A comparative study with two administration schedules of leucovorin and 5-fluorouracil in advanced colorectal cancer.
One hundred and seven previously untreated patients with measurable metastatic colorectal cancer who were treated with 5-fluorouracil (5FU) and leucovorin (LV) in two different maximum doses and schedules were retrospectively analyzed. Group A, 52 pts, was treated with LV 200 mg/m2/D i.v. push, followed by 5FU 700 mg/m2/D i.v. 1 h infusion for 5 D. Cycle was repeated every 21 D. Group B, 55 pts, was treated with LV 500 mg/m2/D in a 2 h infusion and 5FU 600 mg/m2/D i.v. bolus at mid-time of LV infusion, repeated every week for 6 wk followed by 2-wk rest period. There was no difference in response (A 8%, B 11%). Median survival for A was 37 (2-131) wk, B was 59 (1-112) wk (P = 0.021), time to progression for A was 20 (0-131) wk, B 30 (0-102) wk (P = 0.021). Administered mean dose intensity of LV was 350.8 mg/m2/wk in group A and 405.0 mg/m2/wk in group B without any significant difference; that of 5FU was significantly higher in group A as compared to group B (1205.3 vs 468.9 mg/m2/wk, respectively) (p < 0.0001). This difference was a consequence of the planned dose intensity for this drug in the two treatment regimens. Toxicity was more frequent and intense in group A for mucositis (P < 0.001), fatigue (P < 0.01), and neurotoxicity (P < 0.05), and in group B for neutropenia (P < 0.001) and nausea-vomiting (P < 0.001). There were one and four iatrogenic deaths in group A and B patients, respectively (NS).(ABSTRACT TRUNCATED AT 250 WORDS)
Tsavaris
N
N
Second Dept of Medical Oncology, Metaxa Cancer Hospital, Piraeus, Greece.
Foutzilas
G
G
Markantonakis
P
P
Mylonakis
N
N
Bacoyannis
C
C
Zisiadis
A
A
Basdanis
G
G
Karvounis
N
N
Sobolos
K
K
Kosmidis
P
P
D000230:Adenocarcinoma / Q000188:drug therapy*; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D015179:Colorectal Neoplasms / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D007262:Infusions, Intravenous; D002955:Leucovorin / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies
D002955:Leucovorin; D005472:Fluorouracil