ASCO23: adjuvant ribociclib yields promising results for early-stage breast cancer
A Phase III clinical trial has demonstrated promising results for the use of Kisqali® (ribociclib) with endocrine therapy for men and women with Stage IIA, IIB, or III HR-positive, HER2-negative breast cancer, who are at risk for recurrence. The findings were recently presented at ASCO (2−6 June, IL, USA) and support a possible new treatment option for these patients.
The focus of the study was whether ribociclib led to improvements in invasive disease-free survival (iDFS), compared with hormonal therapy alone. The team found that people in the ribociclib group (7.4% of patients) experienced a recurrence vs 237 people in the hormonal therapy alone group (9.2% of patients). The 3-year iDFS rates were 90.4% in the ribociclib group compared with 87.1% in the hormonal therapy alone group. Overall, adding ribociclib reduced the risk for recurrence by 25%.
Ribociclib is currently approved by the US FDA to treat metastatic forms of this condition (in combination with an aromatase inhibitor or fulvestrant depending on menopausal status), this study has highlighted improved outcomes for people with earlier stage disease that has not yet spread to the lymph nodes.
The team explained that next steps of the study involve the long-term evaluation of the treatment on quality-of-life outcomes.
“While early, these results are very promising and suggest that there will be a role for adjuvant ribociclib for Stage II and higher hormone receptor-positive (HR-positive), HER2-negative breast cancer,” commented Rita Nanda, ASCO Expert.