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KISQALI patient portrayal.

Recurrence is far too common among patients with early breast cancer

For patients with stage II and III HR+ eBC, risk of recurrence is a significant lifelong concern

Despite treatment with adjuvant ET, patients remain at risk of recurrence with incurable metastatic disease—including those patients with no to low nodal involvement1-4 
Table describing recurrence risk by nodal status. Recurrence risk with N0 disease (no nodal involvement): within 3 years up to 1 in 9, within 20 years 1 in 3. With N1 disease (1-3 nodes): within 3 years up to 1 in 8, within 20 years 1 in 3. With N2/N3 disease (4+ nodes): within 3 years up to 1 in 4, within 20 years, 1 in 2.
Table describing the risk of recurrence by disease stage. Stage II: within 3 years up to 12%, within 20 years 27%- 37%. Stage III: within 3 years up to 21%, within 20 years 46%-57%.

The 3- and 20-year risk of recurrence rates are derived from distinct data sets gathered from unique patient populations; there was no longitudinal follow-up between patient groups or points in time. These data reflect recent outcomes published for patients with HR+ eBC who may be appropriate for treatment with CDK4/6 inhibitors, who were treated with standard ET, including tamoxifen. KISQALI is not indicated for concomitant use with tamoxifen due to an increased risk for QT prolongation.2,3,5,6 

3-year risk of recurrence rates are 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 arms. The 3-year data listed for stage III also include some patients with stage IIB disease, due to differentiated data breakouts between trials.2,3

20-year risk of recurrence rates are based on rates of distant recurrence in a meta-analysis of 78 randomized trials in the Early Breast Cancer Trialists’ Collaborative Group (EBCTCG) database of 74,194 women with ER+ breast cancer who had 5 years of scheduled ET. Rates include patients with T1/T2 disease and <10 involved nodes.5

CDK=cyclin-dependent kinase; eBC=early breast cancer; ER+=estrogen receptor-positive; ET=endocrine therapy; iDFS=invasive disease-free survival.
 
References: 1. Slamon DJ, Fasching PA, Hurvitz S, et al. Rationale and trial design of NATALEE: a phase III trial of adjuvant ribociclib + endocrine therapy versus endocrine therapy alone in patients with HR+/HER2− early breast cancer. Ther Adv Med Oncol. 2023;15:1-16. doi:10.1177/17588359231178125 2. Mayer EL, Dueck AC, Martin M, et al. Palbociclib with adjuvant endocrine therapy in early breast cancer (PALLAS): interim analysis of a multicentre, open-label, randomised, phase 3 study. Lancet Oncol. 2021;22(2):212-222. doi:10.1016/S1470-2045(20)30642-2 3. Johnston SRD, Toi M, O’Shaughnessy J, et al. Abemaciclib plus endocrine therapy for hormone receptor-positive, HER2-negative, node-positive, high-risk early breast cancer (monarchE): results from a preplanned interim analysis of a randomised, open-label, phase 3 trial. Lancet Oncol. 2023;24(1):77-90. doi:10.1016/S1470-2045(22)00694-5 4. Pan H, Gray R, Braybrooke J, et al; EBCTCG. 20-year risks of breast-cancer recurrence after stopping endocrine therapy at 5 years. N Engl J Med. 2017;377(19)(suppl):1836-1846. doi:10.1056/NEJMoa1701830 5. Pan H, Gray R, Braybrooke J, et al; EBCTCG. 20-year risks of breast-cancer recurrence after stopping endocrine therapy at 5 years. N Engl J Med. 2017;377(19):1836-1846. doi:10.1056/NEJMoa1701830 6. Kisqali. Prescribing information. Novartis Pharmaceuticals Corp.