Safety in Japanese Advanced Breast Cancer Patients Who Received Abemaciclib in MONARCH 2 and MONARCH 3: Assessment of Treatment-Emergent Neutropenia, Diarrhea, and Increased Alanine Aminotransferase and Aspartate Aminotransferase Levels

References

• Saika K, Sobue T. Epidemiology of breast cancer in Japan and the US. JMAJ. 2009;52(1):39–44.
   Google Scholar
• Mizukoshi MM, Hossian SZ, Poulos A. Comparative analysis of breast cancer incidence rates between Australia and Japan: screening target implications. Asian Pac J Cancer Prev. 2020;21(7):2123–2129. doi:10.31557/APJCP.2020.21.7.2123
   PubMedGoogle Scholar
• Cancer Today. Japan fact sheet - Globocan. International Agency for Research on Cancer; 2020. Available from: https://gco.iarc.fr/today/data/factsheets/populations/392-japan-fact-sheets.pdf. Accessed July 19, 2021.
   Google Scholar
• Kohler BA, Sherman RL, Howlader N, et al. Annual report to the nation on the status of cancer, 1975–2011, featuring incidence of breast cancer subtypes by race/ethnicity, poverty, and state. J Natl Cancer Inst. 2015;107(6):djv048. doi:10.1093/jnci/djv048
   PubMed Web of Science ®Google Scholar
• Nagaraj G, Ma CX. Clinical challenges in the management of hormone receptor-positive, human epidermal growth factor receptor 2-negative metastatic breast cancer: a literature review. Adv Ther. 2021;38(1):109–136. doi:10.1007/s12325-020-01552-2
   PubMed Web of Science ®Google Scholar
• Cardoso F, Paluch-Shimon S, Senkus E, et al. 5th ESO-ESMO international consensus guidelines for advanced breast cancer (ABC 5). Ann Oncol. 2020;31(12):1623–1649. doi:10.1016/j.annonc.2020.09.010
   PubMed Web of Science ®Google Scholar
• Martin M, Garcia-Saenz JA, Manso L, et al. Abemaciclib, a CDK4 and CDK6 inhibitor for the treatment of metastatic breast cancer. Future Oncol. 2020;16(33):2763–2778. doi:10.2217/fon-2020-0604
   PubMed 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;35(25):2875–2884. doi:10.1200/JCO.2017.73.7585
   PubMed Web of Science ®Google Scholar
• Sledge GW Jr., Toi M, Neven P, et al. The effect of abemaciclib plus fulvestrant on overall survival in hormone receptor-positive, ERBB2-negative breast cancer that progressed on endocrine therapy-MONARCH 2: a randomized clinical trial. JAMA Oncol. 2020;6(1):116–124. doi:10.1001/jamaoncol.2019.4782
   PubMed Web of Science ®Google Scholar
• Johnston S, Martin M, Di Leo A, et al. MONARCH 3 final PFS: a randomized study of abemaciclib as initial therapy for advanced breast cancer. NPJ Breast Cancer. 2019;5:5. doi:10.1038/s41523-018-0097-z
   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. doi:10.1200/JCO.2017.75.6155
   PubMed Web of Science ®Google Scholar
• Goetz MP, Martin M, Tokunaga E, et al. Health-related quality of life in MONARCH 3: abemaciclib plus an aromatase inhibitor as initial therapy in HR+, HER2- advanced breast cancer. Oncologist. 2020;25(9):e1346–e1354. doi:10.1634/theoncologist.2020-0084
   PubMed Web of Science ®Google Scholar
• Rugo HS, Huober J, Garcia-Saenz JA, et al. Management of abemaciclib-associated adverse events in patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: safety analysis of MONARCH 2 and MONARCH 3. Oncologist. 2021;26(1):e53–e65. doi:10.1002/onco.13531
   PubMed Web of Science ®Google Scholar
• Takahashi M, Tokunaga E, Mori J, et al. Japanese subgroup analysis of the phase 3 MONARCH 3 study of abemaciclib as initial therapy for patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer. Breast Cancer. 2022;29(1):174–184. doi:10.1007/s12282-021-01295-0
   PubMed Web of Science ®Google Scholar
• Inoue K, Masuda N, Iwata H, et al. Japanese subpopulation analysis of MONARCH 2: phase 3 study of abemaciclib plus fulvestrant for treatment of hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer that progressed on endocrine therapy. Breast Cancer. 2021;28(5):1038–1050. doi:10.1007/s12282-021-01239-8
