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Breast cancer: 6 vs 12 months of adjuvant trastuzumab

In the treatment of HER2-positive early breast cancer, six months of adjuvant trastuzumab is non-inferior to 12 months and results in significantly less cardiac toxicity and severe adverse events, according to new research.

The phase 3 randomised controlled non-inferiority trial was carried out at 152 NHS hospitals to determine if six months of adjuvant trastuzumab is non-inferior to 12 months using a primary end point of four-year disease-free survival (DFS).

Between 4 October 2007 and 31 July 2015, 2045 patients were randomised to 12 months' trastuzumab and 2043 were randomised to six months' trastuzumab. Sixty-nine per cent of patients had ER-positive disease; 90% received anthracyclines (49% with taxanes; 41% without taxanes); 10% received taxanes without anthracyclines; 54% received trastuzumab sequentially after chemotherapy; and 85% received adjuvant chemotherapy (58% were node negative).

At 6.1 years, four-year DFS rates were 89.5% (95% CI 88.1%-90.8%) in the six-month group and 90.3% (95% CI 88.9%-91.5%) in the 12-month group (hazard ratio [HR] 1.10; 90% CI 0.96-1.26; non-inferiority P=0.01), demonstrating non-inferiority.

Congruent results were found for overall survival (non-inferiority P=0.0003) and landmark analyses six months from starting trastuzumab (non-inferiority P=0.03 for DFS and P=0.006 for overall survival).

Six months' trastuzumab resulted in fewer patients reporting adverse events of severe grade (19% vs 24% for 12-month patients; P=0.0003) or stopping early because of cardiotoxicity (3% vs 8% for 12-month patients; P<0.0001).

Health economic analysis showed that six months' trastuzumab resulted in significantly lower lifetime costs than 12 months' trastuzumab, with similar lifetime quality-adjusted life-years to 12 months of treatment, suggesting there is a high probability that 6 months of trastuzumab is cost-effective compared with 12 months' trastuzumab.


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