A comprehensive safety evaluation of trabectedin and drug-drug interactions of trabectedin-based combinations

BioDrugs

Volumn 28, Issue 6, 2014, Pages 499-511

  Leporini, Christian ^a   Patanè, Marinella ^a   Saullo, Francesca ^a   Rende, Pierandrea ^a   Gallelli, Luca ^a   Paola, Eugenio ^a   Toscano, Rosa ^b   Lucia, Maria ^b   Rossi, Marco ^a   Sarro, Giovambattista ^a   Russo, Emilio ^a  

^a UNIVERSITY MAGNA GRAECIA OF CATANZARO   (Italy)

^b Hospital San Francesco di Paola   (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; CARBOPLATIN; CYTOCHROME P450 3A4; DEXAMETHASONE; DOXORUBICIN; GEMCITABINE; PACLITAXEL; TRABECTEDIN; 1,3 DIOXOLANE DERIVATIVE; ANTINEOPLASTIC AGENT; TETRAHYDROISOQUINOLINE DERIVATIVE;

ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANEMIA; ANOREXIA; ANTIINFLAMMATORY ACTIVITY; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BONE MARROW SUPPRESSION; BONE MARROW TOXICITY; CANCER CHEMOTHERAPY; CANCER RECURRENCE; CANCER RESISTANCE; CARDIOTOXICITY; CONSTIPATION; DIARRHEA; DRUG DISTRIBUTION; DRUG ELIMINATION; DRUG MECHANISM; DRUG METABOLISM; DRUG SAFETY; DRUG TOLERABILITY; FATIGUE; HUMAN; IMMUNOMODULATION; MAXIMUM PLASMA CONCENTRATION; MONOTHERAPY; MULTIDRUG RESISTANCE; NAUSEA; NEUROTOXICITY; NEUTROPENIA; OVARY CANCER; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PLASMA CONCENTRATION-TIME CURVE; REVIEW; RHABDOMYOLYSIS; SEVERE HEPATIC IMPAIRMENT; SIDE EFFECT; SOFT TISSUE SARCOMA; THROMBOCYTOPENIA; VOMITING; DRUG INTERACTION; FEMALE; NEOPLASM RECURRENCE, LOCAL; OVARIAN NEOPLASMS; RADIATION RESPONSE; SARCOMA;

ANTINEOPLASTIC AGENTS; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; DIOXOLES; DRUG INTERACTIONS; FEMALE; HUMANS; NEOPLASM RECURRENCE, LOCAL; OVARIAN NEOPLASMS; SARCOMA; TETRAHYDROISOQUINOLINES;

EID: 84915784738     PISSN: 11738804     EISSN: 1179190X     Source Type: Journal    
DOI: 10.1007/s40259-014-0100-7     Document Type: Review

References (98)

1. Clark MA, Fisher C, Judson I, Thomas JM. Soft-tissue sarcomas in adults. N Engl J Med. 2005;353(7):701-11.
2. Casali PG, Blay JY. Soft tissue sarcomas: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2010;21(Suppl 5):v198-203.
3. Amankwah EK, Conley AP, Reed DR. Epidemiology and therapies for metastatic sarcoma. Clin Epidemiol. 2013;5:147-62.
4. Ducimetiere F, Lurkin A, Ranchere-Vince D, Decouvelaere AV, Peoc'h M, Istier L, et al. Incidence of sarcoma histotypes and molecular subtypes in a prospective epidemiological study with central pathology review and molecular testing. PloS ONE. 2011;6(8):e20294.
5. ESMO/European Sarcoma Network Working Group. Soft tissue and visceral sarcomas: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2012;23 Suppl 7:vii92-9.
6. Antman K, Crowley J, Balcerzak SP, Rivkin SE, Weiss GR, Elias A, et al. An intergroup phase III randomized study of doxorubicin and dacarbazine with or without ifosfamide and mesna in advanced soft tissue and bone sarcomas. J Clin Oncol. 1993;11(7):1276-85.
7. No authors listed. Doxorubicin (adriamycin): a new anticancer drug. Med Lett Drugs Ther. 1975;17(10):42-3.
8. Merimsky O, Meller I, Flusser G, Kollender Y, Issakov J, Weil-Ben-Arush M, et al. Gemcitabine in soft tissue or bone sarcoma resistant to standard chemotherapy: a phase II study. Cancer Chemother Pharmacol. 2000;45(2):177-81.
