Carmichael J, Allerheiligen S, Walling J. Dose level 2 is recommended for phase II studies since it causes tolerable toxicity in all patients. 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. . The GFR used in the Calvert formula to calculate AUC dosing should not exceed 125 mL/min. government site. Creatinine Clearance (CrCl) calculated via the Cockcroft-Gault equation. official website and that any information you provide is encrypted If using an estimated kidney function in the Calvert formula, the ADDIKD guideline recommends the use of BSA-adjusted eGFR. A number of SNPs have also recently been identified for the steroid and xenbiotic receptor (SXR), a common-pathway receptor which transcriptionally activates a number of the drug elimination genes such as CYP3A4, MRP2 and MDR1 (Zhang et al, 2001). -. HHS Vulnerability Disclosure, Help Disclaimer, National Library of Medicine -, J Natl Cancer Inst. Ideal body weight (IBW): Relapse rate for the cisplatin containing regimen was 11% for patients with a nadir white cell count (WCC) of over 2.0109 per litre compared with 4% for patients whose WCC fell below 2.0109 per litre after chemotherapy. The ePub format uses eBook readers, which have several "ease of reading" features The maximum dose is based on a capped GFR estimate at 125 mL/min for patients with normal renal function: Horizontal bars represent interpatient variation in systemic exposure. Carboplatin-based combination chemotherapy for testicular cancer: relationship among administration dose of carboplatin, renal function and myelosuppression. Calvert Equation. Int J Clin Pharmacol Ther. in general, the dosage of carboplatin is four times the dosage of cisplatin.32 more than 50% of the administered dosage is excreted unchanged in the urine within 24 hours. Ghazal-Aswad S, Tilby MJ, Lind M, Baily N, Sinha DP, Calvert AH, Newell DR. Pharmacokinetically guided dose escalation of carboplatin in epithelial ovarian cancer: effect on drugplasma AUC and peripheral blood drugDNA adduct levels. Similarly, BSA-based dosing may reduce the cure rate of intermediate prognosis testis cancer by almost 10% compared to a dosing method that prevents underdosing (Samson et al, 1984; Horwich et al, 1997). Suzuki K, Matsumoto K, Hashimoto K, Kurokawa K, Jinbo S, Suzuki T, Imai K, Yamanaka H, Kawashima K, Takahashi H. Li S, Huang H, Liao H, Zhan J, Guo Y, Zou BY, Jiang WQ, Guan ZZ, Yang XQ. Drug elimination can be enhanced by activation of the steroid xenobiotic receptor (SXR) and other nuclear receptors (Synold et al, 2001; Kast et al, 2002). 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). Unfortunately, only 22% (10 of 45 studies) compared the target AUC and measured AUC (615). 2. Overview of neurologic complications of platinum-based chemotherapy. used to calculate carboplatin dose, with the estimated GFR being obtained from Cockcroft-Gault equation, CKDEPI equation, and the Janowitz et al.'s equation. The guidelines allow a framework in which to work, in an area currently fraught with uncertainty. (1) derived the dosage formula in three stages. This site needs JavaScript to work properly. 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). There are two limitations in this development process. OncPharm-Carboplatin Calculator Height is Required! carboplatin - UpToDate. Graphics. Calvert AH, Newell DR, Gumbrell LA, et al. The error terms given in the parentheses represent the standard errors of estimates of slope (i.e., 1.21) and the intercept (i.e., 23). Langer CJ, Leighton JC, Comis RL, O'Dwyer PJ, McAleer CA, Bonjo CA, et al. Calculated carboplatin doses are rounded to the nearest whole number. You may switch to Article in classic view. 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. dose calculation, under-dose, body surface area, Hypothetical phase I study of a drug with linear pharmacokinetics. These are not comprehensive and should be used in conjunction with clinical experience and good clinical practice. Simplified calculation of body surface area. To use this online calculator for Carboplatin AUC Dose for Male, enter Target AUC (AUC) & GFR for male (mL/min) (GFR) and hit the calculate button. Received 2001 Oct 8; Revised 2002 Jan 9; Accepted 2002 Jan 17. doi: 10.1002/rcr2.741. 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. Consideration should be given to using a range of fixed doses for a particular drug that could be used as the starting dose and for dose adjustments. It is clear that for most cancers there is a plateau in the doseresponse curve for cytotoxic chemotherapy. A pharmacologically guided phase I study of carboplatin in combination with methotrexate and vinblastine in advanced urothelial cancer. 