Entinostat for the treatment of breast cancer

References

• Siegel RL, Miller KD, Jemal A. Cancer statistics, 2016. CA Cancer J Clin. 2016;66(1):7–30.
   PubMed Web of Science ®Google Scholar
• The Cancer Genome Atlas Network. Comprehensive molecular portraits of human breast tumours. Nature. 2012;490:61–70.
   PubMed Web of Science ®Google Scholar
• Coates AS, Winer EP, Goldhirsch A, et al. Tailoring therapies—improving the management of early breast cancer: St Gallen international expert consensus on the primary therapy of early breast cancer 2015. Ann Oncol. 2015;26:1533–1546.
   PubMed Web of Science ®Google Scholar
• Senkus E, Kyriakides E, Ohno S, et al. Primary breast cancer: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2015;26:v8–v30.
   PubMed Web of Science ®Google Scholar
• Venkatesan S. Tumor evolutionary principles: how intratumor heterogeneity influences cancer treatment and outcome. Am Soc Clin Oncol Educ Book. 2016;35:e141–9.
   Google Scholar
• Burrel AR, McGranah N, Bartek J, et al. The causes and consequences of genetic heterogeneity in cancer evolution. Nature. 2013;501:338–345. .
   PubMed Web of Science ®Google Scholar
• Goelz SE, Vogelstein B, Hamilton SR, et al. Hypomethylation of DNA from benign and malignant human colon neoplasms. Science. 1985;228:187–190.
   PubMed Web of Science ®Google Scholar
• Esteller M, Corn PG, Baylin SB, et al. A gene hypermethylation profile of human cancer. Cancer Res. 2001.61:3225–3229.
   PubMed Web of Science ®Google Scholar
• Esteller M. Cancer epigenomics: DNA methylomes and histone-modification maps. Nat Rev Genet. 2007;8:286–298.
   PubMed Web of Science ®Google Scholar
• Zwergel C, Stazi G, Valente S, et al. Histone deacetylase inhibitors: updated studies in various epigenetic-related diseases. J Clin Epigenet. 2016;2:1.
   Google Scholar
• Verdin E, Ott M. 50 years of protein acetylation: from gene regulation to epigenetics, metabolism and beyond. Nat Rev Mol Biol. 2014;16:258–264.
   PubMed Web of Science ®Google Scholar
• Hess-Stumpp H. Histone deacetylase inhibitors and cancer: from cell biology to the clinic. Eur J Cell Biol. 2005;84:109–121.
   PubMed Web of Science ®Google Scholar
• Oronsky B, Oronsky N, Knox S, et al. Episensitization: therapeutic tumor resensitization by epigenetic agents: a review and reassessment. Anticancer Agents Med Chem. 2014;14:1121–1127.
   PubMed Web of Science ®Google Scholar
• Saito A, Yamashita T, Mariko Y, et al. A synthetic inhibitor of histone deacetylase, MS-27-275, with marked in vivo antitumor activity against human tumors. Proc Natl Acad Sci U S A. 1999;96:4592–4597.
   PubMed Web of Science ®Google Scholar
• Sausville EA, Alley MC, Pacula-Cox CM, et al. Pharmacologic evaluations of MS-275 (NSC706995), a novel benzamide structure with a unique spectrum of antitumor activity. Proc Am Assoc Cancer Res. 2001;42:927.
   Google Scholar
• Ryan QC, Headlee D, Acharya M, et al. Phase I and pharmacokinetic study of MS-275, a histone deacetylase inhibitor, in patients with advanced and refractory solid tumors or lymphoma. J Clin Oncol. 2005 Jun 10;23:3912–3922.
   PubMed Web of Science ®Google Scholar
• Hooker JM, Kim SW, Alexoff D, et al. Histone deacetylase inhibitor, MS-275, exhibits poor brain penetration: PK studies of [C]MS-275 using positron emission tomography. ACS Chem Neurosci. 2010;1:65–73.
   PubMed Web of Science ®Google Scholar
• Batlevi CL, Kasamon Y, Bociek RG, et al. ENGAGE- 501: phase II study of entinostat (SNDX-275) in relapsed and refractory Hodgkin lymphoma. Haematologica. 2016;101:968–975.
   PubMed Web of Science ®Google Scholar
• Yang X, Phillips DL, Ferguson AT, et al. Synergistic activation of functional estrogen receptor (ER)-alpha by DNA methyltransferase and histone deacetylase inhibition in human ER-alpha-negative breast cancer cells. Cancer Res. 2001;61:7025–7029.
   PubMed Web of Science ®Google Scholar
• Sabnis JG, Goloubeva O, Chumsri S, et al. Functional activation of the estrogen receptor-α and aromatase by the HDAC inhibitor, entinostat, sensitizes of ER-negative tumors to letrozole. Cancer Res. 2011 March 1;71:1893–1903.
