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Found 1 Presentation For Request "301P"
301P - Sodium-glucose cotransporter-2 (SGLT-2) inhibitors for alpelisib (ALP)-induced hyperglycemia: A report of 6 cases from SOLAR-1
- Yen-Shen Lu (Taipei, Taiwan)
Abstract
Background
In the phase III SOLAR-1 trial (NCT02437318), ALP (PI3Kα inhibitor) + fulvestrant (FUL) significantly improved progression-free survival vs. FUL alone in patients (pts) with HR+/HER2
Methods
Hyperglycemia was assessed at baseline and over time using fasting plasma glucose and glycated haemoglobin.
Results
In SOLAR-1, 284 pts were randomized to ALP + FUL, median duration of ALP exposure was 5.5 months, and 190 pts (67%) developed hyperglycemia as of 30 Sept 2019, with 18 pts (6%) discontinuing ALP treatment due to hyperglycemia. A total of 166 pts received concomitant hypoglycemic medications, mainly metformin (87%). In addition to metformin, 6 pts received an SGLT-2 inhibitor, consisting of empagliflozin, ipragliflozin, and dapagliflozin. All 6 pts had ≥ 1 risk factor at baseline for developing hyperglycemia: prediabetes (n = 4; 1 with history of type 2 diabetes), diabetes (n = 2), and obesity (n = 2). The most severe hyperglycemia in these pts was grade (G) 3 (n = 5). After initiating an SGLT-2 inhibitor, all subsequent hyperglycemia events were G 1/2, except one G 3 event with steroids as a confounding factor. Duration of ALP ranged from 9.5 to 27.7 months in pts who discontinued; 2 pts were continuing to receive ALP after 37.0 and 40.0 months, respectively. None of the 6 pts discontinued ALP due to hyperglycemia.
Conclusions
In 166 pts treated for ALP-related hyperglycemia, 87% received metformin-based concomitant hypoglycemic medications. In 6 pts, addition of an SGLT-2 inhibitor stabilized blood glucose level, allowing them to continue ALP treatment. These results warrant further investigation of using SGLT-2 inhibitors for ALP-induced hyperglycemia in a larger sample size study.
Clinical trial identification
NCT02437318 (May 7, 2015).
Editorial acknowledgement
Medical writing support was provided by Mihaela Marina, PhD, at MediTech Media, Ltd, funded by Novartis Pharmaceuticals Corporation.
Legal entity responsible for the study
Novartis Pharmaceuticals Corporation.
Funding
Novartis Pharmaceuticals Corporation.
Disclosure
Y-S. Lu: Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution), Research Grant; Advisory Board/Consultancy; Speaker's Bureau: Novartis; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Research Grant; Advisory Board/Consultancy: Pfizer; Research grant/Funding (institution), Research Grant: Roche; Research grant/Funding (institution), Research Grant: Merck Sharp & Dohme; Honoraria (self), Advisory/Consultancy, Advisory Board/Consultancy: Boehringer Ingelheim; Honoraria (self), Speaker Bureau/Expert testimony, Speaker's Bureau: Eisai. M. Margeli Vila: Advisory/Consultancy, Advisory/Consultancy: Novartis; Advisory/Consultancy, Advisory/Consultancy: Pfizer; Advisory/Consultancy, Advisory/Consultancy: Roche; Advisory/Consultancy, Advisory/Consultancy: Kern. F. Ghaznawi: Shareholder/Stockholder/Stock options, Full/Part-time employment, Employment and Stock Ownership: Novartis. F. Gaudenzi: Shareholder/Stockholder/Stock options, Full/Part-time employment, Employment and Stock Ownership: Novartis. A. Ridolfi: Shareholder/Stockholder/Stock options, Full/Part-time employment, Employment and Stock Ownership: Novartis. I. Lorenzo: Shareholder/Stockholder/Stock options, Full/Part-time employment, Employment and Stock Ownership: Novartis. M. Ruiz Borrego: Research grant/Funding (institution), Research Grant: Novartis; Research grant/Funding (institution), Research Grant: Eli Lilly; Research grant/Funding (institution), Research Grant: Pfizer. All other authors have declared no conflicts of interest.