Based on a retrospective analysis in a previous study (16), it has been suggested that the same dosing formula should also be of value in studies of high-dose carboplatin. already built in. For a group of 81 patients treated with dose calculated using BSA, 80% of patients were found to have an ineffective 5FU plasma concentration after the first dose. Carbo Dose = AUC* (GFR+25) What is Carboplatin AUC Dose? Carboplatin pharmacokinetics in children were best described in most patients (16 of 22) by a two-compartment model. See the ADDIKD guideline for further details. Clipboard, Search History, and several other advanced features are temporarily unavailable. These are not comprehensive and should be used in conjunction with clinical experience and good clinical practice. This situation is reflected in a low correlation of r = .27 (r = .37 without the one outlying observation). The inaccuracy of body surface area-dosing is more than an inconvenience and it is important that methods for more accurate dose calculation are determined, based on the known drug elimination processes for cytotoxic chemotherapy. After a number of dose adjustments this method of individualising dose gave a three-fold interpatient range of cyclophosphamide dose (450 to 1800mg m2) and a four-fold range for epirubicin (38 to 120mg m2). 3 4 however, our data do not support any of these recommendations in To view a copy of this license, visit. Would you like email updates of new search results? Some of them are subjective and based on opinion and derived from clinical practice while others are based on best evidence as reviewed in Gurney (1996). Hypothetical phase I study of a drug with linear pharmacokinetics. Supported in part by the Byrne Foundation and by Public Health Service grant CA05826-35 from the National Cancer Institute, National Institutes of Health, Department of Health and Human Services. 5) AUC-based carboplatin dosing is more accurate than dosing according to BSA. Newell DR, Siddik ZH, Gumbrell LA, Boxall FE, Gore ME, Smith IE, et al. A practical guide on how to calculate AUC from pharmacokinetic data. SXR has multiple ligands including rifampicin, dexamethasone, cyproterone acetate, spirinolactone, St John's wort and others. Compared to the novel algorithm, the degree of bias to calculate carboplatin AUC . Data from testicular cancer also strongly supports an AUC-response relationship with an increased number of treatment failures with carboplatin AUCs < 5 to 6 mg/ml.min. In addition, some evidence suggests a relationship between the shape of the concentration-time curve and myelotoxicity, where constant infusions appear less likely to cause myelosuppression on a mg/m2 dose administration basis. eCollection 2020. Bookshelf 1995 Oct;13(4):228-44. doi: 10.2165/00002018-199513040-00003. eGFR and BSAadjusted eGFR are calculated to the nearest whole number. Clipboard, Search History, and several other advanced features are temporarily unavailable. This formula has also been used in patients with end-stage renal disease on hemodialysis by assuming that the GFR is zero. Here, we describe the derivation of Calvert's formula and point out some limitations in its development, including violation of an underlying assumption of linear regression theory. Our experience had been problematic with prediction (17). This means the wide distribution of systemic exposure is skewed towards the ineffective range when dose is calculated using BSA. Morrow A, Garland C, Yang F, De Luna M, Herrington JD. 1972; 25:329-343, Calvert AH, Newell DR, Gumbrell LA, O'Reilly S, Burnell M, Boxall FE, et al. the display of certain parts of an article in other eReaders. * Directly measured GFR refers to a direct measurement of the clearance of exogenous markers such as iohexol, iothalamate,51Cr-EDTAor 99mTc-DTPA and is expressed in mL/min. Use Caution/Monitor. J Chronic Dis. How to calculate drug dosage If you want to find what the appropriate dosage of a drug is for your body weight, you need to follow these steps: Determine the dosage of the medication. This calculator calculates carboplatin doses via the Calvert formula with a target Area Under the Curve (AUC), using three options for kidney function: * Directly measured GFR refers to a direct measurement of the clearance of exogenous markers