New York City-based Memorial Sloan Kettering Cancer Center researchers found higher rates of hyperglycemia in patients treated with a common breast cancer medication than reported in the original clinical trial submitted to the FDA.
The study, published in Cancer, treated 247 patients with alpelisib, a drug that targets a protein involved in cell growth. The standard care with alpelisib resulted in 80.3 percent of patients experiencing some level of hyperglycemia and 40.2 percent experiencing serious hyperglycemia. The median onset time after starting the medication was 16 days. Among those who developed hyperglycemia, 66.4 percent received treatment, most commonly with the diabetes drug metformin.
Alpelisib was approved by the FDA in 2019 in combination with fulvestrant, an estrogen receptor blocker, for certain cases of metastatic breast cancer. The clinical trial found the rates of hyperglycemia were 34 percent for any grade and 13 percent for serious hyperglycemia.