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William J. Gradishar, MD, FACP, FASCO
William J. Gradishar, MD, FACP, FASCO
Posted: Friday, February 24, 2023
Currents efforts have been directed at establishing an effective strategy to prevent hyperglycemia in patients with hormone receptor–positive, HER2-negative, PIK3CA-mutated advanced breast carcinoma who are receiving the kinase inhibitor alpelisib and the hormone therapy fulvestrant, according to a poster presented at the Journal of Advanced Practitioner in Oncology conference JADPRO Live (Abstract JL1011E). The use of extended-release metformin, with or without the addition of the sodium-glucose cotransporter 2 inhibitor dapagliflozin, may prove to be a useful way to mitigate the risk of hyperglycemia in this patient population, suggested William J. Gradishar, MD, FACP, FASCO, of Northwestern University Feinberg School of Medicine, Chicago, and colleagues.
The EPIK-B4 phase II study is actively recruiting adult men and postmenopausal women for enrollment, with a goal of complete enrollment of 132 patients by the end of 2023. All patients must have confirmed hormone receptor–positive, HER2-negative, PIK3CA-mutated advanced breast carcinoma and at least one risk factor for hyperglycemia. Patients will be stratified based on their baseline diabetes status.
All patients will be treated with 500 mg of extended-release metformin with or without 5 mg of dapagliflozin from day 1 of the first cycle. The goal is to increase the dosage gradually to a maximum of 2 g of extended-release metformin and 10 mg of dapagliflozin. Concurrently, patients will receive 300 mg daily of alpelisib from day 8 of the first cycle and 500 mg of fulvestrant on days 1 and 15 of the first cycle and on the first day of subsequent cycles.
The present study aims to assess this treatment regimen’s efficacy in mitigating the risk of hyperglycemia. After 8 weeks of treatment, glucose levels greater than 250 mg/dL will be considered indicative of severe hyperglycemia. The researchers also plan to examine overall response rates, clinical benefit rates, and progression-free survival to determine this regimen’s tolerability, response, and safety.
Disclosure: No disclosure information was provided.
Journal of Advanced Practitioner in Oncology
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