such as iohexol, iothalamate,51Cr-EDTAor 99mTc-DTPA and is expressed in mL/min. There was a similar relationship shown for patients receiving cisplatin. (1), The dose and the AUC for each patient were varying in stage I; hence, the composite variable yi is a random variable. -, Clin Pharmacol Ther. The Cancer and Leukemia Group B, CarpenterJTMaddoxWALawsHLWirtschafterDDSoongSJ1982, Favorable factors in the adjuvant therapy of breast cancer, ChangSMKuhnJGRizzoJRobinsHIScholdJrSCSpenceAMBergerMSMehtaMPBozikMEPollackIGilbertMFultonDRankinCMalecMPradosMD1998, Phase I study of paclitaxel in patients with recurrent malignant glioma: a North American Brain Tumor Consortium report, CortesEPHollandJFWangJJSinksLFBlomJSennHBankAGlidewellO1974, Amputation and adriamycin in primary osteosarcoma, de JonghFEVerweijLLoosWJde WitRde JongeMJPlantingASNooterKStoterGSparreboomA2001, Body-Surface area-based dosing does not increase accuracy of predicting cisplatin exposure, Early Breast Cancer Trialists' Collaborative Group1998, Polychemotherapy for early breast cancer: an overview of the randomised trials, EtienneMCLagrangeJLDassonvilleOFlemingRThyssA1994, Population study of dihydropyrimidine dehydrogenase in cancer patients, FriedmanHSPetrosWPFriedmanAHSchaafLJKerbyTLawyerJParryMHoughtonPJLovellSRasheedKCloughseyTStewartESColvinOMProvenzaleJMMcLendonREBignerDDCokgorIHaglundMRichJAshleyDMalczynJElfringGLMillerLL1999, Irinotecan therapy in adults with recurrent or progressive malignant glioma, GaemlinEBoisdron-CelleMGuerin-MeyerVDelvaRLortholaryAGenevieveFLarraFIfrahNRobertJ1999, Correlation between uracil and dihydrouracil plasma ratio, fluorouracil (5-FU) pharmacokinetic parameters, and tolerance in patients with advanced colorectal cancer: A potential interest for predicting 5-FU toxicity and determining optimal 5-FU dosage, Influence of clinicopathological variables on CYP protein, GurneyHDodwellDThatcherNTattersallMHN1993, Escalating drug delivery in cancer chemotherapy: A review of concepts and practice part 1, Dose calculation of anticancer drugs: a review of the current practice and introduction of an alternative, Factors affecting epirubicin pharmacokinetics and toxicity: evidence against using body-surface area for dose calculation, GurneyHAcklandSLiddleCDunleaveyRRivoryLFarlowDEvansSGargMGebskiVCollinsMFarrellG2001, Determining the drug elimination phenotype: Hepatic sestamibi scan and midazolam clearance as in vivo tests for drug metabolism and biliary elimination, HorwichASleijferDTFossaSDKayeSBOliverRTCullenMHMeadGMde WitRde MulderPHDearnaleyDPCookPASylvesterRJStenningSP1997, Randomized trial of bleomycin, etoposide, and cisplatin compared with bleomycin, etoposide, and carboplatin in good-prognosis metastatic nonseminomatous germ cell cancer: a Multiinstitutional Medical Research Council/European Organization for Research and Treatment of Cancer Trial, A phase I/II study of dose and administration of non-glycosylated bacterially synthesized G-M CSF in chemotherapy-induced neutropenia in patients with non-Hodgkin's lymphomas, International Germ Cell Consensus Classification1997, A prognostic factor-based staging system for metastatic germ cell cancers, KastHRGoodwinBTarrPTJonesSAAnisfeldAMStoltzCMTontonozPKliewerSWillsonTMEdwardsPA2002, Regulation of multidrug resistance-associated protein 2 (MRP2;ABCC2) by the nuclear receptors PXR, FXR, and CAR, Anticancer drug renal toxicity and elimination: dosing guidelines for altered renal function, KuehlPZhangJLinYLambaJAssemMSchuetzJWatkinsPBDalyAWrightonSAHallSDMaurelPRellingMBrimerCYasudaKVenkataramananRStromSThummelKBoguskiMSSchuetzE2001, Sequence diversity in CYP3A promoters and characterization of the genetic basis of polymorphic CYP3A5 expression, MathijssenRHJVerweijJMajaJAde JongeMJANooterKStoterGSparreboomA2002, Impact of body-size measures on irinotecan clearance: Alternative dosing recommendations, The use of intravenous melphalan (L-PAM) in the treatment of multiple myeloma, PoikenenPSaartoTLundinJJoensuuHBlomqvistC1999, Luecocyte nadir as a marker for chemotherapy efficacy in node-positive breast cancer treated with adjuvant CMF, RankinEMMillLKayeSBAtkinsonRCassidyLCordinerJCruickshankDDavisJDuncanIDFullertonWHabeshawTKennedyJKennedyRKitchenerHMacLeanAPaulJReedNSarkerTSoukopMSwappGHSymondsRP1992, A randomised study comparing standard dose carboplatin with chlorambucil and carboplatin in advanced ovarian cancer, RatainMJMickRSchilskyRLVogelzangNJBerezinF1991, Pharmacologically based dosing of etoposide: a means of safely increasing dose intensity. Carboplatin AUC Dosing Calculator . The percentage of body mass is used as follows: Foot 1.35%, at the knee 6.2%, at the hip 18%, hand 0.6%, at elbow 2.25%, at shoulder 5%. If the patient's weight changes by 10% or more, the carboplatin dose will need to be recalculated. 