The Pharmaceutical Journal
Vol 269 No 7214 p313
7 September 2002

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The Lancet (www.thelancet.com)

Murine antibody unsuccessful in treating patients with colon cancer

A murine monoclonal antibody, edrecolomab, that recognises a cell-surface glyco-protein expressed on epithelial tissues and various carcinomas is an inferior treatment option to fluorouracil and folinic acid in patients with colon cancer, researchers say.

Dr Cornelis Punt, University Medical Centre St Radboud, Netherlands, and colleagues randomly assigned 2,761 patients with resected stage III colorectal cancer, from centres in 27 countries, including the United Kingdom, to receive, after surgery, edrecolomab plus fluorouracil-folinic acid (n=912), fluorouracil-folinic acid alone (n=927), or edrecolomab alone (n=922).

They say that edrecolomab is associated with significantly shorter overall and disease-free survival than fluorouracil-folinic acid therapy. The addition of edrecolomab to fluorouracil and folinic acid did not improve overall survival or disease-free survival. After three years, there were 219 deaths in the edrecolomab group, 190 deaths in the combination therapy group and 184 deaths in the fluorouracil and folinic acid group.

The authors comment that "one possible explanation for the lack of efficacy of edrecolomab might be its murine origin". They conclude that edrecolomab mono-therapy, as well as the addition of edrecolomab to fluorouracil-folinic acid therapy, should not be considered for adjuvant treatment in patients with resected stage III colo-rectal cancer. "On the basis of these findings, fluorouracil-folinic acid chemo-therapy should remain the standard of care for these patients."

The study is published in The Lancet (2002;360:671).

Researchers from GlaxoSmithKline, supplier of edrecolomab, were involved in this study.