Effect of renal dysfunction on toxicity in three decades of cancer therapy evaluation program-sponsored single-agent phase I studies

Journal of Clinical Oncology

Volumn 34, Issue 2, 2016, Pages 110-116

  Beumer, Jan H ^a,b,c   Ding, Fei ^a   Tawbi, Hussein ^a,c   Lin, Yan ^a,d   Viluh, Diana ^e   Chatterjee, Indrani ^e   Rinker, Matthew ^e   Chow, Selina L ^a   Ivy, S Percy ^f  

^a UNIVERSITY OF PITTSBURGH CANCER INSTITUTE   (United States)

^b UNIVERSITY OF PITTSBURGH   (United States)

^c UNIVERSITY OF PITTSBURGH SCHOOL OF MEDICINE   (United States)

^d UNIVERSITY OF PITTSBURGH GRADUATE SCHOOL OF PUBLIC HEALTH   (United States)

^e Theradex   (United States)

^f NATIONAL CANCER INSTITUTE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALBUMIN; ANTINEOPLASTIC AGENT; CISPLATIN; CREATININE; BIOLOGICAL MARKER;

ADOLESCENT; AGED; ALBUMIN BLOOD LEVEL; ARTICLE; BODY SURFACE; CANCER CHEMOTHERAPY; COMPARATIVE STUDY; CONTROLLED STUDY; CREATININE BLOOD LEVEL; CREATININE CLEARANCE; EVALUATION STUDY; FEMALE; FOOD AND DRUG ADMINISTRATION; GLOMERULUS FILTRATION RATE; HUMAN; KIDNEY DYSFUNCTION; KIDNEY FUNCTION; MAJOR CLINICAL STUDY; MALE; MILD RENAL IMPAIRMENT; MODERATE RENAL IMPAIRMENT; NATIONAL HEALTH ORGANIZATION; NEPHROTOXICITY; PHASE 1 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; REFERENCE DATABASE; SEVERE RENAL IMPAIRMENT; UREA NITROGEN BLOOD LEVEL; WEIGHT GAIN; ADULT; BLOOD; CHEMICALLY INDUCED; CHRONIC KIDNEY FAILURE; DRUG EFFECTS; FACTUAL DATABASE; KIDNEY; METABOLISM; MIDDLE AGED; PATIENT SELECTION; SEVERITY OF ILLNESS INDEX; STATISTICS AND NUMERICAL DATA; UNITED STATES; VERY ELDERLY;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; BIOMARKERS; CLINICAL TRIALS, PHASE I AS TOPIC; CREATININE; DATABASES, FACTUAL; FEMALE; HUMANS; KIDNEY; MALE; MIDDLE AGED; PATIENT SELECTION; RENAL INSUFFICIENCY, CHRONIC; SEVERITY OF ILLNESS INDEX; UNITED STATES;

EID: 84954322688     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2014.59.7302     Document Type: Article

References (31)

