The efficacy of trabectedin in treating ovarian cancer

References

• Prevention CfDCa. Ovarian cancer statistics 2015. Available from: https://www.cdc.gov/cancer/ovarian/statistics/.
   Google Scholar
• Foley OW, Rauh-Hain JA, del carmen MG. Recurrent epithelial ovarian cancer: an update on treatment. Oncology (Williston Park). 2013;27(4):288-94, 298.
   PubMed Web of Science ®Google Scholar
• Siegel R, Naishadham D, Jemal A. Cancer statistics, 2012. CA Cancer J Clin. 2012;62(1):10–29.
   PubMed Web of Science ®Google Scholar
• Alvarez RD, Matulonis UA, Herzog TJ, et al. Moving beyond the platinum sensitive/resistant paradigm for patients with recurrent ovarian cancer. Gynecol Oncol. 2016;141(3):405–409.
   PubMed Web of Science ®Google Scholar
• Alvarez RD, Karlan BY, Strauss JF. “Ovarian cancers: evolving paradigms in research and care”: report from the Institute of Medicine. Gynecol Oncol. 2016;141(3):413–415.
   PubMed Web of Science ®Google Scholar
• Cuevas C, Francesch A. Development of Yondelis (trabectedin, ET-743). A semisynthetic process solves the supply problem. Nat Prod Rep. 2009;26(3):322–337.
   PubMed Web of Science ®Google Scholar
• Larsen AK, Galmarini CM, D’Incalci M. Unique features of trabectedin mechanism of action. Cancer Chemother Pharmacol. 2016;77(4):663–671.
   PubMed Web of Science ®Google Scholar
• Administration USFaD. FDA news release: FDA approves new therapy for certain types of advanced soft tissue sarcoma. 2015. Available from: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm468832.htm.
   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 Res. 2016;34(8):786–793.
   Google Scholar
• D’Incalci M, Galmarini CM. A review of trabectedin (ET-743): a unique mechanism of action. Mol Cancer Ther. 2010;9(8):2157–2163.
   PubMed Web of Science ®Google Scholar
• Tavecchio M, Simone M, Erba E, et al. Role of homologous recombination in trabectedin-induced DNA damage. Eur J Cancer. 2008;44(4):609–618.
   PubMed Web of Science ®Google Scholar
• Takebayashi Y, Pourquier P, Zimonjic DB, et al. Antiproliferative activity of Ecteinascidin 743 is dependent upon transcription-coupled nucleotide-excision repair. Nat Med. 2001;7(8):961–966.
   PubMed Web of Science ®Google Scholar
• Damia G, Imperatori L, Stefanini M, et al. Sensitivity of CHO mutant cell lines with specific defects in nucleotide excision repair to different anti-cancer agents. Int J Cancer. 1996;66(6):779–783.
   PubMed Web of Science ®Google Scholar
• Zewail-Foote M, Li VS, Kohn H, et al. The inefficiency of incisions of Ecteinascidin 743-DNA adducts by the UvrABC nuclease and the unique structural feature of the DNA adducts can be used to explain the repair-dependent toxicities of this antitumor agent. Chem Biol. 2001;8(11):1033–1049.
   PubMedGoogle Scholar
• Colmegna B, Uboldi S, Frapolli R, et al. Increased sensitivity to platinum drugs of cancer cells with acquired resistance to trabectedin. Br J Cancer. 2015;113(12):1687–1693.
   PubMed Web of Science ®Google Scholar
• Leporini C, Patane M, Saullo F, et al. A comprehensive safety evaluation of trabectedin and drug-drug interactions of trabectedin-based combinations. BioDrugs. 2014;28(6):499–511.
   PubMed Web of Science ®Google Scholar
• Dossi R, Frapolli R, di Giandomenico S, et al. Antiangiogenic activity of trabectedin in myxoid liposarcoma: involvement of host TIMP-1 and TIMP-2 and tumor thrombospondin-1. Int J Cancer. 2015;136(3):721–729.
   PubMed Web of Science ®Google Scholar
• Germano G, Frapolli R, Simone M, et al. Antitumor and anti-inflammatory effects of trabectedin on human myxoid liposarcoma cells. Cancer Research. 2010;70(6):2235–2244.