9. Hensley ML, Blessing JA, Degeest K, Abulafia O, Rose PG, Homesley HD. Fixed-dose rate gemcitabine plus docetaxel as second-line therapy for metastatic uterine leiomyosarcoma: a Gynecologic Oncology Group phase II study. Gynecol Oncol. 2008;109(3):323-8.
10. Maki RG, Wathen JK, Patel SR, Priebat DA, Okuno SH, Samuels B, 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(19):2755-63.
11. van der Graaf WT, Blay JY, Chawla SP, Kim DW, Bui-Nguyen B, Casali PG, et al. Pazopanib for metastatic soft-tissue sarcoma (PALETTE): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2012;379(9829):1879-86.
12. Demetri GD, Chawla SP, von Mehren M, Ritch P, Baker LH, Blay JY, et al. Efficacy and safety of trabectedin in patients with advanced or metastatic liposarcoma or leiomyosarcoma after failure of prior anthracyclines and ifosfamide: results of a randomized phase II study of two different schedules. J Clin Oncol. 2009;27(25):4188-96.
13. Le Cesne A, Blay JY, Judson I, Van Oosterom A, Verweij J, Radford J, 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):576-84.
14. Yovine A, Riofrio M, Blay JY, Brain E, Alexandre J, Kahatt C, et al. Phase II study of ecteinascidin-743 in advanced pretreated soft tissue sarcoma patients. J Clin Oncol. 2004;22(5):890-9.
15. Garcia-Carbonero R, Supko JG, Manola J, Seiden MV, Harmon D, Ryan DP, 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):1480-90.
16. Le Cesne A, Domont J, Cioffi A, Bonvalot S, Terrier P, Ray-Coquard I, et al. Mapping the literature: role of trabectedin as a new chemotherapy option in advanced pretreated soft tissue sarcoma. Drugs Today (Barc). 2009;45(6):403-21.
17. Le Cesne A, Yovine A, Blay JY, Delaloge S, Maki RG, Misset JL, et al. A retrospective pooled analysis of trabectedin safety in 1,132 patients with solid tumors treated in phase II clinical trials. Investig New Drugs. 2012;30(3):1193-202.
18. Blay JY, Italiano A, Ray-Coquard I, Cesne A, Duffaud F, Rios M, et al. Long-term outcome and effect of maintenance therapy in patients with advanced sarcoma treated with trabectedin: an analysis of 181 patients of the French ATU compassionate use program. BMC Cancer. 2013;13(1):64.
19. Samuels BL, Chawla S, Patel S, von Mehren M, Hamm J, Kaiser PE, et al. Clinical outcomes and safety with trabectedin therapy in patients with advanced soft tissue sarcomas following failure of prior chemotherapy: results of a worldwide expanded access program study. Ann Oncol. 2013;24(6):1703-9.
20. Gronchi A, Bui BN, Bonvalot S, Pilotti S, Ferrari S, Hohenberger P, et al. Phase II clinical trial of neoadjuvant trabectedin in patients with advanced localized myxoid liposarcoma. Ann Oncol. 2012;23(3):771-6.
21. Grosso F, Jones RL, Demetri GD, Judson IR, Blay JY, Le Cesne A, et al. Efficacy of trabectedin (ecteinascidin-743) in advanced pretreated myxoid liposarcomas: a retrospective study. Lancet Oncol. 2007;8(7):595-602.
22. Grosso F, Sanfilippo R, Virdis E, Piovesan C, Collini P, Dileo P, et al. Trabectedin in myxoid liposarcomas (MLS): a long-term analysis of a single-institution series. Ann Oncol. 2009;20(8): 1439-44.
23. Bosetti C, Bertuccio P, Levi F, Lucchini F, Negri E, La Vecchia C. Cancer mortality in the European Union, 1970-2003, with a joinpoint analysis. Ann Oncol. 2008;19(4):631-40.
24. Colombo N, Peiretti M, Parma G, Lapresa M, Mancari R, Carinelli S, et al. Newly diagnosed and relapsed epithelial ovarian carcinoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2010;21(Suppl 5):v23-30.
25. Vermorken JB. Second-line randomized trials in epithelial ovarian cancer. Int J Gynecol Cancer. 2008;18(Suppl 1):59-66.
26. Friedlander M, Trimble E, Tinker A, Alberts D, Avall-Lundqvist E, Brady M, et al. Clinical trials in recurrent ovarian cancer. Int J Gynecol Cancer. 2011;21(4):771-5.
