• Clin Cancer Res · May 2009

    Multicenter Study Clinical Trial

    A universal formula based on cystatin C to perform individual dosing of carboplatin in normal weight, underweight, and obese patients.

    • Antonin Schmitt, Laurence Gladieff, Amélie Lansiaux, Christine Bobin-Dubigeon, Marie-Christine Etienne-Grimaldi, Michèle Boisdron-Celle, Françoise Serre-Debauvais, Frédéric Pinguet, Anne Floquet, Eliane Billaud, Chantal Le Guellec, Nicolas Penel, Mario Campone, Rémy Largillier, Olivier Capitain, Michel Fabbro, Nadine Houede, Jacques Medioni, Philippe Bougnoux, Isabelle Lochon, and Etienne Chatelut.
    • Institut Claudius-Regaud and EA3035 University of Toulouse, Toulouse, France.
    • Clin Cancer Res. 2009 May 15; 15 (10): 3633-9.

    PurposeIt has recently been shown that it is possible to improve the prediction of carboplatin clearance by adding plasma cystatin C level (cysC), an endogenous marker of glomerular filtration rate, to the other patient characteristics routinely used for carboplatin individual dosing, namely serum creatinine (Scr), actual body weight (ABW), age, and sex. This multicenter pharmacokinetic study was done to evaluate prospectively the benefit of using cysC for carboplatin individual dosing.Experimental DesignThe 357 patients included in the study were receiving carboplatin as part of established protocols. A population pharmacokinetic analysis was done using NONMEM program. Seven covariates studied were as follows: Scr, cysC, age, sex, ABW, ideal body weight, and lean body mass.ResultsThe best covariate equation was as follows: carboplatin clearance (mL/min) = 117.8. (Scr/75)(-0.450). (cysC/1,00)(-0.385). (ABW/65)(+0.504). (age/56)(-0.366). 0.847(sex), with Scr in micromol/L, cysC in mg/L, ABW in kilograms, age in years, and sex = 0 for male. Using an alternative weight descriptor (ideal body weight or lean body mass) did not improve the prediction. This final covariate model was validated by bootstrap analysis. The bias (mean percentage error) and imprecision (mean absolute percentage error) were +1% and 15%, respectively, on the total population, and were of a similar magnitude in each of the three subgroups of patients defined according to their body mass index.ConclusionFor the first time, a unique formula is proposed for carboplatin individual dosing to patients, which is shown to be equally valid for underweight, normal weight, and obese patients.

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