A comprehensive safety analysis confirms rhabdomyolysis as an uncommon adverse reaction in patients treated with trabectedin

Cancer Chemotherapy and Pharmacology

Volumn 69, Issue 6, 2012, Pages 1557-1565

  Grosso, Federica ^a   D'Incalci, Maurizio ^b   Cartoafa, Mirela ^c   Nieto, Antonio ^c   Fernández Teruel, Carlos ^c   Alfaro, Vicente ^c   Lardelli, Pilar ^c   Roy, Elena ^c   Gómez, Javier ^c   Kahatt, Carmen ^c   Soto Matos, Arturo ^c   Judson, Ian ^d  

^a SC Oncologia SS Antonio and Biagio and C Arrigo General Hospital   (Italy)

^b MARIO NEGRI INSTITUTE FOR PHARMACOLOGICAL RESEARCH   (Italy)

^c PHARMAMAR S A   (Spain)

^d ROYAL MARSDEN HOSPITAL   (United Kingdom)

Author keywords

Creatine phosphokinase; Rhabdomyolysis; Trabectedin

Indexed keywords

AMIODARONE; APREPITANT; ATORVASTATIN; CARBIDOPA PLUS LEVODOPA; CLARITHROMYCIN; DILTIAZEM; DOXORUBICIN; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; LERCANIDIPINE; TRABECTEDIN; VERAPAMIL;

ACUTE KIDNEY FAILURE; ADVANCED CANCER; AREA UNDER THE CURVE; ARTICLE; BONE MARROW SUPPRESSION; BREAST CANCER; CLINICAL TRIAL (TOPIC); COMPASSIONATE USE; DRUG CLEARANCE; DRUG SAFETY; ENDOMETRIUM CANCER; HUMAN; INCIDENCE; INCIDENTAL FINDING; LIVER FUNCTION TEST; MAXIMUM PLASMA CONCENTRATION; MULTIPLE CYCLE TREATMENT; NEUTROPENIA; OSTEOSARCOMA; OVARY CANCER; PRIORITY JOURNAL; PROGNOSIS; RECOMMENDED DRUG DOSE; RHABDOMYOLYSIS; RISK FACTOR; SIDE EFFECT; SOFT TISSUE SARCOMA; SOLID TUMOR; THROMBOCYTOPENIA;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS, PHYTOGENIC; BONE MARROW; CREATINE KINASE; CYTOCHROME P-450 CYP3A; DIOXOLES; FEMALE; HUMANS; MALE; MIDDLE AGED; MULTIVARIATE ANALYSIS; RHABDOMYOLYSIS; TETRAHYDROISOQUINOLINES;

EID: 84863793434     PISSN: 03445704     EISSN: 14320843     Source Type: Journal    
DOI: 10.1007/s00280-012-1864-4     Document Type: Article

References (24)

