Ribociclib for post-menopausal women with HR+/HER2- advanced or metastatic breast cancer

References

• Cancer of the breast (Female) - cancer stat facts. [cited 2017 May 10]. Available from: https://seer.cancer.gov/statfacts/html/breast.html
   Google Scholar
• Gong Y, Liu Y, Ji P, et al. Impact of molecular subtypes on metastatic breast cancer patients: a SEER population-based study. Sci Rep. 2017;7(45411):1–10.
   PubMed Web of Science ®Google Scholar
• National Comprehensive Cancer Network clinical practice guidelines in oncology. Breast Cancer. 2017;V2 [cited 2017 May 10]. Available from: https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf
   Google Scholar
• Rugo HS, Rumble RB, Macrae E, et al. Endocrine therapy for hormone receptor-positive metastatic breast cancer: American society of clinical oncology guideline. J Clin Oncol. 2016;34(25):3069–3103.
   PubMed Web of Science ®Google Scholar
• Dawood S, Broglio K, Ensor J, et al. Survival differences among women with de novo stage IV and relapsed breast cancer. Ann Oncol. 2010;21(11):2169–2174.
   PubMed Web of Science ®Google Scholar
• Kennecke H, Yerushalmi R, Woods R, et al. Metastatic behavior of breast cancer subtypes. J Clin Oncol. 2010;28(20):3271–3277.
   PubMed Web of Science ®Google Scholar
• Giuliano M, Schiff R, Osborne CK, et al. Biological mechanisms and clinical implications of endocrine resistance in breast cancer. Breast. 2011;20(S3):S42–49.
   PubMed Web of Science ®Google Scholar
• Alberts B, Johnson A, Lewis J, et al. Molecular biology of the cell. 4th ed. New York (NY): Garland Science; 2002.
   Google Scholar
• Lange CA, Yee D. Killing the messenger: targeting loss of cell cycle control in endocrine-resistant breast cancer. Endocr Relat Cancer. 2011;18:C19–C24.
   PubMed Web of Science ®Google Scholar
• Lamb R, Lehn S, Rogerson L, et al. Cell cycle regulators cyclin D1 and CDK4/6 have estrogen receptor-dependent functions in migration and stem cell-like activity. Cell Cycle. 2013;12:2384–2394.
   PubMed Web of Science ®Google Scholar
• Sherr CJ. Cancer cell cycles. Science. 1996;274:1672–1677.
   PubMed Web of Science ®Google Scholar
• Spring L, Bardia A, Modi S. Targeting the cyclin D-cyclin-dependent kinase (CK)4/6-retinoblastoma pathway with selective CDK 4/6 inhibitors in hormone receptor-positive breast cancer: rationale, current status, and future directions. Discov Med. 2016;21(113):65–74.
   PubMed Web of Science ®Google Scholar
• Finn RS, Aleshin A, Slamon DJ. Targeting the cyclin-dependent kinases (CDK) 4/6 in estrogen receptor-positive breast cancer. Breast Cancer Res. 2016;18(1):17.
   PubMed Web of Science ®Google Scholar
• Ibrance (palbociclib). Prescribing information. [cited 2017 May 10]. Available from: http://labeling.pfizer.com/ShowLabeling.aspx?id=2191
   Google Scholar
• Eli Lilly and company [press release]. [cited 2017 May 17]. Available from: https://investor.lilly.com/releasedetail.cfm?releaseid=935735/
   Google Scholar
• Dickler MN, Tolaney SM, Rugo HS, et al. MONARCH1: results from a phase II study of abemaciclib, a CDK4 and CDK6 inhibitor, as monotherapy, in patients with HR+/HER2- breast cancer, after chemotherapy for advanced disease. J Clin Oncol. 2016;34 Abstract 510 [cited 2017 May 17]. Available from: http://meetinglibrary.asco.org/content/164546-176
   Web of Science ®Google Scholar
• Sledge GW Jr, Toi M, Neven P, et al. MONARCH 2: abemaciclib in combination with fulvestrant in women with HR+/HER2- advanced breast cancer who had progressed while receiving endocrine therapy. J Clin Oncol. 2017 Jun 3;35:2875–2884. Published online before print.
   PubMed Web of Science ®Google Scholar
• Kisqali (ribociclib) prescribing information. [cited 2017 May 10]. Available from: https://www.pharma.us.novartis.com/sites/www.pharma.us.novartis.com/files/kisqali.pdf
   Google Scholar
• Patnaik A, Rosen LS, Tolaney SM, et al. Efficacy and safety of abemaciclib, an inhibitor of CDK 4 and CDK6, for patients with breast cancer, non-small cell lung cancer, and other solid tumors. Cancer Discov. 2016;6(7):740–753.
