Afinitor® (everolimus) plus exemestane more than doubles progression-free survival (PFS) and reduces risk of cancer progression by 57% versus exemestane alone in patients with advanced breast cancer, according to research presented yesterday at the 2011 European Multidisciplinary Cancer Congress in Stockholm, Sweden.
BOLERO-2 (Breast cancer trials of OraL EveROlimus-2) examined the safety and efficacy of everolimus in combination with exemestane versus exemestane alone in postmenopausal women with ER+HER2- advanced breast cancer who recurred or progressed while on or following previous treatment with letrozole or anastrozole.
At a pre-planned analysis, the trial met its primary endpoint of PFS showing treatment with everolimus improved PFS to 6.9 months compared to 2.8 months (hazard ratio 0.43 [95% confidence interval (CI): 0.35 to 0.54]; p<0.0001) by local investigator assessment.
This significant improvement was consistent across all subgroups, including number of prior therapies, presence of visceral disease, bone metastases and prior use of chemotherapy.
European Multidisciplinary Cancer Congress