27. Hanker LC, Loibl S, Burchardi N, Pfisterer J, Meier W, Pujade-Lauraine E, et al. The impact of second to sixth line therapy on survival of relapsed ovarian cancer after primary taxane/platinum-based therapy. Ann Oncol. 2012;23(10):2605-12.
28. Monk BJ, Coleman RL. Changing the paradigm in the treatment of platinum-sensitive recurrent ovarian cancer: from platinum doublets to nonplatinum doublets and adding antiangiogenesis compounds. Int J Gynecol Cancer. 2009;19(Suppl 2):S63-7.
29. Carter NJ, Keam SJ. Trabectedin: a review of its use in soft tissue sarcoma and ovarian cancer. Drugs. 2010;70(3):355-76.
30. European Medicines Agency (EMA). Yondelis (trabectedin): Summary of product characteristics. http://www.ema.europa.eu/ Accessed February 2014; 2012.
31. Monk BJ,Herzog TJ, KayeSB,KrasnerCN,Vermorken JB,Muggia FM, et al. Trabectedin plus pegylated liposomal doxorubicin in recurrent ovarian cancer. J Clin Oncol. 2010;28(19):3107-14.
32. D'Incalci M, Galmarini CM. A review of trabectedin (ET-743): a unique mechanism of action. Mol Cancer Ther. 2010;9(8): 2157-63.
33. Gajdos C, Elias A. Trabectedin: safety and efficacy in the treatment of advanced sarcoma. Clin Med Insights Oncol. 2011;16(5): 35-43.
34. Chuk MK, Balis FM, Fox E. Trabectedin. Oncologist. 2009;14(8):794-9.
35. Schoffski P, Casali PG, Taron M, Van Oosterom AT, Judson IR, Grosso F, et al. DNA repair functionality modulates the clinical outcome of patients with advanced sarcoma treated with trabectedin (ET-743) [abstract]. J Clin Oncol. 2006; 24(Suppl 18):9522.
36. Herrero AB, Martin-Castellanos C, Marco E, Gago F, Moreno S. Cross-talk between nucleotide excision and homologous recombination DNA repair pathways in the mechanism of action of antitumor trabectedin. Cancer Res. 2006;66(16):8155-62.
37. Tavecchio M, Simone M, Erba E, Chiolo I, Liberi G, Foiani M, et al. Role of homologous recombination in trabectedin-induced DNA damage. Eur J Cancer. 2008;44(4):609-18.
38. Allavena P, Signorelli M, Chieppa M, Erba E, Bianchi G, Marchesi F, et al. Anti-inflammatory properties of the novel antitumor agent yondelis (trabectedin): inhibition of macrophage differentiation and cytokine production. Cancer Res. 2005;65(7): 2964-71.
39. Germano G, Frapolli R, Belgiovine C, Anselmo A, Pesce S, Liguori M, et al. Role of macrophage targeting in the antitumor activity of trabectedin. Cancer Cell. 2013;23(2):249-62.
40. Germano G, Frapolli R, Simone M, Tavecchio M, Erba E, Pesce S, et al. Antitumor and anti-inflammatory effects of trabectedin on human myxoid liposarcoma cells. Cancer Res. 2010;70(6): 2235-44.
41. Allavena P, Mantovani A. Immunology in the clinic review series; focus on cancer: tumour-associated macrophages: undisputed stars of the inflammatory tumour microenvironment. Clin Exp Immunol. 2012;167(2):195-205.
42. D'Angelo D, Borbone E, Palmieri D, Uboldi S, Esposito F, Frapolli R, et al. The impairment of the High Mobility Group A (HMGA) protein function contributes to the anticancer activity of trabectedin. Eur J Cancer. 2013;49(5):1142-51.
43. Berlingieri MT, Manfioletti G, Santoro M, Bandiera A, Visconti R, Giancotti V, et al. Inhibition of HMGI-C protein synthesis suppresses retrovirally induced neoplastic transformation of rat thyroid cells. Mol Cell Biol. 1995;15(3):1545-53.
44. Berlingieri MT, Pierantoni GM, Giancotti V, Santoro M, Fusco A. Thyroid cell transformation requires the expression of the HMGA1 proteins. Oncogene. 2002;21(19):2971-80.
45. Scala S, Portella G, Fedele M, Chiappetta G, Fusco A. Adenovirus-mediated suppression of HMGI(Y) protein synthesis as potential therapy of human malignant neoplasias. Proc Natl Acad Sci USA. 2000;97(8):4256-61.
