Azienda Ospedaliera Umberto I, Ancona, Italy
11. ¹¹Centrum Onkologii W Krakowie, Krakow, Poland
12. ¹²Institut de Recherche Pierre Fabre, Boulogne-Billancourt, France
13. ¹³General Teaching Hospital, Prague, Czech Republic

Correspondence: Dr A Chan, Suite 41, 146 Mounts Bay Road, Perth 6000, Australia. E-mail: arlene.chan@bigpond.com

Received 25 May 2006; Revised 31 July 2006; Accepted 1 August 2006; Published online 12 September 2006.

Abstract

The aim of this international phase II trial was to determine the efficacy and safety profile of weekly vinorelbine plus trastuzumab as first-line chemotherapy for women with HER 2-overexpressing metastatic breast cancer. Sixty-nine patients with tumours overexpressing HER 2 received vinorelbine: 30 mg m^-2 week^-1 and trastuzumab: 4 mg kg^-1 on day 1 as a loading dose followed by 2 mg kg^-1 week^-1 starting on day 8. Sixty-two patients were evaluable for response and 69 patients were evaluable for toxicity. The overall response rate was 62.9%. The median time to response was 8.4 weeks, the median duration of response was 17.5 months, the median progression-free survival was 9.9 months (95% CI, 5.6–12.1) and the one-year progression-free survival was 39.1%. The median survival for all patients was 23.7 months (95% CI, 18.4–32.6). This regimen was safe: grade 3–4 neutropenia were observed over 17.7% of courses in 83.8% of patients, with only two episodes of febrile neutropenia (0.1%) in two patients (2.9%). Only one patient discontinued treatment due to grade 3 symptomatic cardiac dysfunction that resolved with therapy. Vinorelbine plus trastuzumab is one of the most active treatment regimens for patients with HER 2-positive metastatic breast cancer and demonstrates a very favourable safety profile allowing prolonged treatment with long-term survival. This study has been presented in part at the following conferences: The San Antonio Breast Cancer Symposium, San Antonio, TX, USA, 2003; The American Society of Clinical Oncology, Orlando, FL, USA, 2005.