title: Factors associated with surgical management following neoadjuvant therapy in patients with primary HER2-positive breast cancer: results from the NeoALTTO phase III trial.
abstract: BACKGROUND
  The NeoALTTO trial showed that dual HER2 blockade nearly doubles the rate of pathologic complete response (pCR) in patients with primary HER2-positive breast cancer. However, this did not translate into a higher rate of breast-conserving surgery (BCS).
  
  
  METHODS
  In NeoALTTO, patients with HER2-positive breast cancer were randomly assigned to either trastuzumab, lapatinib or their combination with paclitaxel before surgery with pCR as the primary end point. We investigated the association between the surgery type and clinicopathological factors and response to treatment, adjusting for the treatment arm.
  
  
  RESULTS
  Four hundred and twenty-nine patients were subjected to breast surgery. Two hundred and forty-two (56%) and 187 (44%) patients underwent mastectomy and BCS, respectively. In a logistic regression model, negative estrogen receptor (ER), multicentricity and the presence of a palpable mass before surgery were significantly associated with a low chance of BCS. Conversely, patients with small tumors and those eligible for BCS at diagnosis were managed more with BCS, independent of the treatment arm. Radiological response was not associated with the surgical decision.
  
  
  CONCLUSIONS
  Tumor characteristics before neoadjuvant therapy play a main role in deciding the type of surgery calling for a clear consensus on the role of BCS in patients responding to neoadjuvant therapy.
authors.affiliation: Division of Medical Oncology, Department of Medicine, European Institute of Oncology, Milan, Italy.
authors.forename: C
authors.initials: C
authors.lastname: Criscitiello
authors.forename: H A
authors.initials: HA
authors.lastname: Azim
authors.forename: D
authors.initials: D
authors.lastname: Agbor-tarh
authors.forename: E
authors.initials: E
authors.lastname: de Azambuja
authors.forename: M
authors.initials: M
authors.lastname: Piccart
authors.forename: J
authors.initials: J
authors.lastname: Baselga
authors.forename: H
authors.initials: H
authors.lastname: Eidtmann
authors.forename: S
authors.initials: S
authors.lastname: Di Cosimo
authors.forename: I
authors.initials: I
authors.lastname: Bradbury
authors.forename: I T
authors.initials: IT
authors.lastname: Rubio
mesh_terms: D000328:Adult; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use; D000972:Antineoplastic Agents, Phytogenic / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000601:surgery*; D003657:Decision Making; D005260:Female; D006801:Humans; D000077341:Lapatinib; D015412:Mastectomy, Segmental; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D017239:Paclitaxel / Q000627:therapeutic use; D011799:Quinazolines / Q000627:therapeutic use; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000378:metabolism*; D011960:Receptors, Estrogen / Q000378:metabolism; D000068878:Trastuzumab; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D000972:Antineoplastic Agents, Phytogenic; D000077341:Lapatinib; D017239:Paclitaxel; D011799:Quinazolines; D018719:Erb-b2 Receptor Tyrosine Kinases; D011960:Receptors, Estrogen; D000068878:Trastuzumab; C508053:ERBB2 protein, human
keywords: HER2; breast cancer; breast conservation; neoadjuvant; surgery; trastuzumab