title: Preoperative therapy with trastuzumab and oral vinorelbine (+/- endocrine therapy) in patients with HER2-positive breast cancer.
abstract: BACKGROUND
  Combined trastuzumab and intravenous vinorelbine yielded high clinical activity as preoperative treatment in patients (pts) with HER 2/neu positive breast cancer.
  
  
  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 > or = 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.
authors.affiliation: Unit of Research in Medical Senology, European Institute of Oncology, Via Ripamonti 435, 20141, Milan, Italy. monica.iorfida@ieo.it
authors.forename: Monica
authors.initials: M
authors.lastname: Iorfida
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Bagnardi
authors.forename: Alessandra
authors.initials: A
authors.lastname: Balduzzi
authors.forename: Silvia
authors.initials: S
authors.lastname: Dellapasqua
authors.forename: Anna
authors.initials: A
authors.lastname: Cardillo
authors.forename: Alberto
authors.initials: A
authors.lastname: Luini
authors.forename: Mattia
authors.initials: M
authors.lastname: Intra
authors.forename: Ida
authors.initials: I
authors.lastname: Minchella
authors.forename: Paolo
authors.initials: P
authors.lastname: Veronesi
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Viale
authors.forename: Aron
authors.initials: A
authors.lastname: Goldhirsch
authors.forename: Marco
authors.initials: M
authors.lastname: Colleoni
mesh_terms: D000911:Antibodies, Monoclonal / Q000008:administration & dosage; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents / Q000008:administration & dosage; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology*; D005260:Female; D006801:Humans; D009367:Neoplasm Staging; D011300:Preoperative Care; D000068878:Trastuzumab; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077235:Vinorelbine
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; D000972:Antineoplastic Agents, Phytogenic; D014747:Vinblastine; D000068878:Trastuzumab; D000077235:Vinorelbine