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FRIDAY, Oct. 4, 2019 (HealthDay News) — The addition of abemaciclib to fulvestrant provides a statistically significant and clinically meaningful gain in median overall survival, regardless of menopausal status, for women with hormone receptor (HR)-positive, erb-b2 receptor tyrosine kinase 2 (ERBB2 [formerly human epidermal growth factor receptor 2])-negative advanced breast cancer that progressed during endocrine therapy, according to a study published online Sept. 29 in JAMA Oncology<\/i>. The research was published to coincide with the European Society of Medical Oncology Congress 2019, held from Sept. 27 to Oct. 1 in Barcelona, Spain.<\/p>\n
George W. Sledge Jr., M.D., from the Stanford University School of Medicine in California, and colleagues randomly assigned patients (premenopausal or perimenopausal with ovarian suppression, postmenopausal) with HR-positive, ERBB2-negative advanced breast cancer that progressed during endocrine therapy (2:1) to receive either abemaciclib (446 patients) or placebo (223 patients), 150 mg every 12 hours on a continuous schedule plus fulvestrant, 500 mg, per label.<\/p>\n
At the prespecified interim period, the researchers found 338 deaths (77 percent of the planned 441 at the final analysis) in the intent-to-treat population, with a median overall survival of 46.7 months for abemaciclib plus fulvestrant and 37.3 months for placebo plus fulvestrant (hazard ratio [HR], 0.757; 95 percent confidence interval [CI], 0.606 to 0.945; P = 0.01). Findings were consistent across all stratifications. More pronounced effects were seen in patients with visceral disease (HR, 0.675; 95 percent CI, 0.511 to 0.891) and primary resistance to prior endocrine therapy (HR, 0.686; 95 percent CI, 0.451 to 1.043). There were significant improvements in time to second disease progression, time to chemotherapy, and chemotherapy-free survival in the abemaciclib arm versus the placebo arm.<\/p>\n
“We still haven’t cured metastatic breast cancer. But this is a drug that increases survival and reduces the need for chemotherapy,” Sledge said in a statement. “Women can live longer and have a relatively good quality of life and more time with their families, their children, and their loved ones.”<\/p>\n
The study was funded by Eli Lilly, the manufacturer of abemaciclib.<\/p>\n
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