TY - JOUR
T1 - Treatment with trastuzumab for 1 year after adjuvant chemotherapy in patients with HER2-positive early breast cancer
T2 - A 4-year follow-up of a randomised controlled trial
AU - Gianni, Luca
AU - Dafni, Urania
AU - Gelber, Richard D.
AU - Azambuja, Evandro
AU - Muehlbauer, Susanne
AU - Goldhirsch, Aron
AU - Untch, Michael
AU - Smith, Ian
AU - Baselga, José
AU - Jackisch, Christian
AU - Cameron, David
AU - Mano, Max
AU - Pedrini, José Luiz
AU - Veronesi, Andrea
AU - Mendiola, Cesar
AU - Pluzanska, Anna
AU - Semiglazov, Vladimir
AU - Vrdoljak, Eduard
AU - Eckart, Michael J.
AU - Shen, Zhenzhou
AU - Skiadopoulos, George
AU - Procter, Marion
AU - Pritchard, Kathleen I.
AU - Piccart-Gebhart, Martine J.
AU - Bell, Richard
PY - 2011/3
Y1 - 2011/3
N2 - Background: Treatment with adjuvant trastuzumab for 1 year improves disease-free survival and overall survival in patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer. We aimed to assess disease-free survival and overall survival after a median follow-up of 4 years for patients enrolled on the Herceptin Adjuvant (HERA) trial. Methods: The HERA trial is an international, multicentre, randomised, open-label, phase 3 trial comparing treatment with trastuzumab for 1 and 2 years with observation after standard neoadjuvant, adjuvant chemotherapy, or both in patients with HER2-positive early breast cancer. The primary endpoint was disease-free survival. After a positive first interim analysis at a median follow-up of 1 year for the comparison of treatment with trastuzumab for 1 year with observation, event-free patients in the observation group were allowed to cross over to receive trastuzumab. We report trial outcomes for the 1-year trastuzumab and observation groups at a median follow-up of 48·4 months (IQR 42·0-56·5) and assess the effect of the extensive crossover to trastuzumab. Our analysis was by intention-to-treat. The HERA trial is registered with the European Clinical Trials Database, number 2005-002385-11. Findings: The HERA trial population comprised 1698 patients randomly assigned to the observation group and 1703 to the 1-year trastuzumab group. Intention-to-treat analysis of disease-free survival showed a significant benefit in favour of patients in the 1-year trastuzumab group (4-year disease-free survival 78·6%) compared with the observation group (4-year disease-free survival 72·2%; hazard ratio [HR] 0·76; 95% CI 0·66-0·87; p
AB - Background: Treatment with adjuvant trastuzumab for 1 year improves disease-free survival and overall survival in patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer. We aimed to assess disease-free survival and overall survival after a median follow-up of 4 years for patients enrolled on the Herceptin Adjuvant (HERA) trial. Methods: The HERA trial is an international, multicentre, randomised, open-label, phase 3 trial comparing treatment with trastuzumab for 1 and 2 years with observation after standard neoadjuvant, adjuvant chemotherapy, or both in patients with HER2-positive early breast cancer. The primary endpoint was disease-free survival. After a positive first interim analysis at a median follow-up of 1 year for the comparison of treatment with trastuzumab for 1 year with observation, event-free patients in the observation group were allowed to cross over to receive trastuzumab. We report trial outcomes for the 1-year trastuzumab and observation groups at a median follow-up of 48·4 months (IQR 42·0-56·5) and assess the effect of the extensive crossover to trastuzumab. Our analysis was by intention-to-treat. The HERA trial is registered with the European Clinical Trials Database, number 2005-002385-11. Findings: The HERA trial population comprised 1698 patients randomly assigned to the observation group and 1703 to the 1-year trastuzumab group. Intention-to-treat analysis of disease-free survival showed a significant benefit in favour of patients in the 1-year trastuzumab group (4-year disease-free survival 78·6%) compared with the observation group (4-year disease-free survival 72·2%; hazard ratio [HR] 0·76; 95% CI 0·66-0·87; p
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U2 - 10.1016/S1470-2045(11)70033-X
DO - 10.1016/S1470-2045(11)70033-X
M3 - Article
C2 - 21354370
AN - SCOPUS:79952041937
VL - 12
SP - 236
EP - 244
JO - The Lancet Oncology
JF - The Lancet Oncology
SN - 1470-2045
IS - 3
ER -