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• W2028785166 abstract "High dose melphalan (MLP, 200 mg/m2) is an important treatment for multiple myeloma, even in the era of novel biological agents. The prevalence of obesity is increasing, but there is little information on how best to adjust the dose in obese patients. Use pharmacokinetic data from 16 lean patients (body mass index, BMI≤25 kg/m2) and 36 obese patients (BMI≥30 kg/m2) with normal renal function (est Cr Cl>60 mL/min) to evaluate alternate size descriptors that best fit the actual drug exposure. Plasma MLP levels were measured in 6-12 blood samples collected from 100 patients who had received a single high dose of MLP (median:192 mg/m2). Individual results of MLP clearance were determined using a two compartment model developed using the NONMEM IV software. Subsequent analysis was restricted to obese and lean patients with normal renal function. Two-sided two-sample T-test was first used to compare MLP clearance of lean and obese patients. Extrapolating from individual clearance results, drug exposure (AUC) for obese patients (AUCobese) was predicted using the formula dose/clearance, where dose was calculated either using actual body weight (ABW) in the formula for BSA or alternate weight descriptors. The AUC for lean patients (AUClean) used ABW in the BSA formula. The ratio of AUCobese: mean AUClean was calculated and compared to unity (indicating equivalent exposure for obese and lean patients) using a two-sided, one-sample T-test. This analysis was repeated for each gender separately. MLP Clearance (L/h) is significantly higher in obese patients compared with lean patients (32.2±10.2 versus 26.1±6.2 L/h, p<0.05), but after normalisation to BSA using ABW, there is no significant difference (15.9±4.8 versus 15.2±3.3 L/h/m2). Using ABW in the BSA formula to determine dose, AUCobese is (mean ± s.d.) 13.6±3.9 mg/L.h, AUClean is 13.8±2.9 mg/L.h, resulting in a ratio of 0.99±0.29, which is not significantly different from 1.0. All other weight descriptors in the BSA formula (predicted normal weight, ideal body weight, adjusted ideal body weight, lean body mass and the mean of ideal and ABW) resulted in AUC ratios that were significantly lower than 1.0 (p<0.05). Use of ABW in the BSA formula to calculate dose rather than alternate weight descriptors achieves equivalent exposure to MLP in obese and lean patients. Continued follow up will assess the significance of these levels in all weight groups." @default.
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• W2028785166 date "2010-02-01" @default.
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• W2028785166 title "Actual Weight To Calculate Surface Area Provides The Best Estimate Of AUC For Melphalan In Myeloma" @default.
• W2028785166 doi "https://doi.org/10.1016/j.bbmt.2009.12.088" @default.
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