46. Fusco A, Fedele M. Roles of HMGA proteins in cancer. Nat Rev Cancer. 2007;7(12):899-910.
47. Di Giandomenico S, Frapolli R, Bello E, Uboldi S, Licandro SA, Marchini S, et al. Mode of action of trabectedin in myxoid liposarcomas. Oncogene. 2013. doi:10.1038/onc.2013.462 (Epub ahead of print).
48. Patel RM. Trabectedin: a novel molecular therapeutic in cancer. Int J Curr Pharm Res. 2011;3:65-70.
49. Kanzaki A, Takebayashi Y, Ren XQ, Miyashita H, Mori S, Akiyama S, et al. Overcoming multidrug drug resistance in P-glycoprotein/ MDR1-overexpressing cell lines by ecteinascidin 743. Mol Cancer Ther. 2002;1(14):1327-34.
50. Abraham I, El Sayed K, Chen ZS, Guo H. Current status on marine products with reversal effect on cancer multidrug resistance. Mar Drugs. 2012;10(10):2312-21.
51. D'Incalci M, Colmegna B, Uboldi S, Frapolli R, Licandro SA, Erba E, et al. Collateral sensitivity to cisplatin of trabectedinresistant cell lines [abstract]. In: AACR-NCI-EORTC international conference on molecular targets and cancer therapeutics; October 19-23, 2013 Boston, MA, USA. 2013 (Abstract: C93).
52. Monk BJ, Dalton H, Benjamin I, Tanovic A. Trabectedin as a new chemotherapy option in the treatment of relapsed platinum sensitive ovarian cancer. Curr Pharmaceut Des. 2012;18(25):3754-69.
53. van Kesteren C, Cvitkovic E, Taamma A, Lopez-Lazaro L, Jimeno JM, Guzman C, 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):4725-32.
54. Puchalski TA, Ryan DP, Garcia-Carbonero R, Demetri GD, Butkiewicz L, Harmon D, 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. 2002;50(4):309-19.
55. Cvetkovic RS, Figgitt DP, Plosker GL. Et-743. Drugs. 2002;62(8):1185-92 (discussion 93-4).
56. Reid JM, Kuffel MJ, Ruben SL, Morales JJ, Rinehart KL, Squillace DP, 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. 2002;8(9):2952-62.
57. Brandon EF, Meijerman I, Klijn JS, den Arend D, Sparidans RW, Lazaro LL, 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):935-43.
58. Beumer JH, Rademaker-Lakhai JM, Rosing H, Lopez-Lazaro L, Beijnen JH, Schellens JH. Trabectedin (Yondelis, formerly ET-743), a mass balance study in patients with advanced cancer. Investig New Drugs. 2005;23(5):429-36.
59. Beumer JH, Rademaker-Lakhai JM, Rosing H, Hillebrand MJ, Bosch TM, Lopez-Lazaro L, et al. Metabolism of trabectedin (ET-743, Yondelis) in patients with advanced cancer. Cancer Chemother Pharmacol. 2007;59(6):825-37.
60. Bruder F, Massa D, Barca M, Crova A, Contu V, Airoldi M. Prolonged disease stability with trabectedin in two mono kidney patients with renal impairment [abstract]. In: 17th annual meeting of the Connective Tissue Oncology Society (CTOS) 2012 14-17 November, 2012; Prague, Czech Republic; 2012.
61. Galizia D, Palesandro E, Nuzzo AM, Pignochino Y, Aliberti S, Aglietta M, et al. Prolonged disease stability with trabectedin in a heavily pretreated elderly patient with metastatic leiomyosarcoma of the thigh and renal failure: a case report and review of the literature. Oncol Res. 2013;20(10):483-90.
62. Thariat J, Etienne-Grimaldi MC, Launay-Vacher V, Soto-Matos A, Fernandez-Teruel C, Ghafari T, et al. Pharmacokinetics of trabectedin on hemodialysis: an application for the management of cancer patients with end-stage renal disease. Cancer Chemother Pharmacol. 2011;68(5):1363-7.
63. Le Cesne A, Judson I, Maki R, Grosso F, Schuetze S, Von Mehren M, et al. Trabectedin is a feasible treatment for soft tissue sarcoma patients regardless of patient age: a retrospective pooled analysis of five phase II trials. Br J Cancer. 2013;109(7): 1717-24.
64. Beumer JH, Schellens JH, Beijnen JH. Hepatotoxicity and metabolism of trabectedin: a literature review. Pharmacol Res. 2005;51(5):391-8.
