The 2-year invasive disease-free survival rate was 93.9% in the neratinib group and 91.6% in the placebo group (HR 0.67, 95% CI 0.50 – 0.91, p=0.0091).r
Kaplan-Meier curves for 2-year invasive disease-free survival (A) and disease-free survival including ductal carcinoma in situ (B) in the intention-to-treat populationr
© Lancet Oncol 2016
The 5-year invasive disease-free survival rates were 90.2% in the neratinib group compared with 87.7% in the placebo group (HR 0.73, 95% CI, 0.57 – 0.92, p = 0.0083). Secondary endpoints, such as distant disease-free survival and time to distant recurrence were not met.r
In the updated analysis, for the subgroup of patients with hormone receptor-positive disease, the HR for invasive disease-free survival in the neratinib group compared with the placebo group was 0.60 (95% CI, 0.43 – 0.83), whereas for the patients with hormone receptor-negative disease, the HR for invasive disease-free survival was 0.95 (95% CI, 0.66 – 1.35).
Kaplan-Meier curves for 5-year invasive disease-free survival for A) ITT population, B) patients with hormone receptor-positive breast cancer and C) hormone receptor-negative breast cancerr
© Lancet Oncol 2017
For the subgroup of patients with hormone-receptor positive disease who initiated treatment ≤ 1 year post-trastuzumab, the 8-year overall survival rate in the neratinib group was 91.5% (95% CI, 88.9 - 93.5) vs 89.4% (95% CI, 86.6 - 91.6) in the placebo group (HR=0.79, 95% CI, 0.55 ‒ 1.13).r