Abemaciclib for the treatment of HR+/HER2- breast cancer

References

• American Cancer Society. Cancer facts & figures 2016. Atlanta (GA): American Cancer Society; 2016. Available from: https://www.cancer.org/research/cancer-facts-statistics/all-cancer-facts-figures/cancer-facts-figures-2016.html
   Google Scholar
• Lobbezoo DJ, van Kampen RJ, Voogd AC, et al. Prognosis of metastatic breast cancer subtypes: the hormone receptor/HER2-positive subtype is associated with the most favorable outcome. Breast Cancer Res Treat. 2013;141(3):507–514.
   PubMed Web of Science ®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
• Witkiewicz AK, Knudsen ES. Retinoblastoma tumor suppressor pathway in breast cancer: prognosis, precision medicine, and therapeutic interventions. Breast Cancer Res. 2014;16(3):207.
   PubMed Web of Science ®Google Scholar
• Thangavel C, Dean JL, Ertel A, et al. Therapeutically activating RB: reestablishing cell cycle control in endocrine therapy-resistant breast cancer. Endocr Relat Cancer. 2011;18(3):333–345.
   PubMed Web of Science ®Google Scholar
• Weinberg RA. The retinoblastoma protein and cell cycle control. Cell. 1995;81(3):323–330.
   PubMed Web of Science ®Google Scholar
• Finn RS, Crown JP, Lang I, et al. The cyclin-dependent kinase 4/6 inhibitor palbociclib in combination with letrozole versus letrozole alone as first-line treatment of oestrogen receptor-positive, HER2-negative, advanced breast cancer (PALOMA-1/TRIO-18): a randomised phase 2 study. Lancet Oncol. 2015;16(1):25–35.
   PubMed Web of Science ®Google Scholar
• Cristofanilli M, Turner NC, Bondarenko I, et al. Fulvestrant plus palbociclib versus fulvestrant plus placebo for treatment of hormone-receptor-positive, HER2-negative metastatic breast cancer that progressed on previous endocrine therapy (PALOMA-3): final analysis of the multicentre, double-blind, phase 3 randomised controlled trial. Lancet Oncol. 2016;17(4):425–439.
   PubMed Web of Science ®Google Scholar
• Finn RS, Martin M, Rugo HS, et al. Palbociclib and letrozole in advanced breast cancer. N Engl J Med. 2016;375(20):1925–1936.
   PubMed Web of Science ®Google Scholar
• O’Brien NA, Di Tomaso E, Ayala R, et al. In vivo efficacy of combined targeting of CDK4/6, ER and PI3K signaling in ER+ breast cancer. [abstract]. Proceedings of the 105th Annual Meeting of the American Association for Cancer Research; 2014 Apr 5-9; San Diego, CA: AACR; Cancer Res. 2014;74(19Suppl): Abstractnr 4756.
   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(18):1738–1748.
   PubMed Web of Science ®Google Scholar
• Tripathy D, Sohn J, Im S-A, et al. First-line ribociclib vs placebo with goserelin and tamoxifen or a non-steroidal aromatase inhibitor in premenopausal women with hormone receptor-positive, HER2-negative advanced breast cancer: results from the randomized phase III MONALEESA-7 trial [abstract]. San Antonio Breast Cancer Symposium; 2017; San Antonio, TX. Abstract GS2–05: Available from: http://www.abstracts2view.com/sabcs/view.php?nu=SABCS17L_828&terms=
   Google Scholar
• Study of efficacy and safety of LEE011 in men and postmenopausal women with advanced breast cancer. (MONALEESA-3). Clinicaltrials.gov. Available from: https://clinicaltrials.gov/ct2/show/NCT02422615
   Google Scholar
• Chen P, Lee NV, Hu W, et al. Spectrum and degree of CDK drug interactions predicts clinical performance. Mol Cancer Ther. 2016 Oct;15(10):2273–2281.
