A pharmacokinetic and safety study of intravenous arsenic trioxide in adult cancer patients with renal impairment

Cancer Chemotherapy and Pharmacology

Volumn 66, Issue 2, 2010, Pages 345-356

  Sweeney, Christopher J ^a,b   Takimoto, Chris ^c   Wood, Leslie ^c   Porter, Jennifer M ^a   Tracewell, William G ^d   Darwish, Mona ^d   D'Andrea, Denise M ^d   Remick, Scot C ^e  

^a INDIANA UNIVERSITY   (United States)

^b DANA FARBER CANCER INSTITUTE   (United States)

^c CTRC Institute for Drug Development   (United States)

^d CEPHALON INC   (United States)

^e UNIVERSITY HOSPITALS OF CLEVELAND   (United States)

Author keywords

Accumulation; Arsenical species; Metabolites; Systemic exposure

Indexed keywords

ANTINEOPLASTIC AGENT; ARSENIC TRIOXIDE; CACODYLIC ACID; DOXORUBICIN; METHANEARSONIC ACID; ORGANOARSENIC DERIVATIVE; OXIDE;

ABDOMINAL PAIN; ADULT; AGED; ANOREXIA; AREA UNDER THE CURVE; ARTICLE; BILIRUBIN BLOOD LEVEL; CANCER PATIENT; CARDIOMYOPATHY; CEREBROVASCULAR ACCIDENT; CLINICAL ARTICLE; CONGESTIVE HEART FAILURE; CONSTIPATION; CONTROLLED STUDY; DIARRHEA; DISEASE ASSOCIATION; DISORIENTATION; DIVERTICULITIS; DOSAGE SCHEDULE COMPARISON; DRUG CLEARANCE; DRUG ELIMINATION; DRUG ERUPTION; DRUG EXCRETION; DRUG FEVER; DRUG HALF LIFE; DRUG INDUCED HEADACHE; DRUG METABOLISM; DRUG SAFETY; DRUG STRUCTURE; DRUG WITHDRAWAL; DYSPNEA; FATIGUE; FEMALE; HEART DEATH; HEART DISEASE; HUMAN; HYPERKALEMIA; HYPOXIA; KIDNEY DISEASE; KIDNEY FAILURE; KIDNEY FUNCTION; LUNG HEMORRHAGE; MALE; MALIGNANT NEOPLASTIC DISEASE; MAXIMUM PLASMA CONCENTRATION; MULTIPLE CYCLE TREATMENT; NAUSEA; PERIPHERAL EDEMA; PLEURA EFFUSION; PRIORITY JOURNAL; QT PROLONGATION; RESPIRATORY FAILURE; SIDE EFFECT; SINGLE DRUG DOSE; SINUS TACHYCARDIA; SOMNOLENCE; STOMATITIS; TIME TO MAXIMUM PLASMA CONCENTRATION; TREATMENT RESPONSE; URINARY EXCRETION; VOMITING; BIOTRANSFORMATION; KARNOFSKY PERFORMANCE STATUS; METABOLISM; METHYLATION; MIDDLE AGED; NEOPLASM;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; AREA UNDER CURVE; ARSENICALS; BIOTRANSFORMATION; FEMALE; HUMANS; KARNOFSKY PERFORMANCE STATUS; KIDNEY DISEASES; MALE; METHYLATION; MIDDLE AGED; NEOPLASMS; OXIDES;

EID: 77953078500     PISSN: 03445704     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00280-009-1169-4     Document Type: Article

References (20)

1. Kwong YL, Todd D (1997) Delicious poison: arsenic trioxide for the treatment of leukemia. Blood 89(9):3487-3488
2. Soignet SL, Maslak P, Wang ZG et al (1998) Complete remission after treatment of acute promyelocytic leukemia with arsenic trioxide. N Engl J Med 339(19):1341-1348
3. Soignet SL, Frankel SR, Douer D et al (2001) United States multicenter study of arsenic trioxide in relapsed acute promyelocytic leukemia. J Clin Oncol 19(18):3852-3860
4. Shen Y, Shen ZX, Yan H et al (2001) Studies on the clinical efficacy and pharmacokinetics of low-dose arsenic trioxide in the treatment of relapsed acute promyelocytic leukemia: a comparison with conventional dosage. Leukemia 15(5):735-741
5. Mathews V, Balasubramanian P, Shaji RV, George B, Chandy M, Srivastava A (2002) Arsenic trioxide in the treatment of newly diagnosed acute promyelocytic leukemia: a single center experience. Am J Hematol 70(4):292-299
6. Mathews V, George B, Lakshmi KM et al (2006) Single-agent arsenic trioxide in the treatment of newly diagnosed acute promyelocytic leukemia: durable remissions with minimal toxicity. Blood 107(7):2627-2632
7. Munshi NC, Tricot G, Desikan R et al (2002) Clinical activity of arsenic trioxide for the treatment of multiple myeloma. Leukemia 16(9):1835-1837
8. Vey N, Bosly A, Guerci A et al (2006) Arsenic trioxide in patients with myelodysplastic syndromes: a phase II multicenter study. J Clin Oncol 24(16):2465-2471
9. Barbey JT, Pezzullo JC, Soignet SL (2003) Effect of arsenic trioxide on QT interval in patients with advanced malignancies. JClin Oncol 21(19):3609-3615
10. Mathews V, Desire S, George B et al (2006) Hepatotoxicity profile of single-agent arsenic trioxide in the treatment of newly diagnosed acute promyelocytic leukemia, its impact on clinical outcome and the effect of genetic polymorphisms on the incidence of hepatotoxicity. Leukemia 20(5):881-883
11. Vahter M (1999) Methylation of inorganic arsenic in different mammalian species and population groups. Sci Prog 82(Pt 1):69-88
12. Vahter M (2002) Mechanisms of arsenic biotransformation. Toxicology 181-182:211-217
13. Aposhian HV, Aposhian MM (2006) Arsenic toxicology: five questions. Chem Res Toxicol 19(1):1-15
14. Chen GQ, Zhou L, Styblo M et al (2003) Methylated metabolites of arsenic trioxide are more potent than arsenic trioxide as apoptotic but not differentiation inducers in leukemia and lymphoma cells. Cancer Res 63(8):1853-1859
15. Styblo M, Del Razo LM, Vega L et al (2000) Comparative toxicity of trivalent and pentavalent inorganic and methylated arsenicals in rat and human cells. Arch Toxicol 74(6):289-299
16. Styblo M, Drobna Z, Jaspers I, Lin S, Thomas DJ (2002) The role of biomethylation in toxicity and carcinogenicity of arsenic: a research update. Environ Health Perspect 110(Suppl 5):767-771
17. Petrick JS, Jagadish B, Mash EA, Aposhian HV (2001) Monomethylarsonous acid (MMA(III)) and arsenite: LD(50) in hamsters and in vitro inhibition of pyruvate dehydrogenase. Chem Res Toxicol 14(6):651-656
18. US Food and Drug Administration (1998) Guidance for industry: pharmacokinetics in patients with impaired renal functionstudy design, data analysis, and impact on dosing and labeling. US Department of Health and Human Services, US Food and Drug Administration, Rockville
19. European Medicines Agency (2004) Note for guidance on the evaluation of the pharmacokinetics of medicinal products in patients with impaired renal function. European Medicines Agency, London
20. Fujisawa S, Ohno R, Shigeno K et al (2007) Pharmacokinetics of arsenic species in Japanese patients with relapsed or refractory acute promyelocytic leukemia treated with arsenic trioxide. Cancer Chemother Pharmacol 59(4):485-493