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Volumn 46, Issue 10, 2007, Pages 867-884

Population pharmacokinetic meta-analysis of trabectedin (ET-743, Yondelis®) in cancer patients

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; ALBUMIN; ALKALINE PHOSPHATASE; ANTIEMETIC AGENT; ASPARTATE AMINOTRANSFERASE; BILIRUBIN; CREATININE; DEXAMETHASONE; LACTATE DEHYDROGENASE; LIVER PROTECTIVE AGENT; PROTEIN; TRABECTEDIN;

EID: 34548837518     PISSN: 03125963     EISSN: 03125963     Source Type: Journal    
DOI: 10.2165/00003088-200746100-00005     Document Type: Article
Times cited : (42)

References (44)
  • 1
    • 0027159440 scopus 로고
    • Molecular and crystal structures of ecteinascidins: Potent antitumor compounds from the Caribbean tunicate Ecteinascidia turbinata
    • Guan Y, Sakai R, Rinehart KL, et al. Molecular and crystal structures of ecteinascidins: potent antitumor compounds from the Caribbean tunicate Ecteinascidia turbinata. J Biomol Struct Dyn 1993; 10: 793-818
    • (1993) J Biomol Struct Dyn , vol.10 , pp. 793-818
    • Guan, Y.1    Sakai, R.2    Rinehart, K.L.3
  • 2
    • 19944426087 scopus 로고    scopus 로고
    • A phase I and pharmacokinetic study of ecteinascidin-743 (Yondelis) in children with re-fractory solid tumors: A Children's Oncology Group study
    • Lau L, Supko JG, Blaney S, et al. A phase I and pharmacokinetic study of ecteinascidin-743 (Yondelis) in children with re-fractory solid tumors: a Children's Oncology Group study. Clin Cancer Res 2005; 11: 672-7
    • (2005) Clin Cancer Res , vol.11 , pp. 672-677
    • Lau, L.1    Supko, J.G.2    Blaney, S.3
  • 3
    • 0033566150 scopus 로고    scopus 로고
    • Ecteinascidin 743: A minor groove alkylator that bends DNA toward the major groove
    • Zewail-Foote M, Hurley LH. Ecteinascidin 743: a minor groove alkylator that bends DNA toward the major groove. J Med Chem 1999; 42: 2493-7
    • (1999) J Med Chem , vol.42 , pp. 2493-2497
    • Zewail-Foote, M.1    Hurley, L.H.2
  • 4
    • 0035146702 scopus 로고    scopus 로고
    • Ecteinascidin-743 (ET-743), a natural marine compound, with a unique mechanism of action
    • Erba E, Bergamaschi D, Bassano L, et al. Ecteinascidin-743 (ET-743), a natural marine compound, with a unique mechanism of action. Eur J Cancer 2001; 37: 97-105
    • (2001) Eur J Cancer , vol.37 , pp. 97-105
    • Erba, E.1    Bergamaschi, D.2    Bassano, L.3
  • 5
    • 0034612344 scopus 로고    scopus 로고
    • Interference of transcriptional activation by the antineoplastic drug ecteinascidin-743
    • Minuzzo M, Marchini S, Broggini M, et al. Interference of transcriptional activation by the antineoplastic drug ecteinascidin-743. Proc Natl Acad Sci U S A 2000; 97: 6780-4
    • (2000) Proc Natl Acad Sci U S A , vol.97 , pp. 6780-6784
    • Minuzzo, M.1    Marchini, S.2    Broggini, M.3
  • 6
    • 17944374027 scopus 로고    scopus 로고
    • Takebayashi Y, Pourquier P, Zimonjic DB, et al. Antiproliferative activity of ecteinascidin 743 is dependent upon transcription-coupled nucleotide-excision repair [published erratum appears in Nat Med 2001; 7 (11): 1255]. Nat Med 2001; 7 (8): 961-6
    • Takebayashi Y, Pourquier P, Zimonjic DB, et al. Antiproliferative activity of ecteinascidin 743 is dependent upon transcription-coupled nucleotide-excision repair [published erratum appears in Nat Med 2001; 7 (11): 1255]. Nat Med 2001; 7 (8): 961-6
  • 7
    • 0031766324 scopus 로고    scopus 로고
    • In vitro antitumor activity of the novel marine agent, ecteinascidin-743 (ET-743, NSC-648766) against human tumors explanted from patients
    • Izbicka E, Lawrence R, Raymond E, et al. In vitro antitumor activity of the novel marine agent, ecteinascidin-743 (ET-743, NSC-648766) against human tumors explanted from patients. Ann Oncol 1998; 9: 981-7
    • (1998) Ann Oncol , vol.9 , pp. 981-987
    • Izbicka, E.1    Lawrence, R.2    Raymond, E.3
  • 8
