For patients with hormone receptor-positive advanced breast cancer with disease progression during or after treatment with an aromatase inhibitor, capivasertib-fulvestrant therapy results in significantly longer progression-free survival than fulvestrant alone, according to a study published in the June 1 issue of the New England Journal of Medicine.
Nicholas C. Turner, M.D., Ph.D., from the Royal Marsden Hospital in London, and colleagues conducted a randomized trial involving premenopausal, perimenopausal, and postmenopausal women and men with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer who had a relapse or disease progression during or after aromatase inhibitor treatment, with or without previous cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor therapy. A total of 708 participants were randomly assigned to receive capivasertib plus fulvestrant or placebo plus fulvestrant in a 1:1 ratio.
The researchers found that the median progression-free survival was 7.2 and 3.6 months in the capivasertib-fulvestrant group and the placebo-fulvestrant group, respectively, in the overall population (hazard ratio for progression or death, 0.60). The median progression-free survival was 7.3 and 3.1 months, respectively, in the AKT pathway-altered population (hazard ratio, 0.50). Rash and diarrhea were the most frequent adverse events of grade 3 or higher in patients receiving capivasertib-fulvestrant.
“Our findings suggest that capivasertib-fulvestrant treatment improved outcomes regardless of previous exposure to a CDK4/6 inhibitor and reinforce the evidence that single-agent endocrine therapy has poor outcomes after receipt of a CDK4/6 inhibitor,” the authors write.
The study was funded by AstraZeneca, the manufacturer of capivasertib. In addition, several authors disclosed ties to industry.
Nicholas C. Turner et al, Capivasertib in Hormone Receptor–Positive Advanced Breast Cancer, New England Journal of Medicine (2023). DOI: 10.1056/NEJMoa2214131
New England Journal of Medicine
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