Trabectedin (ET-743): Evaluation of its use in advanced soft-tissue sarcoma

Future Oncology

Volumn 3, Issue 4, 2007, Pages 381-392

  Schöffski, Patrick ^a   Wolter, Pascal ^a   Clement, Paul ^a   Sciot, Raf ^a   De Wever, Ivo ^a   Wozniak, Agnieszka ^a   Stefan, Cristiana ^a   Dumez, Herlinde ^a  

^a UNIVERSITY OF LEUVEN   (Belgium)

Author keywords

DNA binding protein; Efficacy; Safety; Soft tissue sarcoma; Trabecredin; Tumor control

Indexed keywords

ALANINE AMINOTRANSFERASE; AMINOTRANSFERASE; ANTHRACYCLINE DERIVATIVE; ANTIEMETIC AGENT; ANTINEOPLASTIC AGENT; ASPARTATE AMINOTRANSFERASE; CAPECITABINE; CYTOTOXIC AGENT; DEXAMETHASONE; DOCETAXEL; DOXORUBICIN; IFOSFAMIDE; PACLITAXEL; TRABECTEDIN;

ADVANCED CANCER; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ALOPECIA; AMINOTRANSFERASE BLOOD LEVEL; ANEMIA; ANTINEOPLASTIC ACTIVITY; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BLOOD TOXICITY; BONE MARROW SUPPRESSION; CANCER CONTROL; CARDIOTOXICITY; CHEMOTHERAPY INDUCED EMESIS; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; CONTINUOUS INFUSION; CROSS RESISTANCE; DIARRHEA; DISEASE FREE SURVIVAL; DOSAGE SCHEDULE COMPARISON; DOSE RESPONSE; DRUG DNA BINDING; DRUG EFFICACY; DRUG ELIMINATION; DRUG FATALITY; DRUG FECES LEVEL; DRUG METABOLISM; DRUG RESPONSE; DRUG SAFETY; DRUG STRUCTURE; DRUG TOLERABILITY; DRUG URINE LEVEL; EVIDENCE BASED MEDICINE; FATIGUE; FEBRILE NEUTROPENIA; HUMAN; HYPERBILIRUBINEMIA; LEIOMYOSARCOMA; LEUKOPENIA; LIPOSARCOMA; LIVER DYSFUNCTION; LIVER FUNCTION TEST; LIVER TOXICITY; MONOTHERAPY; MUCOSA INFLAMMATION; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUROTOXICITY; NEUTROPENIA; NONHUMAN; OPTIMAL DRUG DOSE; OUTCOME ASSESSMENT; OVERALL SURVIVAL; PREMEDICATION; PRIORITY JOURNAL; RECOMMENDED DRUG DOSE; SIDE EFFECT; SOFT TISSUE SARCOMA; SOLID TUMOR; THROMBOCYTOPENIA; UNSPECIFIED SIDE EFFECT;

ANTINEOPLASTIC AGENTS, ALKYLATING; DIOXOLES; DISEASE-FREE SURVIVAL; EVALUATION STUDIES AS TOPIC; HUMANS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; SARCOMA; TETRAHYDROISOQUINOLINES; TREATMENT OUTCOME;

EID: 34547867058     PISSN: 14796694     EISSN: 17448301     Source Type: Journal    
DOI: 10.2217/14796694.3.4.381     Document Type: Article

References (56)

