Clinical experience with edrecolomab: a monoclonal antibody therapy for colorectal carcinoma.

Edrecolomab (monoclonal antibody 17-1A) is a murine monoclonal antibody that recognizes the human tumor-associated antigen Ep-CAM (otherwise known as 17-1A). It is being developed for the adjuvant treatment of colorectal cancer. In a study of 189 patients with resected stage III colorectal cancer, treatment with edrecolomab resulted in a 32% increase in overall survival compared with no treatment (P<0.01) and decreased the tumor recurrence rate by 23% (P<0.04). In terms of safety, edrecolomab was well tolerated. Based on these study results, edrecolomab is currently under investigation in large multicenter phase III studies both as monotherapy and in combination with 5-fluorouracil-based chemotherapy versus chemotherapy alone for the treatment of stage III colon cancer. Although these studies are still ongoing, an interim analysis of safety data indicated that the combination of edrecolomab with chemotherapy is well tolerated. In addition, edrecolomab monotherapy demonstrated a favorable safety profile compared with chemotherapy. Edrecolomab is also currently being tested in large multicenter adjuvant phase III studies in stage II/III rectal cancer and stage II colon cancer. Edrecolomab represents a novel therapeutic approach and has the potential to become a treatment of choice as monotherapy in stage II colon cancer and in combination with chemotherapy in stage II/III rectal and stage III colon cancer.