   PubMed Web of Science ®Google Scholar
• Germano G, Frapolli R, Belgiovine C, et al. Role of macrophage targeting in the antitumor activity of trabectedin. Cancer Cell. 2013;23(2):249–262.
   PubMed Web of Science ®Google Scholar
• Allavena P, Signorelli M, Chieppa M, et al. Anti-inflammatory properties of the novel antitumor agent Yondelis (trabectedin): inhibition of macrophage differentiation and cytokine production. Cancer Research. 2005;65(7):2964–2971.
   PubMed Web of Science ®Google Scholar
• Perez-Ruixo JJ, Zannikos P, Hirankarn S, et al. Population pharmacokinetic meta-analysis of trabectedin (ET-743, Yondelis) in cancer patients. Clin Pharmacokinet. 2007;46(10):867–884.
   PubMed Web of Science ®Google Scholar
• Brandon EF, Meijerman I, Klijn JS, et al. In-vitro cytotoxicity of ET-743 (trabectedin, Yondelis), a marine anti-cancer drug, in the Hep G2 cell line: influence of cytochrome P450 and phase II inhibition, and cytochrome P450 induction. Anticancer Drugs. 2005;16(9):935–943.
   PubMed Web of Science ®Google Scholar
• Mascilini F, Amadio G, Di Stefano MG, et al. Clinical utility of trabectedin for the treatment of ovarian cancer: current evidence. Onco Targets Ther. 2014;7:1273–1284.
   PubMed Web of Science ®Google Scholar
• JanssenMD. Full prescribing information for YONDELIS® (trabectedin) 2016 [cited 2016 December 9]. Available from: https://www.janssenmd.com/pdf/yondelis/YONDELIS_PI.pdf.
   Google Scholar
• Beumer JH, Rademaker-Lakhai JM, Rosing H, et al. Metabolism of trabectedin (ET-743, Yondelis) in patients with advanced cancer. Cancer Chemother Pharmacol. 2007;59(6):825–837.
   PubMed Web of Science ®Google Scholar
• Chuk MK, Balis FM, Fox E. Trabectedin. Oncologist. 2009;14(8):794–799.
   PubMed Web of Science ®Google Scholar
• Hing J, Perez-Ruixo JJ, Stuyckens K, et al. 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
• van Kesteren C, Cvitkovic E, Taamma A, et al. Pharmacokinetics and pharmacodynamics of the novel marine-derived anticancer agent Ecteinascidin 743 in a phase I dose-finding study. Clin Cancer Res. 2000;6(12):4725–4732.
   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.
   PubMed Web of Science ®Google Scholar
• Thertulien R, Manikhas GM, Dirix LY, et al. Effect of trabectedin on the QT interval in patients with advanced solid tumor malignancies. Cancer Chemother Pharmacol. 2012;69(2):341–350.
   PubMed Web of Science ®Google Scholar
• Valoti G, Nicoletti MI, Pellegrino A, et al. Ecteinascidin-743, a new marine natural product with potent antitumor activity on human ovarian carcinoma xenografts. Clin Cancer Res. 1998;4(8):1977–1983.
   PubMed Web of Science ®Google Scholar
• Ryan DP, Supko JG, Eder JP, et al. Phase I and pharmacokinetic study of Ecteinascidin 743 administered as a 72-hour continuous intravenous infusion in patients with solid malignancies. Clin Cancer Res. 2001;7(2):231–242.
   PubMed Web of Science ®Google Scholar
• Taamma A, Misset JL, Riofrio M, et al. Phase I and pharmacokinetic study of Ecteinascidin-743, a new marine compound, administered as a 24-hour continuous infusion in patients with solid tumors. J Clin Oncol Res. 2001;19(5):1256–1265.
   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
• van Kesteren C, Twelves C, Bowman A, et al. Clinical pharmacology of the novel marine-derived anticancer agent Ecteinascidin 743 administered as a 1- and 3-h infusion in a phase I study. Anticancer Drugs. 2002;13(4):381–393.
   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
• Forouzesh B, Hidalgo M, Chu Q, et al. Phase I and pharmacokinetic study of trabectedin as a 1- or 3-hour infusion weekly in patients with advanced solid malignancies. Clin Cancer Res. 2009;15(10):3591–3599.
