TY - CHAP M1 - Book, Section TI - Breast Cancer A1 - Barnett, Chad M. A1 - Boster, Bonnie Lin A1 - Michaud, Laura Boehnke A2 - DiPiro, Joseph T. A2 - Talbert, Robert L. A2 - Yee, Gary C. A2 - Matzke, Gary R. A2 - Wells, Barbara G. A2 - Posey, L. Michael PY - 2017 T2 - Pharmacotherapy: A Pathophysiologic Approach, 10e AB - Content UpdateJune 3, 2019Alpelisib Approved for PIK3CA Mutated Breast Cancers: Alpelisib (Piqray®) is the first PI3K inhibitor approved by the FDA and is indicated for adults with hormone receptor (HR) positive and human epidermal growth factor (HER2) negative advanced or metastatic breast who have progressed on prior endocrine therapy. PIK3CA mutations are common, occurring in about 35% of all breast cancers. In the SOLAR-1 trial, the median progression free survival was 11.0 months in the alpelisib arm compared to 5.7 months in the placebo group (HR 0.65, 95% CI 0.50–1.25, P=.00065). Overall response rate is 36%, compared to 16% in the placebo group. The most common adverse effects are hyperglycemia, nausea and rash. SN - PB - McGraw-Hill Education CY - New York, NY Y2 - 2024/04/18 UR - accesspharmacy.mhmedical.com/content.aspx?aid=1164185033 ER -