From the Guidelines
Kisqali (ribociclib) is a CDK4/6 inhibitor used in combination with an aromatase inhibitor for the treatment of hormone receptor-positive, HER2-negative advanced or metastatic breast cancer in adult patients. This medication works by blocking specific proteins that promote cancer cell growth, and its use has been supported by studies such as the one published in the Journal of the National Comprehensive Cancer Network, which demonstrated improved progression-free survival (PFS) with the combination of a CDK4/6 inhibitor and an aromatase inhibitor compared to an aromatase inhibitor alone 1.
Key Points
- Kisqali is typically taken orally once daily for 21 days, followed by 7 days off treatment, in combination with an aromatase inhibitor or fulvestrant.
- The standard starting dose is 600 mg daily, though dose adjustments may be necessary based on side effects such as decreased white blood cell counts, nausea, fatigue, diarrhea, hair loss, vomiting, headache, and liver enzyme abnormalities.
- Regular blood tests are required during treatment to monitor for potential complications, as seen in studies where grade 3 and 4 adverse effects included neutropenia, leukopenia, anemia, and fatigue 1.
- Kisqali has been shown to significantly improve progression-free survival in breast cancer patients by effectively preventing cancer cells from dividing and multiplying, thereby slowing tumor growth and disease progression, with an improvement in PFS of 25.3 vs 16.0 months (HR for progression or death was 0.56; 95% CI, 0.45–0.70) in a phase III study 1.
Treatment Considerations
- The use of Kisqali in combination with an aromatase inhibitor has demonstrated improved PFS and objective response rate (ORR) compared to an aromatase inhibitor alone, making it a viable treatment option for patients with hormone receptor-positive, HER2-negative advanced or metastatic breast cancer 1.
- As with any medication, it is essential to weigh the benefits and risks of treatment with Kisqali, considering factors such as the patient's overall health, potential side effects, and the impact on quality of life.
From the FDA Drug Label
KISQALI is a prescription medicine used to treat adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer KISQALI (ribociclib) is a kinase inhibitor.
KISQALI is a prescription medicine used to treat adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer. It is a kinase inhibitor. The main uses of KISQALI are:
- In combination with an aromatase inhibitor for stage II and III early breast cancer with a high risk of coming back that has gotten worse or has spread to other parts of the body (advanced or metastatic breast cancer)
- In combination with an aromatase inhibitor as the first endocrine-based therapy, or fulvestrant as the first endocrine-based therapy or following disease progression on endocrine therapy. 2
From the Research
What is Kisqali
- Kisqali, also known as ribociclib, is a cyclin-dependent kinase 4/6 inhibitor used in combination with endocrine therapy for the treatment of hormone receptor-positive, HER2-negative advanced or metastatic breast cancer 3, 4, 5, 6.
- It is FDA-approved for use in premenopausal, perimenopausal, and postmenopausal women with HR+/HER2- advanced or metastatic breast cancer 3, 4, 5.
- Kisqali has been shown to improve progression-free survival (PFS) and overall survival (OS) in patients with HR+/HER2- advanced or metastatic breast cancer when used in combination with aromatase inhibitors or fulvestrant 3, 4, 5, 6.
Mechanism of Action
- Kisqali works by inhibiting cyclin-dependent kinases 4 and 6, which are involved in cell differentiation and growth 4, 7.
- By inhibiting these kinases, Kisqali helps to slow down the growth and spread of cancer cells 4, 7.
Common Adverse Reactions
- The most common adverse reactions associated with Kisqali include neutropenia, nausea, fatigue, diarrhea, leukopenia, alopecia, vomiting, constipation, headache, and back pain 3, 4, 6.
- Kisqali can also cause liver function test abnormalities and QTc prolongation, and may be contraindicated in patients with certain cardiac conditions or risk factors for QTc prolongation 5, 7.