2 years versus 1 year of adjuvant trastuzumab for HER2-positive breast cancer (HERA): An open-label, randomised controlled trial

Aron Goldhirsch, Richard D. Gelber, Martine J. Piccart-Gebhart, Evandro De Azambuja, Marion Procter, Thomas M. Suter, Christian Jackisch, David Cameron, Harald A. Weber, Dominik Heinzmann, Lissandra Dal Lago, Eleanor McFadden, Mitch Dowsett, Michael Untch, Luca Gianni, Richard Bell, Claus Henning Köhne, Anita Vindevoghel, Michael Andersson, A. Murray BruntDouglas Otero-Reyes, Santai Song, Ian Smith, Brian Leyland-Jones, Jose Baselga

Research output: Contribution to journalArticlepeer-review

Abstract

Background Trastuzumab has established efficacy against breast cancer with overexpression or amplification of the HER2 oncogene. The standard of care is 1 year of adjuvant trastuzumab, but the optimum duration of treatment is unknown. We compared 2 years of treatment with trastuzumab with 1 year of treatment, and updated the comparison of 1 year of trastuzumab versus observation at a median follow-up of 8 years, for patients enrolled in 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 chemotherapy, adjuvant chemotherapy, or both in 5102 patients with HER2-positive early breast cancer. The primary endpoint was disease-free survival. The comparison of 2 years versus 1 year of trastuzumab treatment involved a landmark analysis of 3105 patients who were disease-free 12 months after randomisation to one of the trastuzumab groups, and was planned after observing at least 725 disease-free survival events. The updated intention-to-treat comparison of 1 year trastuzumab treatment versus observation alone in 3399 patients at a median follow-up of 8 years (range 0-10) is also reported. This study is registered with ClinicalTrials.gov, number NCT00045032. Findings We recorded 367 events of disease-free survival in 1552 patients in the 1 year group and 367 events in 1553 patients in the 2 year group (hazard ratio [HR] 0·99, 95% CI 0·85-1·14, p=0·86). Grade 3-4 adverse events and decreases in left ventricular ejection fraction during treatment were reported more frequently in the 2 year treatment group than in the 1 year group (342 [20·4%] vs 275 [16·3%] grade 3-4 adverse events, and 120 [7·2%] vs 69 [4·1%] decreases in left ventricular ejection fraction, respectively). HRs for a comparison of 1 year of trastuzumab treatment versus observation were 0·76 (95% CI 0·67-0·86, p

Original languageEnglish
Pages (from-to)1021-1028
Number of pages8
JournalLancet
Volume382
Issue number9897
DOIs
Publication statusPublished - 2013

ASJC Scopus subject areas

  • Medicine(all)

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