Michelle E. Melisko, MD, associate clinical professor, Department of Medicine, University of California, San Francisco Helen Diller Family Comprehensive Cancer Center, reflects on the findings from the MINDACT trial in breast cancer.

In light of the results from the TAILORx trial and its use of Oncotype DX, there is more attention being given to the evaluation of patients with breast cancer in clinical trials with genetic diagnostic tests. In 2016, the MINDACT trial verified MammaPrint as a clinically useful diagnostic tool in the treatment of patients with high-risk, node-positive, grade 3 breast cancer. The fact that MammaPrint looks at 70 genes and tumors in many different ways may give greater insight into the biology of the cancer, Melisko says.

In MINDACT, risk of tumor recurrence was assessed 2 ways—genetically through MammaPrint or clinically. The group of patients who were deemed clinically high risk but were categorized as low risk by MammaPrint were randomized to receive chemotherapy or not. Those who did not receive chemotherapy at 5 years had an almost 95% chance of being alive without distant metastases. The benefits of chemotherapy are often seen in the first 5 years, Melisko says, so any relapse that occurs beyond 5 years is most likely a failure of endocrine therapy.

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Dr. Melisko Reflects on Findings From the MINDACT Trial in Breast Cancer

Michelle E. Melisko, MD, clinical professor of medicine, University of California, San Francisco (UCSF), explains the discussion around duration of use of aromatase inhibitors (AIs) in patients who have estrogen receptor-positive breast cancer.

More than 10 years ago, it was established that continuing with an AI after tamoxifen was beneficial. MA.17R looked at the extension of an AI beyond 5 years, demonstrating an added benefit of an AI for 10 years—meeting its statistically significant endpoint.

The NSABP B-42 trial had a similar design, but these were patients who may not have had tamoxifen previously. There was a reduction in recurrences, but it did not meet the statistically significant endpoint.

Michelle E. Melisko, MD, clinical professor of medicine, University of California, San Francisco (UCSF), explains the discussion around duration of use of aromatase inhibitors in patients who have estrogen receptor-positive breast cancer.
 

Dr. Melisko on Duration of Aromatase Inhibitor Use in Breast Cancer

Michelle E. Melisko, MD, clinical professor of medicine, University of California, San Francisco (UCSF), discusses the MA.17R study for patients with breast cancer.

The MA.17R study was a follow-up of the trial MA.17 where patients received 5 years of tamoxifen and were then randomized to receive placebo or an aromatase inhibitor (AI). More than 10 years ago, it was discovered that continuing an AI was beneficial, states Melisko.

MA.17R looked at the extension of an AI beyond 5 years, evaluating the added benefit of continuing an AI for 10 years compared to 5 years. Some women in the study received hormonal therapy for 15 years.

This trial met a statistically significant endpoint of reducing recurrences and improving disease-free survival. According to Melisko, this data was practice changing.

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Dr. Melisko on the MA.17R Study for ER+ Breast Cancer

Michelle E. Melisko, MD, a clinical professor of medicine, University of California, San Francisco (UCSF), discusses the role of neoadjuvant chemotherapy in estrogen receptor (ER)-positive breast cancer.

Neoadjuvant treatment is adventitious for some patients who have large tumors, node-positive tumors, or biologically high-risk cancers.

UCSF conducted a clinical trial, I-SPY, which looked at neoadjuvant chemotherapy in combination with experimental therapies to try to improve the rates of pathologic complete response.

ER-positive diseases rarely achieve a pathologic complete response, so chemotherapy may not be best for this patient population, explains Melisko. Neoadjuvant endocrine therapy, especially in combination with biological therapies such as CDK4/6 inhibitors, may be a better approach for patients who are ER-positive, says Melisko.

Michelle E. Melisko, MD

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Dr. Melisko Reflects on Findings From the MINDACT Trial in Breast Cancer

Dr. Melisko on Duration of Aromatase Inhibitor Use in Breast Cancer

Dr. Melisko on the MA.17R Study for ER+ Breast Cancer

Dr. Melisko on the Role of Neoadjuvant Chemotherapy in ER+ Cancer