Surgery following neoadjuvant therapy in patients with HER2-positive locally advanced or inflammatory breast cancer participating in the NeOAdjuvant Herceptin (NOAH) study.

Abstract

AIM:

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).

PATIENTS AND 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: V Semiglazov, W Eiermann, M Zambetti, A Manikhas, A Bozhok, A Lluch, S Tjulandin, M D Sabadell, A Caballero, P Valagussa, J Baselga, L Gianni
• Journal: European journal of surgical oncology : the journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology (Eur J Surg Oncol) Vol. 37 Issue 10 Pg. 856-63 (Oct 2011) ISSN: 1532-2157 [Electronic] England
• PMID: 21843921 (Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2011 Elsevier Ltd. All rights reserved.

Chemical References

• Antibodies, Monoclonal
• Antibodies, Monoclonal, Humanized
• Receptor, ErbB-2
• Trastuzumab

Topics

• Adult
• Aged
• Antibodies, Monoclonal (therapeutic use)
• Antibodies, Monoclonal, Humanized
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Breast Neoplasms (drug therapy, mortality, pathology, surgery)
• Chemotherapy, Adjuvant
• Disease-Free Survival
• Female
• Humans
• Inflammatory Breast Neoplasms (drug therapy, pathology, surgery)
• Mastectomy, Segmental (methods)
• Middle Aged
• Neoadjuvant Therapy (methods)
• Neoplasm Invasiveness (pathology)
• Neoplasm Staging
• Prognosis
• Receptor, ErbB-2 (genetics, metabolism)
• Risk Assessment
• Survival Analysis
• Trastuzumab
• Treatment Outcome