Abstract
One hundred and eighty seven patients (155 males, 32 females) with histologically proven and previously untreated head and neck cancer were entered in the study. A total of 222 cycles of therapy were analyzed (cisplatin 100 mg m-2 on day 1 and 5-day continuous intravenous infusion of 5-FU 550-1069 mg m-2 day-1, mean 875.5 mg m-2 day-1). Significant interpatient variability for various 5-FU pharmacokinetic parameters was observed including an almost ten-fold range in 5-FU clearance (5-FU Cl, ml min-1 m-2 = 791-7769, mean 2820.7). Log 5-FU Cl was not modified by 5-FU dose (r = -0.1034, P = 0.124, n = 222). Poor linear correlations between log 5-FU Cl and hepatic function tests were observed (respective r and P values for 222 cycles, log AST:0.0526, 0.4365; Log ALT: -0.1167, 0.0842; Log A1K. Phos.:0.154, 0.0214; Log GGT: 0.0652, 0.3436; Log LDH: -0.0984, 0.1563; Log bilirubin: 0.1278, 0.0601). The log 5-FU Cl was also poorly correlated with the serum concentration of various nutritional proteins (respective r and P values for 222 cycles, Albumin: 0.0110, 0.8714; prealbumin: -0.1067, 0.1129; transferrin: 0.0439, 0.5226). Laboratory data including indices of hepatic function and nutritional status cannot account for the interpatient variability in 5-FU disposition.
Highlights
The pharmacokinetics of several drugs are altered in patients with poor nutritional status (Krishnaswamy, 1978)
The purpose of this study was to determine the influence of 5-FU dose, hepatic function, and nutritional status on the pharmacokinetics of 5-FU following continuous intravenous administration in 187 patients with head and neck cancer
One hundred and eighty-seven patients (155 males, 32 females) with histologically proven and previously untreated head and neck cancer were entered in the study
Summary
The pharmacokinetics of several drugs are altered in patients with poor nutritional status (Krishnaswamy, 1978). Especially with head and neck cancer and digestive cancer, may be of poor nutritional status due to difficulty in eating, toxicity to treatment (nausea and vomiting), tumour-induced cachexia or a combination of these problems. Since the therapeutic range of anticancer agents is believed to be narrow, alterations in the pharmacokinetics of anticancer agents due to poor nutritional status may cause increased toxicity. Since 5-FU is increasingly administered as initial therapy for patients with head and neck cancer (Thyss et al, 1986b; Amrein & Weitzman, 1985; Kish et al, 1982) and in adjuvant therapy for digestive tract cancer, it is important to determine if nutritional status alters the disposition of 5-FU
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