), 4Princess Mxima Center for Pediatric Oncology, 3584 CS Utrecht, The Netherlands, 5Emma Childrens Hospital, Amsterdam UMC, Amsterdam Medical Center, Pediatric Oncology, 1081 HV Amsterdam, The Netherlands; ln.cmumadretsma@knibba.f, 6Amsterdam UMC, Vrije Universiteit Amsterdam, Clinical Pharmacology and Pharmacy, 1081 HV Amsterdam, The Netherlands; ln.cmumadretsma@mlehliw.ja, 7Laboratory of Medical Oncology, Amsterdam University Medical Center, VUMC, 1081 HV Amsterdam, The Netherlands; ln.cmumadretsma@llewyenoh.r (R.J.H. This has been studied extensively in adults [ 18 , 19 ]. Bethesda, MD 20894, Web Policies Male = 50 kg + (2.3 * (Height in inches - 60)) Female = 45.5 kg + (2.3 * (Height in inches - 60)) Carboplatin dose based on the Calvert formula is: Dosage = Target AUC x (GFR + 25) Carboplatin and target AUC The carboplatin dosage value is calculated by taking into account the target area concentration versus time curve and estimated GFR. and G.L.K. Wells J.C.K., Fewtrell M.S., Davies P.S.W., Williams J.E., Coward W.A., Cole T.J. Disclaimer, National Library of Medicine The https:// ensures that you are connecting to the Subgroup analyses were performed for gender and body mass index. Bouquegneau A, Vidal-Petiot E, Moranne O, Mariat C, Boffa JJ, Vrtovsnik F, Scheen AJ, Krzesinski JM, Flamant M, Delanaye P. Br J Clin Pharmacol. van Warmerdam LJ, Rodenhuis S, ten Bokkel Huinink WW, Maes RA, Beijnen JH. The creatinine clearance used to calculate the carboplatin dose will be from PHYS 75 at Emory University the kidneys are working and then calculate the dose based on the kidney function. -, Clin Physiol. Dodgshun A.J., Quinlan C., Sullivan M.J. Cystatin C based equation accurately estimates glomerular filtration rate in children with solid and central nervous system tumours: Enough evidence to change practice? GFR = glomerular filtration rate, CL cr = creatinine clearance, TBW . This formula has proven to be, in both retrospective and prospective studies, a reliable tool to calculate the optimal dose of carboplatin Future studies should determine the value of the creatinine clearance as a measure for the GFR. Serum creatinine concentration for renal function estimation and measured creatinine clearance (24-h urine collection) were available on the same day from these patients. Estimating glomerular filtration rate (GFR) in children. Prediction of total body water in infants and children. Anthropometric dosing is hampered by a weight-dependent bias. Hjorth L., Wiebe T., Karpman D. Correct evaluation of renal glomerular filtration rate requires clearance assays. a To convert to mol/L multiply by 88.4. National Kidney Disease Education Program CKD and Drug Dosing: Information for Providers. At various time points, venous blood (2 mL) was collected into tubes containing lithium heparin anticoagulant. ); ln.cmumadretsma@pmaknekob.a (A.B. This could be a most welcome follow-up study. The impact of this and other clinical factors on pCR rate, dose intensity (DI) and toxicity was assessed. However, the only study so far evaluating eGFR for carboplatin dosing in pediatric oncology patients compared eGFR with a gold standard GFR measurement and extrapolated these findings to drug exposure [15]. Ann Pharmacother. 2001 May;47(5):373-9. doi: 10.1007/s002800000260. The delivered area under the curve (dAUC) was calculated [ (actual carboplatin dose at cycle 1 dose calculated with uncapped/unbanded eGFR) 6] and dichotomized at the median value. Creatinine clearance (Ccr), calculated using the Cockroft-Gault, Jelliffe, Modified-Jelliffe or Wright formulae, has been used as a substitute for the GFR. In this study, the CKD-EPI equation was found to have better performance than the MDRD equation; however, further research is needed to determine if widespread use of CKD-EPI is appropriate. The choice of sampling points was based on population PK modeling and on sampling points described earlier in the literature for carboplatin [5,6,21]. The United Kingdom Childrens Cancer Study Group. Appropriate patient weight and serum creatinine should be used . MR It is necessary to establish a consistent approach to estimating creatinine clearance so that we can reduce vari- ability across institutions and translate clinical trial results into clinical practice. This formula