    • 20044372153 scopus 로고    scopus 로고
    • 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
    • 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: 576-84
    • (2005) J Clin Oncol , vol.23 , pp. 576-584
    • Le Cesne, A.1    Blay, J.Y.2    Judson, I.3
  • 9
    • 0036154945 scopus 로고    scopus 로고
    • A phase I and pharmacokinetic study of ecteinascidin-743 on a daily x 5 schedule in patients with solid malignancies
    • 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: 75-85
    • (2002) Clin Cancer Res , vol.8 , pp. 75-85
    • Villalona-Calero, M.A.1    Eckhardt, S.G.2    Weiss, G.3
  • 10
    • 0142121506 scopus 로고    scopus 로고
    • Phase I and pharmacokinetic study of Yondelis (ecteinascidin-743; ET-743) administered as an infusion over 1h or 3h every 21 days in patients with solid tumours
    • Twelves C, Hoekman K, Bowman A, et al. Phase I and pharmacokinetic study of Yondelis (ecteinascidin-743; ET-743) administered as an infusion over 1h or 3h every 21 days in patients with solid tumours. Eur J Cancer 2003; 39: 1842-51
    • (2003) Eur J Cancer , vol.39 , pp. 1842-1851
    • Twelves, C.1    Hoekman, K.2    Bowman, A.3
  • 11
    • 0035281641 scopus 로고    scopus 로고
    • Phase I and pharmacokinetic study of ecteinascidin-743, a new marine compound, administered as a 24-hour continuous infusion in patients with solid tumors
    • 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 2001; 19: 1256-65
    • (2001) J Clin Oncol , vol.19 , pp. 1256-1265
    • Taamma, A.1    Misset, J.L.2    Riofrio, M.3
  • 12
    • 0036239748 scopus 로고    scopus 로고
    • Clinical pharmacology of the novel marine-derived anticancer agent ecteinascidin 743 administered as a 1- and 3-h infusion in a phase I study
    • 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: 381-93
    • (2002) Anticancer Drugs , vol.13 , pp. 381-393
    • van Kesteren, C.1    Twelves, C.2    Bowman, A.3
  • 13
    • 0043073206 scopus 로고    scopus 로고
    • Phase II study of ecteinascidin 743 in heavily pretreated patients with recurrent osteosarcoma
    • Laverdiere C, Kolb EA, Supko JG, et al. Phase II study of ecteinascidin 743 in heavily pretreated patients with recurrent osteosarcoma. Cancer 2003; 98: 832-40
    • (2003) Cancer , vol.98 , pp. 832-840
    • Laverdiere, C.1    Kolb, E.A.2    Supko, J.G.3
  • 14
    • 2342461682 scopus 로고    scopus 로고
    • Phase II and pharmacokinetic study of ecteinascidin 743 in patients with progressive sarcomas of soft tissues refractory to chemotherapy
    • 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: 1480-90
    • (2004) J Clin Oncol , vol.22 , pp. 1480-1490
    • Garcia-Carbonero, R.1    Supko, J.G.2    Manola, J.3
  • 15
    • 0035206179 scopus 로고    scopus 로고
    • A comparison of limited sampling strategies for prediction of ecteinascidin 743 clearance when administered as a 24-h infusion
    • van Kesteren C, Mathjt RA, Lopez-Lazaro L, et al. A comparison of limited sampling strategies for prediction of ecteinascidin 743 clearance when administered as a 24-h infusion. Cancer Chemother Pharmacol 2001; 48: 459-66
    • (2001) Cancer Chemother Pharmacol , vol.48 , pp. 459-466
    • van Kesteren, C.1    Mathjt, R.A.2    Lopez-Lazaro, L.3
  • 16
    • 0036387382 scopus 로고    scopus 로고
    • Pharmacokinetics of ecteinascidin 743 administered as a 24-h continuous infusion to adult patients with soft tissue sarcomas: Associations with clinical characteristics, pathophysiological variables and toxicity
    • Puchalski TA, Ryan DP, Garcia-Carbonero R, et al. Pharmacokinetics of ecteinascidin 743 administered as a 24-h continuous infusion to adult patients with soft tissue sarcomas: associations with clinical characteristics, pathophysiological variables and toxicity. Cancer Chemother Pharmacol 2002; 50: 309-19
    • (2002) Cancer Chemother Pharmacol , vol.50 , pp. 309-319
