Theresa Shao, MD, assistant professor of hematology-oncology, Icahn School of Medicine, Tisch Cancer Institute, Mount Sinai Health System, discusses the prognosis of patients with HER2-positive breast cancer.

The last few years have brought an emergence of new targeted therapies for the neoadjuvant and adjuvant settings, significantly changing the outlook for patients with HER2-positive breast cancer. Looking at the APHINITY study or trials with neratinib (Nerlynx), the invasive disease-free survival rates at 3 and 5 years are on the order of 90%, which is amazing, Shao says.

There also recent studies suggesting that patients with HER2-positive breast cancer may be doing better than other subtypes of breast cancer, or at least as well as patients with estrogen receptor—positive or HER2-negative disease. This is completely different than a decade ago, Shao notes, when a diagnosis of HER2-positive disease was seen as an aggressive, poor prognosis for which there were limited treatment options. Now, agents like trastuzumab (Herceptin) and pertuzumab (Perjeta)—and most recently, ado-trastuzumab emtansine (T-DM1; Kadcyla)&mdash;are prolonging survival for these patients and even hinting at curative strategies.

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Dr. Shao on Prognosis of Patients With HER2+ Breast Cancer

Theresa Shao, MD, assistant professor of medicine, hematology and medical oncology, Icahn School of Medicine, Mount Sinai Medical Center, discusses managing toxicities associated with neratinib (Nerlynx) in patients with HER2-positive breast cancer.

The CONTROL trial was designed to see whether the addition of budesonide or colestipol to loperamide prophylaxis could offset the high rates of neratinib-associated diarrhea seen in patients in the ExteNET trial. In the ExteNET trial, patients did not receive prophylaxis, instead, they were given loperamide (Imodium) as needed, says Shao.

Results of the study demonstrated that if patients received prophylaxis with loperamide and colestipol during the first cycle of therapy, there was a significant reduction in grade 3/4 diarrhea. With the regimen, the incidence of diarrhea went from 40% to 10%, says Shao. This approach resulted in a smaller discontinuation rate as well, she adds. As such, if a physician decides to proceed with neratinib for a patient, he/she should be ready to prescribe colestipol and loperamide prophylaxis as well.

Theresa Shao, MD

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