   PubMed Web of Science ®Google Scholar
• Heldring N, Nilsson M, Buehrer B, et al. Identification of tamoxifen-induced co-regulator interaction surfaces within the ligand-binding domain of estrogen receptors. Mol Cell Biol. 2004;24:3445–3459.
   PubMed Web of Science ®Google Scholar
• Légaré S, Basik M. Minireview: the link between ERα corepressors and histone deacetylases in tamoxifen resistance in breast cancer. Mol Endocrinol. 2016 Sep;30:965–976.
   PubMed Web of Science ®Google Scholar
• Yardley DA, Ismail-Khan RR, Melichar B, et al. Randomized phase ii, double- blind, placebo-controlled study of exemestane with or without entinostat in postmenopausal women with locally recurrent or metastatic estrogen receptor-positive breast cancer progressing on treatment with a nonsteroidal aromatase inhibitor. J Clin Oncol. 2013 Jun 10;31:2128–2135.
   PubMed Web of Science ®Google Scholar
• Perez EA. Treatment strategies for advanced hormone receptor-positive and human epidermal growth factor 2-negative breast cancer: the role of treatment order. Drug Resist. 2016;24:13–22.
   Web of Science ®Google Scholar
• Exemestane With or Without Entinostat in Treating Patients With Recurrent Hormone Receptor-Positive Breast Cancer That is Locally Advanced or Metastatic (2014). Available from: http://clinicaltrials.gov (Identification No. NCT02115282)
   Google Scholar
• Lee J, Bartholomeusz C, Mansour O, et al. A class I histone deacetylase inhibitor, entinostat, enhances lapatinib efficacy in HER2-overexpressing breastcancer cells through FOXO3-mediated Bim1 expression. Breast Cancer ResTreat. 2014;146:259–272.
   PubMed Web of Science ®Google Scholar
• NCT01434303: https://clinicaltrials.gov/ct2/show/NCT01434303.
   Google Scholar
• Luque-Cabal M, García-Teijido P, Fernández-Pérez Y, et al. Mechanisms behind the resistance to trastuzumab in HER2Amplified breast cancer and strategies to overcome it. Clin Med Insights Oncol. 2016;10:21–30.
   PubMed Web of Science ®Google Scholar
• Azacitidine and Entinostat in Treating Patients With Recurrent Advanced Non-Small Cell Lung Cance (2006). Available from: http://clinicaltrials.gov (Identification No. NCT00387465)
   Google Scholar
• Phase 1b/2 Study of Avelumab With or Without Entinostat in Patients With Advanced Epithelial Ovarian Cancer (2016). Available from: http://clinicaltrials.gov (Identification No. NCT02915523)
   Google Scholar
• A Phase 2 Multi-Center Study of Entinostat (SNDX-275) in Patient With Relapsed or Refractory Hodgkin's Lymphoma (2009). Available from: http://clinicaltrials.gov (Identification No. NCT00866333)
   Google Scholar
• Azacitidine With or Without Entinostat in Treating Patients With Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Acute Myeloid Leukemia (2006). Available from: http://clinicaltrials.gov (Identification No. NCT00313586)
   Google Scholar
• Ross JS, Slodkowska EA, Symmans WF, et al. The HER-2 receptor and breast cancer: ten years of targeted anti-HER-2 therapy and personalized medicine. Oncologist. 2009;14:320–368.
   PubMed Web of Science ®Google Scholar
• Slamon DJ, Leyland-Jones B, Shak S, et al. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med. 2001;344:783–792.
   PubMed Web of Science ®Google Scholar
• Valabrega G, Montemurro F, Aglietta M. Trastuzumab: mechanism of action, resistance and future perspectives in HER2-overexpressing breast cancer. Ann Oncol. 2007;18(6):977–984.
   PubMed Web of Science ®Google Scholar
• Wang L, Zhang Q, Zhang J, et al. PI3K pathway mactivation results in low efficacy of both trastuzumab and lapatinib. BMC Cancer. 2011;11:248.
   PubMed Web of Science ®Google Scholar
• Huang X, Gao L, Wang S, et al. HDAC inhibitor SNDX-275 induces apoptosis in erbB2-overexpressing breast cancer cells via down-regulation of erbB3 expression. Cancer Res. 2009;69:8403–8411.
   PubMed Web of Science ®Google Scholar
• Huang X, Wang S, Lee CK, et al. HDAC inhibitor SNDX-275 enhances efficacy of trastuzumab in erbB2-overexpressing breast cancer cells and exhibits potential to overcome trastuzumab resistance. Cancer Lett. 2011 Aug 1;307:72–79.
   PubMed Web of Science ®Google Scholar
• Lim B, Murthy RK, Jackson S, et al. Open-label phase Ib study of entinostat (E), and lapatinib (L) alone, and in combination with trastuzumab (T) in patients (pts) with HER2+ metastatic (mHER2+) breast cancer after progression on trastuzumab. J Clin Oncol. 2016;34, n.15 supplement: 609.
   Google Scholar
• Lehmann BD, Bauer JA, Chen X, et al. Identification of human triple-negative breast cancer subtypes and preclinical models for selection of targeted therapies. J Clin Invest. 2011;121:2750–2767.
