Estimating the magnitude of trastuzumab effects within patient subgroups in the HERA trial.


Autoria(s): Untch, M.; Gelber, R D; Jackisch, C.; Procter, Marion; Baselga, J; Bell, Richard H; Cameron, David A; Bari, M; Smith, Ian; Leyland-Jones, Brian; Azambuja, Evandro; Wermuth, P; Khasanov, R; Feng-Yi, F; Constantin, C; Mayordomo, J I; Su, C-H; Yu, S-Y; Lluch, Ana; Senkus-Konefka, E; Price, Caroline; Haslbauer, F; Suarez Sahui, T; Srimuninnimit, V; Colleoni, Marco Angelo; Coates, Alan; Piccart-Gebhart, Martine; Goldhirsch, Aron; HERA study team
Data(s)

01/06/2008

Resumo

BACKGROUND: Trastuzumab (Herceptin(R)) improves disease-free survival (DFS) and overall survival for patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer. We aimed to assess the magnitude of its clinical benefit for subpopulations defined by nodal and steroid hormone receptor status using data from the Herceptin Adjuvant (HERA) study. PATIENTS AND METHODS: HERA is an international multicenter randomized trial comparing 1 or 2 years of trastuzumab treatment with observation after standard chemotherapy in women with HER2-positive breast cancer. In total, 1703 women randomized to 1-year trastuzumab and 1698 women randomized to observation were included in these analyses. Median follow-up was 23.5 months. The primary endpoint was DFS. RESULTS: The overall hazard ratio (HR) for trastuzumab versus observation was 0.64 [95% confidence interval (CI) 0.54-0.76; P < 0.0001], ranging from 0.46 to 0.82 for subgroups. Estimated improvement in 3-year DFS in subgroups ranged from +11.3% to +0.6%. Patients with the best prognosis (those with node-negative disease and tumors 1.1-2.0 cm) had benefit similar to the overall cohort (HR 0.53, 95% CI 0.26-1.07; 3-year DFS improvement +4.6%, 95% CI -4.0% to 13.2%). CONCLUSIONS: Adjuvant trastuzumab therapy reduces the risk of relapse similarly across subgroups defined by nodal status and steroid hormone receptor status, even those at relatively low risk for relapse.

Comparative Study

Journal Article

Multicenter Study

Randomized Controlled Trial

Research Support, Non-U.S. Gov't

info:eu-repo/semantics/published

Formato

No full-text files

Identificador

uri/info:doi/10.1093/annonc/mdn005

uri/info:pii/mdn005

uri/info:pmid/18296421

http://hdl.handle.net/2013/ULB-DIPOT:oai:dipot.ulb.ac.be:2013/55858

Idioma(s)

en

Fonte

Annals of oncology, 19 (6

Palavras-Chave #Sciences bio-médicales et agricoles #Antibodies, Monoclonal -- therapeutic use #Antineoplastic Agents -- therapeutic use #Breast Neoplasms -- drug therapy #Breast Neoplasms -- metabolism #Female #Humans #Internationality #Lymphatic Metastasis #Middle Aged #Receptor, erbB-2 -- metabolism #Receptors, Estrogen -- metabolism #Receptors, Progesterone -- metabolism #Survival Analysis #Adjuvant therapy #Breast cancer #Disease-free survival #HER2-oncogene #Subgroubs #Trastuzumab
Tipo

info:eu-repo/semantics/article

info:ulb-repo/semantics/articlePeerReview

info:ulb-repo/semantics/openurl/article