1. Jemal A, Tiwari RC, Murray T et al. Cancer statistics, 2004. CA Cancer J. Clin. 54, 8-29 (2004).
2. Brennan MF, Casper ES, Harrison L: Soft-tissue sarcoma. In: Cancer: Principles and Practice of Oncology. VT De Vita, Hellman S, Rosenberg SA (Eds). Lippincott-Raven Publisher, PA, USA, 1738-1788 (1997).
3. Mouridsen HT, Bastholt L, Somers R et al.: Adriamycin versus epirubicin in advanced soft-tissue sarcomas. A randomized Phase II/Phase II study of the EORTC soft-tissue and Bone Sarcoma Group. Eur. J. Cancer Clin. Oncol. 23, 1477-1483 (1987).
4. Santoro A, Tursz T, Mouridsen HT 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. 13, 1537-1545 (1995).
5. Bokemeyer C, Franzke A, Hartmann JT et al.: A Phase I/II study of sequential, dose-escalated, high dose ifosfamide plus doxorubicin with peripheral blood stem cell support for the treatment of patients with advanced soft-tissue sarcomas. Cancer 80, 1221-1227 (1997).
6. 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 37, 870-877 (2001).
7. Le Cesne A, Judson I, Crowther D et al.: Randomized Phase III study comparing conventional-dose doxorubicin plus ifosfamide versus high-dose doxorubicin plus ifosfamide plus recombinant human granulcocyte-macrophage colony-stimulating factor in advanced soft-tissue sarcomas: a trial of the European Organization for Research and Treatment of Cancer/Soft-Tissue and Bone Sarcoma Group. J. Clin. Oncol. 18, 2676-2684 (2000).
8. Nielsen OS, Dombernowsky P, Mouridsen H et al.: High-dose epirubicin is not an alternative to standard-dose doxorubicin in the treatment of advanced soft-tissue sarcomas. A study of the EORTC soft-tissue and bone sarcoma group. Br. J. Cancer 78, 1634-1639 (1998).
9. Patel SR, Vadhan-Raj S, Burgess MA et al.: Results of two consecutive trials of dose-intensive chemotherapy with doxorubicin and ifosfamide in patients with sarcomas. Am. J. Clin. Oncol. 21, 317-321 (1998).
10. Patel SR, Vadhan-Raj S, Papadopolous N et al.: High-dose ifosfamide in bone and soft-tissue sarcomas: results of Phase II and pilot studies - dose-response and schedule dependence. J. Clin. Oncol. 15, 2378-2384 (1997).
11. Cvetkovic RS, Figgitt DP, Plosker GL: Et-743. Drugs 62, 1185-92; discussion 1193-1194 (2002).
12. Hartmann JT, Patel S: Recent developments in salvage chemotherapy for patients with metastatic soft-tissue sarcoma. Drugs 65, 167-178 (2005).
13. Bay JO, Ray-Coquard I, Fayette J et al.: Docetaxel and gemcitabine combination in 133 advanced soft-tissue sarcomas: a retrospective analysis. Int. J. Cancer. 119, 706-711 (2006).
14. Pommier Y, Kohlhagen G, Bailly C, Waring M et al.: DNA, sequence- and structure-selective alkylation of guanine N2 in die DNA minor groove by ecteinascidin 743, a potent antitumor compound fican the Caribbean tunicate Ecteinascidia turbinata. Biochemistry 35, 13303-13309 (1996).
15. Zewail-Foote M, Hurley LH: Ecteinascidin 743: a minor groove alkylator that bends DNA toward the major groove. J. Med. Chem. 42, 2493-2497 (1999).
16. Li WW, Takahashi N, Jhanwar S et al.: Sensitivity of soft-tissue sarcoma cell lines to chemotherapeutic agents: identification of ecteinascidin-743 as a potent cytotoxic agent. Clin. Cancer Res. 7, 2908-2911 (2001).
17. Hendriks HR, Fiebig HH, Giavazzi R et al.: High antitumour activity of ET-743 against human tumour xenografts from melanoma, non-small-cell lung and ovarian cancer. Ann. Oncol. 10, 1233-1240 (1999).
18. Valoti G, Nicoletti MI, Pellegrino A et al.: Ecteinascidin-743, a new marine natural product with potent antitumour activity on human ovarian carcinoma xenografts. Clin. Cancer Res. 4, 1977-1983 (1998).
19. Forouzeh B. Hildago M, Denis L et al.: Phase I and pharmacokinetic study of the marine-derived DNA minor groove binder ET-743 on a weekly x 3 every-4-week schedule in patients with advanced solid malignancies. Programs and Abstracs of the AACR-NCI EORTC International Conference. Miami Beach, FL, USA, 29 October-2 November (2001) (Abstract 373).
