A randomized study of on-line plasma perfusion over protein A-sepharose and 5-fluorouracil chemotherapy in patients with metastatic colorectal carcinoma.

Abstract

To evaluate the safety of on-line plasma perfusion over protein-A sepharose and the therapeutic advantage of combining plasma perfusion (PP) over protein-A sepharose with 5-fluorouracil (5-FU) chemotherapy in patients with metastatic colorectal carcinoma (MCRC), thirty patients were randomized after surgery of primary CRC to receive a combination of 5-FU and 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). Bi-weekly on-line PP over 200 ml protein-A sepharose gel (group A) or 200 ml sepharose gel (group B) were performed with a Cobe 2997 blood cell separator for a maximum of 19 treatments per patient. 5-FU was given at 1000 mg/m2/d on days 1-5 of a 4-weekly cycle until progression. PP was well tolerated and no severe or life-threatening toxicity was observed. Mild clinical side-effects consisted of fever and chills (36% in group A, 23% in group B). The most common biological effects of PP over protein-A sepharose were significant drops in IgG (66% of pre-PP values), CH50 and C3 (73% of pre-PP values) and a significant generation of C3a and C5a anaphylatoxins. Tumor response rates were 40% for group A, 0% for group B and 20% for group C. The median survival times tended to be longer in group A (17 months) than in group B (10 months) and in group C (9 months). This is the first randomized trial showing some therapeutic advantage in combining PP over protein-A sepharose with conventional chemotherapy in MCRC.

• Authors: A Faradji, A Bohbot, J Damonte, J P Arnaud, M Eber, D Laustriat, J Goetz, M L Wiesel, G Follea, Y Piemont
• Journal: The International journal of artificial organs (Int J Artif Organs) Vol. 14 Issue 2 Pg. 109-15 (Feb 1991) ISSN: 0391-3988 [Print] United States
• PMID: 2037387 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Staphylococcal Protein A
• Sepharose
• Fluorouracil

Topics

• Chromatography, Gel
• Colorectal Neoplasms (therapy)
• Combined Modality Therapy
• Female
• Fluorouracil (therapeutic use)
• Humans
• Immunosorbent Techniques
• Liver Neoplasms (secondary, therapy)
• Male
• Middle Aged
• Perfusion
• Plasma
• Sepharose
• Staphylococcal Protein A