POSITIVE NEWS CONTINUES TO EMERGE FOR ADVANCED BREAST CANCER PATIENTS
KISQALI EXPLORATORY SUBGROUP ANALYSIS FROM MONALEESA-3 AND MONALEESA-7, RESULTS ADD TO BODY OF OVERALL SURVIVAL EVIDENCE
Denise Yardley, MD, Principal Investigator, Sarah Cannon Research Institute
There are approximately 155,000 individuals in the US are living with metastatic breast cancer.
Up to 11% of new breast cancer cases are initially stage IV or metastatic.
Nearly 30% of women initially diagnosed with the early-stage disease will ultimately develop metastatic lesions, often months or even years later.
And as of 2017, in the United States, nearly 1 in 7 women with metastatic BC were younger than 50. ……Denise Yardley, MD, is the Principal Investigator for the Sarah Cannon Research Institute.
Indication
KISQALI® (ribociclib) is a prescription medicine used in combination with: • an aromatase inhibitor to treat pre/perimenopausal or postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has spread to other parts of the body (metastatic), as the first endocrine-based therapy; or • fulvestrant to treat postmenopausal women with HR-positive, HER2-negative metastatic breast cancer as the first endocrine-based therapy or with disease progression following endocrine therapy. It is not known if KISQALI is safe and effective in children. IMPORTANT SAFETY INFORMATION What is the most important information I should know about KISQALI? KISQALI may cause serious side effects, including: Lung problems. KISQALI may cause severe or life-threatening inflammation of the lungs during treatment that may lead to death. Tell your health care provider right away if you have any new or worsening symptoms, including:- trouble breathing or shortness of breath
- cough with or without mucus
- chest pain
- yellowing of your skin or the whites of your eyes (jaundice)
- dark or brown (tea-colored) urine
- feeling very tired
- loss of appetite
- pain on the right side of your stomach area (abdomen)
- bleeding or bruising more easily than normal
- have any heart problems, including heart failure, irregular heartbeats, and QT prolongation
- have ever had a heart attack
- have a slow heartbeat (bradycardia)
- have problems with the amount of potassium, calcium, phosphorus, or magnesium in your blood
- have fever, chills, or any other signs or symptoms of infection
- have liver problems
- have any other medical conditions
- are pregnant, or plan to become pregnant. KISQALI can harm your unborn baby
- If you are able to become pregnant, your health care provider should do a pregnancy test before you start treatment with KISQALI.
- Females who are able to become pregnant and who take KISQALI should use effective birth control during treatment and for at least 3 weeks after the last dose of KISQALI.
- Talk to your health care provider about birth control methods that may be right for you during this time.
- If you become pregnant or think you are pregnant, tell your health care provider right away.
- are breastfeeding or plan to breastfeed. It is not known if KISQALI passes into your breast milk. Do not breastfeed during treatment with KISQALI and for at least 3 weeks after the last dose of KISQALI
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KISQALI may cause fertility problems if you are male and take KISQALI. This may affect your ability to father a child. Talk to your health care provider if this is a concern for you.
Tell your health care provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of KISQALI. For more information, ask your health care provider or pharmacist. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. Please see accompanying full Prescribing Information. References- Yardley, Denise, A. et. al. Overall survival (OS) in patients (pts) with advanced breast cancer (ABC) with visceral metastases (Mets), including those with liver Mets, treated with ribociclib (RIB) plus endocrine therapy (ET) in the MONALEESA (ML) -3 and -7 trials. Presented at the American Society of Clinical Oncology (ASCO) meeting (Abstract #1054).
- Wang, R., Zhu, Y., Liu, X. et al. The Clinicopathological features and survival outcomes of patients with different metastatic sites in stage IV breast cancer. BMC Cancer 19, 1091 (2019).
- National Cancer Institute. Dictionary of Cancer Terms. Available at: https://www.cancer.gov/publications/dictionaries/cancer-terms/def/visceral. Accessed November 2018.
