Treatment options for anthracycline-resistant, advanced soft-tissue sarcoma: the role of eribulin

References

• National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Soft tissue sarcoma. Version 2.2016. Available from: https://www.nccn.org/professionals/physician_gls/pdf/sarcoma.pdf [Last accessed 2016 Sep 19]
   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.
   Google Scholar
• Casali PG, Blay JY. ESMO/CONTICANET/EUROBONET consensus panel of experts. Soft tissue sarcomas: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2010;21(Suppl 5):v198–v203.
   Google Scholar
• SEER Stat Fact Sheets: Soft tissue including heart cancer. Available from: http://seer.cancer.gov/statfacts/html/soft.html [Last accessed 30 May 2016]
   Google Scholar
• Singer S. Soft tissue sarcoma. In DeVita VT, Lawrence TS, Rosenberg SA, et al. eds. DeVita, Hellman, and Rosenberg’s cancer: principles & practice of oncology. 10th. Philadelphia, PA: Wolters Kluwer Health/Lippincott Williams & Wilkins; 2011.
   Google Scholar
• Schöffski P, Hompes D, Wozniak A, et al. Soft tissue sarcoma: the clinically relevant basics and an update on systemic therapy options for patients with advanced disease. Belg J Med Oncol. 2013;7:80–88.
   Google Scholar
• Coindre JM, Terrier P, Guillou L, et al. Predictive value of grade for metastasis development in the main histologic types of adult soft tissue sarcomas: a study of 1240 patients from the French Federation of Cancer Centers Sarcoma Group. Cancer. 2001;91:1914–1926.
   Google Scholar
• Blay JY, Sleijfer S, Schoffski P, et al. International expert opinion on patient-tailored management of soft tissue sarcomas. Eur J Cancer. 2014;50:679–689.
   Google Scholar
• Hui JY. Epidemiology and etiology of sarcomas. Surg Clin North Am. 2016;96:901–914.
   Google Scholar
• Clark MA, Fisher C, Judson I, et al. Soft-tissue sarcomas in adults. N Engl J Med. 2005;353:701–711.
   Google Scholar
• Jones RL, Fisher C, Al-Muderis O, et al. Differential sensitivity of liposarcoma subtypes to chemotherapy. Eur J Cancer. 2005;41:2853–2860.
   Google Scholar
• Patel SR, Burgess MA, Plager C, et al. Myxoid liposarcoma. Experience with chemotherapy. Cancer. 1994;74:1265–1269.
   Google Scholar
• Sleijfer S, Seynaeve C, Verweij J. Using single-agent therapy in adult patients with advanced soft tissue sarcoma can still be considered standard care. Oncologist. 2005;10:833–841.
   Google Scholar
• Skubitz KM, D’Adamo DR. Sarcoma. Mayo Clin Proc. 2007;82:1409–1432.
   Google Scholar
• Spira AI, Ettinger DS. The use of chemotherapy in soft-tissue sarcomas. Oncologist. 2002;7:348–359.
   Google Scholar
• Martin-Liberal J, Alam S, Constantinidou A, et al. Clinical activity and tolerability of a 14-day infusional ifosfamide schedule in soft-tissue sarcoma. Sarcoma. 2013;2013:868973.
   Google Scholar
• Noujaim J, Constantinidou A, Messiou C, et al. Successful ifosfamide rechallenge in soft-tissue sarcoma. Am J Clin Oncol. 2015. [Epub ahead of print].
   Google Scholar
• Sanfilippo R, Bertulli R, Marrari A, et al. High-dose continuous-infusion ifosfamide in advanced well-differentiated/dedifferentiated liposarcoma. Clin Sarcoma Res. 2014;4:16.
   Google Scholar
• Judson I, Verweij J, Gelderblom H, et al. Doxorubicin alone versus intensified doxorubicin plus ifosfamide for first-line treatment of advanced or metastatic soft-tissue sarcoma: a randomised controlled phase 3 trial. Lancet Oncol. 2014;15:415–423.
