MEET ERIN: She was recently diagnosed with stage II (T2N0) HR+/HER2- eBC
Find out why KISQALI + AI is right for patients with stage II/III HR+/HER2- eBC at high risk of recurrence.
BACKGROUND
Get to know Erin
Erin is 43 years old and lives in St Louis with her husband, 2 daughters, and their dog, Ozzie. She loves working as a real estate agent, but is happiest when cooking and enjoying movie nights at home with her family.
- She first noticed a lump in her left breast after a self-examination and immediately reached out to her doctor
- Erin is in remission after undergoing a lumpectomy followed by adjuvant chemotherapy and radiation and has been on hormone therapy for 11 months
Discover more: download Erin's patient profile.
EVALUATION
Erin’s clinical evaluation
Age | 43 |
Menopausal status | Premenopausal |
Clinical features |
|
Hormone receptor assay status | ER+/PR-/HER2- |
Gene expression profile assay results | 34 (Oncotype DX® test score) |
ECOG PS | 0 |
Prior therapy | Lumpectomy; adjuvant chemotherapy; adjuvant radiation |
Current therapy | Hormone therapy (11 months) |
DIAGNOSIS: Stage II (T2N0) HR+/HER2- eBC with high genomic risk
RISK OF RECURRENCE
Estimated risk of recurrence for patients with stage II/III N0 HR+/HER2- eBC
3-year risk of recurrence is based on iDFS outcomes among patients with HR+/HER2- eBC who received ET in select CDK4/6 inhibitor clinical trials. Data are from control arms only; no comparisons should be made between results from CDK4/6 inhibitor trial arms.1
CDK, cyclin-dependent kinase; ET, endocrine therapy; iDFS, invasive disease-free survival.
ANALYSIS
KISQALI + AI consistently reduced the risk of recurrence in patients with stage II/III HR+/HER2- eBC at high risk of recurrence, including those with high-risk node-negative disease
The iDFS benefit seen in the N0 subgroup was consistent with the overall population
In the 5-year prespecified analysis, at a median follow-up of 55.4 months, reduction in risk of recurrence (iDFS) at the 5-year landmark was 85.5% for KISQALI + AI vs 81.0% for AI alone (absolute difference 4.5%); there was a 28.4% relative reduction in the risk of an iDFS event; HR=0.716 (95% CI: 0.618-0.829).3
KISQALI is approved for all patients with T4N0 and T3N0 disease; if T2N0: grade 3, or grade 2 with Ki-67 ≥20% or high genomic risk. The 5-year analysis was prespecified and observational in nature; as such, there was no prespecified statistical procedure controlling for type 1 error.
iDFS was defined as the time from randomization to the date of the first event of local invasive breast cancer recurrence, regional invasive recurrence, distant recurrence, contralateral invasive breast cancer, second primary non-breast invasive cancer (excluding basal and squamous cell carcinomas of the skin), or death (any cause).2
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). At a median follow-up of 60.1 months, iDFS for the prespecified N0 subgroup at the 5-year landmark was 90.3% for KISQALI + NSAI vs 84.6% for NSAI alone; HR=0.606 (95% CI: 0.372-0.986). In the 5-year prespecified analysis, prespecified subgroups included anatomic stage (stage II: HR=0.660 [95% CI: 0.493-0.884]; stage III: HR=0.730 [95% CI: 0.615-0.865]), nodal status (N0: HR=0.606 [95% CI: 0.372-0.986]; N1, N2, N3: HR=0.737 [95% CI: 0.631-0.860]), and menopausal status (premenopausal/men: HR=0.714 [95% CI: 0.565-0.902]; postmenopausal: HR=0.734 [95% CI: 0.608-0.887]). The 5-year analysis was prespecified and observational in nature; as such, there was no prespecified statistical procedure controlling for type 1 error.2-6
KISQALI + AI consistently improved iDFS across subgroups, regardless of stage, nodal status, or menopausal status
KISQALI may be right for a variety of patients with stage II/III HR+/HER2- eBC.
KISQALI—the only CDK4/6 inhibitor approved for patients like Erin who have stage II N0 HR+/HER2- eBC with high genomic risk
See which patient types could benefit from KISQALI.
Patients with stage IIA, T2N0 HR+/HER2- eBC must meet the following criteria to be eligible for treatment with KISQALI: grade 3, or grade 2 with Ki-67 ≥20% or high genomic risk.6
