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Rates of hyperglycemia were markedly elevated in patients receiving alpelisib as standard care compared with their counterparts enrolled in clinical trials, revealing a disparity between real-world outcomes and clinical trial results. Notably, a high baseline hemoglobin A1c (HbA1c) level emerged as a crucial factor linked to alpelisib-induced hyperglycemia, often necessitating dose adjustments. These findings were published in Cancer.
The combination of fulvestrant and alpelisib, a PI3K inhibitor, improved progression-free survival in patients with metastatic hormone receptor-positive, PIK3CA-mutant breast cancer. This study aimed to elucidate the occurrence, potential risk factors, and effective strategies for addressing hyperglycemia induced by alpelisib.
This retrospective study assessed 247 patients with metastatic breast cancer and treated with alpelisib between 2013 and 2021 at Memorial Sloan Kettering Cancer Center in New York, New York. Prescription timelines for alpelisib and pertinent patient and tumor attributes were extracted from medical records. The study evaluated risk factors linked to hyperglycemia and the instances of alpelisib dose reduction or discontinuation.
Median baseline body mass index was 25.4 kg/m2 and median HbA1c was 5.5%. A total of 152 (61.5%) patients developed hyperglycemia, with 72 (29.2%) patients developing grade 3-4 hyperglycemia. Median time to onset of hyperglycemia was 16 days.
Slightly more than 40% of patients (100) received alpelisib on a clinical trial. Notably, rates of hyperglycemia were significantly higher in patients receiving alpelisib in the real-world setting (any-grade hyperglycemia, 80.3% vs 34.0%; grade 3-4 hyperglycemia, 40.2% vs 13.0%; P <.001).
Approximately 40% of patients (101) who developed hyperglycemia received treatment, which was most frequently metformin. In total, 49 (19.8%) patients were referred to an endocrinologist, and referral correlated with prescribing an SGLT2 inhibitor (P =.007).
Hyperglycemia rates were significantly higher in patients treated with alpelisib as standard care than in patients treated on clinical trials, the researchers concluded. These results suggest a need to routinely optimize glycemic control prior to initiating alpelisib.
Disclosures: Some authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Reference
Shen S, Chen Y, Carpio A, Chang C, Iyengar NM. Incidence, risk factors, and management of alpelisib-associated hyperglycemia in metastatic breast cancer. Cancer. Published online September 25, 2023. doi:10.1002/cncr.34928
