title: Surgery following neoadjuvant therapy in patients with HER2-positive locally advanced or inflammatory breast cancer participating in the NeOAdjuvant Herceptin (NOAH) study.
abstract: OBJECTIVE
  To describe surgical outcomes in patients with HER2-positive locally advanced (LABC) or inflammatory breast cancer (IBC) participating in the NeOAdjuvant Herceptin (NOAH) study (ISRCTN86043495).
  
  
  METHODS
  A total of 235 patients with HER2-positive disease were randomized to neoadjuvant trastuzumab plus chemotherapy (doxorubicin plus paclitaxel, followed by paclitaxel, followed by cyclophosphamide, methotrexate and fluorouracil) or neoadjuvant chemotherapy alone. Of these patients, 228 received their allocated treatment (115 received trastuzumab plus chemotherapy and 113 received chemotherapy alone) and were potentially eligible for surgery. Mastectomy was required for all patients with IBC and was recommended for all patients with LABC. However, breast-conserving therapy could be considered for patients with peripheral neoplasms measuring ≤ 4 cm in diameter at diagnosis, with a favorable ratio of tumor to breast volume, or at the patient's request if there had been a good response to treatment.
  
  
  RESULTS
  As previously reported, the addition of trastuzumab to neoadjuvant chemotherapy improved the overall, complete and pathological complete response to therapy and significantly improved event-free survival (the primary endpoint of the study). Trastuzumab also enabled more patients to have breast conserving surgery (BCS) (23% versus 13% respectively) without an apparent detrimental effect on local disease control (no patient treated with trastuzumab plus chemotherapy had experienced a local recurrence after BCS at the time of analysis).
  
  
  CONCLUSIONS
  Although this was not an aim of the trial, neoadjuvant trastuzumab given concurrently with chemotherapy enabled 23% of patients with HER2-positive LABC/IBC to avoid mastectomy (including a small number of patients with IBC).
authors.affiliation: NN Petrov Research Institute of Oncology, St. Petersburg Oncology, 68, Leningradskaya Str. Pesochny-2, St. Petersburg, Russian Federation, Russia. ssemiglazov@mail.ru
authors.forename: V
authors.initials: V
authors.lastname: Semiglazov
authors.forename: W
authors.initials: W
authors.lastname: Eiermann
authors.forename: M
authors.initials: M
authors.lastname: Zambetti
authors.forename: A
authors.initials: A
authors.lastname: Manikhas
authors.forename: A
authors.initials: A
authors.lastname: Bozhok
authors.forename: A
authors.initials: A
authors.lastname: Lluch
authors.forename: S
authors.initials: S
authors.lastname: Tjulandin
authors.forename: M D
authors.initials: MD
authors.lastname: Sabadell
authors.forename: A
authors.initials: A
authors.lastname: Caballero
authors.forename: P
authors.initials: P
authors.lastname: Valagussa
authors.forename: J
authors.initials: J
authors.lastname: Baselga
authors.forename: L
authors.initials: L
authors.lastname: Gianni
mesh_terms: D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000601:surgery*; D017024:Chemotherapy, Adjuvant; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D058922:Inflammatory Breast Neoplasms / Q000188:drug therapy / Q000473:pathology / Q000601:surgery; D015412:Mastectomy, Segmental / Q000379:methods; D008875:Middle Aged; D020360:Neoadjuvant Therapy / Q000379:methods*; D009361:Neoplasm Invasiveness / Q000473:pathology; D009367:Neoplasm Staging; D011379:Prognosis; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000235:genetics / Q000378:metabolism*; D018570:Risk Assessment; D016019:Survival Analysis; D000068878:Trastuzumab; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D018719:Erb-b2 Receptor Tyrosine Kinases; D000068878:Trastuzumab