1. Superfin D, Iannucci AA, Davies AM: Commentary: Oncologic drugs in patients with organ dysfunction-A summary. Oncologist 12:1070-1083, 2007
2. Venook AP, Egorin MJ, Rosner GL, et al: Phase I and pharmacokinetic trial of gemcitabine in patients with hepatic or renal dysfunction: Cancer and Leukemia Group B 9565. J Clin Oncol 18:2780-2787, 2000
3. US Department of Health and Human Services, Food and Drug Administration: Guidance for Industry: Pharmacokinetics in patients with impaired renal function-Study design, data analysis, and impact on dosing and labeling, 1998. http://www.fda.gov/downloads/Drugs/.../Guidances/UCM204959.pdf
4. Murray B, Bates J, Buie L: Impact of a new assay for measuring serum creatinine levels on carboplatin dosing. Am J Health Syst Pharm 69:1136-1141, 2012
5. Mosteller RD: Simplified calculation of bodysurface area. N Engl J Med 317:1098, 1987
6. Cockcroft DW, Gault MH: Prediction of creatinine clearance from serum creatinine. Nephron 16:31-41, 1976
7. Jelliffe RW: Letter: Creatinine clearance-Bedside estimate. Ann Intern Med 79:604-605, 1973
8. Levey AS, Bosch JP, Lewis JB, et al: A more accurate method to estimate glomerular filtration rate from serum creatinine: A new prediction equation-Modification of Diet in Renal Disease Study Group. Ann Intern Med 130:461-470, 1999
9. Levey AS, Greene T, Kusek JW, et al: A simplified equation to predict glomerular filtration rate from serum creatinine. J Am Soc Nephrol 11:A0828, 2000 (abstr)
10. Edwards BK, Howe HL, Ries LA, et al: Annual report to the nation on the status of cancer, 1973-1999, featuring implications of age and aging on U.S. cancer burden. Cancer 94:2766-2792, 2002
11. Egorin MJ: Cancer pharmacology in the elderly. Semin Oncol 20:43-49, 1993
12. Forbes GB, Reina JC: Adult lean body mass declines with age: Some longitudinal observations. Metabolism 19:653-663, 1970
13. Lindeman RD, Tobin J, Shock NW: Longitudinal studies on the rate of decline in renal function with age. J Am Geriatr Soc 33:278-285, 1985
14. Wildiers H, Highley MS, de Bruijn EA, et al: Pharmacology of anticancer drugs in the elderly population. Clin Pharmacokinet 42:1213-1242, 2003
15. Egorin MJ, Van Echo DA, Tipping SJ, et al: Pharmacokinetics and dosage reduction of cisdiammine(1,1-cyclobutanedicarboxylato)platinum in patients with impaired renal function. Cancer Res 44:5432-5438, 1984
16. Venook AP, Enders Klein C, Fleming G, et al: A phase I and pharmacokinetic study of irinotecan in patients with hepatic or renal dysfunction or with prior pelvic radiation: CALGB 9863. Ann Oncol 14:1783-1790, 2003
17. Miller AA, Murry DJ, Owzar K, et al: Phase I and pharmacokinetic study of erlotinib for solid tumors in patients with hepatic or renal dysfunction: CALGB 60101. J Clin Oncol 25:3055-3060, 2007
18. Miller AA, Murry DJ, Owzar K, et al: Phase I and pharmacokinetic study of sorafenib in patients with hepatic or renal dysfunction: CALGB 60301. J Clin Oncol 27:1800-1805, 2009
19. Gibbons J, Egorin MJ, Ramanathan RK, et al: Phase I and pharmacokinetic study of imatinib mesylate in patientswith advancedmalignancies and varying degrees of renal dysfunction: A study by the National Cancer Institute Organ Dysfunction Working Group. J Clin Oncol 26:570-576, 2008
20. Leal TB, Remick SC, Takimoto CH, et al: Doseescalating and pharmacological study of bortezomib in adult cancer patients with impaired renal function: A National Cancer Institute Organ Dysfunction Working Group Study. Cancer Chemother Pharmacol 68:1439-1447, 2011
21. Takimoto CH, Remick SC, Sharma S, et al: Dose-escalating and pharmacological study of oxaliplatin in adult cancer patients with impaired renal function: A National Cancer Institute Organ Dysfunction Working Group Study. J Clin Oncol 21:2664-2672, 2003
22. National Kidney Foundation: K/DOQI clinical practice guidelines for chronic kidney disease: Evaluation, classification, and stratification. Am J Kidney Dis 39:S1-S266, 2002 (suppl 1)
23. Hyman DM, Eaton AA, Gounder MM, et al: Nomogram to predict cycle-one serious drug-related toxicity in phase I oncology trials. J Clin Oncol 32:519-526, 2014
24. Huang SM, Temple R, Xiao S, et al: When to conduct a renal impairment study during drug development: US Food and Drug Administration perspective. Clin Pharmacol Ther 86:475-479, 2009
25. Griggs JJ, Mangu PB, Anderson H, et al: Appropriate chemotherapy dosing for obese adult patients with cancer: American Society of Clinical Oncology clinical practice guideline. J Clin Oncol 30:1553-1561, 2012
26. Gaspari F, Perico N, Remuzzi G: Application of newer clearance techniques for the determination of glomerular filtration rate. Curr Opin Nephrol Hypertens 7:675-680, 1998
27. Poole SG, Dooley MJ, Rischin D: A comparison of bedside renal function estimates and measured glomerular filtration rate (Tc99mDTPA clearance) in cancer patients. Ann Oncol 13:949-955, 2002
28. Quinton A, Lewis P, Ali P, et al: A comparison of measured and estimated glomerular filtration rate for carboplatin dose calculation in stage I testicular seminoma. Med Oncol 30:661, 2013
29. Stevens LA, Nolin TD, Richardson MM, et al: Comparison of drug dosing recommendations based on measured GFR and kidney function estimating equations. Am J Kidney Dis 54:33-42, 2009
30. Ainsworth NL, Marshall A, Hatcher H, et al: Evaluation of glomerular filtration rate estimation by Cockcroft-Gault, Jelliffe, Wright and Modification of Diet in Renal Disease (MDRD) formulae in oncology patients. Ann Oncol 23:1845-1853, 2012
31. Murray PT, Ratain MJ: Estimation of the glomerular filtration rate in cancer patients: A new formula for new drugs. J Clin Oncol 21:2633-2635, 2003