The Role of Everolimus in Breast Cancer and the BOLERO Trials

Denise A. Yardley, MD, senior investigator, Sarah Cannon Research Institute, discusses the role of Afinitor (everolimus) in breast cancer and the BOLERO trials.

The next steps in testing the role of everolimus in breast cancer include extending the benefit seen in advanced patients with metastatic disease to an early disease setting. Yardley says that trials are launching to measure the role of everolimus in improving cure rates in patients with early-stage postmenopausal hormone receptor-positive disease.

Clinical Pearls I

While the oncology community is awaiting results from the BOLERO-1 trial, the BOLERO-2 and BOLERO-3 trials demonstrated significant benefit. Results from the BOLERO-2 trial showed a doubling in progression-free survival in postmenopausal patients who were hormone receptor-positive. Yardley says that the PI3K/AKT/mTOR pathway, which was central in the BOLERO-2 trial, could play a role in HER2-positive patients. Data from the BOLERO-3 trial showed an extended control of disease when everolimus was added to chemotherapy and trastuzumab for the treatment of patients with HER2-positive disease.

• Everolimus should be looked at to extend the benefit seen in advanced patients with metastatic disease to an earlier disease setting
• Trials are launching to measure the role of everolimus in improving cure rates in patients with early-stage postmenopausal HR+ disease

Clinical Pearls II

• BOLERO-2 showed a doubling in PFS for patients with HR+ postmenopausal patients
• The PI3K/AKT/mTOR pathway could play a role in HER2+ patients
• The oncology community is eagerly awing results from the BOLERO-1 trial
• Results from BOLERO-3 demonstrated that everolimus plus chemotherapy and trastuzumab extended control of disease