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Evaluation of alpelisib-induced hyperglycemia prophylaxis and associated risk factors in PIK3CA-mutated hormone-receptor positive, human epidermal growth factor-2 negative advanced breast cancer.

Publication ,  Journal Article
Burnette, SE; Poehlein, E; Lee, H-J; Force, J; Westbrook, K; Moore, HN
Published in: Breast Cancer Res Treat
January 2023

PURPOSE: SOLAR-1 investigated alpelisib-fulvestrant (ALP + FLV) in patients with HR + /HER2-, PIK3CA-mutated advanced breast cancer and demonstrated a clinically significant increase in all-grade and grade (G) 3-4 hyperglycemia (HG) compared to placebo-fulvestrant. Given high rates of HG, a preventative protocol and identification of associated risk factors was implemented. METHODS: This single-center, retrospective study included patients receiving ALP + FLV. One week before ALP initiation, patients started an insulin-sensitizer. Patients had fasting plasma glucose (FPG) levels drawn day 8, 15, 28, then monthly. Primary outcome was incidence of G2-4 HG by day 28. Risk factors assessed included age, BMI, FPG, and HbA1c. Number of risk factors were compared between patients with and without HG. RESULTS: Sixteen women were included with median age of 59 years. The cohort was 69% White, 25% Black, 75% with BMI ≥ 25 kg/m2, and 50% with history of diabetes. By day 28, 9 patients (56%) had G2-4 HG, with only 3 (19%) G3 and zero G4. Patients with G2-4 HG had a median of 2 risk factors compared to only 1 if no HG (p = 0.03). 5 patients (31%) required a temporary hold of ALP and 3 (19%) required dose reduction due to HG. 13 patients permanently discontinued ALP-9 due to disease progression and 4 from an adverse event (only 1 HG). CONCLUSION: Implementation of a HG prophylaxis protocol with ALP in a single-center study demonstrated fewer G3-4 HG events compared to that seen in SOLAR-1 (19% vs 36.6%). An increase in HG-associated risk factors correlated with a higher incidence of G2-4 HG.

Duke Scholars

Published In

Breast Cancer Res Treat

DOI

EISSN

1573-7217

Publication Date

January 2023

Volume

197

Issue

2

Start / End Page

369 / 376

Location

Netherlands

Related Subject Headings

  • Risk Factors
  • Retrospective Studies
  • Receptor, erbB-2
  • Receptor, ErbB-2
  • Oncology & Carcinogenesis
  • Middle Aged
  • Hyperglycemia
  • Humans
  • Fulvestrant
  • Female
 

Citation

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Burnette, S. E., Poehlein, E., Lee, H.-J., Force, J., Westbrook, K., & Moore, H. N. (2023). Evaluation of alpelisib-induced hyperglycemia prophylaxis and associated risk factors in PIK3CA-mutated hormone-receptor positive, human epidermal growth factor-2 negative advanced breast cancer. Breast Cancer Res Treat, 197(2), 369–376. https://doi.org/10.1007/s10549-022-06798-8
Burnette, Sarah E., Emily Poehlein, Hui-Jie Lee, Jeremy Force, Kelly Westbrook, and Heather N. Moore. “Evaluation of alpelisib-induced hyperglycemia prophylaxis and associated risk factors in PIK3CA-mutated hormone-receptor positive, human epidermal growth factor-2 negative advanced breast cancer.Breast Cancer Res Treat 197, no. 2 (January 2023): 369–76. https://doi.org/10.1007/s10549-022-06798-8.
Burnette, Sarah E., et al. “Evaluation of alpelisib-induced hyperglycemia prophylaxis and associated risk factors in PIK3CA-mutated hormone-receptor positive, human epidermal growth factor-2 negative advanced breast cancer.Breast Cancer Res Treat, vol. 197, no. 2, Jan. 2023, pp. 369–76. Pubmed, doi:10.1007/s10549-022-06798-8.
Journal cover image

Published In

Breast Cancer Res Treat

DOI

EISSN

1573-7217

Publication Date

January 2023

Volume

197

Issue

2

Start / End Page

369 / 376

Location

Netherlands

Related Subject Headings

  • Risk Factors
  • Retrospective Studies
  • Receptor, erbB-2
  • Receptor, ErbB-2
  • Oncology & Carcinogenesis
  • Middle Aged
  • Hyperglycemia
  • Humans
  • Fulvestrant
  • Female