fr Italy--encouraging results w neoadjuvant herceptin+oral vinorelbine in her2+s(ER+s

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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 Iorfidaai, Vincenzo Bagnardiefg, Alessandra Balduzziai, Silvia Dellapasquaai, Anna Cardilloai, Alberto Luinid, Mattia Intrad, Ida Minchellah, Paolo Veronesid, Giuseppe Vialebc, Aron Goldhirschi, Marco Colleoniai
Received 28 August 2009; received in revised form 20 November 2009; accepted 27 December 2009. published online 01 February 2010.



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.