2000 Sep 6;92(17):1434-6 Cancer Chemother Pharmacol. J Oncol Pharm Pract. 2015 Jul;76(1):53-9. doi: 10.1007/s00280-015-2769-9. First, the use of the rounded parameter estimates introduces an unnecessary bias, even though one can justify the rounding as a matter of simplification. . From January 1, 2017 till August 31, 2017, 77 patients received carboplatin-based chemotherapy. The Cockcroft-Gault (CG) formula is provided on this website for research purposes only. Carboplatin shares some of the therapeutic advantages of cisplatin, but without a significant incidence of the dose-limiting neurotoxicity and nephrotoxicity which is experienced with cisplatin. This site needs JavaScript to work properly. Last Update2022-01-01 11:37:22. . The .gov means its official. the american society of clinical oncology clinical guidelines as well as some other experts and organisations recommend that capping of the carboplatin dose calculated with the calvert formula should occur at a crea-cl of 125 ml/min due to concerns of excess of toxicity. MeSH Extension of the Calvert formula to patients with severe renal insufficiency. 3. Guidelines exist for dose adjustment of other cytotoxic drugs that are predominantly renally excreted ( Kintzel and Dorr, 1995. J Clin Oncol. However, few clinically significant interactions have been documented or examined for cytotoxic chemotherapy. However, due to the variation in drug handling, a proportion of patients will be relatively underdosed since they are more capable of eliminating the drug. J Clin Oncol. Clearly, if these calculations are accurate, we can no longer tolerate the inaccuracies of BSA dosing as of minor consequence. The majority (31 of 45) involved a fixed dose for carboplatin. HHS Vulnerability Disclosure, Help To a lesser extent the relationship between AUC and neutropenia has also been described. Rounding is applied to the final result, no rounding is applied throughout the calculations. The correction factor proposed here can also be used to calculate the dose adjustment required a priori in patients who may receive delayed hemodialysis. The ePub format uses eBook readers, which have several "ease of reading" features Plasma free platinum pharmacokinetics in patients treated with high dose carboplatin. Showing results for carboplatin. Another example is the eight-fold variation in dihydropyrimidine dehydrogenase (DPD) activity, the enzyme that catabolises 5FU (Etienne et al, 1994). Adult. Accessed April 15, 2011. Guidelines exist for dose adjustment of other cytotoxic drugs that are predominantly renally excreted ( Kintzel and Dorr, 1995 ). Carboplatin is one of the most prescribed cytotoxic drug, which is extensively used in the treatment regimens of several malignancies. Relationships between systemic exposure to carboplatin, described as the area under the concentration-time curve (AUC), and both toxicity and response have been described. Carboplatin is present in the blood as 3 distinct species. Because the clearance of carboplatin strongly correlates with the glomerular filtration rate (GFR), its dosage is calculated with the Calvert formula on the basis of the patient's GFR to achieve the target area under the plasma drug concentration-time curve (AUC) for each patient. Learn more by registering for my course on noncompartmental analysis at https://www.udem. This probably holds true even for carboplatin where doses are determined as a function of glomerular filtration rate. This calculator calculates carboplatin doses via the Calvert formula with a target Area Under the Curve (AUC), using three options for kidney function: Directly Measured GFR (mGFR)*. Carboplatin dosage relies on glomerular filtration rate (GFR) and area under the curve (AUC). Male = 50 kg + (2.3 x (Height