A randomized study of on-line plasma perfusion over protein A-sepharose and 5-fluorouracil chemotherapy in patients with metastatic colorectal carcinoma.
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.
Faradji
A
A
Service d'Onco-Hématologie, C.H.U. Hautepierre, Strasbourg, France.
Bohbot
A
A
Damonte
J
J
Arnaud
J P
JP
Eber
M
M
Laustriat
D
D
Goetz
J
J
Wiesel
M L
ML
Follea
G
G
Piemont
Y
Y
D002850:Chromatography, Gel; D015179:Colorectal Neoplasms / Q000628:therapy*; D003131:Combined Modality Therapy; D005260:Female; D005472:Fluorouracil / Q000627:therapeutic use*; D006801:Humans; D007163:Immunosorbent Techniques; D008113:Liver Neoplasms / Q000556:secondary* / Q000628:therapy; D008297:Male; D008875:Middle Aged; D010477:Perfusion; D010949:Plasma; D012685:Sepharose; D013205:Staphylococcal Protein A
D013205:Staphylococcal Protein A; D012685:Sepharose; D005472:Fluorouracil