    • Puchalski, T.A.1    Ryan, D.P.2    Garcia-Carbonero, R.3
  • 17
    • 34548817428 scopus 로고    scopus 로고
    • Data on file, Johnson and Johnson Pharmaceutical Research and Development, 2006
    • Data on file, Johnson and Johnson Pharmaceutical Research and Development, 2006
  • 18
    • 34548824193 scopus 로고    scopus 로고
    • R279741 Yondelis™ intravenous formulation (Trabectedin) Investigator's brochure
    • Johnson & Johnson Pharmaceutical Research & Development, Edition 3, Apr
    • Johnson & Johnson Pharmaceutical Research & Development. R279741 Yondelis™ intravenous formulation (Trabectedin) Investigator's brochure. Edition 3. Raritan (NJ): Johnson & Johnson Pharmaceutical Research & Development, 2006 Apr
    • (2006) Raritan (NJ): Johnson & Johnson Pharmaceutical Research & Development
  • 19
    • 23844542907 scopus 로고    scopus 로고
    • Trabectedin (Yondelis™, formerly ET-743), a mass balance study in patients with advanced cancer
    • 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 2005; 23: 429-36
    • (2005) Invest New Drugs , vol.23 , pp. 429-436
    • Beumer, J.H.1    Rademaker-Lakhai, J.M.2    Rosing, H.3
  • 20
    • 0000074019 scopus 로고    scopus 로고
    • Cytochrome P450 catalyzed metabolism of ecteinascidin 743 by rat and human liver microsomes
    • Kuffel MJ, Reid JM, Ames MM. Cytochrome P450 catalyzed metabolism of ecteinascidin 743 by rat and human liver microsomes. Proc Am Assoc Cancer Res 1997; 38: 596
    • (1997) Proc Am Assoc Cancer Res , vol.38 , pp. 596
    • Kuffel, M.J.1    Reid, J.M.2    Ames, M.M.3
  • 21
    • 0002706017 scopus 로고    scopus 로고
    • Characterization of the in vitro metabolism, pharmacokinetics, and biliary excretion of ecteinascidin 743 (NSC 648766) in male and female rats
    • Reid JM, Kuffel MJ, Squillace DP, et al. Characterization of the in vitro metabolism, pharmacokinetics, and biliary excretion of ecteinascidin 743 (NSC 648766) in male and female rats. Ann Oncol 1998; 9: 50
    • (1998) Ann Oncol , vol.9 , pp. 50
    • Reid, J.M.1    Kuffel, M.J.2    Squillace, D.P.3
  • 22
    • 31544458696 scopus 로고    scopus 로고
    • In vitro characterization of the human biotransformation and CYP reaction phenotype of ET-743 (Yondelis, Trabectidin), a novel marine anti-cancer drug
    • Brandon EF, Sparidans RW, Guijt KJ, et al. In vitro characterization of the human biotransformation and CYP reaction phenotype of ET-743 (Yondelis, Trabectidin), a novel marine anti-cancer drug. Invest New Drugs 2006; 24: 3-14
    • (2006) Invest New Drugs , vol.24 , pp. 3-14
    • Brandon, E.F.1    Sparidans, R.W.2    Guijt, K.J.3
  • 23
    • 0027715858 scopus 로고
    • The importance of modeling interoccasion variability in population pharmacokinetic analyses
    • Karlsson MO, Sheiner LB. The importance of modeling interoccasion variability in population pharmacokinetic analyses. J Pharmacokinet Biopharm 1993; 21: 735-50
    • (1993) J Pharmacokinet Biopharm , vol.21 , pp. 735-750
    • Karlsson, M.O.1    Sheiner, L.B.2
  • 24
    • 0035281734 scopus 로고    scopus 로고
    • Ecteinascidin-743: A marine-derived compound in advanced, pretreated sarcoma patients. Preliminary evidence of activity
    • Delaloge S, Yovine A, Taamma A, et al. Ecteinascidin-743: a marine-derived compound in advanced, pretreated sarcoma patients. Preliminary evidence of activity. J Clin Oncol 2001; 19: 1248-55
    • (2001) J Clin Oncol , vol.19 , pp. 1248-1255
    • Delaloge, S.1    Yovine, A.2    Taamma, A.3
  • 25
    • 1542398698 scopus 로고    scopus 로고
    • Phase II study of ecteinascidin-743 in advanced pretreated soft tissue sarcoma patients
    • 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: 890-9
    • (2004) J Clin Oncol , vol.22 , pp. 890-899
    • Yovine, A.1    Riofrio, M.2    Blay, J.Y.3
  • 26
    • 33745259879 scopus 로고    scopus 로고
    • A phase II study of Yondelis (trabectedin, ET-743) as a 24-h continuous intravenous infusion in pretreated advanced breast cancer