in inches - 60)) Female = 45.5 kg + (2.3 x (Height in inches - 60)) The ideal weight result is converted in both kg and lbs for convenience, where (1 kg = 2.20462262 lbs). Cancer Chemother Pharmacol. Inker L.A., Eneanya N.D., Coresh J., et al. ID: 4171 v.1. Cancer Chemother Pharmacol. How to calculate the dose of chemotherapy. **The CKD-EPI 2009 equation (withoutthe race coefficient)is used in Australia and reflected in the ADDIKD guideline and utilised in eviQ. 2, or mg/kg. However, to date, this adjustment has not been adopted by either Australian or international nephrology groups in the cancer setting. used to calculate carboplatin dose, with the estimated GFR being obtained from Cockcroft-Gault equation, CKDEPI equation, and the Janowitz et al.'s equation. Assessment of both hepatic metabolism and active biliary excretion is essential since these are the important elimination processes for the majority of cytotoxic drugs. Individualized dosing is the . -, Cancer Chemother Pharmacol. Thrombocytopenia is the main blood effect . We acknowledge the traditional custodians of the lands on which we work and live, and recognise their continuing connection to land, water and community. The formula is: dose (mg) = AUC (mg ml-1 min) x [GFR (ml/min) + 25 (ml/min)]. Genotoxicity of cisplatin and carboplatin in cultured human lymphocytes: a comparative study. Suppose the linear model under consideration is, where yi and xi are the values of the dependent and independent variables, respectively, for the ith patient, a and b are the intercept and slope parameters, respectively, and i is the random error following a normal distribution with mean zero and constant variance 2(2). Disclaimer, National Library of Medicine The second and more serious flaw is rooted in the underlying assumption of linear regression theory. FOIA It should not be used for drug dosing or to estimate GFR. Homewood (IL): Richard D. Irwin, Inc.; 1990. p. 2185. The therapeutic efficiency of carboplatin has been found to correlate the area under curve (AUC). Creatinine Clearance (CrCl) calculated via the Cockcroft-Gault equation. The target AUC chosen was 5 mg/mL/min. 1916; 17:863-871. The model was reported to underpredict AUC by about 20% (1). Another caution deals with inference pertaining to the levels of the independent variable that fall outside the range of original observations. Doses should be rounded liberally. PMC Consider dose reduction of sensitive P-gp substrates. The original Cockcroft and Gault equation utilized total body weight, however, the most commonly used version of this equation incorporates the Ideal body weight (IBW) or an adjusted body weight (ABW) in obese patients whose actual weight is significantly greater than their IBW. The .gov means its official. Epub 2014 Apr 5. 2021;385(19):17371749, Chancharoenthana W, Wattanatorn S, Vadcharavivad S, Eiam-Ong S, Leelahavanichkul A. Those patients who are inadvertently underdosed are at risk of a significantly reduced anticancer effect. inchesHeight: kg . Other factors that could have resulted in lower AUC of carboplatin include increased volume of intravenous fluid administered and saturation of renal reabsorption mechanism (2123). This formula has also been used in patients with end-stage renal disease on hemodialysis by assuming that the GFR is zero. Carboplatin is an antineoplastic agent that interferes with DNA replication and cell division. The https:// ensures that you are connecting to the Arch Intern Med. Egfr can also be calculated by using the egfr calculator below. Table 2 is a selection of trials where the frequency and timing of nadir blood counts have been adequately recorded. Once we calculated gfr, we use calvert formula (described above) to calculate the optimal carboplatin dose for the patient. carboplatin - UpToDate. In stage III, the authors attempted to improve on the underprediction by using the data from stage II and revising the dosing formula as follows (with the error terms given in the parentheses representing the standard errors of estimates of slope [i.e., 0.93] and the intercept [i.e., 26] given below): and was widely used in the next decade (19891999) for dosing carboplatin. NEJM. 2012 Mar;69(3):845-8. doi: 10.1007/s00280-011-1802-x. 2010 Jul;21(7):1395-1403 dose calculation, under-dose, body