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Phase I study of protracted venous infusion of 5‐fluorouracil
Author(s) -
Lokich J.,
Bothe A.,
Fine N.,
Perri J.
Publication year - 1981
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/1097-0142(19811215)48:12<2565::aid-cncr2820481204>3.0.co;2-e
Subject(s) - medicine , cumulative dose , fluorouracil , anesthesia , ambulatory , stomatitis , loading dose , adverse effect , infusion pump , surgery , chemotherapy , gastroenterology
A Phase I study of protracted continuous infusion 5‐fluorouracil was undertaken at a starting dose of 200 mg/m 2 /day. The drug was delivered via a tunneled subclavian venous access site by a portable infusion pump (Cor‐Med) permitting ambulatory monitoring. Seventeen patients were administered 19 courses at incremental dose rates from 200 mg/m 2 /day to 600 mg/m 2 /day; treatment was terminated at the onset of stomatitis. At dose rates of 300 mg/m 2 /day or less, the treatment did not require interruption for up to 60 days or up to 36 g cumulative dose. For dose rates of 350 to 600 mg/m 2 /day, the treatment always required interruption: mean duration 20 day for 350 mg/m 2 /day; 9 day for 400 mg/m 2 /day; and 14 day for 600 mg/m 2 /day. Mean cumulative dose at the higher dose rates was 10.9 g (350 mg/m 2 /day); 7.9 g (400 mg/m 2 /day); and 15.3 g (600 mg/m 2 /day). Mean cumulative dose at 200 mg/m 2 /day was 11.5 g and at 300 mg/m 2 /day, was 22.6 g. Protracted venous infusion allows for a substantial cumulative dose of 5‐FU and at dose rate delivery of 300 mg/m 2 day may be administered for up to 60 days without adverse effects due to the drug or to the presence of an indwelling venous access line.