65. Staddon AP, Parekh T, Knoblauch RE, Keung C, Bernard A, Aymes AL, et al. Phase I/IIa, randomized, open-label, drug-drug interaction study of trabectedin and rifampin in patients with advanced cancer. J Clin Oncol. 2013;31(15 suppl):abstr e13512).
66. Fayette J, Coquard IR, Alberti L, Boyle H, Meeus P, Decouvelaere AV, et al. ET-743: a novel agent with activity in soft-tissue sarcomas. Curr Opin Oncol. 2006;18(4):347-53.
67. Blay JY, von Mehren M, Samuels BL, Fanucchi MP, Ray-Coquard I, Buckley B, et al. Phase I combination study of trabectedin and doxorubicin in patients with soft-tissue sarcoma. Clin Cancer Res. 2008;14(20):6656-62.
68. Sessa C, Perotti A, Noberasco C, De Braud F, Gallerani E, Cresta S, et al. Phase I clinical and pharmacokinetic study of trabectedin and doxorubicin in advanced soft tissue sarcoma and breast cancer. Eur J Cancer. 2009;45(7):1153-61.
69. von Mehren M, Schilder RJ, Cheng JD, Temmer E, Cardoso TM, Renshaw FG, 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):1802-9.
70. Vidal L, Garcia-Matin M, Tan S, Montes A, Judson I, Cuadra C, et al. Phase I combination study of trabectedin and carboplatin in advanced solid tumours. Ann Oncol. 2004;15(Suppl 2):iii106.
71. Messersmith WA, Jimeno A, Ettinger D, Laheru D, Brahmer J, Lansey 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):181-8.
72. Chu Q, Mita A, Forouzesh B, Tolcher AW, Schwartz G, Nieto A, 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):2656-65.
73. Sessa C, Cresta S, Noberasco C, Capri G, Gallerani E, De Braud F, et al. Phase I clinical and pharmacokinetic study of trabectedin and cisplatin in solid tumours. Eur J Cancer. 2009;45(12): 2116-22.
74. Papadopoulos KP, Chu Q, Patnaik A, Mita MM, Cooper J, van Maanen R, et al. Phase I and pharmacokinetic (PK) study of sequential paclitaxel and trabectedin every 2 weeks in patients with advanced solid tumors. J Clin Oncol. 2006;24(18S):2029.
75. Perez-Ruixo JJ, Zannikos P, Hirankarn S, Stuyckens K, Ludwig EA, Soto-Matos A, et al. Population pharmacokinetic meta-analysis of trabectedin (ET-743, Yondelis) in cancer patients. Clin Pharmacokinet. 2007;46(10):867-84.
76. Lee JK, Leslie EM, Zamek-Gliszczynski MJ, Brouwer KL. Modulation of trabectedin (ET-743) hepatobiliary disposition by multidrug resistance-associated proteins (Mrps) may prevent hepatotoxicity. Toxicol Appl Pharmacol. 2008;228(1):17-23.
77. Paz-Ares L, Lopez-Pousa A, Poveda A, Balana C, Ciruelos E, Bellmunt J, et al. Trabectedin in pre-treated patients with advanced or metastatic soft tissue sarcoma: a phase II study evaluating co-treatment with dexamethasone. Investig New Drugs. 2012;30(2):729-40.
78. Baxter K, editor. Antineoplastics. In: Stockley's drug interactions: a source book of interactions, their mechanisms, clinical importance and management. 9th ed. London: Pharmaceutical Press; 2010.
79. Grosso F, D'Incalci M, Cartoafa M, Nieto A, Fernandez-Teruel C, Alfaro V, et al. A comprehensive safety analysis confirms rhabdomyolysis as an uncommon adverse reaction in patients treated with trabectedin. Cancer Chemother Pharmacol. 2012; 69(6):1557-65.
80. Strippoli S, Lorusso V, Albano A, Guida M. Herbal-drug interaction induced rhabdomyolysis in a liposarcoma patient receiving trabectedin. BMC Complement Alt Med. 2013;13:199.
81. Ploner F, Lamm W, Schur S, Eisterer W, Kuhr T, Lindorfer A, et al. The Austrian experience with trabectedin in non-selected patients with metastatic soft tissue sarcoma (STS). J Cancer Res Clin Oncol. 2013;139(8):1337-42.
82. Schur S, Lamm W, Kostler WJ, Hoetzenecker K, Nemecek E, Schwameis K, et al. Trabectedin in patients with metastatic soft tissue sarcoma: a retrospective single center analysis. Anticancer Drugs. 2013;24(7):725-30.
