A randomized study of combined 5-fluorouracil and plasma perfusion over protein A-sepharose in human advanced colorectal carcinoma.
To evaluate the advantage with regard to toxicity, response rate, time to progression and survival of combination chemoimmunotherapy over single-agent chemotherapy in patients with metastatic colorectal carcinoma (CRC), 30 patients were randomized to receive a combination of 5-fluorouracil (5-FU) by continuous i.v. infusion and plasma perfusion (PP) over protein A-Sepharose (group A), or a combination of 5-FU and PP over sepharose (group B) or 5-FU alone (group C). 5-FU was given at 1,000 mg/m2/d on days 1-5 of a 4-weekly cycle until progression. Patients of groups A and B received bi-weekly on-line PPs until disease progression or for a maximum of 19 treatments. PP was well tolerated and no severe or life-threatening toxicity was observed. The response rates were 10% for the group A (1 PR), 0% for the group B and 20% for the group C (1 CR + 1 PR). The times to tumor progression for patients in groups A and C were 22 months, 12 and 11 months, respectively and the median survival times were 17 months, 10 months and 9 months. Although the time to progression and survival tended to be higher in patients treated with protein A. PP, these differences were not statistically significant. This is the first report of a randomized trial showing some therapeutic advantage in combining protein A. PP with 5-FU in CRC patients. Further randomized studies are required to demonstrate the real true value of this chemoimmunotherapeutic approach.
Faradji
A
A
Service d'Onco-Hématologie, CHU Hautepierre, Strasbourg, France.
Bohbot
A
A
Damonte
J
J
Arnaud
J P
JP
North
M L
ML
Goetz
J
J
Wiesel
M L
ML
Bergerat
J P
JP
Dufour
P
P
Follea
G
G
D000328:Adult; D000368:Aged; D015179:Colorectal Neoplasms / Q000473:pathology / Q000601:surgery / Q000628:therapy*; D003131:Combined Modality Therapy; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage*; D006801:Humans; D008113:Liver Neoplasms / Q000556:secondary; D008297:Male; D008875:Middle Aged; D010956:Plasmapheresis; D016032:Randomized Controlled Trials as Topic; D012685:Sepharose; D013205:Staphylococcal Protein A
D013205:Staphylococcal Protein A; D012685:Sepharose; D005472:Fluorouracil