Adam Brufsky, MD, PhD: Clinical Trial Data Supporting These Choices

Are there any clinical trial data that would inform this choice?

The most important data that we have is a trial called BOLERO-II. This is a trial where hundreds of women with metastatic breast cancer that was ER-positive that had progressed through non-steroidal aromatase inhibitors were given exemestaine or exemestane and everolimus. In the exemestane arm of the trial, the median progression-free survival was a little over 4 months. In the exemestane and everolimus arm of the trial, the median progression-free survival was at least 8 months. In fact, if you used the independent review committee, it was even higher than that and closer to 10 months.

ER+/HER2-Breast Cancer: Case 2

Mary is a 62-year-old woman, who in mid-2014 complained of rib pain. Rib plain films revealed a lytic lesion of the left 5th rib. Bone scan revealed multiple areas of uptake in the lumbosacral spine and ribs.

PET-CT revealed lytic lesions in the lumbosacral spine and ribs, and a 3 cm right upper lobe lesion in the lung with a PET SUV value of 6, indicating malignancy

A mammogram and ultrasound of the left breast revealed a 2 cm speculated mass in the upper outer quadrant of the left breast

Core needle biopsy of this lesion revealed infiltrating ductal carcinoma, ER 80%, Her2 negative

She was placed on denosumab 120 mg SQ monthly, and anastrozole 1 mg orally daily. Her pain resolved within 1 month, and on follow-up CT at 4 months her bone lesions appeared sclerotic and her lung lesion had reduced to 2 cm. Her anastrozole and denosumab were continued

In mid-2015 she again complained of worsening low back pain and left hip pain. Repeat PET-CT demonstrated new lytic lesions in the left iliac crest as well as an enlargement of the lung lesion to 4 cm.

She was placed on fulvestrant 500 mg IM monthly and denosumab was continued. Within 2 months her pain improved, and a repeat CT of the chest in late 2015 demonstrated reduction of the lung lesion to 2 cm

In March 2016 she complained of new right scapular pain. A PET-CT revealed new lytic lesions of the left scapula and right ribs, and a new lung nodule in the left upper lobe 1 cm in diameter with an increase in the right upper lobe lesion to 3 cm