83. Martin-Liberal J, Judson I. Safety evaluation of trabectedin in treatment of soft-tissue sarcomas. Exp Opin Drug Saf. 2013; 12(6):905-11.
84. Gounaris I, Hatcher HM, Davidson D, Sherbourne K, Alam S, Zaki KA, et al. Trabectedin for advanced soft tissue sarcomas: a single institution experience. Future Oncol. 2014 Jan 22 [Epub ahead of print].
85. Demetri GD, Schuetze S, Blay JY, Chawla S, von Mehren M, Casali P, et al. Long-term results of a randomized phase II study of trabectedin by two different dose and schedule regimens in patients with advanced liposarcoma or leiomyosarcoma after failure of prior anthracyclines and ifosfamide [abstract]. J Clin Oncol. 2009;27:538 (abstract 10509).
86. Lawrie TA, Bryant A, Cameron A, Gray E, Morrison J. Pegylated liposomal doxorubicin for relapsed epithelial ovarian cancer. Cochrane Database Syst Rev. 2013;7:CD006910.
87. Ueda T, Kakunaga S, Ando M, Yonemori K, Sugiura H, Yamada K, Kawai A. Phase I and pharmacokinetic study of trabectedin, a DNA minor groove binder, administered as a 24-h continuous infusion in Japanese patients with soft tissue sarcoma. Invest New Drugs. 2014 Apr 3 [Epub ahead of print].
88. Lebedinsky C, Gomez J, Park YC, Nieto A, Soto-Matos A, Parekh T, et al. Trabectedin has a low cardiac risk profile: a comprehensive cardiac safety analysis. Cancer Chemother Pharmacol. 2011;68(5):1223-31.
89. Thertulien R, Manikhas GM, Dirix LY, Vermorken JB, Park K, Jain MM, et al. Effect of trabectedin on the QT interval in patients with advanced solid tumor malignancies. Cancer Chemother Pharmacol. 2012;69(2):341-50.
90. Casali PG, Sanfilippo R, D'Incalci M. Trabectedin therapy for sarcomas. Curr Opin Oncol. 2010;22(4):342-6.
91. Grosso F, Dileo P, Sanfilippo R, Stacchiotti S, Bertulli R, Piovesan C, et al. Steroid premedication markedly reduces liver and bone marrow toxicity of trabectedin in advanced sarcoma. Eur J Cancer. 2006;42(10):1484-90.
92. del Campo JM, Roszak A, Bidzinski M, Ciuleanu TE, Hogberg T, Wojtukiewicz MZ, 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):1794-802.
93. Theman TA, Hartzell TL, Sinha I, Polson K, Morgan J, Demetri GD, et al. Recognition of a new chemotherapeutic vesicant: trabectedin (ecteinascidin-743) extravasation with skin and soft tissue damage. J Clin Oncol. 2009;27(33):e198-200.
94. Schoffski P, Cerbone L, Wolter P, De Wever I, Samson I, Dumez H, et al. Administration of 24-h intravenous infusions of trabectedin in ambulatory patients with mesenchymal tumors via disposable elastomeric pumps: an effective and patient-friendly palliative treatment option. Onkologie. 2012;35(1-2):14-7.
95. Martella F, Salutari V, Pisano C, Marchetti C, Pietta F, Caringella AM, et al. Retrospective analysis of trabectedin infusion in an outpatient setting by peripherally inserted central venous catheters (PICC): a multicentric Italian experience [abstract]. Eur J Cancer. 2013;49(Supplement 2):Abstract 3844.
96. Grosso F, Demetri GD, Blay JY, Judson I, Le Cesne A, Spreafico C, et al. Patterns of tumor response to trabectedin (ET743) in myxoid liposarcomas [abstract]. J Clin Oncol. 2006 June 20, 2006;24(18 Suppl):9511.
97. Blay JY, Casali P, Nieto A, Tanovic A, Le Cesne A. Efficacy and safety of trabectedin as an early treatment for advanced or metastatic liposarcoma and leiomyosarcoma. Future Oncol. 2014; 10(1):59-68.
98. Le Cesne A, Ray-Coquard I, Duffaud F, Chevreau C, Penel N, Bui B, et al. A large retrospective analysis of trabectedin in 885 patients with advanced soft tissue sarcoma [abstract]. J Clin Oncol. 2013;31(suppl): abstr 1056.