is called the creatinine clearance and tends to exceed the true GFR by 10 to 20 percent or more depending upon the proportion of urinary creatinine that is derived from tubular secretion [ 4 ]. As a temporary measure, it has been suggested that physicians limit the dose of car- boplatin in order to avoid overdosing if they are using the IDMS method to measure serum creatinine. Carboplatin Dosing in Children Using Estimated Glomerular Filtration Rate: Equation Matters, predicted carboplatin clearance (mL/min) = eGFR (mL/min) + 0.36 body weight (kg), AUC (mg/mL.min) = dose (mg)/clearance (mL/min). It is most commonly used to treat lung and ovarian cancers, but has been used off-label in many other diseases. The ePub format is best viewed in the iBooks reader. eGFR: estimated glomerular filtration rate. In conclusion, cystatin C-based eGFR equations for carboplatin dosing in children lead to more accurate carboplatin exposure. Federal government websites often end in .gov or .mil. The University of Chicago Current and Emerging Options for Patients With Melanoma Brain Metastases by Firas Y. Kreidieh, MD, and Hussein A., Treatment of Amyloid Light Chain Cardiac Amyloidosis: Systematic Review and Future Directions by Dunya Alsomali,, The Clinical Importance of Prognostic Markers in CLL with John N. Allan, MD, Nivolumab and Relatlimab as Frontline Therapy in Advanced Melanoma with Nikhil I. Khushalani, MD, 2022 - Millennium Medical Publishing - All Rights Reserved. 1 Original Cockcroft-Gault equation: CrCl = (140age)(weight in kg) (0.85, if female) 72*SCr Glomerular filtration rate in children with solid tumors: Normative values and a new method for estimation. INSTRUCTIONS For use in patients with stable renal function to estimate creatinine clearance. The dose required to achieve the target AUC is then esti- mated based on one of the available formulas, ideally the one that was studied in the clinical trial that is being used as the basis for the treatment decision. http://ctep.cancer.gov/ content/docs/Carboplatin_Information_Letter.pdf. Okamoto H, Nagatomo A, Kunitoh H, Kunikane H, Watanabe K. Cancer Chemother Pharmacol. This model was implemented in MWPharm++ 1.35 (Mediware a.s., Praha, Czech Republic). Chicago, Illinois. and 19.3% capped both creatinine clearance and serum creatinine. Estimating glomerular filtration rate for the full age spectrum from serum creatinine and cystatin C. Berg U.B., Nyman U., Bck R., Hansson M., Monemi K., Herthelius M., Bjrk J. Simultaneous determination of intact cisplatin and its metabolite monohydrated cisplatin in human plasma. First, we did not use a gold standard GFR technique for direct comparison with the eGFR equations and did not assess the most accurate CKiD-3 equation incorporating anthropometric data, creatinine, urea and cystatin C [29,43], as urea had not been measured. Performance in measurement of serum Cystatin C by Laboratories participating in the College of American Pathologists 2014 CYS Survey. 2010 Nov 29. Chatelut E., Boddy A.V., Peng B., Rubie H., Lavit M., Dezeuze A., Pearson A.D.J., Roch H., Robert A., Newell D.R., et al. Nephron. The ethanol precipitation method was validated to be similar to the ultrafiltration methodology for both cisplatin and carboplatin [22] and was therefore preferred for the current study. Beumer J.H., Inker L.A., Levey A.S. Conclusion: Clipboard, Search History, and several other advanced features are temporarily unavailable. Hosp Pharm. For all methods, the plot is skewed towards positive %PE indicating a trend towards overdosing of carboplatin. A decreased renal (kidney) function would Qualitative variables are displayed as numbers (%). CTEP Action Letter. Currently, there is not much evidence for its utility in the context of car- boplatin dosing. Kidneys play an important role in clearing (excreting) drugs. Measuring serum creatinine with the IDMS method may result in overestimation of the GFR in patients with normal renal function, and if the carbopla- tin dose is calculated based on this method, the dose may result in drug-related toxicities. Using cystatin C-based eGFR equations for carboplatin dosing in children leads to more accurate carboplatin-exposure in patients with normal renal function compared to anthropometric dosing. To ensure patient safety