The breast cancer drug alpelisib often triggers hyperglycemia — high blood sugar levels — a “serious side effect” which requires management, a study has found.
Alpelisib, which is taken orally, works by targeting the phosphoinositide 3-kinase (PI3K) protein that is involved in cell growth and, when mutated, can contribute to cancer.
The Food and Drug Administration has approved its use in combination with the “estrogen receptor blocker” fulvestrant for cases of metastatic breast cancer caused by mutations in the gene that codes for a particular PI3K subunit.
Unfortunately, explains oncologist Dr Sherry Shen and colleagues at the Memorial Sloan Kettering Cancer Center in New York City, targeting PI3K can induce hyperglycemia.
If sufficiently severe, such elevated blood sugar levels can cause both dehydration and kidney damage and require hospitalisation.
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In their study, Dr Shen and her team set out to assess how common this unintended side-effect is, what the risk factors for it are, and how it is typically treated.
The researchers looked both at patients receiving standard care at the Memorial Sloan Kettering Cancer Center, as well as those enrolled in a clinical trial.
Among 147 patients treated with alpelisib as part of standard care, hyperglycemia developed in 80.3 percent of cases, and serious hyperglycemia in 40.2 percent of cases.
Rates were found to be lower in the 100-patient-strong clinical trial, with only 34 percent of the subjects developing hyperglycemia and 13 percent its serious form.
On average, high blood sugar levels manifested 16 days after administration of alpelisib began. Around two-thirds of patients with hyperglycemia went on to receive treatment for the condition, typically with the common diabetes drug metformin.
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The team noted that an initial elevation in hemoglobin A1c levels — an indicator of high blood sugar — was a warning sign for the risk of developing hyperglycemia.
Dr Shen said: “If a patient is identified to have a PI3KCA mutation and thus eligible for treatment with alpelisib, we should be checking hemoglobin A1c level and partnering with the patient’s primary care physician and/or endocrinologist to optimize their blood sugar levels.
“This needs to be done months before initiating alpelisib, because once alpelisib is started, hyperglycemia usually develops within the first two weeks of treatment.
“Being pre-emptive about improving glycemic status and treating prediabetes/diabetes will hopefully lower the patient’s risk of developing hyperglycemia — and thus lower their risk of needing to discontinue a drug that could be effective for their cancer.”
As paper co-author and breast oncologist Dr Neil Iyengar notes, optimizing a patient’s blood sugar levels often involves changes to diet and exercise patterns — and potentially the introduction of medications like metformin.
He added: “Improving metabolic risk factors through lifestyle interventions may also improve dose delivery of alpelisib.
“Ongoing clinical trials by our group and other groups are testing whether metabolic interventions such as the ketogenic diet, or newer medications used to treat diabetes, could also improve the treatment efficacy of cancer therapies that target the PI3K pathway.”
The full findings of the study were published in the journal Cancer.
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