Articles2 years versus 1 year of adjuvant trastuzumab for HER2-positive breast cancer (HERA): an open-label, randomised controlled trial
Introduction
About 15–20% of breast cancers exhibit overexpression or amplification of the HER2 oncogene. Trastuzumab substantially reduces disease recurrence and death in patients with this type of early breast cancer and is now used widely in the adjuvant setting. Initial trials compared 1 year of trastuzumab treatment with a no trastuzumab control group.1, 2, 3 Further follow-up confirmed a persistent benefit of 1 year of treatment compared with observation alone.4, 5, 6 The HERceptin Adjuvant (HERA) trial is unique in that it also included randomisation of patients to 2 years of trastuzumab to allow comparison of two different durations of treatment. We report the first results of the comparison of 2 years versus 1 year of adjuvant trastuzumab, and update the comparison of 1 year of trastuzumab versus observation at a median follow-up of 8 years.
Section snippets
Study design and participants
The HERA trial design, eligibility criteria, randomisation, treatment plan, follow-up and monitoring, and statistical analyses have been described elsewhere.1, 5 Briefly, between Dec 7, 2001, and June 20, 2005, a total of 5102 patients were randomly allocated to three groups: observation, trastuzumab for 1 year, and trastuzumab for 2 years. All patients included had locally assessed HER2-positive early-stage invasive breast cancer confirmed by the central laboratory (in Kassel, Germany), and
Results
Figure 1 shows the trial profile. Three patients with no record of written informed consent were excluded from analyses. The cohorts for comparison in the landmark analysis were well balanced in terms of demographics and baseline disease characteristics, including tumour size, node status, and hormone-receptor status (table 1). Overall, local laboratory analysis of hormone receptors showed that about half of the patients had hormone-receptor-positive disease (table 1). 1471 (92·6%) of the 1588
Discussion
Patients with HER2-positive early breast cancer given adjuvant trastuzumab have shown substantial improvements in disease-free and overall survival outcomes compared with those given no trastuzumab.10 Trastuzumab is the most effective targeted drug in breast cancer since tamoxifen. Findings from the HERA trial have supported the beneficial effects of trastuzumab, and this report extends the evidence of a substantial improvement in disease-free and overall survival to a median of 8 years'
References (16)
- et al.
2-year follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer: a randomised controlled trial
Lancet
(2007) - et al.
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
Lancet Oncol
(2011) - et al.
Current paradigms for the use of HER2-targeted therapy in early-stage breast cancer
Clin Breast Cancer
(2008) - et al.
Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer
N Engl J Med
(2005) - et al.
Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer
N Engl J Med
(2005) - et al.
Adjuvant trastuzumab in HER2-positive breast cancer
N Engl J Med
(2011) - et al.
Four-year follow-up of trastuzumab plus adjuvant chemotherapy for operable human epidermal growth factor receptor 2-positive breast cancer: joint analysis of data from NCCTG N9831 and NSABP B-31
J Clin Oncol
(2011) - et al.
Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial
Biometrics
(1975)
Cited by (0)
- †
Joint senior authorship