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ESMO 2017: Extended Adjuvant Neratinib for Early-Stage HER2-Positive Breast Cancer

By: Meg Barbor, MPH
Posted: Monday, September 18, 2017

In patients with early-stage HER2-positive breast cancer, invasive disease–free survival rates were better at 5 years among those treated with 1 year of adjuvant neratinib than among those who were not. These results of the phase III ExteNET trial were presented by Miguel Martin, MD, of the Hospital General Universitario Gregorio Marañón, Madrid, at the 2017 European Society for Medical Oncology (ESMO) Congress (Abstract 1490). However, in a companion poster presentation on this study (Poster 177P), neratinib was associated with a transient deterioration in health-related quality of life, possibly due to neratinib-related diarrhea. Suzette Delaloge, MD, of the Institut Gustave Roussy, Villejuif, France, presented these quality-of-life findings.

The preplanned 5-year analysis was based on 2840 patients in the intent-to-treat population, half of whom received oral neratinib and the other half, placebo, administered for 1 year after initial trastuzumab-based therapy. After a median follow-up of 5.2 years, invasive disease–free survival rates were 90.2% with neratinib and 87.7% with placebo.

According to Dr. Delaloge, neratinib was associated with a decrease in health-related quality-of-life scores at month 1 compared with the placebo, but the between-group differences later diminished. The authors suggested this decrease was due to neratinib-related diarrhea, which may be controlled with prophylaxis and may not prove to be clinically important.