Breast cancer is the most common cancer affecting millions worldwide. Around 2.3 million women were diagnosed with breast cancer in 2020. Of these patients, there were around 685,000 recorded deaths.1 The numbers are not improving despite having modern treatment options.
Survival rates vary widely between countries, with low- and middle-income countries generally having lower survival rates compared to high-income countries. Late-stage diagnosis, lack of early detection programs, limited diagnostic and treatment facilities, and treatment delay contribute to the low survival rates in developing countries. Younger women are disproportionately affected by breast cancer and they tend to have larger tumors, more metastatic lymph nodes, and poor overall survival.2
Endocrine therapy involves medication such as tamoxifen, aromatase inhibitors, fulvestrant, and ovarian function suppression.3 Around 30-60% of individuals diagnosed with HR+/HER2- stage II and III early breast cancer who receive endocrine therapy alone face the risk of breast cancer recurrence. The risk of recurrence is higher within three years after diagnosis.4 A significant number of these patients have limited treatment options beyond the standard chemotherapy and endocrine therapy.5
Targeted Therapy for HR+/HER2- Advanced Breast Cancer with Ribociclib.
Ribociclib is a commonly used treatment for ER-positive, HER2-negative breast cancer that requires treatment beyond surgery and radiation therapy. It is a targeted therapy used in combination with hormone (Endocrine) therapy. Ribociclib is a CDK (cyclin-dependent kinase) inhibitor, which works by blocking the activity of a protein called kinase that aids in cell growth and division.6
The efficacy and safety of Ribociclib is well established in multiple clinical trials including MONALEESA-2 study. When combined with endocrine therapy, Ribociclib is proven to significantly decrease the risk of recurrence compared to standard adjuvant endocrine therapy alone. Ribociclib has also significantly improved patient’s quality of life.7
Ribociclib improves overall survival.
Key findings from the MONALEESA-2 study have established the efficacy of Ribociclib in improving overall survival. At a median follow-up of 80 months, the median overall survival was 63.9 months with Ribociclib + Letrozole compared to 51.4 months with Letrozole. The study established statistically significant overall survival and preserved quality of life in 1L postmenopausal patients.8,12
Ribociclib provides rapid response.
Clinical studies have consistently shown that Ribociclib, in combination with hormone therapy, can start demonstrating clinical benefits, such as improved progression-free survival, as early as 8 weeks of treatment. Treatment with Ribociclib in combination with Letrozole provided a rapid response and improved progression-free survival with a reduction in tumor size after 8 weeks of treatment.9
Ribociclib is precise.
Ribociclib specifically inhibits CDK4/6, a crucial protein involved in cell growth and division. This inhibition effectively hinders cancer cell growth and metastasis.6 Selective inhibition not only targets cancer cell division but also minimizes the impact on healthy cells, potentially improving quality of life. In comparison to Abemaciclib, Ribociclib has shown better symptom-related quality of life in postmenopausal women with HR+/HER2- advanced breast cancer, particularly when used as a first-line treatment. 10 Ribociclib gives a fighting chance to millions of patients.
National Comprehensive Cancer Network® (NCCN®) now differentiates Ribociclib as the only Category 1 Preferred first-line treatment option in combination with an AI for patients with HR+/HER2- mBC.12
Conclusion
Ribociclib is a commonly used treatment option for ER-positive, HER2-negative breast cancer that requires treatment beyond surgery and radiation therapy. It is a targeted therapy known as a CDK4/6 inhibitor that shuts down certain processes that cancer cells need to divide. Ribociclib is effective, rapid, and precise making it the ideal option to treat metastatic breast cancer.
