F. Dicostanzo et al., HYDROXYUREA MAY INCREASE THE ACTIVITY OF FLUOROURACIL PLUS FOLINIC ACID IN ADVANCED GASTROINTESTINAL CANCER - PHASE-II STUDY, Cancer investigation, 14(3), 1996, pp. 234-238
In a phase II trial, 36 patients with advanced gastrointestinal cancer
were treated with: folinic acid (FA) 500 mg/m(2) in a 2-hr intravenou
s (IV) infusion, 5-fluorouracil (5-FU) 600 mg/m(2) as an IV push injec
tion 1 hr after FA, and hydroxyurea (HU) 35 mg/kg/day given p.o. in th
ree administrations (every 8 hr) 6 hr after 5-FU. Cycles consisted of
six weekly treatments for 6 weeks, followed by a 2-week rest period. T
hirty-three patients were evaluable for response and 36 for toxicity;
73% had previous chemotherapy. The response rate was 30% (CR + PR), th
e median duration of response was 21 weeks (range 5-36), and time to f
ailure was 17 weeks (range 3-51). The response in patients previously
exposed to chemotherapy was 29% and 44% in chemotherapy-naive patients
. The median survival for all entered patients was 28 weeks (range 6-5
4). The most common toxicity was gastrointestinal: diarrhea 22/36 (61%
), mucositis 15/36 (42%), and nausea and vomiting 15/36 (42%); hematol
ogical toxicity was mild. We conclude that HU can potentiate the activ
ity of 5-FU plus FA in advanced gastrointestinal cancer; in particular
, HU can restore the activity of 5-FU in patients previously exposed t
o chemotherapy.