   PubMed Web of Science ®Google Scholar
• Pardo B, Salazar R, Ciruelos E, et al. Phase I and pharmacokinetic study of trabectedin 3-hour infusion every three weeks in patients with advanced cancer and alteration of hepatic function. Med Oncol. 2012;29(3):2240–2250.
   PubMed Web of Science ®Google Scholar
• von Mehren M, Schilder RJ, Cheng JD, et al. A phase I study of the safety and pharmacokinetics of trabectedin in combination with pegylated liposomal doxorubicin in patients with advanced malignancies. Ann Oncol. 2008;19(10):1802–1809.
   PubMed Web of Science ®Google Scholar
• Chu Q, Mita A, Forouzesh B, et al. Phase I and pharmacokinetic study of sequential paclitaxel and trabectedin every 2 weeks in patients with advanced solid tumors. Clin Cancer Res. 2010;16(9):2656–2665.
   PubMed Web of Science ®Google Scholar
• Vidal L, Magem M, Barlow C, et al. Phase I clinical and pharmacokinetic study of trabectedin and carboplatin in patients with advanced solid tumors. Invest New Drugs. 2012;30(2):616–628.
   PubMed Web of Science ®Google Scholar
• Gore L, Rivera E, Basche M, et al. Phase I combination study of trabectedin and capecitabine in patients with advanced malignancies. Invest New Drugs. 2012;30(5):1942–1949.
   PubMed Web of Science ®Google Scholar
• Sessa C, Cresta S, Noberasco C, et al. Phase I clinical and pharmacokinetic study of trabectedin and cisplatin in solid tumours. Eur J Cancer. 2009;45(12):2116–2122.
   PubMed Web of Science ®Google Scholar
• Sessa C, del Conte G, Christinat A, et al. Phase I clinical and pharmacokinetic study of trabectedin and cisplatin given every three weeks in patients with advanced solid tumors. Invest New Drugs. 2013;31(5):1236–1243.
   PubMed Web of Science ®Google Scholar
• von Mehren M, Bookman M, Meropol NJ, et al. Phase I study of the safety and pharmacokinetics of trabectedin with docetaxel in patients with advanced malignancies. Cancer Chemother Pharmacol. 2015;75(5):1047–1055.
   PubMed Web of Science ®Google Scholar
• Sessa C, de Braud F, Perotti A, et al. Trabectedin for women with ovarian carcinoma after treatment with platinum and taxanes fails. J Clin Oncol Res. 2005;23(9):1867–1874.
   Google Scholar
• Krasner CN, McMeekin DS, Chan S, et al. A phase II study of trabectedin single agent in patients with recurrent ovarian cancer previously treated with platinum-based regimens. Br J Cancer. 2007;97(12):1618–1624.
   PubMed Web of Science ®Google Scholar
• del Campo JM, Roszak A, Bidzinski M, et al. Phase II randomized study of trabectedin given as two different every 3 weeks dose schedules (1.5 mg/m2 24 h or 1.3 mg/m2 3 h) to patients with relapsed, platinum-sensitive, advanced ovarian cancer. Ann Oncol. 2009;20(11):1794–1802.
   PubMed Web of Science ®Google Scholar
• del Campo JM, Sessa C, Krasner CN, et al. Trabectedin as single agent in relapsed advanced ovarian cancer: results from a retrospective pooled analysis of three phase II trials. Med Oncol. 2013;30(1):435.
   PubMed Web of Science ®Google Scholar
• Lorusso D, Scambia G, Pignata S, et al. Prospective phase II trial of trabectedin in BRCA-mutated and/or BRCAness phenotype recurrent ovarian cancer patients: the MITO 15 trial. Ann Oncol. 2016;27(3):487–493.
   PubMed Web of Science ®Google Scholar
• Powell SN, Kachnic LA. Roles of BRCA1 and BRCA2 in homologous recombination, DNA replication fidelity and the cellular response to ionizing radiation. Oncogene. 2003;22(37):5784–5791.
   PubMed Web of Science ®Google Scholar
• Monk BJ, Sill MW, Hanjani P, et al. Docetaxel plus trabectedin appears active in recurrent or persistent ovarian and primary peritoneal cancer after up to three prior regimens: a phase II study of the Gynecologic Oncology Group. Gynecol Oncol. 2011;120(3):459–463.
