Clinical efficacy of eribulin mesylate for the treatment of metastatic soft tissue sarcoma

References

• Schöffski P, Chawla S, Maki RG, et al. Eribulin versus dacarbazine in previously treated patients with advanced liposarcoma or leiomyosarcoma: a randomised, open-label, multicentre, phase 3 trial. Lancet Lond Engl. 2016;387:1629–1637.
   PubMed Web of Science ®Google Scholar
• Jo VY, Fletcher CDM. WHO classification of soft tissue tumours: an update based on the 2013 (4th) edition. Pathology. 2014;46:95–104.
   PubMed Web of Science ®Google Scholar
• Schöffski P, Cornillie J, Wozniak A, et al. Soft tissue sarcoma: an update on systemic treatment options for patients with advanced disease. Oncol Res Treat. 2014;37:355–362.
   PubMedGoogle Scholar
• Stiller CA, Trama A, Serraino D, et al. Descriptive epidemiology of sarcomas in Europe: report from the RARECARE project. Eur J Cancer. 2013;49:684–695.
   PubMed Web of Science ®Google Scholar
• Schöffski P, Ray-Coquard IL, Cioffi A, et al. Activity of eribulin mesylate in patients with soft-tissue sarcoma: a phase 2 study in four independent histological subtypes. Lancet Oncol. 2011;12:1045–1052.
   PubMed Web of Science ®Google Scholar
• Santoro A, Tursz T, Mouridsen H, et al. Doxorubicin versus CYVADIC versus doxorubicin plus ifosfamide in first-line treatment of advanced soft tissue sarcomas: a randomized study of the European Organization for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group. J Clin Oncol. 1995;13:1537–1545.
   PubMed Web of Science ®Google Scholar
• Pautier P, Floquet A, Penel N, et al. Randomized multicenter and stratified phase II study of gemcitabine alone versus gemcitabine and docetaxel in patients with metastatic or relapsed leiomyosarcomas: a Federation Nationale des Centres de Lutte Contre le Cancer (FNCLCC) French Sarcoma Group Study (TAXOGEM study). Oncologist. 2012;17:1213–1220.
   PubMed Web of Science ®Google Scholar
• Bramwell V, Blackstein M, Belanger K, et al. A phase II study of docetaxel in chemotherapy-naïve patients with recurrent or metastatic adult soft tissue sarcoma. Sarcoma. 1998;2:29–33.
   PubMedGoogle Scholar
• Schlemmer M, Reichardt P, Verweij J, et al. Paclitaxel in patients with advanced angiosarcomas of soft tissue: a retrospective study of the EORTC soft tissue and bone sarcoma group. Eur J Cancer. 2008;44:2433–2436.
   PubMed Web of Science ®Google Scholar
• van der Graaf WTA, Blay JY, Chawla SP, et al. Pazopanib for metastatic soft-tissue sarcoma (PALETTE): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet Lond Engl. 2012;379:1879–1886.
   PubMed Web of Science ®Google Scholar
• Mir O, Brodowicz T, Italiano A, et al. Safety and efficacy of regorafenib in patients with advanced soft tissue sarcoma (REGOSARC): a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Oncol. 2016;17:1732–1742.
   PubMed Web of Science ®Google Scholar
• HALAVEN prescribing information [Internet]. Woodcliff Lake (NJ): Eisai Inc; 2016. [cited 2017 Feb 11]. Available from: http://www.halaven.com/pdfs/HALAVEN-Full-Prescribing-Information.pdf
   Google Scholar
• Huyck TK, Gradishar W, Manuguid F, et al. Eribulin mesylate. Nat Rev Drug Discov. 2011;10:173–174.
   PubMed Web of Science ®Google Scholar
• Jackson KL, Henderson JA, Phillips AJ. The halichondrins and E7389. Chem Rev. 2009;109:3044–3079.
   PubMed Web of Science ®Google Scholar
• Towle MJ, Salvato KA, Budrow J, et al. In vitro and in vivo anticancer activities of synthetic macrocyclic ketone analogues of halichondrin B. Cancer Res. 2001;61:1013–1021.
   PubMed Web of Science ®Google Scholar
• Seletsky BM, Wang Y, Hawkins LD, et al. Structurally simplified macrolactone analogues of halichondrin B. Bioorg Med Chem Lett. 2004;14:5547–5550.
   PubMed Web of Science ®Google Scholar
• Yu MJ, Zheng W, Seletsky BM. From micrograms to grams: scale-up synthesis of eribulin mesylate. Nat Prod Rep. 2013;30:1158–1164.
   PubMed Web of Science ®Google Scholar
• Dybdal-Hargreaves NF, Risinger AL, Mooberry SL. Eribulin mesylate: mechanism of action of a unique microtubule-targeting agent. Clin Cancer Res. 2015;21:2445–2452.
   PubMed Web of Science ®Google Scholar
• Bai R, Nguyen TL, Burnett JC, et al. Interactions of halichondrin B and eribulin with tubulin. J Chem Inf Model. 2011;51:1393–1404.
   PubMed Web of Science ®Google Scholar
• Jordan MA, Kamath K, Manna T, et al. The primary antimitotic mechanism of action of the synthetic halichondrin E7389 is suppression of microtubule growth. Mol Cancer Ther. 2005;4:1086–1095.
   PubMed Web of Science ®Google Scholar
• Smith JA, Wilson L, Azarenko O, et al. Eribulin binds at microtubule ends to a single site on tubulin to suppress dynamic instability. Biochem Mosc. 2010;49:1331–1337.
