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Expert Weighs In on Neratinib Ahead of FDA Panel Review

Angelica Welch
Published: Tuesday, May 09, 2017

Wolfgang Janni, MD, PhD

Wolfgang Janni, MD, PhD

With the impending FDA Oncologic Drugs Advisory Committee review of neratinib for patients with HER2-positive breast cancer following adjuvant trastuzumab (Herceptin), the breast cancer community is focused on the side effects of this agent.

, Wolfgang Janni, MD, PhD, professor and chair of the Department of Obstetrics and Gynecology, University of Ulm, Germany, discussed toxicity management with neratinib and other agents for HER2-positive breast cancer, as well as emerging treatments and impactful trials in the field.

OncLive: Can you discuss your work in the management of toxicities associated with HER2-targeted therapies?

Janni: In my opinion, there is no doubt that the benefit of HER2/neu targeted treatment in breast cancer, both in early and advanced breast cancer, outweighs, by far, the adverse effects. In this setting, though, we have to carefully look out for adverse effects of whatever we do, especially the drugs associated with HER2/neu targeted treatment.

Cardiotoxicities are a dangerous risk, but by doing what I just summarized, it can be lowered substantially. The same this is true about diarrhea, and even though it is not as life-threatening, it influences the quality of life of the patient. Using agents like loperamide can significantly lower the incidence of diarrhea—it is an acute, but manageable side effect of neratinib therapy.

What are the letting developments in the adjuvant setting for HER2-positive breast cancer?

In the adjuvant setting, we already have the positive data from the ExteNET study with extended adjuvant treatment of trastuzumab followed by neratinib. And this year at ASCO we will have the results of the APHINITY study, which is dual-targeted treatment of trastuzumab and pertuzumab for 1 year. We already know this is a positive study as per a press release by Roche; we are all looking forward to seeing the data and weighing the strategy of extended adjuvant treatment versus dual targeted treatment for 1 year in these patients. 
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