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Dynamics of hyperglycemia of patients treated with alpelisib: exploratory interim analysis of ITACA trial

Marija Pancirov1, Josipa Flam2, Jelena Šuto Pavičić1

  • 1Department of Oncology, University Hospital Center Split, School of Medicine, University of Split, 21 000 Split, Croatia.

The Oncologist
|March 28, 2025
PubMed
Abstract

Insights

Hyperglycemia frequently occurs within the first week of alpelisib treatment for advanced breast cancer (BC). Early monitoring and management are crucial for patients receiving alpelisib and fulvestrant therapy.

Area of Science:

  • Oncology
  • Pharmacology
  • Endocrinology

Background:

  • Alpelisib plus fulvestrant improves outcomes in PIK3CA-mutated, HR+, HER2- advanced breast cancer (BC) post-endocrine therapy.
  • Hyperglycemia is a common on-target toxicity of alpelisib, affecting over 60% of patients.

Purpose of the Study:

  • To explore dietary modifications and evening dosing of alpelisib to mitigate hyperglycemia.
  • To quantify the incidence and timing of hyperglycemia in the ITACA trial.

Main Methods:

  • Interim analysis of the ITACA trial involving 23 patients with HR+, HER2- metastatic BC.
  • Assessed grade 2-4 hyperglycemia-free survival and time to onset of hyperglycemia.

Main Results:

  • 91.3% of patients experienced hyperglycemia within the first week of alpelisib initiation.
  • Median grade 2-4 hyperglycemia-free survival was 6 days.

Conclusions:

  • Alpelisib rapidly induces hyperglycemia, even with dietary interventions.
  • Proactive monitoring and early management of hyperglycemia are essential within the first week of treatment.
Keywords:
PIK3CA mutationalpelisibbreast cancerdietglucosehyperglycemia

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