    • Zelek L, Yovine A, Brain E, et al. A phase II study of Yondelis (trabectedin, ET-743) as a 24-h continuous intravenous infusion in pretreated advanced breast cancer. Br J Cancer 2006; 94: 1610-4
    • (2006) Br J Cancer , vol.94 , pp. 1610-1614
    • Zelek, L.1    Yovine, A.2    Brain, E.3
  • 27
    • 20144377216 scopus 로고    scopus 로고
    • Trabectedin for women with ovarian carcinoma after treatment with platinum and taxanes fails
    • 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 2005; 23: 1867-74
    • (2005) J Clin Oncol , vol.23 , pp. 1867-1874
    • Sessa, C.1    De Braud, F.2    Perotti, A.3
  • 28
    • 1942516814 scopus 로고    scopus 로고
    • Simple and sensitive liquid chromatographic quantitative analysis of the novel marine anticancer drug Yondelis (ET-743, trabectedin) in human plasma using column switching and tandem mass spectrometric detection
    • Stokvis E, Rosing H, Lopez-Lazaro L, et al. Simple and sensitive liquid chromatographic quantitative analysis of the novel marine anticancer drug Yondelis (ET-743, trabectedin) in human plasma using column switching and tandem mass spectrometric detection. J Mass Spectrom 2004; 39: 431-6
    • (2004) J Mass Spectrom , vol.39 , pp. 431-436
    • Stokvis, E.1    Rosing, H.2    Lopez-Lazaro, L.3
  • 29
    • 7844247581 scopus 로고    scopus 로고
    • Quantitative determination of ecteinascidin 743 in human plasma by miniaturized high-performance liquid chromatography coupled with electrospray ionization tandem mass spectrometry
    • Rosing H, Hillebrand MJ, Jimeno JM, et al. Quantitative determination of ecteinascidin 743 in human plasma by miniaturized high-performance liquid chromatography coupled with electrospray ionization tandem mass spectrometry. J Mass Spectrom 1998; 33: 1134-40
    • (1998) J Mass Spectrom , vol.33 , pp. 1134-1140
    • Rosing, H.1    Hillebrand, M.J.2    Jimeno, J.M.3
  • 32
    • 0017864678 scopus 로고
    • Geometric method for measuring body surface area: A height-weight formula validated in infants, children, and adults
    • Haycock GB, Schwartz GJ, Wisotsky DH. Geometric method for measuring body surface area: a height-weight formula validated in infants, children, and adults. J Pediatr 1978; 93: 62-6
    • (1978) J Pediatr , vol.93 , pp. 62-66
    • Haycock, G.B.1    Schwartz, G.J.2    Wisotsky, D.H.3
  • 33
    • 0031827755 scopus 로고    scopus 로고
    • Improvement of the Cockcroft-Gault equation for predicting glomerular filtration in cancer patients
    • Martin L, Chatelut E, Boneu A, et al. Improvement of the Cockcroft-Gault equation for predicting glomerular filtration in cancer patients. Bulletin Du Cancer 1998; 85: 631-6
    • (1998) Bulletin Du Cancer , vol.85 , pp. 631-636
    • Martin, L.1    Chatelut, E.2    Boneu, A.3
  • 34
    • 85046914570 scopus 로고    scopus 로고
    • Comparison of stepwise covariate model building strategies in population pharmacokinetic-pharmacodynamic analysis
    • Wählby U, Jonsson EN, Karlsson MO. Comparison of stepwise covariate model building strategies in population pharmacokinetic-pharmacodynamic analysis. AAPS PharmSci 2002; 4 (4): E27
    • (2002) AAPS PharmSci , vol.4 , Issue.4
    • Wählby, U.1    Jonsson, E.N.2    Karlsson, M.O.3
  • 35
    • 24944518102 scopus 로고    scopus 로고
    • Verweij J. Ecteinascidin-743 (ET-743): early test or effective treatment in soft tissue sarcomas? J Clin Oncol 2005; 23: 5420-3
    • Verweij J. Ecteinascidin-743 (ET-743): early test or effective treatment in soft tissue sarcomas? J Clin Oncol 2005; 23: 5420-3
  • 37
    • 42149132719 scopus 로고    scopus 로고
    • Semi-mechanistic pharmacokinetic and pharmacodynamic model for hepatoprotective effect of dexamethasone on transient transaminitis after trabectedin (ET-743) treatment
    • In press