   Google Scholar
• Doxil (doxorubicin HCl liposome injection) [prescribing information]. Raritan, NJ: Ortho Biotech Products, LP; 2008.
   Google Scholar
• Ifex (ifosfamide) [prescribing information]. Deerfield, IL: Baxter Healthcare Corporation; 2012.
   Google Scholar
• Tap WD, Jones RL, van Tine BA, et al. Olaratumab and doxorubicin versus doxorubicin alone for treatment of soft-tissue sarcoma: an open-label phase 1b and randomised phase 2 trial. Lancet. 2016;388:488–497.
   Google Scholar
• Lartruvo (olaratumab) [prescribing information]. Indianapolis, IN: Eli Lilly and Company; 2017.
   Google Scholar
• Seddon B. First-line treatment in advanced or metastatic disease: one size fits all or adapted to specific histiotypes? Curr Opin Oncol. 2016;28:323–330.
   Google Scholar
• 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. 2016;387:1629–1637.
   Google Scholar
• Halaven (eribulin mesylate) injection [prescribing information]. Woodcliff Lake, NJ: Eisai Inc.; 2016.
   Google Scholar
• Halaven [summary of product characteristics]. Hertfordshire, UK: Eisai Europe Limited; 2016.
   Google Scholar
• The Pharmaceuticals and Medical Devices Agency Annual Report FY 2015 (Apr 2015 - Mar 2016). Available from: http://www.pmda.go.jp/files/000214925.pdf [Last accessed Jan 20, 2016]
   Google Scholar
• van Oosterom AT, Mouridsen HT, Nielsen OS, et al. Results of randomised studies of the EORTC Soft Tissue and Bone Sarcoma Group (STBSG) with two different ifosfamide regimens in first- and second-line chemotherapy in advanced soft tissue sarcoma patients. Eur J Cancer. 2002;38:2397–2406.
   Google Scholar
• Borden EC, Amato DA, Rosenbaum C, et al. Randomized comparison of three adriamycin regimens for metastatic soft tissue sarcomas. J Clin Oncol. 1987;5:840–850.
   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.
   Google Scholar
• Maki RG, Wathen JK, Patel SR, et al. Randomized phase II study of gemcitabine and docetaxel compared with gemcitabine alone in patients with metastatic soft tissue sarcomas: results of sarcoma alliance for research through collaboration study 002 [corrected]. J Clin Oncol. 2007;25:2755–2763.
   Google Scholar
• Garcia-Del-Muro X, Lopez-Pousa A, Maurel J, et al. Randomized phase II study comparing gemcitabine plus dacarbazine versus dacarbazine alone in patients with previously treated soft tissue sarcoma: a Spanish Group for Research on Sarcomas study. J Clin Oncol. 2011;29:2528–2533.
   Google Scholar
• van der Graaf WT, Blay JY, Chawla SP, et al. Pazopanib for metastatic soft-tissue sarcoma (PALETTE): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2012;379:1879–1886.
   Google Scholar
• Yondelis (trabectedin) [prescribing information]. Horsham, PA: Janssen Products, LP; 2016.
   Google Scholar
• Yondelis [summary of product characteristics]. Madrid, Spain: Pharma Mar, S.A..
   Google Scholar
• Sanfilippo R, Dileo P, Blay JY, et al. Trabectedin in advanced synovial sarcomas: a multicenter retrospective study from four European institutions and the Italian rare cancer network. Anticancer Drugs. 2015;26:678–681.
   Google Scholar
• Le Cesne A, Cresta S, Maki RG, et al. A retrospective analysis of antitumour activity with trabectedin in translocation-related sarcomas. Eur J Cancer. 2012;48:3036–3044.
   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.
   Google Scholar
• Schutz FA, Choueiri TK, Sternberg CN. Pazopanib: clinical development of a potent anti-angiogenic drug. Crit Rev Oncol Hematol. 2011;77:163–171.
