Trabectedin: the evidence for its place in therapy in the treatment of soft tissue sarcoma

References

• Jemal A, Siegel R, Ward E, Murray T, Xu J, Thun MJ. Cancer statistics, 2007. CA Cancer J Clin. 2007;57(1):43–66.
   PubMed Web of Science ®Google Scholar
• Lawrence W Jr, Donegan WL, Natarajan N, Mettlin C, Beart R, Winchester D. Adult soft tissue sarcomas. A pattern of care survey of the American College of Surgeons. Ann Surg. 1987;205(4):349–359.
   PubMed Web of Science ®Google Scholar
• Fletcher CD. The evolving classification of soft tissue tumours: an update based on the new WHO classification. Histopathology. 2006;48(1):3–12.
   PubMed Web of Science ®Google Scholar
• Borden EC, Baker LH, Bell RS, et al. Soft tissue sarcomas of adults: state of the translational science. Clin Cancer Res. 2003;9(6):1941–1956.
   PubMed Web of Science ®Google Scholar
• Wolf PS, Flum DR, Tanas MR, Rubin BP, Mann GN. Epithelioid sarcoma: the University of Washington experience. Am J Surg. 2008;196(3):407–412.
   PubMed Web of Science ®Google Scholar
• Brennan MF, Harrison CE. Sarcomas of soft tissue and bone. In: DeVita VT, Lawrence TS, Rosenberg SA, DePinho RA, Weinberg RA, editors. Cancer: Principles and Practice of Oncology. 5th edition. Philadelphia, PA: Lippincott Williams & Wilkinson; 1997.
   Google Scholar
• Morton DL, Tepper AK. Bone and soft tissue sarcomas. In: Holland JF, Frei E, Bast RC, Morton DL, editors. Cancer Medicine. Philadelphia, PA: Lippincott Williams & Wilkins; 1997.
   Google Scholar
• Blay JY, van Glabbeke M, Verweij J, et al. Advanced soft-tissue sarcoma: a disease that is potentially curable for a subset of patients treated with chemotherapy. Eur J Cancer. 2003;39(1):64–69.
   PubMed Web of Science ®Google Scholar
• Koea JB, Leung D, Lewis JJ, Brennan MF. Histopathologic type: an independent prognostic factor in primary soft tissue sarcoma of the extremity? Ann Surg Oncol. 2003;10(4):432–440.
   PubMed Web of Science ®Google Scholar
• Baker LH, Frank J, Fine G, et al. Combination chemotherapy using adriamycin, DTIC, cyclophosphamide, and actinomycin D for advanced soft tissue sarcomas: a randomized comparative trial. A phase III, Southwest Oncology Group Study (7613). J Clin Oncol. 1987;5(6): 851–861.
   PubMed Web of Science ®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. J Clin Oncol. 2007;25(19): 2755–2763.
   PubMed Web of Science ®Google Scholar
• Pervaiz N, Colterjohn N, Farrokhyar F, Tozer R, Figueredo A, Ghert M. A systematic meta-analysis of randomized controlled trials of adjuvant chemotherapy for localized resectable soft-tissue sarcoma. Cancer. 2008;113(3):573–581.
   PubMed Web of Science ®Google Scholar
• Judson I, Radford JA, Harris M, et al. Randomised phase II trial of pegylated liposomal doxorubicin (DOXIL/CAELYX) versus doxorubicin in the treatment of advanced or metastatic soft tissue sarcoma: a study by the EORTC Soft Tissue and Bone Sarcoma Group. Eur J Cancer. 2001;37(7):870–877.
   PubMed Web of Science ®Google Scholar
• Skubitz KM. Phase II trial of pegylated-liposomal doxorubicin (Doxil) in sarcoma. Cancer Invest. 2003;21(2):167–176.
   PubMed Web of Science ®Google Scholar
• Casper ES, Waltzman RJ, Schwartz GK, et al. Phase II trial of paclitaxel in patients with soft-tissue sarcoma. Cancer Invest. 1998;16(7):442–446.
   PubMed Web of Science ®Google Scholar
• Guan Y, Sakai R, Rinehart KL, Wang AH. Molecular and crystal structures of ecteinascidins: potent antitumor compounds from the Caribbean tunicate Ecteinascidia turbinata. J Biomol Struct Dyn. 1993;10(5):793–818.
   PubMed Web of Science ®Google Scholar
• D’Incalci M, Colombo T, Ubezio P, et al. The combination of yondelis and cisplatin is synergistic against human tumor xenografts. Eur J Cancer. 2003;39(13):1920–1926.
   PubMed Web of Science ®Google Scholar
• Pommier Y, Kohlhagen G, Bailly C, Waring M, Mazumder A, Kohn KW. DNA sequence- and structure-selective alkylation of guanine N2 in the DNA minor groove by ecteinascidin 743, a potent antitumor compound from the Caribbean tunicate Ecteinascidia turbinata. Biochemistry. 1996;35(41):13303–13309.
   PubMed Web of Science ®Google Scholar
• Gajate C, An F, Mollinedo F. Differential cytostatic and apoptotic effects of ecteinascidin-743 in cancer cells. Transcription-dependent cell cycle arrest and transcription-independent JNK and mitochondrial mediated apoptosis. J Biol Chem. 2002;277(44):41580–41589.
   PubMed Web of Science ®Google Scholar
• Delaloge S, Yovine A, Taamma A, et al. Ecteinascidin-743: a marinederived compound in advanced, pretreated sarcoma patients – preliminary evidence of activity. J Clin Oncol. 2001;19(5):1248–1255.
