Preoperative therapy with trastuzumab and oral vinorelbine (± endocrine therapy) in patients with HER2-positive breast cancer

Iorfida, Monica; Bagnardi, Vincenzo; Balduzzi, Alessandra; Dellapasqua, Silvia; Cardillo, Anna; Luini, Alberto; Intra, Mattia; Minchella, Ida; Veronesi, Paolo; Viale, Giuseppe; Goldhirsch, Aron; Colleoni, Marco

doi:10.1016/j.breast.2009.12.011

« Previous Next »The Breast
Volume 19, Issue 2 , Pages 128-132, April 2010

Preoperative therapy with trastuzumab and oral vinorelbine (± endocrine therapy) in patients with HER2-positive breast cancer

Monica Iorfida
- Unit of Research in Medical Senology, European Institute of Oncology, Via Ripamonti 435, 20141, Milan, Italy
- Department of Medicine, European Institute of Oncology Milan, via Ripamonti 435, Milan 20141, Italy
- Corresponding author. Tel.: +39 02 57489502; fax: +39 02 94379205.
Vincenzo Bagnardi
- Division of Epidemiology and Biostatistics, European Institute of Oncology, Via Ripamonti 435, 20141, Milan, Italy
- Department of Statistics, University of Milan-Bicocca, Milan, Italy
- Frontier Science and Technology Research Foundation, Southern Europe, Milan, Italy
Alessandra Balduzzi
- Unit of Research in Medical Senology, European Institute of Oncology, Via Ripamonti 435, 20141, Milan, Italy
- Department of Medicine, European Institute of Oncology Milan, via Ripamonti 435, Milan 20141, Italy
Silvia Dellapasqua
- Unit of Research in Medical Senology, European Institute of Oncology, Via Ripamonti 435, 20141, Milan, Italy
- Department of Medicine, European Institute of Oncology Milan, via Ripamonti 435, Milan 20141, Italy
Anna Cardillo
- Unit of Research in Medical Senology, European Institute of Oncology, Via Ripamonti 435, 20141, Milan, Italy
- Department of Medicine, European Institute of Oncology Milan, via Ripamonti 435, Milan 20141, Italy
Alberto Luini
- Division of Senology, European Institute of Oncology, Via Ripamonti 435, 20141, Milan, Italy
Mattia Intra
- Division of Senology, European Institute of Oncology, Via Ripamonti 435, 20141, Milan, Italy
Ida Minchella
- Medical Care Unit, European Institute of Oncology Milan, via Ripamonti 435, Milan 20141, Italy
Paolo Veronesi
- Division of Senology, European Institute of Oncology, Via Ripamonti 435, 20141, Milan, Italy
Giuseppe Viale
- Division of Pathology, European Institute of Oncology, Via Ripamonti 435, 20141, Milan, Italy
- University of Milan School of Medicine, Milan, Italy
Aron Goldhirsch
- Department of Medicine, European Institute of Oncology Milan, via Ripamonti 435, Milan 20141, Italy
Marco Colleoni
- Unit of Research in Medical Senology, European Institute of Oncology, Via Ripamonti 435, 20141, Milan, Italy
- Department of Medicine, European Institute of Oncology Milan, via Ripamonti 435, Milan 20141, Italy

Received 28 August 2009; received in revised form 20 November 2009; accepted 27 December 2009. published online 01 February 2010.

Abstract

Background

Combined trastuzumab and intravenous vinorelbine yielded high clinical activity as preoperative treatment in patients (pts) with HER 2/neu positive breast cancer.

Patients and methods

We tested a preoperative combination of trastuzumab with oral vinorelbine (oV) in pts with locally advanced (T2-T4 N0-3 M0) HER2-positive breast cancer. Trastuzumab was administered i.v q 3 wks and oV was administered at the dose of 55 mg/sqm on days 1 and 3 q 3 wks, for 8 courses. Pts with ER ≥ 10% tumors received endocrine therapy with letrozole 2.5 mg/day, plus monthly triptorelin if premenopausal.

Results

Forty-five pts entered the study. The overall response rate (CR + PR) was 76% (95% CI: 60%–87%). pCR was observed in 4 pts (10%). Among ER-positive tumors 21/25 pts obtained a clinical response (84%) and two pts obtained a pCR (8%).

Conclusions

The combination of trastuzumab and oral vinorelbine demonstrated encouraging activity in patients with HER 2 positive ER-positive tumors. Alternative strategies should be investigated in patients with endocrine non responsive disease.

Keywords: Preoperative therapy, Trastuzumab, Oral vinorelbine, Breast cancer