Ribociclib Addition Assessed for PFS in HR+ HER2− Advanced Breast CA
HealthDay News — Ribociclib is beneficial for pre- and perimenopausal women with hormone receptor positive (HR+), human epidermal growth factor receptor 2-negative (HER2−) advanced breast cancer (ABC), according to a study presented at the annual San Antonio Breast Cancer Symposium, held from December 5 to 9 in Texas.
Debu Tripathy, MD, from the University of Texas MD Anderson Cancer Center in Houston, and colleagues reported the results from a randomized phase III trial assessing ribociclib + tamoxifen/non-steroidal aromatase inhibitor and goserelin in pre- and peri-menopausal women. A total of 672 patients with HR+, HER2− ABC were randomized in a 1:1 ratio to ribociclib or placebo combined with tamoxifen or letrozole/anastrozole + goserelin.
The researchers found that progression-free survival (PFS) was significantly improved in the ribociclib versus the placebo arm (median PFS: 23.8 versus 13.0 months; hazard ratio, 0.553). Consistent PFS benefits were seen for ribociclib versus placebo in subgroup analyses. The overall response rate was 51 percent for ribociclib versus 36 percent for placebo, and clinical benefit rate was 80 versus 67 percent in patients with measurable disease at baseline.
"Longer follow-up is needed to determine whether the trial will meet its secondary end point of overall survival," Tripathy said in a statement. "However, these initial results are very exciting."
One author disclosed financial ties to Novartis, which manufactures ribociclib and funded the study.