and facilitate a medical-team approach, the single most appropriate method available at each institute or medical team should be consistently used to calculate the dose of carboplatin . New Model for Estimating Glomerular Filtration Rate in Patients With Cancer. All tests were done at a two-sided significance level of 0.05. This dosing calculator adjusts for renal . Choice of equations was based on performance in validation studies using gold standard GFR measurements [33]. The predicted creatinine production rate in females is 85% of the calculated value because they have a smaller muscle mass per kilogram, and it is muscle mass that determines creatinine production. 2019 Jan;75(1):51-57. doi: 10.1007/s00228-018-2552-z. and transmitted securely. Cancer Chemother Pharmacol. Leon O. Jacobson Professor of Medicine Director, Center for Personalized Therapeutics Associate Director for Clinical Sciences Cancer Research Center All hospitals used the Calvert formula to calculate carboplatin dose with glomerular filtration rate estimated by a formula, most commonly the Cockcroft-Gault equation (80.7%). The necessity of adjusting the serum PAP-Cr in carboplatin dosing formulas was confirmed as the bias and precision of the estimation was seen in all of the participating institutions as shown by decrease in the absolute value of MPE and RMSE for each institution. Calculating Drug Dosages according to GFR. Carboplatin dosing. Therefore, it is assumed there is limited additional value of adding urea in an equation for this specific population. 1996;37(3):266-70. doi: 10.1007/BF00688327. 2022 Jul 19;24(3):583. doi: 10.3892/etm.2022.11520. In children, a number of eGFR equations have been developed using either creatinine and/or cystatin C [ 20 ]. Unlike the other commonly used formulas (eg, Cockroft-Gault, Jelliffe), it is based on the new creatinine assay. This can result in suboptimal treatment [40] since underestimation of creatinine will lead to an overestimation of GFR and overdosing of carboplatin with the potential of increased toxicity. -, Ann Oncol. -. H&O What are the new changes in serum creatinine, and how might they affect carboplatin dosing? Fourth, calculation of the observed carboplatin AUC was based on the publication by Ekhart et al. Epub 2018 Sep 15. This approach assumes that the extra-renal clearance of carboplatin is linearly related to weight. Of note, the difference in eGFR between both age groups was highest for the Berg equation and lowest for the Schwartzcrea equation. New standardized cystatin C and creatinine GFR equations in children validated with inulin clearance. Data can be obtained at reasonable request. Renal function-based dosing results in more reproducible and reliable drug exposure than anthropometric dosing [8,9] and real-time monitoring with adaptive dosing has been associated with more consistent platinum exposure in children [10]. The authors declare no conflict of interest. of serum creatinine-based GFR estimations, the GFR or creatinine clearance should be directly measured in each patient whenever possible. In children, muscle mass increases with age so that serum creatinine can only be used to monitor renal function after correction for anthropometric data or age [39]. Epub 2012 May 10. All authors have read and agreed to the published version of the manuscript. In renally-impaired patients who received single agent Carboplatin Injection therapy, the incidence of severe leukopenia, neutropenia, or thrombocytopenia has been about 25% when the dosage modifications in the table below have . MeSH Janowitz T., Williams E.H., Marshall A., Ainsworth N., Thomas P., Sammut S.J., Shepherd S., White J., Mark P., Lynch A., et al. This was adjusted for children by introducing a weight-dependent term of 0.36 (i.e., 25 divided by the weight of an average adult of 70 kg) to be added to GFR in the Newell equation [6]. Prospective validation of renal functionbased carboplatin dosing in children with cancer: A United Kingdom childrens cancer study group trial. Results: The dotted lines indicate the thresholds of percentage error of +25% and 10%. This site needs JavaScript to work properly. 