   PubMed Web of Science ®Google Scholar
• Yovine A, Riofrio M, Blay JY, et al. Phase II study of ecteinascidin- 743 in advanced pretreated soft tissue sarcoma patients. J Clin Oncol. 2004;22(5):890–899.
   PubMed Web of Science ®Google Scholar
• Lau L, Supko JG, Blaney S, et al. A phase I and pharmacokinetic study of ecteinascidin-743 (Yondelis) in children with refractory solid tumors. A Children’s Oncology Group study. Clin Cancer Res. 2005; 11(2 Pt 1):672–677.
   PubMed Web of Science ®Google Scholar
• Twelves C, Hoekman K, Bowman A, et al. Phase I and pharmacokinetic study of Yondelis (Ecteinascidin-743; ET-743) administered as an infusion over 1 h or 3 h every 21 days in patients with solid tumours. Eur J Cancer. 2003;39(13):1842–1851.
   PubMed Web of Science ®Google Scholar
• Villalona-Calero MA, Eckhardt SG, Weiss G, et al. A phase I and pharmacokinetic study of ecteinascidin-743 on a daily x 5 schedule in patients with solid malignancies. Clin Cancer Res. 2002;8(1):75–85.
   PubMed Web of Science ®Google Scholar
• Takahashi N, Li WW, Banerjee D, Scotto KW, Bertino JR. Sequence-dependent enhancement of cytotoxicity produced by ecteinascidin 743 (ET-743) with doxorubicin or paclitaxel in soft tissue sarcoma cells. Clin Cancer Res. 2001;7(10):3251–3257.
   PubMed Web of Science ®Google Scholar
• Blay JY, von Mehren M, Samuels BL, et al. Phase I combination study of trabectedin and doxorubicin in patients with soft-tissue sarcoma. Clin Cancer Res. 2008;14(20):6656–6662.
   PubMed Web of Science ®Google Scholar
• Demetri GD, von Mehren M, Blanke CD, et al. Efficacy and safety of imatinib mesylate in advanced gastrointestinal stromal tumors. N Engl J Med. 2002;347(7):472–480.
   PubMed Web of Science ®Google Scholar
• Messersmith WA, Jimeno A, Ettinger D, et al. Phase I trial of weekly trabectedin (ET-743) and gemcitabine in patients with advanced solid tumors. Cancer Chemother Pharmacol. 2008;63(1):181–188.
   PubMed Web of Science ®Google Scholar
• Le Cesne A, Blay JY, Judson I, et al. Phase II study of ET-743 in advanced soft tissue sarcomas: a European Organisation for the Research and Treatment of Cancer (EORTC) soft tissue and bone sarcoma group trial. J Clin Oncol. 2005;23(3):576–584.
   PubMed Web of Science ®Google Scholar
• Blay JY, Le Cesne A, Verweij J, et al. A phase II study of ET-743/ trabectedin (‘Yondelis’) for patients with advanced gastrointestinal stromal tumours. Eur J Cancer. 2004;40(9):1327–1331.
   PubMed Web of Science ®Google Scholar
• Garcia-Carbonero R, Supko JG, Manola J, et al. Phase II and pharmacokinetic study of ecteinascidin 743 in patients with progressive sarcomas of soft tissues refractory to chemotherapy. J Clin Oncol. 2004;22(8):1480–1490.
   PubMed Web of Science ®Google Scholar
• Garcia-Carbonero R, Supko JG, Maki RG, et al. Ecteinascidin-743 (ET-743) for chemotherapy-naive patients with advanced soft tissue sarcomas: multicenter phase II and pharmacokinetic study. J Clin Oncol. 2005;23(24):5484–5492.
   PubMed Web of Science ®Google Scholar
• Bramwell VH, Mouridsen HT, Santoro A, et al. Cyclophosphamide versus ifosfamide: final report of a randomized phase II trial in adult soft tissue sarcomas. Eur J Cancer. Clin Oncol. 1987;23(3):311–321.
   Web of Science ®Google Scholar
• Edmonson JH, Ryan LM, Blum RH, et al. Randomized comparison of doxorubicin alone versus ifosfamide plus doxorubicin or mitomycin, doxorubicin, and cisplatin against advanced soft tissue sarcomas. J Clin Oncol. 1993;11(7):1269–1275.
   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(7):1537–1545.
   PubMed Web of Science ®Google Scholar
• Grosso F, Dileo P, Sanfilippo R, et al. Steroid premedication markedly reduces liver and bone marrow toxicity of trabectedin in advanced sarcoma. Eur J Cancer. 2006;42(10):1484–1490.
   PubMed Web of Science ®Google Scholar
• Schoffski P, Wolter P, Clement P, et al. Trabectedin (ET-743): evaluation of its use in advanced soft-tissue sarcoma. Future Oncol. 2007;3(4):381–392.
   Google Scholar
• Medicines.org.uk. Pharma Mar SA. Available from: http://www.emc.medicines.org.uk/. Accessed March 31st, 2008.
   Google Scholar
• Hing J, Perez-Ruixo JJ, Stuyckens K, Soto-Matos A, Lopez-Lazaro L, Zannikos P. Mechanism-based pharmacokinetic/pharmacodynamic meta-analysis of trabectedin (ET-743, Yondelis) induced neutropenia. Clin Pharmacol Ther. 2008;83(1):130–143.
   PubMed Web of Science ®Google Scholar
• Fetterly GJ, Owen JS, Stuyckens K, et al. Semimechanistic pharmacokinetic/pharmacodynamic model for hepatoprotective effect of dexamethasone on transient transaminitis after trabectedin (ET-743) treatment. Cancer Chemother Pharmacol. 2008;62(1):135–147.
   Google Scholar