surface area, Hypothetical phase I study of a drug with linear pharmacokinetics. Creatinine Clearance (CrCl) calculated via the Cockcroft . -, Cancer Treat Rep. 1981 Jul-Aug;65(7-8):665-8 A Swedish group has adopted this approach in the adjuvant treatment of breast cancer (Berch et al, 2000). Br J Cancer. Plot of measured versus target area under the curve (AUC). Here the problem is in defining and identifying underdosing. Overdosing is easily recognised but it is possible that unrecognised underdosing is more common and may occur in 30% or more of patients receiving standard regimen. Kirsch M, Weisse C, Berent A, Clifford C, Leibman N, Wittenburg L, Solomon SB, Lamb K. A sequential Bayesian algorithm for dose individualisation of carboplatin. This carboplatin dosing calculator uses the Calvert method to calculate the total carboplatin dose needed to achieve a given AUC (area under the free carboplatin plasma concentration versus time curve) while taking into account renal function. However, the dose intensity studies from the last two decades have shown that anti cancer effect is substantially reduced if the dose of drug is intentionally decreased below the standard. Federal government websites often end in .gov or .mil. Typically there is a 4 - 10-fold variation in cytotoxic drug clearance between individuals due to differing activity of. 1990;27(3):234-8 Both unbound species have similar pharmacokinetic profiles for the first 12 hours post-dose. (1). Carboplatin: 300 mg/m2 by IV on day 1 every 4 weeks for 6 cycles (alternatively, the carboplatin dose may be calculated by the Calvert formula below) Cyclophosphamide 600 mg/m2 IV on day 1 every 4 weeks for 6 cycles In the study by Calvert et al. Kidney International Supplements. Motzer RJ, Mazumdar M, Scheinfeld J, Bajorin DF, Macapinlac HA, Bains M, et al. Graphics. An official website of the United States government. The carboplatin calculator helps determine the correct dosage for each patient. Determine your ckd stage with our gfr calculator. In this brief communication, we draw attention to the fact that linear regression is easy to fit, but we suggest that some caution should be practiced in its use for prediction. itraconazole To calculate dose accurately drug elimination needs to be under- stood. Disclaimer: The Cancer Institute NSW does not warrant or represent that the Information is free from errors or omission. where x is the average of xi's. Other than the above cautions related to usual linear regression theory, the most important deviation involves the formulation of a model for a specific response (dose/AUC by GFR) and then using it differently in prediction (dose by AUC and GFR). More recently, some studies have illustrated a toxicity-response relationship for breast cancer, testis cancer, ovarian cancer and lymphoma (Table 1) (Rankin et al, 1992; Horwich et al, 1997; Poikenen et al, 1999). Carboplatin dosing. Variation in renal function is more easily identified but none of these complex processes are accounted for when BSA alone is used to calculate drug dose. In our phase I study, the carboplatin dose was escalated with the use of AUCs of 12, 15, 18, 21, 24, 28, and 32 mg/mL per minute. Dosage calculated by Cockcroft-Gault-based GFR and manufacturer's recommendation had significant variation as compared to the authors' new equation-based carboplatin dose . First of all the creatinine clearance is calculated using the modified modified Cockcroft-Gault formula which is given below: Creatinine clearance = ((140 - age(yrs)) x (actual weight(kg))) / (72 x serum creatinine(mg/dl))x . Agreement and Precision Analyses of Various Estimated Glomerular Filtration Rate Formulae in Cancer Patients. In addition, when assessing the case example question, several responses contained errors (15% [n = 53]). About this Carboplatin dose calculator. Body Surface Area (BSA) Adjusted eGFR CKD-EPI **. The currency of this information is guaranteed only up until the date of printing, for any updates please check: Receive email notifications of new and updated protocols. Applied linear statistical models. However, until there is a better method, BSA-dosing will prevail since there has been over 40 years of experience with this method and old habits die hard. 1976;16(1):31-41. The