3044 POSTER Capecitabine or Folinic acid/Fluorouracil i.v. bolus plus Eloxatin evaluation (COFFE trial) in metastatic colorectal carcinoma (MCRC): final results of the Southern Italy Cooperative Oncology Group (SICOG) phase III trial 0401

2007 ◽  
Vol 5 (4) ◽  
pp. 248-249 ◽  
Author(s):  
P. Comella ◽  
B. Massidda ◽  
G. Filippelli ◽  
A. Farris ◽  
D. Natale ◽  
...  
Keyword(s):  
Colorectal Carcinoma ◽  
Folinic Acid ◽  
Southern Italy ◽  
Phase Iii ◽  
Oncology Group ◽  
Metastatic Colorectal Carcinoma ◽  
Phase Iii Trial

The modulation of fluorouracil with leucovorin in metastatic colorectal carcinoma: a prospective randomized phase III trial. Gastrointestinal Tumor Study Group.

1989 ◽  
Vol 7 (10) ◽  
pp. 1419-1426 ◽  
Author(s):  
N Petrelli ◽  
H O Douglass ◽  
L Herrera ◽  
D Russell ◽  
D M Stablein ◽  
...  
Keyword(s):  
Colorectal Carcinoma ◽  
Low Dose ◽  
Phase Iii ◽  
High Dose ◽  
Metastatic Colorectal Carcinoma ◽  
Phase Iii Trial ◽  
Severe Diarrhea ◽  
Gastrointestinal Tumor Study Group ◽  
The Impact ◽  
Dose Limiting Toxicity

A total of 343 patients with previously untreated metastatic measurable colorectal carcinoma were studied to evaluate the impact on toxicity, response, and survival of leucovorin-modulated fluorouracil (5-FU). A maximally tolerated intravenous bolus loading course regimen of 5-FU alone (500 mg/m2 x 5 days every 4 weeks with 25 mg/m2 escalation) was compared with a high-dose leucovorin regimen (600 mg/m2 of 5-FU with 500 mg/m2 of leucovorin weekly for 6 weeks with a 2-week rest) and with a similar low-dose leucovorin regimen (600 mg/m2 of 5-FU with 25 mg/m2 of leucovorin weekly for 6 weeks with a 2-week rest). The dose-limiting toxicity for the two 5-FU and leucovorin regimens was gastrointestinal, specifically diarrhea; severe diarrhea was seen frequently, and treatment-related toxicity was implicated in the demise of 11 of the patients (5%). Significant improvements in response rates were observed with a response rate of 33 of 109 (30.3%) on the high-dose leucovorin regimen (P less than .01 v control); 13 of 107 (12.1%) on the 5-FU control; and 21 of 112 (18.8%) on the low-dose leucovorin regimen. A trend toward longer survival in the 5-FU plus high-dose leucovorin regimen was observed. In this study, leucovorin was shown to significantly enhance the therapeutic effect of 5-FU in metastatic colorectal carcinoma.

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