Adverse events of alpelisib: A postmarketing study of the World Health Organization pharmacovigilance database

Abstract

Disproportionality analysis by information components (ICs) were used to evaluate the potential association between adverse events (AEs) and alpelisib.Results: A total of 33 327 reports were extracted, 5695 of them were chosen with alpelisib as the suspected drug. After combining the same ID, 687 cases remained. The 45-64-years group had the most cases (n = 203, 29.55%). There were 129 Preferred Terms with significant signals. Hyperglycaemia (IC025 = 6.74), breast cancer metastatic (IC025 = 5.85) and metastases to liver (IC025 = 4.70) were the AEs with the strongest signal. AEs with the most cases were hyperglycaemia (n = 595), rash (n = 535) and diarrhoea (n = 475). Conclusion:We established a comprehensive list of AEs potentially associated with alpelisib. AEs with the most significant signals were hyperglycaemia, breast cancer metastatic, metastases to liver. The AEs with the most cases were hyperglycaemia, rash, diarrhoea, blood glucose increase and nausea.

Personalized Biomarker-Based Umbrella Trial for Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: KCSG HN 15-16 TRIUMPH Trial

“…20 In general, the toxicity profile was in line with previous reports. 12,[19][20][21][22][23] In this study, alpelisib showed hyperglycemia (61.9%), which is similar to the incidence in the SOLAR-1 trial. 22 Diarrhea (62.5%) and acneiform skin rash (3.13%), which are commonly observed in EGFR tyrosine kinase inhibitors, were the most common AEs in poziotinib.…”

Alpelisib-related adverse events: The FDA Adverse Event Reporting System Database (FAERS) pharmacovigilance study

“…According to disproportionality analysis, the most common signals at the SOC level were gastrointestinal disorders, general disorders and administration site conditions, metabolism and nutrition disorders, skin and subcutaneous tissue disorders, investigations and neoplasms benign, malignant and unspecified (incl cysts and polyps). The occurrence of the above SOCs was also confirmed in CHEN et al [ 21 ]. This is consistent with our results.…”

“…In 2021, Chen et al studied the AEs of alpelisib based on this database of VigiBase database. In our study, a total of 5, 647 patients of AEs of alpelisib were retained from 2019 to 2022, while CHEN et al reported only 687 cases from 2019 to 2021 [ 21 ]. Notably our report presented a more accurate and detailed description of alpelisib AEs, with the disproportionality analysis and an assessment of time to onset of AEs.…”

Real world outcomes with alpelisib in metastatic hormone receptor-positive breast cancer patients: A single institution experience

“…Our study expands upon the rapidly accumulating reports of real-world experience with alpelisib outside a clinical trial (12)(13)(14)(15)(16)(17)(18). We report a low ORR to alpelisib at 12.5% in a cohort of heavily pretreated patients with a median of 3 lines of prior treatment including chemotherapy, with rather a brief duration of response with a median of 5.77 months.…”