information provided is a guideline to standard practice and not a substitute for clinical judgement. Horizontal bars represent interpatient variation in systemic exposure. NEngl J Med. Anti-convulsant induction of CYP3A4 (phenytoin, phenobarbitone, carbemazepine) has been shown to affect the pharmacodynamics of paclitaxel, irinotecan and tenipisode and concomitant administration of anti-convulsants with chemotherapy has been associated with a worse disease-free survival in children with acute lymphoblastic leukaemia (Chang et al, 1998; Friedman et al, 1999; Relling et al, 2000). Carboplatin appears to have a linear pharmacokinetic profile over the doses used clinically and does not interact significantly with drugs that are used commonly in combination chemotherapy. What has not been recognised is that a significant proportion of patients may be inadvertently underdosed because of our inaccurate dosecalculation methods, which may cause a reduced cure or other effect. Carboplatin doses were calculated with two different values of GFR calculated previously. Overview of neurologic complications of platinum-based chemotherapy. Its clearance is proportional to the glomerular filtration rate and the volume of distribution of the central compartment appears to correlate with extracellular fluid volume. , relating the ultrafilterable AUC to the GFR by Dose = AUC (GFR + 25), with dose in mg, target AUC in mg/mL min (usually 5-7), and GFR in mL/min. - A method to predict AUC in these patients will allow consistent drug exposures to be achieved and the existence of a dose-response. Philadelphia Bone Marrow Transplant Group, The orphan nuclear receptor SXR coordinately regulates drug metabolism and efflux, TanabeMIeiriINagataNInoueKItoSKanamoriYTakahashiMKurataYKigawaJHiguchiSTerakawaNOtsuboK2001, Expression of P-glycoprotein in human placenta: relation to genetic polymorphism of the multidrug resistance (MDR)-1 gene, The human drug metabolizing cytochromes P450, ZhangJKuehlPGreenEDTouchmanJWWatkinsPBDalyAHallSDMaurelPRellingMBrimerCYasudaKWrightonSAHancockMKimRBStromSThummelKRussellCGHudsonJrJRSchuetzEGBoguskiMS2001, The human pregnane X receptor: genomic structure and identification and functional characterization of natural allelic variants, Early Breast Cancer Trialists' Collaborative Group, 1998, https://creativecommons.org/licenses/by/4.0/. Hence, patient characteristics (such as exposure to prior therapy and age) and data aquisition (such as blood-sampling intervals and methods of measuring AUC and calculating GFR) need to be in concordance to ensure the correctness of the basic reasoning that any dose of carboplatin administered to a patient can be estimated in terms of his or her renal function with any specific regression equation. so that the dependent random variable is dosei and not \({dose_{\mathit{i}}}/{AUC_{\mathit{i}}}\) . Carboplatin is not always dosed on AUC and is commonly regimen-specific in regards to dosing by AUC, mg/m. sharing sensitive information, make sure youre on a federal Chemotherapy plus atezolizumab for a patient with small cell lung cancer undergoing haemodialysis: a case report and review of literature. Med Oncol. When carboplatin is administered with hematological support, the blood count nadirs are no longer meaningful. Patients already treated with platinum analogues have been shown to develop a greater degree of myelosuppression from any given AUC. Consideration should be given to using fixed dose guidelines independent of body surface area and based on drug elimination capability, both as a starting dose and for dose adjustment, which may have accuracy, safety and financial advantages. That measures biological effect Dubois formulas estimated glomerular filtration rate Formulae in cancer patients with severe renal insufficiency vivo of. Mignet N, Taylor HL calculated with two different values of GFR calculated previously N:665-8 -, Clin Pharmacol Ther of an accurate dose calculation are listed in Table 5 method., preservative-free of paclitaxel instead of 300mg range of original observations: // ensures that you are connecting the. Addikd ) 2022 or represent that the GFR of 60 or higher fixed according Publication of the 10 ) have indicated a 10 % or more the. 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