   Google Scholar
• Jordan MA, Wilson L. Microtubules as a target for anticancer drugs. Nat Rev Cancer. 2004;4:253–265.
   PubMed Web of Science ®Google Scholar
• Wozniak KM, Nomoto K, Lapidus RG, et al. Comparison of neuropathy-inducing effects of eribulin mesylate, paclitaxel, and ixabepilone in mice. Cancer Res. 2011;71:3952–3962.
   PubMed Web of Science ®Google Scholar
• Agoulnik SI, Kawano S, Taylor N, et al. Eribulin mesylate exerts specific gene expression changes in pericytes and shortens pericyte-driven capillary network in vitro. Vasc Cell. 2014;6:3.
   PubMedGoogle Scholar
• Funahashi Y, Okamoto K, Adachi Y, et al. Eribulin mesylate reduces tumor microenvironment abnormality by vascular remodeling in preclinical human breast cancer models. Cancer Sci. 2014;105:1334–1342.
   PubMed Web of Science ®Google Scholar
• Tozer GM, Kanthou C, Baguley BC. Disrupting tumour blood vessels. Nat Rev Cancer. 2005;5:423–435.
   PubMed Web of Science ®Google Scholar
• Jung HY, Fattet L, Yang J. Molecular pathways: linking tumor microenvironment to epithelial-mesenchymal transition in metastasis. Clin Cancer Res. 2015;21:962–968.
   PubMed Web of Science ®Google Scholar
• Yoshida T, Ozawa Y, Kimura T, et al. Eribulin mesilate suppresses experimental metastasis of breast cancer cells by reversing phenotype from epithelial-mesenchymal transition (EMT) to mesenchymal-epithelial transition (MET) states. Br J Cancer. 2014;110:1497–1505.
   PubMed Web of Science ®Google Scholar
• Goel S, Mita AC, Mita M, et al. A phase I study of eribulin mesylate (E7389), a mechanistically novel inhibitor of microtubule dynamics, in patients with advanced solid malignancies. Clin Cancer Res. 2009;15:4207–4212.
   PubMed Web of Science ®Google Scholar
• Tan AR, Rubin EH, Walton DC, et al. Phase I study of eribulin mesylate administered once every 21 days in patients with advanced solid tumors. Clin Cancer Res. 2009;15:4213–4219.
   PubMed Web of Science ®Google Scholar
• Dubbelman A-C, Rosing H, Jansen RS, et al. Mass balance study of [14C]eribulin in patients with advanced solid tumors. Drug Metab Dispos. 2012;40:313–321.
   PubMed Web of Science ®Google Scholar
• Towle MJ, Nomoto K, Asano M, et al. Broad spectrum preclinical antitumor activity of eribulin (Halaven(R)): optimal effectiveness under intermittent dosing conditions. Anticancer Res. 2012;32:1611–1619.
   PubMed Web of Science ®Google Scholar
• Kolb EA, Gorlick R, Reynolds CP, et al. Initial testing (stage 1) of eribulin, a novel tubulin binding agent, by the pediatric preclinical testing program. Pediatr Blood Cancer. 2013;60:1325–1332.
   PubMed Web of Science ®Google Scholar
• Synold TW, Morgan RJ, Newman EM, et al. A phase I pharmacokinetic and target validation study of the novel anti-tubulin agent E7389: a California Cancer Consortium trial. J Clin Oncol. 2005;23(16_suppl):3036.
   Web of Science ®Google Scholar
• Mukohara T, Nagai S, Mukai H, et al. Eribulin mesylate in patients with refractory cancers: a phase I study. Invest New Drugs. 2012;30:1926–1933.
   PubMed Web of Science ®Google Scholar
• Kawai A, Araki N, Naito Y, et al. Phase 2 study of eribulin in patients with previously treated advanced or metastatic soft tissue sarcoma. Jpn J Clin Oncol. 2016;248–253.
   PubMed Web of Science ®Google Scholar
• ESMO/European Sarcoma Network Working Group. Soft tissue and visceral sarcomas: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2014;25(Suppl 3):iii102–iii112.
   PubMed Web of Science ®Google Scholar
• Stacchiotti S, Tortoreto M, Bozzi F, et al. Dacarbazine in solitary fibrous tumor: a case series analysis and preclinical evidence vis-a-vis temozolomide and antiangiogenics. Clin Cancer Res. 2013;19:5192–5201.
   PubMed Web of Science ®Google Scholar
• Demetri GD, von Mehren M, Jones RL, et al. Efficacy and safety of trabectedin or dacarbazine for metastatic liposarcoma or leiomyosarcoma after failure of conventional chemotherapy: results of a phase III randomized multicenter clinical trial. J Clin Oncol. 2016;34:786–793.
   PubMed Web of Science ®Google Scholar
• Wiemer EA, Wozniak A, Burger H, et al. Identification of microRNA biomarkers for response of advanced soft tissue sarcomas to eribulin: translational results of the EORTC 62052 trial. Eur J Cancer. 2017;75:33–40.
   PubMed Web of Science ®Google Scholar
• Rickles RJ, Matsui J, Zhu P, et al. Identification of combinatorial drugs that synergistically kill both eribulin-sensitive and eribulin-insensitive tumor cells. Glob J Cancer Ther. 2015;1:9–17.
   Google Scholar