20. Ryan DP, Supko JG. Eder JP et al.: Phase I and pharmacokinetic study of ecteinascidin 743 administered as a 72-h continuous intravenous irfusion in patients with solid malignancies. Clin. Cancer Res. 7, 231-242 (2001).
21. Taamma A, Misser JL, Riofrio M et al.: Phase I and pharmacokinetic study of ecteinascidin-743, a new marine compound, administered as a 24-h continuous infusion in patients with solid tumors. J. Clin. Oncol. 19, 1256-1265 (2001).
22. 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 39, 1842-1851 (2003).
23. 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. 6, 4725-4732 (2000).
24. van Kesteren C, Twelves C, Bowman A et al.: Clinical pharmacology of the novel marine-derived anticancer agent Ectienascidin 743 administered as a 1- and 3-h infusion in a Phase I study. Anticancer Drugs 13, 381-393 (2002).
25. 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. 8, 75-85 (2002).
26. 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. 11, 672-627 (2005).
27. Puchalski TA, Ryan DP, Garcia-Carbonero R et al.: Pharmacokinetics of ecteinascidin-743 administered as a 24-h continuous intravenous infusion to adult patients with soft-tissue sarcomas: associations with clinical characteristics, pathophysiological variables and toxicity. Cancer Chemother. Pharmacol. 50, 309-319 (2002).
28. Brandon EF, Meijerman I, Klijn KS et al.: In-vitro cytotoxicity of ET-743 (trabectedin. Yondelis™), a marine anticancer drug, in the Hep G2 cell line: influence of cytochrome P450 and Phase II inhibition, and cytochrome P450 induction. Anticancer Drugs 16, 935-943 (2005).
29. Reid JM, Kuffel MJ, Ruben SL et al.: Rat and human liver cytochrome P-450 isoform metabolism of ecteinascidin-743 does not predict gender-dependent toxicity in humans. Clin. Cancer Res. 8, 2952-2962 (2002).
30. Beumer JH, Rademaker-Lakhai JM, Rosing H et al.: Trabectedin (Yondelis™, formerly ET-743), a mass balance study in patients with advanced cancer. Invest. New Drugs 23, 429-436 (2005).
31. Van Glabbeke M, van Oosterom AT, Oosterhuis JW et al.: Prognostic factors for the outcome of chemotherapy in advanced soft-tissue sarcoma: an analysis of 2,185 patients treated with and anthracycline-containing first-line regime - a European Organization for Research and Treatment, of Cancer Soft-Tissue and Bone Sarcoma Group Study. J. Clin. Oncol. 17, 150-157 (1999).
32. 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. 22, 1480-1490 (2004).
33. 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. 23, 576-584 (2005).
34. Yovine A, Riofrio M, Blay JY et al.: Phase II study of ecteinascidin-743 in advanced pretreated soft-tissue sarcoma patients. J. Clin. Oncol. 22, 890-899 (2004).
35. Le Cesne A, Demetri G, Jean L et al.: Impact of Yondelis in the natural history of patients with pretreated advanced soft-tissue sarcomas: Long-term follow-up results. Program and Abstracts of the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics. Boston, MA, USA, 17-21 November (2003) (Abstract 31).
36. Morgan JA, Le Cesne A, Chawla SP et al.: Randomized Phase II study of trabectedin in patients with liposarcoma and leiomyosarcoma after failure of prior anthracycline and ifosfamide. Program and Abstract of the 43rd ASCO Annual Meeting Chicago, IL, USA, 1-5 June (2007) (Abstract 10060).
37. Samuels BL, Rushing D, Chawla SP et al.: Randomized Phase II study of trabectedin (ET-743) given by two different dosing schedules in patients with leiomyossarcomas or liposarcomas refractory to conventional doxorubicin and ifosfamide chemotherapy. Program and Abstract of the 40th ASCO Annual Meeting. New Orleans, LA. USA, 5-8 June (2004). J. Clin. Oncol. 22(14S) (2004) (Abstract 9000).
38. 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. 23, 5484-5492 (2005).
39. 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. 11, 1269-1275 (1993).
40. Donald S, Verschoyle RD, Greaves P et al.: Complete protection by high-dose dexamethasone against the hepatotoxicity of the novel antitumor drug Yondelis™ (ET-743) in the rat. Cancer Res. 63, 5902-5908 (2003).
41. 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 42, 1484-1490 (2006).