1. Bosch X, Poch E, Grau JM (2009) Rhabdomyolysis and acute kidney injury. N Engl J Med 361:62-72
2. Brain EG (2002) Safety and efficacy of ET-743: the French experience. Anticancer Drugs 13(Suppl 1):S11-S14
3. Brandon EF, Sparidans RW, Guijt KJ, Lowenthal S, Meijerman I, Beijnen JH, Schellens JH (2006) 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 24:3-14
4. Carter NJ, Keam SJ (2007) Trabectedin: a review of its use in the management of soft tissue sarcoma and ovarian cancer. Drugs 67:2257-2276
5. Cervellin G, Comelli I, Lippi G (2010) Rhabdomyolysis: historical background, clinical, diagnostic and therapeutic features. Clin Chem Lab Med 48:749-756
6. Cziraky MJ, Willey VJ, McKenney JM, Kamat SA, Fisher MD, Guyton JR, Jacobson TA, Davidson MH (2006) Statin safety: an assessment using an administrative claims database. Am J Cardiol 97:61C-68C
7. Chatzizisis YS, Misirli G, Hatzitolios AI, Giannoglou GD (2008) The syndrome of rhabdomyolysis: complications and treatment. Eur J Intern Med 19:568-574
8. Del Campo JM, Roszak A, Bidzinski M, Ciuleanu TE, Hogberg T, Wojtukiewicz MZ, Poveda A, Boman K, Westermann AM, Lebedinsky C (2009) 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 20:1794-1802
9. Demetri GD, Chawla SP, von Mehren M, Ritch P, Baker LH, Blay JY, Hande KR, Keohan ML, Samuels BL, Schuetze S, Lebedinsky C, Elsayed YA, Izquierdo MA, Gomez J, Park YC, Le Cesne A (2009) 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 27:4188-4196
10. Dhand UK (2006) Clinical approach to the weak patient in the intensive care unit. Respir Care 51:1024-1040; discussion 1040-1021
11. Fetterly GJ, Owen JS, Stuyckens K, Passarell JA, Zannikos P, Soto-Matos A, Izquierdo MA, Perez-Ruixo JJ (2008) Semimechanistic pharmacokinetic/ pharmacodynamic model for hepatoprotective effect of dexamethasone on transient transaminitis after trabectedin (ET-743) treatment. Cancer Chemother Pharmacol 62:135-147
12. Grosso F, D'Incalci M (2011) Problems in dealing with very rare adverse effects of new anticancer drugs: the example of trabectedin. Tumori 97:256
13. Grosso F, Dileo P, Sanfilippo R, Stacchiotti S, Bertulli R, Piovesan C, Jimeno J, D'Incalci M, Gescher A, Casali PG (2006) Steroid premedication markedly reduces liver and bone marrow toxicity of trabectedin in advanced sarcoma. Eur J Cancer 42:1484-1490
14. Khan FY (2009) Rhabdomyolysis: a review of the literature. Neth J Med 67:272-283
15. Kumar AA, Bhaskar E, Palamaner Subash Shantha G, Swaminathan P, Abraham G (2009) Rhabdomyolysis in community acquired bacterial sepsis-a retrospective cohort study. PLoS ONE 4:e7182
16. Monk BJ, Herzog TJ, Kaye SB, Krasner CN, Vermorken JB, Muggia FM, Pujade-Lauraine E, Lisyanskaya AS, Makhson AN, Rolski J, Gorbounova VA, Ghatage P, Bidzinski M, Shen K, Ngan HY, Vergote IB, Nam JH, Park YC, Lebedinsky CA, Poveda AM (2010) Trabectedin plus pegylated liposomal doxorubicin in recurrent ovarian cancer. J Clin Oncol 28:3107-3114
17. Pasternak RC, Smith SC Jr, Bairey-Merz CN, Grundy SM, Cleeman JI, Lenfant C (2002) ACC/AHA/NHLBI clinical advisory on the use and safety of statins. Circulation 106:1024-1028
18. Paz-Ares L, Lopez-Pousa A, Poveda A, Balana C, Ciruelos E, Bellmunt J, Del Muro JG, Provencio M, Casado A, Rivera-Herrero F, Izquierdo MA, Nieto A, Tanovic A, Cortes-Funes H, Buesa JM (2010) Trabectedin in pre-treated patients with advanced or metastatic soft tissue sarcoma: a phase II study evaluating co-treatment with dexamethasone. Invest New Drugs (in press)
19. Perez-Ruixo JJ, Zannikos P, Hirankarn S, Stuyckens K, Ludwig EA, Soto-Matos A, Lopez-Lazaro L, Owen JS (2007) Population pharmacokinetic meta-analysis of trabectedin (ET-743, yondelis(( R))) in cancer patients. Clin Pharmacokinet 46:867-884
20. Ryan DP, Supko JG, Eder JP, Seiden MV, Demetri G, Lynch TJ, Fischman AJ, Davis J, Jimeno J, Clark JW (2001) Phase I and pharmacokinetic study of ecteinascidin 743 administered as a 72-hour continuous intravenous infusion in patients with solid malignancies. Clin Cancer Res 7:231-242
21. Singh D, Chander V, Chopra K (2005) Rhabdomyolysis. Methods Find Exp Clin Pharmacol 27:39-48
22. Villalona-Calero MA, Eckhardt SG, Weiss G, Hidalgo M, Beijnen JH, van Kesteren C, Rosing H, Campbell E, Kraynak M, Lopez-Lazaro L, Guzman C, Von Hoff DD, Jimeno J, Rowinsky EK (2002) A phase I and pharmacokinetic study of ecteinascidin- 743 on a daily 9 5 schedule in patients with solid malignancies. Clin Cancer Res 8:75-85
23. Weibrecht K, Dayno M, Darling C, Bird SB (2010) Liver aminotransferases are elevated with rhabdomyolysis in the absence of significant liver injury. J Med Toxicol 6:294-300
24. Yovine A, Riofrio M, Blay JY, Brain E, Alexandre J, Kahatt C, Taamma A, Jimeno J, Martin C, Salhi Y, Cvitkovic E, Misset JL (2004) Phase II study of ecteinascidin-743 in advanced pretreated soft tissue sarcoma patients. J Clin Oncol 22:890-899