   PubMed Web of Science ®Google Scholar
• Eisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009;45(2):228–247. doi:10.1016/j.ejca.2008.10.026
   PubMed Web of Science ®Google Scholar
• Roberto M, Astone A, Botticelli A, et al. CDK4/6 inhibitor treatments in patients with hormone receptor positive, Her2 negative advanced breast cancer: potential molecular mechanisms, clinical implications and future perspectives. Cancers. 2021;13(2):322. doi:10.3390/cancers13020332
   PubMed Web of Science ®Google Scholar
• Onesti CE, Jerusalem G. CDK4/6 inhibitors in breast cancer: differences in toxicity profiles and impact on agent choice. A systematic review and meta-analysis. Expert Rev Anticancer Ther. 2021;21(3):283–298. doi:10.1080/14737140.2021.1852934
   PubMed Web of Science ®Google Scholar
• George MA, Qureshi S, Omene C, Toppmeyer DL, Ganesan S. Clinical and pharmacologic differences of CDK4/6 inhibitors in breast cancer. Front Oncol. 2021;11:693104. doi:10.3389/fonc.2021.693104
   PubMed Web of Science ®Google Scholar
• Ettl J. Management of adverse events due to cyclin-dependent kinase 4/6 inhibitors. Breast Care. 2019;14(2):86–92. doi:10.1159/000499534
   PubMed Web of Science ®Google Scholar
• Kikuchi M, Tanaka Y, Yokota M, et al. Analysis of the selection of CDK4/6 inhibitors based on experience using palbociclib. Biomed Rep. 2019;11(6):253–256. doi:10.3892/br.2019.1248
   PubMed Web of Science ®Google Scholar
• Chen Y, Noma S, Taguchi Y, et al. Characteristics of interstitial lung disease in patients from post-marketing data on metastatic breast cancer patients who received abemaciclib in Japan. Breast Cancer. 2021;28(3):710–719. doi:10.1007/s12282-020-01207-8
   PubMed Web of Science ®Google Scholar
• Yap YS, Lu YS, Tamura K, et al. Insights into breast cancer in the East vs the West: a review. JAMA Oncol. 2019;5(10):1489–1496. doi:10.1001/jamaoncol.2019.0620
   PubMed Web of Science ®Google Scholar
• Yap YS, Chiu J, Ito Y, et al. Ribociclib, a CDK 4/6 inhibitor, plus endocrine therapy in Asian women with advanced breast cancer. Cancer Sci. 2020;111(9):3313–3326. doi:10.1111/cas.14554
   PubMed Web of Science ®Google Scholar
• Warth B, Raffeiner P, Granados A, et al. Metabolomics reveals that dietary xenoestrogens alter cellular metabolism induced by palbociclib/letrozole combination cancer therapy. Cell Chem Biol. 2018;25(3):291–300.e3. doi:10.1016/j.chembiol.2017.12.010
   PubMed Web of Science ®Google Scholar
• Roncato R, Angelini J, Pani A, et al. CDK4/6 inhibitors in breast cancer treatment: potential interactions with drug, gene, and pathophysiological conditions. Int J Mol Sci. 2020;21(17):6350. doi:10.3390/ijms21176350
   PubMed Web of Science ®Google Scholar
• Lin CH, Yap YS, Lee KH, et al. Contrasting epidemiology and clinicopathology of female breast cancer in Asians vs the US population. J Natl Cancer Inst. 2019;111(12):1298–1306. doi:10.1093/jnci/djz090
   PubMedGoogle Scholar
• Lee KWC, Lord S, Finn RS, et al. The impact of ethnicity on efficacy and toxicity of cyclin D kinase 4/6 inhibitors in advanced breast cancer: a meta-analysis. Breast Cancer Res Treat. 2019;174(1):271–278. doi:10.1007/s10549-018-5054-x
   PubMed Web of Science ®Google Scholar
• Kan Z, Ding Y, Kim J, et al. Multi-omics profiling of younger Asian breast cancers reveals distinctive molecular signatures. Nat Commun. 2018;9(1):1725. doi:10.1038/s41467-018-04129-4
   PubMed Web of Science ®Google Scholar
• Deng J, Wang ES, Jenkins RW, et al. CDK4/6 inhibition augments antitumor immunity by enhancing T-cell activation. Cancer Discov. 2018;8(2):216–233. doi:10.1158/2159-8290.CD-17-0915
   PubMed Web of Science ®Google Scholar
• Pala L, Conforti F, Goldhirsch A. Ethnicity-based differences in breast cancer features and responsiveness to CDK4/6 inhibitors combined with endocrine therapy. Lancet Oncol. 2020;21(3):e130. doi:10.1016/S1470-2045(20)30072-3
   PubMedGoogle Scholar