42. Schöffski P: DNA repair functionality as a molecular signature for sensitivity/resistance in sarcoma patients treated with trabectedin. Presented at: 43rd ASCO Annual Meeting, Los Angeles, CA, USA, April. 14-18 (2007).
43. Grosso F, Demetri G, Blay JY et al.: Patterns of tumor response to trabectedin in myxoid liposarcomas. Program and Abstracts of the 42nd ASCO Annual Meeting. Atlanta, GA, USA, 2-6 June (2006). J. Clin. Oncol. 24(18S) (2006) (Abstract 9511).
44. Del Campo J, Roszak A, Ciuleanu T et al.: Phase II open label randomized study of trabectedin given as two different dosing schedules in women with platinum-sensitive, recurrent ovarian carcinoma: Preliminary results. Program and Abstracts of the 42nd ASCO Annual Meeting. Atlanta, GA, USA, 2-6 June (2006). J. Clin. Oncol. 24(18S) (2006) (Abstract 5031).
45. McMeekin, DS, Krasner C, Chan S et al.: Final results of a Phase II study of weekly trabectedin in second/third line ovarian cancer. Program and Abstracts of the 41st ASCO Annual Meeting. Orlando, FL, USA, 13-17 May (2005). J. Clin. Oncol. 23(16S) (2005) (Abstract 5011).
46. McMeekin S, del Campo JM, Colombo N et al.: Trabectedin in relapsed advanced ovarian cancer: a pooled analysis of three Phase II studies. Presented at: 43rd ASCO Annual Meeting. Chicago, IL, USA, 1-5 June (2007) (Abstract 5579).
47. 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. 23, 1867-1874 (2005).
48. Gurtler JS, Goldstein L, Delprete S et al.: Trabectedin in third line breat cancer a multicenter, randomized, Phase II study comparing two administration regimens. Program and Abstracts of the 41st ASCO Annual Meeting. Orlando, FL, USA, 13-17 May (2005). J. Clin. Oncol. 23(16S) (2005) (Abstract 625).
49. Zelek L, Yovine A, Brain E et al.: A P base II study of Yondelis™ (trabectedin, ET-743) as a 24-h continuous intravenous infusion in pretreated advanced breast cancer. Br. J. Cancer 94, 1610-1614 (2006).
50. Michaelson T, Gilligan W, Kantoff ME et al.: Phase II study of three h, weekly infusion of trabectedin in men with metastatic, androgen-independent prostate carcinoma. Programa and Abstracts of the 41st ASCO Annual Meeting. Orlando, FL, USA. 13-17 May (2005). J. Clin. Oncol. 23(16S) (2005) (Absract 4517).
51. Cohen RB, Schilder RJ, Cheng J et al.: Final results of a combination study between trabectedin and pegylated liposomal doxorubicin in patients with advanced malignancies. Program and Abstracts of the 41st ASCO Annual Meeting. Orlando, FL, USA, 13-17 May (2005). J. Clin. Oncol. 23(16S) (2005) (Abstract 3074).
52. Gianni L, Grasselli G, De Braud F et al.: Definition of the least toxic sequence and optimal therapeutic dose of Yondelis™ in combination with doxorubicin in patients with untreated metastatic soft-tissue sarcomas and advanced pre-treated anthracycline-naive breast cancer patients. Programs and Abstract of the AACR-NCI EORTC International Conference. Boston, MA, USA, 26-30 October (2003) (Abstract A49).
53. Gore I, Rivera E, Lavalle K et al.: Phase I combination study of trabectedin and capecitabine in patients with advanced malignancies. Program and Abstract of the 42nd ASCO Annual Meeting. Atlanta, GA, USA, 2-6 June (2006). J. Clin. Oncol. 24(18S) (2006) (Abstract 2079).
54. Papadopoulos KP, Chu Q, Patnaik A et al.: Phase I and pharmacokinetic study of sequential paclitaxel and trabectedin every 2 weeks in patients with advanced solid tumors. Program and Abstracts of the 42nd ASCO Annual Meeting. Atlanta, GA, USA, 2-6 June (2006). J. Clin. Oncol. 24(18S) (2006) (Abstract 2029).
55. von Mehren M, Buck D, Temmer E et al.: Phase I study of trabectedin in combination with docetaxel in patients with advanced malignancies. Program and Abstracts of the 42nd ASCO Annual Meeting. Atlanta, GA, USA, 2-6 June (2006). J. Clin. Med. 24(18S) (2006) (Abstract 2068).
56. Blay JY, von Mehren M, Samuels BP, et al.: Combination of trabectedin (T) and doxorubicin (D) for the treatment of patients with soft-tissue sarcoma (STS): Safety and efficacy analysis, Presented at: 43rd ASCO Annual Meeting. Chicago, IL, USA, 1-5 June) (2007) (Abstract 10078).