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Annals of Oncology Advance Access originally published online on January 12, 2006
Annals of Oncology 2006 17(4):630-636; doi:10.1093/annonc/mdj110
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© 2006 European Society for Medical Oncology

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. Papaldo1, A. Fabi1, G. Ferretti1,*, M. Mottolese2, A. M. Cianciulli3, B. Di Cocco1, M. S. Pino1, P. Carlini1, S. Di Cosimo1, I. Sacchi4, I. Sperduti5, C. Nardoni1 and F. Cognetti1

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

* Correspondence to: Dr G. Ferretti, Division of Medical Oncology "A", Regina Elena Cancer Institute, Via Elio Chianesi 53, 00144 Rome, Italy. Tel: +39 06 526 65354. E-mail: gia.fer{at}flashnet.it

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.

Key words: weekly vinorelbine, trastuzumab, HER2, metastatic breast cancer


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