Phase II trial of chronomodulated infusion of 5-fluorouracil and folinic acid in metastatic colorectal cancer.
Forty three patients with metastatic colorectal cancer (MCC) received a daily administration of 5-fluorouracil (600 mg/m2/d at the first course, 700 mg/m2/d at the second and 800 mg/m2/d at the third course), and l-folinic acid (150 mg/m2/d) or dl-folinic acid (300 mg/m2/d) both chronomodulated from 22:00 to 10.00 am with peak delivery rate at 4.00 for 5 days every 21 days. Only severe mucositis and diarrhea occurred in 19 courses (5.7% Gr 3; 0.6% Gr 4) in 14 patients. Objective response (OR) was evaluated in 40 patients because of one toxicity and two early progressions. No OR was observed in the 15 previously-treated patients versus 28.5% (8/28) partial responses in chemotherapy naïve patients; overall the median survival was 13 months. These results without toxicity and with low OR rate indicate the necessing of a more intensive treatment and confirm the place of oxaliplatin in the chemotherapy of MCC.
Cure
H
H
Centre Jean Perrin and INSERM U484, Clermont-Ferrand, France.
Chevalier
V
V
Pezet
D
D
Bousquet
J
J
Focan
C
C
Levi
F
F
Garufi
C
C
Chipponi
J
J
Chollet
P
P
D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D002940:Circadian Rhythm; D015179:Colorectal Neoplasms / Q000188:drug therapy*; D018450:Disease Progression; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D007262:Infusions, Intravenous; D002955:Leucovorin / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009367:Neoplasm Staging; D016896:Treatment Outcome
D000964:Antimetabolites, Antineoplastic; D002955:Leucovorin; D005472:Fluorouracil