3 4 however, our data do not support any of these recommendations in 5) AUC-based carboplatin dosing is more accurate than dosing according to BSA. 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. Rounding is applied to the final result, no rounding is applied throughout the calculations. 1991;27(5):389-93 One consequence is unexpected underdosing which leads to reduced effectiveness of chemotherapy. -, Cancer Chemother Pharmacol. 1995 Dec;22(6 Suppl 15):34-7 To avoid this situation, a new model could be devised with AUC as an independent variable: where i is a random error term with mean zero and variance 2. Paclitaxel and carboplatin in the treatment of advanced non-small-cell lung cancer: a phase II toxicity, response, and survival analysis. A common single-nucleotide polymorphism (SNP) or CYP3A5 has recently been identified and others are being searched for (Kuehl et al, 2001). Height is necessary for weight correction in obese patients. 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). In the majority of circumstances dose calculations for carboplatin are based solely on renal function. Indices of relative weight and adiposity. Phase I study of paclitaxel on a 3-hour schedule followed by carboplatin in untreated patients with stage IV non-small cell lung cancer. official website and that any information you provide is encrypted Carboplatin is an antineoplastic agent that interferes with DNA replication and cell division. Efforts have been aimed at predicting alteration in drug elimination in those with grossly abnormal liver or renal function with limited success. Cancer Chemother Pharmacol. Carboplatin Dose (mg) Developed by : Sherif Abdou, Pharm.D, Northwestern Memorial Scott Wirth, Pharm.D, BCOP, University of Illinois Andrew Crawford, Pharm.D, University of Illinois Sandra Cuellar Puri, Pharm.D, BCOP, University of Illinois As a result, the variance of the random error term changes to AUCi2 2 rather than 2 violating the assumption of constant variance. It is also useful to predict the AUC and estimate the resultant toxicity in such patients. The data presented in Fig. An official website of the United States government. Disclaimer: The Cancer Institute NSW does not warrant or represent that the Information is free from errors or omission. Can the lack of effect on normal tissue (i.e. These are total platinum and 2 unbound species, carboplatin itself and a decarboxylated platinum-containing degradation product. 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. The relationship between AUC and response rate is not as clear, this may be related to the lack of studies describing both the dose and AUC of carboplatin. 3. Carboplatin is not always dosed on AUC and is commonly regimen-specific in regards to dosing by AUC, mg/m. Clipboard, Search History, and several other advanced features are temporarily unavailable. The first of these methods assays both unbound platinum species, the second is specific for carboplatin. BSA-adjusted eGFRCKD-EPI (mL/min) = [eGFRCKD-EPI (mL/min/1.73 m2) BSA (m2)]/ 1.73. (1), The dose and the AUC for each patient were varying in stage I; hence, the composite variable yi is a random variable. Thrombocytopenia is the main blood effect . BSA-dosing can no longer be viewed as an inaccuracy causing minor inconvenience in treatment of cancer patients. In other words, the impact of this violation is expected to be more severe for higher values of AUC. Carboplatin is one of the most prescribed cytotoxic drug, which is extensively used in the treatment regimens of several malignancies. You may notice problems with User enters pre-amputation height, amputated weight and chooses all missing limbs. Istradefylline 40 mg/day increased peak levels and AUC of P-gp substrates in clinical trials. To calculate dose accurately drug elimination needs to be under- stood. 1972; 25:329-343, Calvert AH, Newell DR, Gumbrell LA, O'Reilly S, Burnell M, Boxall FE, et al. The end point of this process is prevention of toxicity rather than identifying the dose for best anti-tumour effect. CrCl is calculated to two decimal places. Carboplatin dosing. 2020 Oct;76(10):1401-1408. doi: 10.1007/s00228-020-02934-9. Pediatric. 