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

Abstract:

:Prospective studies of dose adaptation of continuous 5FU 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) of a randomized trial comparing standard dose of 5FU (20 patients) and monitoring of 5FU 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 of 5FU doses (55.5% versus 40.0%, p < 0.001). These interesting results will be confirmed at the end of the trial, which is expected to include 126 patients.

journal_name

Anticancer Res

journal_title

Anticancer research

authors

Fety R,Rolland F,Barberi-Heyob M,Merlin JL,Conroy T,Hardouin A,Riviere A,Milano G

subject

Has Abstract

pub_date

1994-11-01 00:00:00

pages

2347-52

issue

6A

eissn

0250-7005

issn

1791-7530

journal_volume

14

pub_type

临床试验,杂志文章,随机对照试验
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