Treatment with trastuzumab for 1 year after adjuvant chemotherapy in patients with HER2-positive early breast cancer: A 4-year follow-up of a randomised controlled trial

Luca Gianni, Urania Dafni, Richard D. Gelber, Evandro Azambuja, Susanne Muehlbauer, Aron Goldhirsch, Michael Untch, Ian Smith, José Baselga, Christian Jackisch, David Cameron, Max Mano, José Luiz Pedrini, Andrea Veronesi, Cesar Mendiola, Anna Pluzanska, Vladimir Semiglazov, Eduard Vrdoljak, Michael J. Eckart, Zhenzhou ShenGeorge Skiadopoulos, Marion Procter, Kathleen I. Pritchard, Martine J. Piccart-Gebhart, Richard Bell

Research output: Contribution to journalArticlepeer-review

Abstract

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

Original languageEnglish
Pages (from-to)236-244
Number of pages9
JournalThe Lancet Oncology
Volume12
Issue number3
DOIs
Publication statusPublished - Mar 2011

ASJC Scopus subject areas

  • Oncology

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