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. Carboplatin dose (mg) = AUCx (GFR + 25) Carboplatin dose (mg) = 7 x (81.25 + 25) Carboplatin dose (mg) = 7 x 106.25 Bookshelf GFR was measured by the Tc-DTPA (i.e., diethylenetriamine penta-acetic acid) method and ranged from 44.6 to 223 mL/minute, with only two patients falling much outside the range of GFR in the study by Calvert et al. Assessment of both hepatic metabolism and active biliary excretion is essential since these are the important elimination processes for the majority of cytotoxic drugs. What is the additional cost of prescribing 305mg of paclitaxel instead of 300mg? 1997;39(4):317-26. doi: 10.1007/s002800050578. FOIA This impact is equivalent to the benefit from the use of adjuvant chemotherapy in node negative breast cancer, or the addition of paclitaxel to the CAF regimen in node positive breast cancer. Yamamoto N, Kamitani T, Kanda K, Ito Y, Hamada M, Ozaki M, Takeuchi N, Yamada T, Kawano M, Maekawa S, Kato T. Cancer Sci. Similarly, the cure rate of cisplatin-based chemotherapy for advanced testicular cancer may be reduced by as much as 10%. For example, the activity of cytochrome P450 (CYP) 3A4/5, the major oxidising enzymes for many cytotoxic drugs varies by as much as 50-fold (Wrighton et al, 1996). The formula is: dose (mg) = AUC (mg ml-1 min) x [GFR (ml/min) + 25 (ml/min)]. The BSA calculator can estimate the body surface area by 5 formulas that are presented below: BSA = 0.0003207 * (Height in cm) 0.3 * (Weight in grams) (0.7285 - ( 0.0188 x Log (grams)) The BSA is an assessment made in order to determine the body surface area which is further on used to estimate the medication dose. 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. Remember that drug elimination varies by at least four-fold between individuals. 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. ID: 4171 v.1. Comparative adverse effect profiles of platinum drugs. Using published data, it can be calculated that there is an almost 20% relative reduction in survival for women receiving adjuvant chemotherapy for breast cancer as a result of unrecognised underdosing. Sequential dose-intensive paclitaxel, ifosfamide, carboplatin, and etoposide salvage therapy for germ cell tumor patients. Med Oncol. 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). Guidelines exist for dose adjustment of other cytotoxic drugs that are predominantly renally excreted ( Kintzel and Dorr, 1995. If lack of myelosuppression is accepted as an indication of underdosing, the frequency of this event can then be determined. When carboplatin is administered with hematological support, the blood count nadirs are no longer meaningful. Accessibility Both unbound species have similar pharmacokinetic profiles for the first 12 hours post-dose. Dose level 3 would be considered the MTD and, AlexandreJBleuzenPBonneterreJSutherlandWMissetJLGuastallaJViensPFaivreSChahineASpielmanMBensmaineAMartyMMahjoubiMCvitkovicE2000, Factors predicting for efficacy and safety of docetaxel in a compassionate-use cohort of 825 heavily pretreated advanced breast cancer patients, BerchJWiklundTEriksteinBLidbrinkELindmanHMalmstromPKellokumpu-LehtinenPBengtssonNOSoderlundGAnkerGWistEOttossonSSalminenELjungmanPHolteHNilssonJBlomqvistCWilkingN2000, Tailored fluorouracil, epirubicin, and cyclophosphamide compared with marrow-supported high-dose chemotherapy as adjuvant treatment for high-risk breast cancer: a randomised trial. How to calculate the dose of chemotherapy. The point estimator of the predicted y is. 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. Studies are underway to define the drug handling genotype and phenotype before drug administration so an individualised dose can be given on the first cycle (Gurney et al, 1998, 2001; Kuehl et al, 2001; Tanabe et al, 2001; Schott et al, 2001; Zhang et al, 2001). The site is secure. Knowing the GFR of a patient and using the target AUC value of 6 mg/ml/min, we can calculate carboplatin dose for the patient. Unable to load your collection due to an error, Unable to load your delegates due to an error. The second and more serious flaw is rooted in the underlying assumption of linear regression theory. We are experimenting with display styles that make it easier to read articles in PMC. Although this difference was not statistically significant, inadvertent underdosing may be an issue for cisplatin as well as carboplatin-containing regimen in the treatment of testicular cancer. It is unreasonable to use a small portion of an extra vial of chemotherapy if the dose prescribe is inaccurate 40% of the time. Pilot study comparing serum chemotherapy levels after intra-arterial and intravenous administration in dogs with naturally occurring urinary tract tumors. After the first 24 h, a majority of the carboplatin is bound to proteins is not easily dialyzable and hence continues to remain in the blood stream despite repeated sessions of hemodialysis. The most simple and widely used formula to calculate the carboplatin dose was proposed by Calvert et al. To estimate the correction factor for the AUC from a given dose of carboplatin, the formula can be generalized to: {\text {Correction factor}} = \left ( {1 + \frac {X} {24} } \right) + Y \times \left ( { \frac { {1 - Z^ {n} }} {1 - Z} - 1} \right) This site needs JavaScript to work properly. The first of these methods assays both unbound platinum species, the second is specific for carboplatin. 