Background: Excessive activation of the PI3K pathway has been associated with malignant transformation and resistance to treatment in various cancer types. Various PI3K inhibitors have been evaluated in phase 3 clinical trials; however, most have been associated with modest clinical improvement and poor tolerability. The safety profile of PI3K inhibitors poses new challenges in treatment monitoring and management of common adverse events (AEs).
Objectives: The purpose of this article is to provide an overview of AEs associated with PI3K inhibitors, with a focus on alpelisib, as well as guidance on the prevention and management of AEs.
Methods: The literature and results from phase 3 trials evaluating the efficacy and safety of endocrine therapy plus PI3K inhibitors in patients with advanced breast cancer were reviewed.
Findings: AEs associated with PI3K inhibitors include hyperglycemia, diarrhea, nausea, rash, and decreased appetite. Prevention strategies are recommended to avoid the development or decrease the severity of these AEs. Patient education and multidisciplinary care are necessary for the optimal care of these patients.