Indication: Ribociclib is prescribed for metastatic breast cancer in adults with HR-positive, HER2-negative breast cancer. It is used with either an aromatase inhibitor or fulvestrant as an initial or subsequent endocrine-based therapy for postmenopausal women and men with disease progression on endocrine therapy.11
Dosage: The recommended dose of Ribociclib is 600 mg taken once daily for 21 days followed by 7 days of treatment, completing a 28-day cycle. When used in combination with Ribociclib, the recommended dose of fulvestrant is 500 mg administered on Days 1, 15, 29, and once monthly thereafter. Pre/perimenopausal women receiving the combination therapy should also be treated with a luteinizing hormone-releasing hormone (LHRH) agonist as per clinical practice standards.11
About the Author: Dr. Vamsi is a Pharm D graduate passionate about clinical research and medical writing. Dr. Vamsi loves traveling and is a health & wellness enthusiast. He believes in good health and is keen to share his knowledge on maintaining good health through good sleep, nutritious well-balanced food, and regular methodical exercise. Click on this link to connect with Dr. Vamsi.
Editorial support was provided by Dr. Geetika Gupta. She is from a dental background with experience in developing medical content for pharmaceutical clients. Click here to connect with Dr. Geetika Gupta on LinkedIn.
References
1. Sun YS, et al. Risk Factors and Preventions of Breast Cancer. Int J Biol Sci. 2017 Nov 1;13(11):1387-1397.
2. Rivera-Franco MM, Leon-Rodriguez E. Delays in Breast Cancer Detection and Treatment in Developing Countries. Breast Cancer (Auckl). 2018 Jan 8;12.
3. Bartsch R. Ribociclib: a valuable addition to treatment options in breast cancer? ESMO Open. 2017 Aug 23;2(3):e000246.
4. Pan, H, Gray, R, Braybrooke, J, et al. 20-year risks of breast-cancer recurrence after stopping endocrine therapy at 5 years. N Engl J Med. Nov 2017;377(19):1836-1846.
5. American Cancer Society. Treatment of breast cancer stages I-III. Available at: https://www.cancer.org/cancer/breast-cancer/treatment/treatment-of-breast-cancer-by-stage/treatment-of-breast-cancer-stages-i-iii.html. Accessed on 24 May 2023.
6. How Kisqali works. Available at : https://www.us.kisqali.com/metastatic-breast-cancer/about-kisqali/how-kisqali-works/ Accessed on 24 May 2023.
7. Yardley DA, Yap YS, et al. Pooled exploratory analysis of survival in patients (pts) with HR+/HER2- advanced breast cancer (ABC) and visceral metastases (mets) treated with ribociclib (RIB) + endocrine therapy (ET) in the MONALEESA (ML) trials. Poster presented at the European Society of Medical Oncology Congress. September 9-13, 2022. Paris, France.
8. Hortobagyi GN, et al. Updated results from MONALEESA-2, a phase III trial of first-line ribociclib plus letrozole versus placebo plus letrozole in hormone receptor-positive, HER2-negative advanced breast cancer. Ann Oncol. 2018 Jul 1;29(7):1541-1547.
9. O'Shaughnessy J, et al. Ribociclib plus letrozole versus letrozole alone in patients with de novo HR+, HER2- advanced breast cancer in the randomized MONALEESA-2 trial. Breast Cancer Res Treat. 2018 Feb;168(1):127-134.
10. Rugo HS, et al. Quality of life with ribociclib versus abemaciclib as first-line treatment of HR+/HER2- advanced breast cancer: a matching-adjusted indirect comparison. Ther Adv Med Oncol. 2023 Feb 24;15:17588359231152843.
11. Kisqali Ribociclib Dosing. Available at : https://www.us.kisqali.com/metastatic-breast-cancer/ Accessed on 24 May 2023.
12. Kisqali. Available at: https://www.hcp.novartis.com/products/kisqali/metastatic-breast-cancer/ Accessed on 24 May 2023
Disclaimer: The matter published in this blog has been developed by independent medical writers from various healthcare backgrounds including members from MedWriters Alumni Network. Although great care has been taken in compiling and checking the information, the authors, Crixus Communications Pvt Ltd and its servants or agents, and sponsors shall not be responsible or in any way liable for any errors, omissions, or inaccuracies in this blog article whether arising from negligence or otherwise, however or for any consequences arising therefrom. The inclusion and exclusion of any product do not mention that the publisher advocates or rejects its use generally or in any particular field or field. For any complaints or feedback please write to [email protected]