1995 Oct;13(4):228-44. doi: 10.2165/00002018-199513040-00003. Dosage calculated by Cockcroft-Gault-based GFR and manufacturer's recommendation had significant variation as compared to the authors' new equation-based carboplatin dose . Use is subject to eviQs disclaimer available at www.eviQ.org.au. 2, or mg/kg. Furthermore, changes in circumstances after the time of publication of the Information may impact on the accuracy of the Information. 2022 Sep;113(9):3110-3119. doi: 10.1111/cas.15439. The https:// ensures that you are connecting to the van Warmerdam LJ, Rodenhuis S, van der Wall E, Maes RA, Beijnen JH. 2019 Oct;12(2):93-97. doi: 10.2478/intox-2019-0011. This formula has also been used in patients with end-stage renal disease on hemodialysis by assuming that the GFR is zero. Epub 2020 Feb 20. The therapeutic efficiency of carboplatin has been found to correlate the area under curve (AUC). 2022 Feb 20;14(2):453. doi: 10.3390/pharmaceutics14020453. -, Ann Oncol. Oguri T, Shimokata T, Ito I, Yasuda Y, Sassa N, Nishiyama M, Hamada A, Hasegawa Y, Ando Y. Body surface area-dosing does not account for the complex processes of cytotoxic drug elimination. The analysis done by using this correction factor shows that the AUC can increase by eightfold in patients who received the adjusted dose but whose hemodialysis was delayed beyond 24 h after infusion. Arch Intern Med. Duffull SB, Begg EJ, Robinson BA, Deely JJ. For toxicity the strongest evidence exists for a relationship between AUC and thrombocytopenia. Carboplatin dosing Formula of Carboplatin AUC dose GFR for Male = ( ( (140-age) / serum creatinine) * 1) (weight (kg) / 72) GFR for Female = ( ( (140-age) / serum creatinine) * 0.85) (weight (kg) / 72) Carboplatin Dose = Target AUC * (GFR + 25) GFR = Glomerular filtration rate people found this article helpful. Scandinavian Breast Group 9401 study, BishopJFDewarJTonerGCSmithJTattersallMHOlverINAcklandSKennedyIGoldsteinDGurneyHWalpoleELeviJStephensonJCanettaR1999, Initial paclitaxel improves outcome compared with CMFP combination chemotherapy as front line therapy in untreated metastatic breast cancer, BudmanDRBerryDACirrincioneCTHendersonICWoodWCWeissRBFerreeCRMussHBGreenMRNortonLFreiIIIE1998, Dose and dose intensity as determinants of outcome in the adjuvant treatment of breast cancer. The variability of the predicted y as given in equation 7 with 2 replaced by AUCi2 2 will increase as higher AUC is targeted. The formula is simplified in the equation as: In stage II, the authors used this formula to dose 31 patients for target AUCs of 38 mg/mL per minute. Until better dose calculation methods are determined most clinicians will continue with the traditional method using BSA. Each vertical tick mark represents an individual patient on the study. A substantial percentage of patients (30 to 75%) receiving commonly used chemotherapy regimen have inadequate myelosuppression and may be underdosed. Twelve rules for dose calculation of chemotherapy are given that can be used as a guideline until better dose-calculation methods become available. FOIA Generally, glomerular filtration rate (GFR) is estimated using serum creatinine and calculated according to the Cockcroft-Gault equation. . Genetic testing for heritable pathogenic variants, Fertility, sex, pregnancy and breastfeeding, How you have anticancer medicine treatment, The International Consensus Guideline for Anticancer Drug Dosing in Kidney Dysfunction (ADDIKD) 2022, International Consensus Guideline for Anticancer Drug Dosing in Kidney Dysfunction (ADDIKD) 2022, Guideline for Dosing in Kidney Dysfunction. In addition, when assessing the case example question, several responses contained errors (15% [n = 53]). NEngl J Med. Analysis at stage I involved a retrospective look at data from pharmacokinetic studies and produced a preliminary dosing relationship as. Prediction of creatinine clearance from serum creatinine. However, most cytotoxic drugs are largely hepatically eliminated. Bednarek A, Mykaa-Ciela J, Pogoda K, Jagieo-Gruszfeld A, Kunkiel M, Winder M, Chudek J. J Oncol. The alternative of using a fixed dose for chemotherapy has recently been suggested for cisplatin and irinotecan after investigators found no relationship between BSA and clearance for both of these drugs (de Jongh et al, 2001; Mathijssen et al, 2002). Most of these 10 studies (eight of the 10) have indicated a 10%20% underprediction. Careers. More studies of quantification of renal absorption are also necessary. J Chronic Dis. 2 Serum creatinine (SCr)-based formulas are used to estimate GFR when calculating carboplatin dosage with the Calvert formula. Carboplatin can be fairly accurately dosed by measuring the GFR. Forty-five studies were found between 1989 through 1999. 