Clinical randomized study of 5FU monitoring versus standard dose in patients with head and neck cancer: preliminary results.

Prospective studies of dose adaptation of continuous SFU infusion combined with cisplatin have shown that pharmacologically guided dosing was feasible in the treatment of head and neck carcinomas. Adaptative dosing results in reduced haematological toxicity, but few data are available for clinical response rate. Preliminary results (38 patients) or a randomized trial comparing standard dose of SFU (20 patients) and monitoring or SFU based on pharmacokinetic information (half-cycle area under the curve, 18 patients) indicate that haematological tolerance and complete response rate were improved. Severe (GIII-GIV) thrombocytopenia and neutropenia were significantly reduced during cycle 2 (0% versus 11.1% and 5.5% versus 27.7% respectively, p<0.01) and cycle 3 (0% versus 27.7% and 6.6% versus 33.3% respectively, p<0.001). The complete response rate was increased in the group with monitoring or SFU doses (55.5% versus 40.0%, p<0.001). These interesting results will be confirmed at the end or the trial, which is expected to include 126 patients