   Google Scholar
• Sleijfer S, Ray-Coquard I, Papai Z, et al. Pazopanib, a multikinase angiogenesis inhibitor, in patients with relapsed or refractory advanced soft tissue sarcoma: a phase II study from the European Organisation for Research and Treatment of Cancer-soft tissue and bone sarcoma group (EORTC study 62043). J Clin Oncol. 2009;27:3126–3132.
   Google Scholar
• Wilhelm SM, Dumas J, Adnane L, et al. Regorafenib (BAY 73-4506): a new oral multikinase inhibitor of angiogenic, stromal and oncogenic receptor tyrosine kinases with potent preclinical antitumor activity. Int J Cancer. 2011;129:245–255.
   Google Scholar
• Stivarga (regorafenib) [prescribing information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals Inc.; 2016.
   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.
   Google Scholar
• Kuznetsov G, Towle MJ, Cheng H, et al. Induction of morphological and biochemical apoptosis following prolonged mitotic blockage by halichondrin B macrocyclic ketone analog E7389. Cancer Res. 2004;64:5760–5766.
   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.
   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.
   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. Biochemistry. 2010;49:1331–1337.
   Google Scholar
• Towle MJ, Salvato KA, Wels BF, et al. Eribulin induces irreversible mitotic blockade: implications of cell-based pharmacodynamics for in vivo efficacy under intermittent dosing conditions. Cancer Res. 2011;71:496–505.
   Google 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.
   Google Scholar
• Kawano S, Asano M, Adachi Y, et al. Antimitotic and non-mitotic effects of eribulin mesilate in soft tissue sarcoma. Anticancer Res. 2016;36:1553–1561.
   Google Scholar
• Terashima M, Sakai K, Togashi Y, et al. Synergistic antitumor effects of S-1 with eribulin in vitro and in vivo for triple-negative breast cancer cell lines. Springerplus. 2014;3:417.
   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.
   Google Scholar
• Hu J, Horwitz SB, McDaid HM. The antitumor efficacy of eribulin is mediated via suppression of invasion and profound induction of cell death in triple negative breast cancer [abstract]. Mol Cancer Ther. 2013;12(11Suppl):AbstractB165.
   Google Scholar
• Towle MJ, Nomoto K, Asano M, et al. Broad spectrum preclinical antitumor activity of eribulin (Halaven®): optimal effectiveness under intermittent dosing conditions. Anticancer Res. 2012;32:1611–1619.
   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.
   Google Scholar
• Demetri GD, Schöffski P, Grignani G, et al. Activity of eribulin in patients with advanced liposarcoma demonstrated in a subgroup analysis from a randomized phase III study of eribulin versus dacarbazine. J Clin Oncol. In press. DOI: 10.1200/JCO.2016.71.6605.
   Google Scholar
• Van Glabbeke M, Verweij J, Judson I, et al. Progression-free rate as the principal end-point for phase II trials in soft-tissue sarcomas. Eur J Cancer. 2002;38:543–549.
   Google Scholar
• Blay JY, Schöffski P, Bauer S, et al. Subgroup analysis of leiomyosarcoma patients from a phase 3, open-label, randomized study of eribulin versus dacarbazine in patients with advanced liposarcoma or leiomyosarcoma. Presented at the European Society of Medical Oncology; 2016 Oct 7–11; Copenhagen, Denmark.
   Google Scholar
• Votrient (pazopanib) [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2016.
   Google Scholar
• Votrient film-coated tablets [summary of product characteristics]. Camberley, UK: Novartis Europharm Limited.
   Google Scholar
• Cortes J, O’Shaughnessy J, Loesch D, et al. Eribulin monotherapy versus treatment of physician’s choice in patients with metastatic breast cancer (EMBRACE): a phase 3 open-label randomised study. Lancet. 2011;377:914–923.
   Google Scholar
• Kaufman PA, Awada A, Twelves C, et al. Phase III open-label randomized study of eribulin mesylate versus capecitabine in patients with locally advanced or metastatic breast cancer previously treated with an anthracycline and a taxane. J Clin Oncol. 2015;33:594–601.
   Google Scholar