- They face a worse prognosis and more aggressive cancer than postmenopausal women1,2
- Quality of life can be a challenge to maintain3
Extend the moment for premenopausal women with HR+/HER2− aBC
KISQALI + NSAI + LHRH agonist is the only CDK4/6 inhibitor that offers statistically significant longer OS than placebo + NSAI + LHRH agonist for premenopausal women with HR+/HER2− aBC4–6
KISQALI is indicated for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy. In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist.7
KISQALI + ET* (along with other CDK4/6 inhibitors) is recognised by ESMO as a standard of care for aBC patients8–11
KISQALI + ET* in premenopausal women with HR+/HER2− aBC is the only CDK4/6 inhibitor recognised by ASCO Clinical Cancer Advances 202012
* KISQALI is not recommended to be used in combination with tamoxifen.7
MONALEESA-7: N=672, double-blind, placebo-controlled, 1:1 randomisation in premenopausal women with HR+/HER2− aBC. As 1L in advanced disease and in patients who received 1 or fewer lines of chemotherapy for aBC. KISQALI 600 mg or placebo orally once daily (3 weeks on/1 week off) + AI (letrozole 2.5 mg or anastrozole 1 mg) or tamoxifen 20 mg orally once daily continuously + LHRH agonist (goserelin 3.6 mg subcutaneously on day 1 of every cycle).4,7
1L, first line; aBC, advanced breast cancer; AI, aromatase inhibitor; ASCO, American Society of Clinical Oncology; CDK4/6, cyclin-dependent kinase 4 and 6; ECOG, Eastern Cooperative Oncology Group; EORTC QLQ-C30, European Organisation for Research and Treatment of Cancer Core Quality of Life questionnaire; ESMO, European Society for Medical Oncology; ET, endocrine therapy; HR+/HER2−, hormone receptor-positive/human epidermal growth factor 2-negative; LHRH, luteinising hormone-releasing hormone; NSAI, non-steroidal aromatase inhibitor; OS, overall survival; QoL, quality of life.
- Bardia A and Hurvitz S. Clin Cancer Res. 2018;24(21):5206–5218.
- Azim Jr HA and Partridge AH. Breast Cancer Res. 2014;16:427.
- Harbeck N, et al. Ther Adv Med Oncol. 2020;12:1758835920943065.
- Im S-A, et al. N Engl J Med. 2019;381(4):307–316.
- Finn RS, et al. Breast Cancer Res Treat. 2020;183:419–428.
- Goetz MP, et al. J Clin Oncol. 2017;35(32):3638–3646.
- KISQALI (ribociclib). Summary of Product Characteristics.
- ESMO. ESMO-MCBS scorecards. Available at: https://www.esmo.org/guidelines/esmo-mcbs/esmo-mcbs-scorecards/scorecard.... Accessed June 2021.
- ESMO. ESMO-MCBS evaluation forms V1.0 & V1.1. Available at: https://www.esmo.org/guidelines/esmo-mcbs/scale-evaluation-forms-v1.0-v1.1. Accessed June 2021.
- ESMO. ESMO-MCBS V1.1. Updated September 2017. Available at: https://www.esmo.org/content/download/117394/2059186/. Accessed June 2021.
- Cardoso F. Highlights from ABC5. Presented at ESO e-Learning Session 511, 23 March 2020.
- Markham MJ, et al. J Clin Oncol. 2020;38(10:1081–1101.