Is Six Months of Adjuvant Targeted Therapy Sufficient for Early Breast Cancer?
The inclusion of adjuvant targeted therapy with chemotherapy for early HER2-positive breast cancer significantly improved patient outcomes. Since 2006, based on data from registration studies, the gold standard for adjuvant therapy has been 12 months of trastuzumab administration. However, similar effects were observed in a smaller study with just 9 weeks of treatment. The presented clinical trial therefore investigated the non-inferiority of shorter treatment duration (6 months).
Methodology, Progress, and Study Objectives
The phase III randomized controlled trial PERSEPHONE was conducted in 152 UK hospitals and included 4088 patients with early HER2-positive breast cancer. Patients were randomized 1:1 to receive adjuvant trastuzumab treatment for 6 or 12 months. All patients also received chemotherapy (49% anthracycline + taxane combination, 41% anthracyclines, 10% taxanes).
The primary objective was disease-free survival (DFS), with secondary objectives including overall survival (OS), cost-effectiveness, and cardiac function during trastuzumab treatment.
Results
The median follow-up was 6.1 years, with 10% of patients dying during the study. The 4-year DFS rate was 89.5% (95% confidence interval [CI] 88.1–90.8%) in the 6-month treatment group and 90.3% (95% CI 88.9–91.5%) in the 12-month treatment group (p = 0.01 for non-inferiority).
Fewer grade ≥ 3 adverse events were reported during the shorter treatment (19% of patients compared to 24% in the 12-month group; p = 0.0003). Treatment discontinuation due to cardiotoxicity occurred in 3% of patients in the shorter treatment group versus 8% in the longer treatment group (p < 0.0001). The shorter treatment appeared to be cost-effective and improved quality of life.
Conclusion
Six-month adjuvant trastuzumab treatment for patients with early HER2-positive breast cancer is non-inferior to 12-month therapy. The shorter treatment was associated with significantly lower cardiotoxicity and fewer severe adverse events.
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Source: Earl H., Hiller L., Vallier A. L. et al. Six versus 12 months' adjuvant trastuzumab in patients with HER2-positive early breast cancer: the PERSEPHONE non-inferiority RCT. Health Technol Assess 2020; 24 (40): 1–190, doi: 10.3310/hta24400.
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