   PubMed Web of Science ®Google Scholar
• National Center for Biotechnology Information. PubChem compound database; CID=44631912. [cited 2017 May 17]. Available from: https://pubchem.ncbi.nlm.nih.gov/compund/44631912
   Google Scholar
• U.S. Food and drug administration, Center for drug evaluation and research. Kisqali (ribociclib) NDA 209092 chemistry review. 2017 Feb 18.
   Google Scholar
• Kim S, Loo A, Chopra R, et al. Abstract PR02: LEE011: an orally bioavailable, selective small molecule inhibitor of CDK4/6– Reactivating Rb in cancer. Am Assoc Cancer Res. 2013;12:PR02–PR02.
   Google Scholar
• O’Leary B, Finn RS, Turner NC. Treating cancer with selective CDK4/6 inhibitors. Nat Rev Clin Oncol. 2016;13(7):417–430.
   PubMed Web of Science ®Google Scholar
• O’Brien NA, Tomaso ED, Ayala R, et al. In vivo efficacy of combined targeting of CDK4/6, ER and PI3K signaling in ER+ breast cancer. Cancer Res. 2014;74(19 Suppl):4756. abstract.
   Web of Science ®Google Scholar
• Hortobagyi GN, Stemmer SM, Burris HA, et al. Ribociclib as first-line therapy for HR-positive, advanced breast cancer. N Engl J Med. 2016;375:1738–1748.
   PubMed Web of Science ®Google Scholar
• Infante JR, Cassier PA, Gerecitano JF, et al. A phase I study of the cyclin-dependent kinase 4/6 inhibitor ribociclib (LEE011) in patients with advanced solid tumors and lymphomas. Clin Cancer Res. 2016;22(23):5696–5705.
   PubMed Web of Science ®Google Scholar
• Curigliano C, Gomez Pardo P, Meric-Bernstam F, et al. Ribociclib plus letrozole in early breast cancer: a presurgical, window-of-opportunity study. Breast. 2016;28:191–198.
   PubMed Web of Science ®Google Scholar
• Hortobagyi GN, Stemmer SM, Burris HA, et al. Updated results from MONALEESA-2, a phase 3 trial of first-line ribociclib + letrozole in hormone receptor-positive (HR+), HER2-negative (HER2-), advanced breast cancer (ABC). J Clin Oncol. 2017;35(suppl;abstr 1038).
   Google Scholar
• Burris HA, Chan A, Campone M. et al. First-line ribociclib + letrozole in patients with HR+, HER2- advanced breast cancer (ABC) presenting with visceral metastases or bone-only disease: a subgroup analysis of the MONALEESA-2 trial. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium. San Antonio (TX): AACR; 2016 Dec 6–10. Cancer Res. 2017;77(4Suppl):Abstract nr P4-22-16.
   Google Scholar
• Sonke GS, Hart LL, Campone M, et al. Efficacy and safety of ribociclib (LEE011) + letrozole in elderly patients with hormone receptor-positive (HR+), HER2-negative (HER2˗) advanced breast cancer (ABC) in MONALEESA-2. Abstract presented at: 2017 European Cancer Congress; 2017 Jan 27–30; Amsterdam. Abstract 2LBA.
   Google Scholar
• Andre F, Stemmer SM, Campone M, et al. Abstract CT045: ribociclib + letrozole for first-line treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC): efficacy by baseline tumor markers. Cancer Res. 2017;77(13 Supplement):CT045.
   Web of Science ®Google Scholar
• Malumbres M, Sotillo R, Santamaría D, et al. Mammalian cells cycle without the D-type cyclin-dependent kinases CDK4 and CDK6. Cell. 2004;118:493–504.
   PubMed Web of Science ®Google Scholar
• Schwartz GK, LoRusso PM, Dickson MA, et al. Phase I study of PD 0332991, a cyclin-dependent kinase inhibitor, administered in 3-week cycles (Schedule 2/1). Br J Cancer. 2011;104:1862–1868.
   PubMed Web of Science ®Google Scholar
• Asghar U, Witkiewicz AK, Turner NC, et al. The history and future of targeting cyclin-dependent kinases in cancer therapy. Nat Rev Drug Discov. 2015;14:130–146.
   PubMed Web of Science ®Google Scholar
• Hu W, Sung T, Jessen BA, et al. Mechanistic investigation of bone marrow suppression associated with palbociclib and its differentiation from cytotoxic chemotherapies. Clin Cancer Res. 2016;22:2000–2008.
   PubMed Web of Science ®Google Scholar
• U.S. Food and drug administration, Center for drug evaluation and research. Kisqali (ribociclib) multi-discipline review. 2017 Mar 15.
   Google Scholar
• Novartis pharmaceuticals corporation [press release]. [cited 2017 May 17]. Available from: https://www.novartis.com/news/media-releases/novartis-lee011-ribociclib-granted-fda-priority-review-first-line-treatment
   Google Scholar