   PubMed Web of Science ®Google Scholar
• Sahebjam S, Rhun EL, Kulanthaivel P, et al. Assessment of concentrations of abemaciclib and its major active metabolites in plasma, CSF, and brain tumor tissue in patients with brain metastases secondary to hormone receptor positive (HR+) breast cancer. J Clin Oncol. 2016;34:suppl; abstr 526.
   Web of Science ®Google Scholar
• Markey MP, Angus SP, Strobeck MW, et al. Unbiased analysis of RB-mediated transcriptional repression identifies novel targets and distinctions from E2F action. Cancer Res.2002 Nov 15;62:6587–6597.
   PubMed Web of Science ®Google Scholar
• Tate SC, Cai S, Ajamie RT, et al. Semi-mechanistic pharmacokinetic/pharmacodynamic modeling of the antitumor activity of LY2835219, a new cyclin-dependent kinase 4/6 inhibitor, in mice bearing human tumor xenografts. Clin Cancer Res. 2014;20(14):3763–3774.
   PubMed Web of Science ®Google Scholar
• Gelbert LM, Cai S, Lin X, et al. Preclinical characterization of the CDK4/6 inhibitor LY2835219: in-vivo cell cycle-dependent/independent anti-tumor activities alone/in combination with gemcitabine. Invest New Drugs. 2014;32(5):825–837.
   PubMed Web of Science ®Google Scholar
• Abemaciclib: PubChem. [ updated 2017 Dec 30]. Available from: https://pubchem.ncbi.nlm.nih.gov/compound/46220502
   Google Scholar
• Patnaik A, Rosen LS, Tolaney SM, et al. Efficacy and safety of abemaciclib, an inhibitor of CDK4 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
• Fujiwara Y, Tamura K, Kondo S, et al. Phase 1 study of abemaciclib, an inhibitor of CDK 4 and 6, as a single agent for Japanese patients with advanced cancer. Cancer Chemother Pharmacol. 2016;78(2):281–288.
   PubMed Web of Science ®Google Scholar
• Tolaney SM, Beeram M, Beck JT, et al. A phase Ib study of abemaciclib with therapies for metastatic breast cancer [abstract]. J Clin Oncol. 2015;33(15Suppl):Abstract522.
   Google Scholar
• Dickler MN, Tolaney SM, Rugo HS, et al. MONARCH 1, a phase II study of abemaciclib, a CDK4 and CDK6 inhibitor, as a single agent, in patients with refractory HR(+)/HER2(-) metastatic breast cancer. Clin Cancer Res. 2017;23(17):5218–5224.
   PubMed Web of Science ®Google Scholar
• A neoadjuvant study of abemaciclib (LY2835219) in postmenopausal women with hormone receptor positive, HER2 negative breast cancer (neoMONARCH). ClinicalTrials.gov. Available from: https://clinicaltrials.gov/ct2/show/NCT02441946
   Google Scholar
• A study of abemaciclib (LY2835219) in participants with breast cancer, non-small cell lung cancer, or melanoma that has spread to the brain. ClinicalTrials.gov. Available from: https://clinicaltrials.gov/ct2/show/NCT02308020
   Google Scholar
• Tolaney SM, Lin NU, Thornton D, et al. Abemaciclib for the treatment of brain metastases (BM) secondary to hormone receptor positive (HR+), HER2 negative breast cancer. J Clin Oncol. 2017;35:suppl; abstr 1019.
   PubMed Web of Science ®Google Scholar
• Goel S, Wang Q, Watt AC, et al. Overcoming therapeutic resistance in HER2-positive breast cancers with CDK4/6 inhibitors. Cancer Cell. 2016;29(3):255–269.