2017 Oct 5;8:76. doi: 10.4103/ijpvm.IJPVM_40_17. Flat Dosing of carboplatin is justified in adult patients with normal renal function. Please enable it to take advantage of the complete set of features! official website and that any information you provide is encrypted ; software, M.E.v.d.V. and G.J.P. 2016 Feb;81(2):349-61. doi: 10.1111/bcp.12817. Derivation of new equations to estimate glomerular filtration rate in pediatric oncology patients. Gynecol Oncol Res Pract. and Creatinine clearance (CrCl) values range from 1.24-2.24 mL/second. 2. Qaddoumi I., Bass J., Wu J., Billups C.A., Wozniak A.W., Merchant T.E., Haik B.G., Wilson M.W., Rodriguez-Galindo C. Carboplatin-associated ototoxicity in children with retinoblastoma. 1989;23(6):367-72 eCollection 2017. 2017 Oct 18;4:15. doi: 10.1186/s40661-017-0054-9. Prevention of Chemotherapy-Induced Nephrotoxicity in Children with Cancer. Based on our data this approach seems appropriate as we observed no systematic relation between %PE and bodyweight in the Newell equation with any of the eGFR methods used. Thomas H., Boddy A., English M.W., Hobson R., Imeson J., Lewis I., Morland B., Pearson A.D.J., Pinkerton R., Price L., et al. and E.d.B. 1998;42(4):307-12. doi: 10.1007/s002800050822. Originating from muscle metabolism, serum creatinine not only reflects GFR but is also influenced by extrarenal factors, such as age, gender, and muscle mass. In patients with kidney impairment, it is important to determine how well Federal government websites often end in .gov or .mil. [41]. Newell D.R., Siddik Z.H., Gumbrell L.A., Boxall F.E., Gore M.E., Smith I.E., Calvert A.H. Therefore, taking the patients kidney function into account to calculate the adequate dose of carboplatin might result in a better exposure of carboplatin within a patient. Prediction of creatinine clearance from serum creatinine. Curr Opin Nephrol Hypertens. HHS Vulnerability Disclosure, Help Background: Serum creatinine-based formulas are used to estimate glomerular filtration rate when calculating carboplatin dosage with the Calvert formula. Our results need to be confirmed in a larger cohort, including a larger age spectrum, to determine its clinical relevance. 1998;42(4):307-12. doi: 10.1007/s002800050822. Studies evaluating carboplatin dos- ing are also being encouraged to address the current issues faced with dosing this drug. The equation is: carboplatin dose (mg) = AUC x [GFR + 25]. The weight used in the above equations is IBW. Millisor V.E., Roberts J.K., Sun Y., Tang L., Daryani V.M., Gregornik D., Cross S., Ward D., Pauley J.L., Molinelli A., et al. FOIA The https:// ensures that you are connecting to the The present study is the first external evaluation of carboplatin dosing using estimated rather than measured GFR in the pediatric Newell equation. Discrepancies between the Cockcroft-Gault and Chronic Kidney Disease Epidemiology (CKD-EPI) Equations: Implications for Refining Drug Dosage Adjustment Strategies. US Food and Drug Administration. Accessibility National Kidney Disease Education Program. However, gold standard GFR measurements using inulin, 51Cr-EDTA, 99Tc-DTPA, 125I-iothalamate or iohexol [14,36,37] are invasive, costly and cumbersome, thereby precluding widespread use in clinical practice. The original study published in 1976 used actual body weight, but it mentioned that a correction factor was likely needed for those who are obese. ; validation, L.M.B., A.B. New model for estimating glomerular filtration rate in patients with cancer. Ekhart C., Rodenhuis S., Schellens J.H.M., Beijnen J.H., Huitema A.D.R. Zorbas Y.G., Ichinose M.N., Sakagamis M.B. Data were collected retrospectively from 128 lung cancer patients with serum creatinine <0.8 mg/dL (71 mol/L) who had received chemotherapy that was mostly platinum-based. Measuring GFR: A systematic review. Bookshelf Diagnostic graphs and additional statistical analyses were made using IBM SPSS statistics 22 (Chicago, IL, USA) and GraphPad Prism 7.0 (San Diego, CA, USA). Calvert AH, Newell DR, Gumbrell LA, et al. Creatinine clearance (Ccr) is widely used as a practical substitute for glomerular filtration rate (GFR) in the Calvert formula . Carboplatin dose is based on the Calvert formula: Dosage = Target AUC x (GFR* + 25) *Where the GFR is provided by the eCrCl. This is not unexpected as total body water for weight [45] as well as BSA for weight (infants versus older children 0.046 vs. 0.042 m2/kg in our cohort) are inversely related to age. Den Bakker E., Gemke R., Van Wijk J.A.E., Hubeek I., Stoffel-Wagner B., Bkenkamp A. Janowitz T, Williams EH, Marshall A, Ainsworth N, Thomas PB, Sammut SJ, Shepherd S, White J, Mark PB, Lynch AG, Jodrell DI, Tavar S, Earl H. J Clin Oncol. In overweight and obese patients they were superior in reducing mean overdose from 24% to roughly 15% (predicted normal weight, CKD-EPI) and 10% (adjusted body weight) and from 25% to 9%, 8% and 4%, respectively. Informed consent was obtained from all subjects involved in the study. