ONCAlert | 2017 San Antonio Breast Cancer Symposium
Breast Cancer Case Studies

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

Adam Brufsky, MD, PhD
Published Online:Apr 20, 2016
Angela is a 56-year-old woman, who in 2013 was diagnosed with a 4 cm IDC of the left breast, ER positive at 50%, PR negative, and HER2 negative.

ER+/HER2-Breast Cancer with Adam Brufsky, MD, PhD and Kimberly Blackwell, MD: Case 1



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

The BOLERO-II trial was a trial of about 400 or 500 women who half had received exemestane alone and half had received exemestane and everolimus. All of these women had progression on a non-steroidal aromatase inhibitor. Basically in this trial, the progression free survival was over 8 to 10 months, depending on who analyzed the data – if it was investigators looking at the data or an independent review committee looking at the data.

Clearly it doubled the progression free survival and what it did, which is really important for these sort of trials and for women who have progressive disease, is there is a certain percentage of women who are going to be long-term non-progressors. That is 10%, 15%, 20% at 2 years, and this makes a big difference in your clinic. These women clearly had progressive disease and are wondering what they're going to do, and actually now they come back to your clinic and they're doing well for a fairly, substantially long period of time.

The major side effects that were seen in this trial that were important to note were about 8% to 10% of people had fairly severe stomatitis. That can be fairly painful and can interfere with eating and drinking. There are many ways to deal with this. Some of us use a steroid mouthwash prophylactically, and there are some clinical trials of that that are currently ongoing. Some of us use a reduced dose. We actually hold the dose for a few days, say if someone is on 10 mg per day of everolimus, we'll cut that to 5 mg per day. There are many ways to deal with this.

Also other side effects we need to be concerned about hyperglycemia in a small number of women, and we also need to be concerned about pneumonitis-like syndrome that can actually mimic progressive disease. If someone does become short of breath on these therapies, you have to be careful that it's not from progression in lungs, but potentially from the pneumonitis from the everolimus, which in many cases is reversible.

I think there is a lot of good clinical trial data that backs up this decision, as well as guides us into trying to figure out what the potential toxicities of this therapy are.

ER+/HER2-Breast Cancer: Case 1

Angela is a 56-year-old woman, who in 2013 was diagnosed with a 4 cm IDC of the left breast, ER positive at 50%, PR negative, and Her2 negative. She was treated with four cycles of neoadjuvant doxorubicin and cyclophosphamide, followed by twelve weeks of paclitaxel.

  • She then had a left MRM with AD, showing a residual 1.5 cm tumor with 3/10 LN positive
  • She received anastrozole, and in early 2015 she complained of low back pain and a bone scan revealed multiple areas of uptake in the lumbosacral spine
  • PET-CT revealed lytic lesions in the lumbosacral spine and pelvis, and a 2 cm low attenuation lesion in the liver with a PET SUV value of 10, indicating malignancy

She was placed on denosumab 120 mg SQ monthly, and fulvestrant 500 mg IM monthly. Her pain resolved within 2 months, and on follow-up CT qt 4 months her bone lesions appeared sclerotic and her liver lesion had reduced to 1 cm. Her fulvestrant and denosumab were continued.

  • In early 2016 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 liver lesion to 3 cm
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