Predicting Hyperglycemia Among Patients Receiving Alpelisib Plus Fulvestrant for Metastatic Breast Cancer

Area of Science:

• Oncology
• Endocrinology
• Pharmacology

Background:

• Hyperglycemia is a known adverse event of alpelisib, often understudied in real-world settings.
• This study investigates alpelisib-associated hyperglycemia frequency and risk factors outside clinical trials.

Purpose of the Study:

• To determine the incidence of alpelisib-associated hyperglycemia in a real-world patient population.
• To identify and evaluate risk factors for developing severe hyperglycemia during alpelisib treatment.

Main Methods:

• Retrospective analysis of 92 patients with PIK3CA-mutated, HR+, metastatic breast cancer treated with alpelisib and fulvestrant.
• Ordinal logistic regression used to assess risk factors: diabetes, prediabetes, BMI, age, and Asian ancestry.

Main Results:

• Hyperglycemia (grades 1-4) occurred in 64.1% of patients, similar to clinical trial data.
• Independent risk factors for grades 2-4 hyperglycemia included pre-existing diabetes, pre-diabetes, Asian ancestry, and elevated BMI.
• Odds ratios: Diabetes (3.75), Prediabetes (6.22), Asian ancestry (7.10), each BMI unit >20 (1.17).

Conclusions:

• Close monitoring for hyperglycemia is crucial for patients on alpelisib, especially those of Asian ancestry or with pre-existing hyperglycemia or elevated BMI.
• The association between alpelisib-associated hyperglycemia and Asian ancestry warrants further investigation.
• Clinical practice has adapted to include diabetes educator consultations at alpelisib initiation due to high hyperglycemia incidence.