   PubMed Web of Science ®Google Scholar
• A study of abemaciclib (LY2835219) in women with HR+, HER2+ locally advanced or metastatic breast cancer (monarcHER). ClinicalTrials.gov. Available from: https://clinicaltrials.gov/ct2/show/NCT02675231
   Google Scholar
• Abemaciclib for patients with retinoblastoma-positive, triple negative metastatic breast cancer. ClinicalTrials.gov. Available from: https://clinicaltrials.gov/ct2/show/NCT03130439
   Google Scholar
• Randomized short-term pre-surgical study to assess the effects of abemaciclib (LY2835219) in early breast cancer patients (ABC-POP). ClinicalTrials.gov. Available from: https://clinicaltrials.gov/ct2/show/NCT02831530?term=NCT02831530&rank=1
   Google Scholar
• A study of abemaciclib (LY2835219) plus tamoxifen or abemaciclib alone in women with metastatic breast cancer (nextMONARCH 1). ClinicalTrials.gov. Available from: https://clinicaltrials.gov/ct2/show/NCT02747004?term=NCT02747004&rank=1
   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;35(25):2875–2884.
   PubMed Web of Science ®Google Scholar
• Goetz MP, Toi M, Campone M, et al. MONARCH 3: abemaciclib as initial therapy for advanced breast cancer. J Clin Oncol. 2017;35(32):3638–3646.
   PubMed Web of Science ®Google Scholar
• Endocrine therapy with or without abemaciclib (LY2835219) following surgery in participants with breast cancer (monarchE). ClinicalTrials.gov. Available from: https://clinicaltrials.gov/ct2/show/NCT03155997
   Google Scholar
• A study of abemaciclib (LY2835219) in participants with breast cancer (MONARCH plus). ClinicalTrials.gov. Available from: https://clinicaltrials.gov/ct2/show/NCT02763566
   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(8):2000–2008.
   PubMed Web of Science ®Google Scholar
• Griggs JJ, Wolff AC. Cyclin-dependent kinase 4/6 inhibitors in the treatment of breast cancer: more breakthroughs and an embarrassment of riches. J Clin Oncol. 2017;35(25):2857–2859.
   PubMed Web of Science ®Google Scholar
• Goetz M, O’Shaughnessy J, Sledge G Jr, et al. The benefit of abemaciclib in prognostic subgroups: an exploratory analysis of combined data from the MONARCH 2 and 3 studies [abstract]. San Antonio Breast Cancer Symposium; 2017; San Antonio, TX. Abstract GS6–02.
   Google Scholar
• Fribbens C, O’Leary B, Kilburn L, et al. Plasma ESR1 mutations and the treatment of estrogen receptor-positive advanced breast cancer. J Clin Oncol. 2016;34(25):2961–2968.
   PubMed Web of Science ®Google Scholar
• Lauring J, Wolff AC. Evolving role of the estrogen receptor as a predictive biomarker: ESR1 mutational status and endocrine resistance in breast cancer. J Clin Oncol. 2016;34(25):2950–2952.
   PubMed Web of Science ®Google Scholar
• Formisano L, Lu Y, Jansen V, et al. Gain-of-function kinase library screen identifies FGFR1 amplification as a mechanism of resistance to antiestrogens and CDK4/6 inhibitors in ER+ breast cancer [abstract]. San Antonio Breast Cancer Symposium, 2017; San Antonio, TX. Abstract GS6–05.
   Google Scholar
• Vora SR, Juric D, Kim N, et al. CDK 4/6 inhibitors sensitize PIK3CA mutant breast cancer to PI3K inhibitors. Cancer Cell. 2014;26(1):136–149.
   PubMed Web of Science ®Google Scholar
• Goel S, DeCristo MJ, Watt AC, et al. CDK4/6 inhibition triggers anti-tumour immunity. Nature. 2017;548(7668):471–475.
   PubMed Web of Science ®Google Scholar
• Rugo HS, Kabos P, Dickler MN, et al. A phase 1b study of abemaciclib plus pembrolizumab for patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (MBC) [abstract]. San Antonio Breast Cancer Symposium; 2017; San Antonio, TX. Abstract P1-09–01
   Google Scholar
• Cortes J, Im SA, Holgado E, et al. The next era of treatment for hormone receptor-positive, HER2-negative advanced breast cancer: triplet combination-based endocrine therapies. Cancer Treat Rev. 2017;61:53–60.
   PubMed Web of Science ®Google Scholar