The SONIA results challenge the need for first-line use of CDK4/6 inhibitors, Sonke told Healio. Indeed, a preplanned subgroup analysis did not indicate a differential effect between palbociclib and ribociclib, and the numbers for abemaciclib are too small for comparison.” Implications Since PFS with all three agents was remarkably similar in the pivotal trials, it is unlikely that the choice for one of the three CDK4/6 inhibitors impacted the read-out of the primary endpoint on PFS. “In addition, most patients used palbociclib, while ribociclib and abemaciclib have become the preferred drug for many patients more recently. “While the treatment landscape has changed since the start of SONIA, it is important to note that patients in both arms were able to receive alpelisib in case of a PIK3CA mutation after second progression,” Sonke said. In addition, first-line treatment with the CDK4/6 inhibitor combination extended time on treatment by 16.6 months, increased incidence of grade 3 to grade 4 adverse events by 42% and increased drug expenditures by approximately $200,000 per patient. second-line setting did not lead to a statistically significant nor clinically relevant PFS benefit (HR = 0.87 95% CI, 0.74-1.03), OS benefit (HR = 0.98 95% CI, 0.8-1.2) or quality-of-life improvement, according to Sonke. Results showed the addition of CDK4/6 inhibitors in the first-line vs. Secondary endpoints included OS, safety, quality of life and cost-effectiveness. Time from randomization to second objective disease progression, as assessed by local investigator, or death served as the primary endpoint. Ninety-one percent of patients in each group received palbociclib (Ibrance, Pfizer) as the CDK4/6 inhibitor. Researchers randomly assigned patients to either first-line treatment with a nonsteroidal aromatase inhibitor plus a CDK4/6 inhibitor of physician’s choice, followed upon progression by fulvestrant, or first-line treatment with a nonsteroidal aromatase inhibitor, followed upon progression by fulvestrant plus a CDK4/6 inhibitor. The phase-3, randomized, investigator-initiated, nationwide SONIA trial included 1,050 premenopausal and postmenopausal women with hormone receptor-positive, HER2-negative, advanced breast cancer receiving treatment across 74 Dutch hospitals. Moreover, these agents come with added toxicity and costs, and many patients have lasting disease remission on endocrine therapy alone.” “While absolute improvement in first-line studies was larger than in second-line studies, only a minority of patients in the control arm of first-line studies crossed over to receive CDK4/6 inhibitors in the second-line setting. Sonke, MD, P h D, researcher at Netherlands Cancer Institute, told Healio. However, comparative data are lacking to help clinicians decide if CDK4/6 inhibitors should be added to first- or second-line endocrine therapy,” Gabe S. “CDK4/6 inhibitors have been shown to improve outcomes for women with estrogen receptor-positive HER2-advanced breast cancer. The findings, presented at ASCO Annual Meeting, suggested second-line cyclin-dependent kinase (CDK)4/6 inhibitors may be the preferred treatment option for most patients. second-line use when added to endocrine therapy for women with hormone receptor-positive, HER2-negative, advanced breast cancer. The results challenge the need for first-line use of CDK4/6 inhibitors.ĬHICAGO - First-line use of cyclin-dependent kinase 4/6 inhibitors did not confer significant benefit vs.CDK4/6 inhibitors in the earlier setting did not lead to statistically significant PFS or OS improvement. If you continue to have this issue please contact to Healio Key takeaways:
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