KISQALI + AI is proven to help reduce the risk of recurrence in patients with stage II or III HR+/HER2- eBC at high risk of recurrence—so they can live the lives they love
At a median follow-up of 33.3 months, iDFS (primary end point) at the 3-year landmark was 90.7% for KISQALI + NSAI vs 87.6% for NSAI alone (absolute difference 3.1%); there was a 25.1% relative reduction in the risk of an iDFS event; HR=0.749 (95% CI: 0.628-0.892)1,2
National Comprehensive Cancer Network® (NCCN®) recommends 3 years of once-daily adjuvant ribociclib (KISQALI®) as a Category 1 Preferred option in combination with an aromatase inhibitor (AI) for appropriate patients with HR+/HER2- early breast cancer (eBC) at high risk of recurrence—the only CDK4/6 inhibitor to receive this designation for both high-risk node-negative and any node-positive disease, including N1 disease with G1 or G2 and tumor size <5 cm.3
High-risk node-negative disease is defined as either tumor size >5 cm, or if tumor size 2-5 cm, either grade 2 (with high genomic risk or Ki-67 ≥20%), or grade 3.3
NCCN makes no warranties of any kind whatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way.3
Category 1: Based upon high-level evidence (≥1 randomized phase III trials or high-quality, robust meta-analyses), there is uniform NCCN consensus (≥85% support of the Panel) that the intervention is appropriate.3
AI, aromatase inhibitor; CDK, cyclin-dependent kinase; eBC, early breast cancer; G, grade; HER2-, human epidermal growth factor receptor 2-negative; HR+, hormone receptor-positive; N, nodal status.
NATALEE was a randomized, multicenter, open-label, phase III study of KISQALI + letrozole or anastrozole (n=2549) vs letrozole or anastrozole (n=2552) for the adjuvant treatment of men and women with stage II/III HR+/HER2- eBC, including all those with node-positive or high-risk node-negative disease (eligible stages and nodal status include: anatomic stage group IIB-III, or anatomic stage group IIA that is either node positive, or node negative with histologic grade 3, or histologic grade 2 with Ki-67 ≥20% and/or high risk by gene signature testing). At a median follow-up of 33.3 months, with 509 iDFS (primary end point) events in the study (226 [8.9%] in the KISQALI arm and 283 [11.1%] in the NSAI-alone arm), iDFS at the 3-year landmark was 90.7% for KISQALI + NSAI vs 87.6% for NSAI alone (absolute difference 3.1%); there was a 25.1% relative reduction in the risk of an iDFS event; HR=0.749 (95% CI: 0.628-0.892).1,2
ET, endocrine therapy; HR, hazard ratio; iDFS, invasive disease-free survival; NSAI, nonsteroidal aromatase inhibitor.
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Ursa Brown-Glaberman, MD, shares her approach for talking with patients about risk of recurrence
How does Dr Brown-Glaberman discuss risk of recurrence with her patients who have stage II/III HR+/HER2- eBC? Watch to get her perspective on talking early and often with patients about their risk and appropriate treatment plan.
Dr Ursa Brown-Glaberman has been compensated for her time by Novartis Pharmaceuticals Corporation.
Novartis strives to ensure you have everything you need to provide care for your patients. Explore our library of resources designed to support you, your staff, and your patients. These tools contain useful information that can help your patients get started and stay on treatment with KISQALI.