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (, carboplatin, children, renal function-based dosing, glomerular filtration rate, cystatin C, retinoblastoma. Common estimation equations for creatinine clearance or gfr. Newell D.R., Pearson A.D., Balmanno K., Price L., A Wyllie R., Keir M., Calvert A.H., Lewis I.J., Pinkerton C.R., Stevens M.C. 2015 Feb;50(2):103-7. doi: 10.1310/hpj5002-103. While anthropometric dosing based on BSA or weight performed reasonably well overall, we observed significant underdosing of carboplatin in studies performed at a bodyweight below 10 kg, although patient numbers were small. Before Wanted: methods to measure or estimate renal function for dosing cancer drugs. Rounding in the Calculator; Carboplatin Dosing Tips; ASCO on Dosing Chemo in Obesity: Equations and Conversions; Leucovorin Nomogram; Amputee Calculator Info; Vial Sizes and Concentrations government site. Kidney Disease: Improving Global Outcomes (KDIGO) CKD Workgroup. Therefore, the creatinine clearance is 0.67mL/ min. The results show that application of the alternate size descriptor adjusted body weight in the Cockcroft-Gault equation can improve dosing accuracy especially in overweight and obese patients with low serum creatinine levels. Impact of various body weights and serum creatinine concentrations on the bias and accuracy of the Cockcroft-Gault equation. Body surface area (BSA) was calculated according to Mosteller [35]. Written informed consent was signed by all patients or parents/guardians, as appropriate, before participating in the study. The most commonly used MDRD formula estimates GFR using 4 variables: serum creatinine, age, race, and gender. There is another formula for renal function that has been suggested to be more accuratethe modification of diet in renal disease (MDRD) formula. was 2.8 months of age [30] and 1 month in Millisors cohort [15]. Measured carboplatin clearance obtained from these individual fits were compared with predicted carboplatin clearance using the Newell equation [6]: As most eGFR equations yield standardized GFR in mL/min/1.73 m2 GFR was converted to absolute GFR in mL/min before use in the Newell formula. What is creatinine clearance? National Kidney Foundation K/DOQI Clinical Practice Guidelines for chronic kidney disease: Evaluation, classification and stratification. Carboplatin dosing in overweight and obese patients with normal renal function, does weight matter? In children with impaired kidney function, this trend might be more pronounced. 1988;21(2):163-7 A multicentric evaluation of IDMS-traceable creatinine enzymatic assays. H&O What are the concerns associated with carboplatin dosing? Pottel H., Dubourg L., Schaeffner E., Eriksen B.O., Melsom T., Lamb E.J., Rule A.D., Turner S.T., Glassock R.J., De Souza V., et al. Third, the age spectrum of our study population differed from the populations in which some of the eGFR equations were calibrated. Combining GFR estimates from cystatin C and creatininewhat is the optimal mix? Best performed the combination of Cockcroft-Gault with adjusted body weight. When GFR is measured using a gold standard technique, a strong relationship with carboplatin clearance has been demonstrated [6]. An official website of the United States government. Combining a cystatin C- and a creatinine-based eGFR yielded similar results. Carboplatin dosing for adult Japanese patients. Purpose: The Calvert formula is a widely applied algorithm for the a priori dosing of carboplatin based on patients glomerular filtration rate (GFR) as accurately measured using the 51Cr-EDTA clearance. Solved Problem: Calculate the creatinine clearance of a 60-year-old, 140 lb, 55 female?
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