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. Accessibility Chemotherapy plus atezolizumab for a patient with small cell lung cancer undergoing haemodialysis: a case report and review of literature. An official website of the United States government. Newell DR, Siddik ZH, Gumbrell LA, Boxall FE, Gore ME, Smith IE, et al. Furthermore they are expensive and possibly unsafe. 1976;16(1):31-41. From January 1, 2017 till August 31, 2017, 77 patients received carboplatin-based chemotherapy. HHS Vulnerability Disclosure, Help Such in vivo tests of drug handling would have the advantage of being applicable to a range of cytotoxic and non-cytotoxic drugs, cleared by similar mechanisms. 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). All patients had prior chemotherapy. NEJM. Phase I trial, including pharmacokinetic and pharmacodynamic correlations, of combination paclitaxel and carboplatin in patients with metastatic non-small-cell lung cancer. Showing results for carboplatin. If the observed GFR of a patient were to fall far beyond the range of those observed in the study by Calvert et al. Carboplatin Dose Calculator. First, the use of the rounded parameter estimates introduces an unnecessary bias, even though one can justify the rounding as a matter of simplification. We pay our respect to Elders past and present. Eur J Clin Pharmacol. To a lesser extent the relationship between AUC and neutropenia has also been described. Calvert AH, Newell DR, Gumbrell LA, O'Reilly S, Burnell M, Boxall FE, et al. Pharmacokinetics of carboplatin in a hemodialysis patient with small-cell lung cancer. The calculator will determine the non-amputated weight based on the amputated weight and the extend of the amputations. The following discussion will remind the clinician of the inaccuracies of this system and will suggest guidelines for dose calculation that encourages consideration of important parameters other than BSA alone. The .gov means its official. DOI: 10.1038/sj/bjc/6600139 Can a clinically significant different pharmacodynamic effect be expected between 650 and 700mg of 5FU? We also discuss the related published literature and recommend practicing caution in its use for a high-dose setting. Federal government websites often end in .gov or .mil. Dubois D, Dubois EF. Error terms for any two subjects are not correlated. Typically there is a 4 - 10-fold variation in cytotoxic drug clearance between individuals due to differing activity of. where x is the average of xi's. www.bjcancer.com. One scenario is that the majority of patients who have normal drug elimination receive a standard fixed dose of drug according to the regimen. and transmitted securely. A Calvert formula-calculated carboplatin dose, based on estimated GFR using IDMS serum creatinine, could be higher than desired and result in increased toxicity. * 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. 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. To calculate dose accurately drug elimination needs to be understood. Now we know the GFR value of the patients using the target AUC which is around 7 mg/ml/min, we can find the dosage of the Carboplatin of the patient. However, a firm relationship cannot be claimed given the low patient numbers and the technique of analysis of these studies. Identification of drug handling capability before treatment can allow the abandonment of BSA-dosing and avoid serious but often unrecognised underdosing. The 25 mL/min is a constant included to account for nonrenal clearance (drug binding . The https:// ensures that you are connecting to the Here is how the Carboplatin AUC Dose for Male calculation can be explained with given input values -> 6.000E+8 = 5* (95+25). mg/kg/dose or mcg/kg/dose. Carboplatin dosage: prospective evaluation of a simple formula based on renal function. The horizontal lines represent the variation in systemic exposure at various dose levels. 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)*. -, Cancer Chemother Pharmacol. Capping the GFR (or Clcr) at 125 mL/min, using an adjusted body weight for overweight or .
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