    • Fetterly G, Owen JS, Stuyckens K, et al. Semi-mechanistic pharmacokinetic and pharmacodynamic model for hepatoprotective effect of dexamethasone on transient transaminitis after trabectedin (ET-743) treatment. Cancer Chemother Pharmacol. In press
    • Cancer Chemother Pharmacol
    • Fetterly, G.1    Owen, J.S.2    Stuyckens, K.3
  • 38
    • 0021355534 scopus 로고
    • Induction of cytochrome P-450 by glucocorticoids and pregnenolone 16 alpha-carbonitrile regulate de novo synthesis of a common form of cytochrome P-450 in cultures of adult rat hepatocytes and in the liver in vivo
    • Schuetz EG, Wrighton SA, Barwick JL, et al. Induction of cytochrome P-450 by glucocorticoids and pregnenolone 16 alpha-carbonitrile regulate de novo synthesis of a common form of cytochrome P-450 in cultures of adult rat hepatocytes and in the liver in vivo. J Biol Chem 1984; 259: 1999-2006
    • (1984) J Biol Chem , vol.259 , pp. 1999-2006
    • Schuetz, E.G.1    Wrighton, S.A.2    Barwick, J.L.3
  • 39
    • 0021361026 scopus 로고
    • Induction of cytochrome P-450 by glucocorticoids in rat liver. II. Evidence that glucocorticoids regulate induction of cytochrome P-450 by a nonclassical receptor mechanism
    • Schuetz EG, Guzelian PS. Induction of cytochrome P-450 by glucocorticoids in rat liver. II. Evidence that glucocorticoids regulate induction of cytochrome P-450 by a nonclassical receptor mechanism. J Biol Chem 1984; 259: 2007-12
    • (1984) J Biol Chem , vol.259 , pp. 2007-2012
    • Schuetz, E.G.1    Guzelian, P.S.2
  • 40
    • 33745161449 scopus 로고    scopus 로고
    • Steriod premedication markedly reduces liver and bone marrow toxicity of trabectedin in advanced sarcoma
    • Jul;
    • Grosso F, Dileo P, Sanfilippo R, et al. Steriod premedication markedly reduces liver and bone marrow toxicity of trabectedin in advanced sarcoma. Eur J Cancer 2006 Jul; 42 (10): 1484-90
    • (2006) Eur J Cancer , vol.42 , Issue.10 , pp. 1484-1490
    • Grosso, F.1    Dileo, P.2    Sanfilippo, R.3
  • 41
    • 14644423300 scopus 로고    scopus 로고
    • Hepatotoxicity and metabolism of trabectedin: A literature review
    • Beumer JH, Schellens JH, Beijnen JH. Hepatotoxicity and metabolism of trabectedin: a literature review. Pharmacol Res 2005; 51: 391-8
    • (2005) Pharmacol Res , vol.51 , pp. 391-398
    • Beumer, J.H.1    Schellens, J.H.2    Beijnen, J.H.3
  • 42
    • 0141731283 scopus 로고    scopus 로고
    • Complete protection by high-dose dexamethasone against the hepatotoxicity of the novel antitumor drug Yondelis (ET-743) in the rat
    • 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 2003; 63: 5902-8
    • (2003) Cancer Res , vol.63 , pp. 5902-5908
    • Donald, S.1    Verschoyle, R.D.2    Greaves, P.3
  • 43
    • 0029783171 scopus 로고    scopus 로고
    • A population pharmacokinetic model for docetaxel (Taxotere): Model building and validation
    • Bruno R, Vivier N, Vergniol JC, et al. A population pharmacokinetic model for docetaxel (Taxotere): model building and validation. J Pharmacokinet Biopharm 1996; 24 (2): 153-72
    • (1996) J Pharmacokinet Biopharm , vol.24 , Issue.2 , pp. 153-172
    • Bruno, R.1    Vivier, N.2    Vergniol, J.C.3
  • 44
    • 34548820320 scopus 로고    scopus 로고
    • Morgan JA, Le Cesne A, Chawla S, et al. Randomized phase II study of trabectedin in patients with liposarcoma and leiomyosarcoma (L-sarcomas) after failure of prior anthracylines (A) and ifosfamide (I). In: 2007 ASCO Annual Meeting Proceedings; 2007 Jun 1-5; Chicago (IL). J Clin Oncol 2007 Jun 20; 25 (18S): 10060
    • Morgan JA, Le Cesne A, Chawla S, et al. Randomized phase II study of trabectedin in patients with liposarcoma and leiomyosarcoma (L-sarcomas) after failure of prior anthracylines (A) and ifosfamide (I). In: 2007 ASCO Annual Meeting Proceedings; 2007 Jun 1-5; Chicago (IL). J Clin Oncol 2007 Jun 20; 25 (18S): 10060


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