   PubMed Web of Science ®Google Scholar
• Monk BJ, Herzog TJ, Kaye SB, et al. Trabectedin plus pegylated liposomal doxorubicin in recurrent ovarian cancer. J Clin Oncol Res. 2010;28(19):3107–3114.
   Google Scholar
• Takahashi N, Li WW, Banerjee D, et al. 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
• Meco D, Colombo T, Ubezio P, et al. Effective combination of ET-743 and doxorubicin in sarcoma: preclinical studies. Cancer Chemother Pharmacol. 2003;52(2):131–138.
   PubMed Web of Science ®Google Scholar
• Monk BJ, Herzog TJ, Kaye SB, et al. Trabectedin plus pegylated liposomal doxorubicin (PLD) versus PLD in recurrent ovarian cancer: overall survival analysis. Eur J Cancer. 2012;48(15):2361–2368.
   PubMed Web of Science ®Google Scholar
• Poveda A, Vergote I, Tjulandin S, et al. Trabectedin plus pegylated liposomal doxorubicin in relapsed ovarian cancer: outcomes in the partially platinum-sensitive (platinum-free interval 6-12 months) subpopulation of OVA-301 phase III randomized trial. Ann Oncol. 2011;22(1):39–48.
   PubMed Web of Science ®Google Scholar
• Kaye SB, Colombo N, Monk BJ, et al. Trabectedin plus pegylated liposomal doxorubicin in relapsed ovarian cancer delays third-line chemotherapy and prolongs the platinum-free interval. Ann Oncol. 2011;22(1):49–58.
   PubMed Web of Science ®Google Scholar
• Monk BJ, Kaye SB, Poveda A, et al. Nibrin is a marker of clinical outcome in patients with advanced serous ovarian cancer treated in the phase III OVA-301 trial. Gynecol Oncol. 2014;132(1):176–180.
   PubMed Web of Science ®Google Scholar
• Monk BJ, Ghatage P, Parekh T, et al. Effect of BRCA1 and XPG mutations on treatment response to trabectedin and pegylated liposomal doxorubicin in patients with advanced ovarian cancer: exploratory analysis of the phase 3 OVA-301 study. Ann Oncol. 2015;26(5):914–920.
   PubMed Web of Science ®Google Scholar
• Pignata SS, Scambia G, Raspagliesi F, et al. The MITO8 phase III international multicenter randomized study testing the effect on survival of prolonging platinum-free interval (PFI) in patients with ovarian cancer (OC) recurring between 6 and 12 months after previous platinum-based chemotherapy: a collaboration of MITO, MANGO, AGO, BGOG, ENGOT, and GCIG. J Clin Oncol Res. 2016; 34(suppl;abstr 5505).
   Google Scholar
• Sehouli J, Alfaro V, Gonzalez-Martin A. Trabectedin plus pegylated liposomal doxorubicin in the treatment of patients with partially platinum-sensitive ovarian cancer: current evidence and future perspectives. Ann Oncol. 2012;23(3):556–562.
   PubMed Web of Science ®Google Scholar
• Clinicaltrials.gov. Phase III international, randomized study of trabectedin plus pegylated liposomal doxorubicin (PLD) versus carboplatin plus PLD in patients with ovarian cancer progressing within 6-12 months of last platinum (NCT01379989). 2016. Available from: https://clinicaltrials.gov/ct2/show/NCT01379989.
   Google Scholar
• Clinicaltrials.gov. Multicenter, randomized, non-comparative, open-label phase II trial on the efficacy and safety of the combination of bevacizumab and trabectedin with or without carboplatin in adult women with platinum partially sensitive recurring ovarian cancer (NCT01735071). 2016. Available from: https://clinicaltrials.gov/ct2/show/NCT01735071.
   Google Scholar
• Clinicaltrials.gov. A study comparing the combination of trabectedin (Yondelis) and Doxil/Caelyx with Doxil/Caelyx for the treatment of advanced-relapsed epithelial ovarian, primary peritoneal, or fallopian tube cancer (NCT01846611). 2016. [cited 2016 July 21]. Available from: https://clinicaltrials.gov/ct2/show/NCT01846611.
   Google Scholar