   PubMed Web of Science ®Google Scholar
• Masuda H, Baggerly K, Wang Y, et al. Differential response to neoadjuvant chemotherapy among 7 triple-negative breast cancer molecular subtypes. Clin Cancer Res. 2013;19(19): 5533–5540.
   PubMed Web of Science ®Google Scholar
• Blick T, Widodo E, Hugo H, et al. Epithelial mesenchymal transition traits in human breast cancer cell lines. Clin Exp Metastasis. 2008;25:629–642.
   PubMed Web of Science ®Google Scholar
• Zou D, Yoon HS, Perez D, et al. Epigenetic silencing in non-neoplastic epithelia identifies E-cadherin (CDH1) as a target for chemoprevention of lobular neoplasia 2009. J Pathol. 2009;218:265–272.
   PubMed Web of Science ®Google Scholar
• Reya T, Morrison SJ, Clarke MF, et al. Stem cells, cancer, and cancer stem cells. Nature. 2001;414:105–111.
   PubMed Web of Science ®Google Scholar
• Shah P, Gau Y, Sabnis G. Histone deacetylase inhibitor entinostat reverses epithelial to mesenchymal transition of breast cancer cells by reversing the repression of E-cadherinBreast. Cancer Res Treat. 2014;143:99–111.
   Google Scholar
• Schech A, Kazi A, Yu S, et al. Histone deacetylase inhibitor entinostat inhibits tumor-initiating cells in triple-negative breast cancer cells. Mol Cancer Ther. 2015;14:1848–1857.
   PubMed Web of Science ®Google Scholar
• Merino VF, Nguyen N, Jin K, et al. Combined treatment with epigenetic, differentiating,and chemotherapeutic agents cooperatively targetstumor-initiating cells in triple-negative breast cancer. Cancer Res. 2016 Apr 1;76:2013–2024.
   PubMed Web of Science ®Google Scholar
• Pili R, Salumbides B, Zhao M, et al. Phase I study of the histone deacetylase inhibitor entinostat in combination with 13-cis retinoic acid in patients with solid tumours. Br J Cancer. 2012;106:77–84.
   PubMed Web of Science ®Google Scholar
• Nanda R, Chow LQ, Dees EC, et al. Pembrolizumab in patients with advanced triple-negative breast cancer: phase Ib KEYNOTE-012 Study. J Clin Oncol. 2016;34(21):2460–2467.
   PubMed Web of Science ®Google Scholar
• Shankaran V, Ikeda H, Bruce AT, et al. IFNγ and lymphocytes prevent primary tumor development and shape tumor immunogenicity. Nature. 2001;410:1107–1111.
   PubMed Web of Science ®Google Scholar
• Gameiro SR, Malamas AS, Tsang KY, et al. Inhibitors of histone deacetylase 1 reverse the immune evasion phenotype to enhance T-cell mediated lysis of prostate and breast carcinoma cells. Oncotarget. 2016;7(7):7390–7402.
   PubMed Web of Science ®Google Scholar
• Yang PM, Lin PJ, Chen CC. CD1d induction in solid tumor cells by histone deacetylase inhibitors through inhibition of HDAC1/2 and activation of Sp1. Epigenetics. 2012;7:390–399.
   PubMed Web of Science ®Google Scholar
• Zheng H, Zhao W, Yan C, et al. HDAC inhibitors enhance TCell chemokine expression and augment response to PD1 immunotherapy inlung adenocarcinoma. Clin Cancer Res. 2016;22:4119–4132.
   PubMed Web of Science ®Google Scholar
• Woods DM, Sodré AL, Villagra A, et al. HDAC inhibition upregulates PD1 ligands in melanoma and augments immunotherapy with PD-1 Blockade. Cancer Immunol Res. 2015;3:1375–1385.
   PubMed Web of Science ®Google Scholar
• Tomita Y, Lee MJ, Lee S, et al. The interplay of epigenetic therapy and immunity in locally recurrent or metastatic estrogen receptor-positive breast cancer: correlative analysis of ENCORE 301, a randomized, placebo-controlled phase II trial of exemestane with or without entinostat. OncoImmunology. 2016;5:e1219008.
   Web of Science ®Google Scholar
• Haynes E, Lewis- Wambi JS. Mechanisms of endocrine resistance in breast cancer: an overview of the proposed roles of noncoding RNA. Breast Cancer Res. 2015;17:40.
   PubMed Web of Science ®Google Scholar
• NCT02437136: https://clinicaltrials.gov/ct2/show/NCT02437136?term=entinostat&rank=16
   Google Scholar
• Connolly R, Li H, Jankowitz RC, et al. Combination epigenetic therapy in advanced breast cancer with 5-azacitidine and entinostat: a phase II national cancer institute/stand up to cancer study. Clin Cancer Res. 2017;23(11):2691-2701.
   PubMed Web of Science ®Google Scholar