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Annals of Oncology Advance Access published online on January 12, 2006
Annals of Oncology, doi:10.1093/annonc/mdj110
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© 2006 European Society for Medical Oncology
Received September 13, 2005
Revised November 11, 2005
Accepted November 14, 2005

original article

A phase II study on metastatic breast cancer patients treated with weekly vinorelbine with or without trastuzumab according to HER2 expression: changing the natural history of HER2-positive disease

P. Papaldo 1, A. Fabi 1, G. Ferretti 1 *, M. Mottolese 2, A. M. Cianciulli 3, B. Di Cocco 1, M. S. Pino 1, P. Carlini 1, S. Di Cosimo 1, I. Sacchi 4, I. Sperduti 5, C. Nardoni 1, and F. Cognetti 1

1 Division of Medical Oncology A, Regina Elena Cancer Institute, Rome, Italy
2 Department of Pathology, Regina Elena Cancer Institute, Rome, Italy
3 Department of Clinical Pathology, Cytogenetic Unit, Rome, Italy
4 Cardiology Unit, Regina Elena Cancer Institute, Rome, Italy
5 Biostatistics Unit, Regina Elena Cancer Institute, Rome, Italy

* To whom correspondence should be addressed.
G. Ferretti, E-mail: gia.fer{at}flashnet.it


  Abstract

Purpose: To observe whether in pretreated metastatic breast cancer patients with HER2-positive disease vinorelbine plus trastuzumab can produce different overall response rate (ORR), time to progression (TTP), and overall survival (OS) from women with HER2-negative tumors treated with vinorelbine alone.

Methods: Between June 2000 and January 2004, 68 consecutive women were enrolled: 33 patients received vinorelbine (V) alone, while 35 patients were given trastuzumab plus vinorelbine (T+V) according to HER2 expression determined by immunohistochemistry. In tumors scored +2, HER2 gene amplification was determined by fluorescence in situ hybridization.

Results: In patients treated with V (HER2-negative tumors) the ORR was 27.3%, while in those given T+V (HER2 positive tumors) the ORR was 51.4%. The median duration of response was 8 months for women treated with V and 10 months for those who received T+V. Patients given T+V had a longer TTP (9 months) and OS (27 months) than those receiving V alone (6 months and 22 months respectively). Toxicity was mild in both groups. Concerning cardiotoxicity in T+V group, 7 patients (20%) had left ventricular systolic disfunction.

Conclusion: Our data suggest that trastuzumab can change the natural history of HER2-positive metastatic breast cancer. In fact, when treated with trastuzumab, women with HER2-positive disease had better prognosis than patients with HER2-negative tumors. Conducting a formal phase III trial comparing vinorelbine alone vs vinorelbine plus trastuzumab in HER2-positive metastatic breast cancer women could be debatable.

Keywords: weekly vinorelbine; trastuzumab; HER2; metastatic breast cancer.
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