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Punt CJ, Nagy A, Douillard JY, et al.
Lancet. 2002;360:671-677.
Preliminary data suggest that edrecolomab, a murine monoclonal antibody to glycoprotein 17-1A, expressed on epithelial tissues and on various carcinomas, might be useful in adjuvant treatment of patients with resected stage III colon cancer. To determine the effect of adding edrecolomab to fluorouracil and folinic acid therapy in affected patients, we conducted an international, multicenter, randomized trial.
The study population included 2761 patients who, following surgery, were randomly assigned to either "combination therapy," consisting of edrecolomab plus fluorouracil and folinic acid (n = 912); "chemotherapy," consisting of fluorouracil and folinic acid only (n = 927); or edrecolomab monotherapy (n = 922). Patients were assessed for survival and disease recurrence after surgery. The primary end point was to determine whether combination therapy improved overall survival compared with chemotherapy. The secondary end point was to determine whether edrecolomab monotherapy was equivalent to chemotherapy in disease-free survival. Analysis was by intention to treat.
No difference was seen in 3-year overall survival among patients receiving combination therapy or chemotherapy (74.7% vs 76.1%; hazard ratio, 0.94; 95% confidence interval [CI], 0.76 to 1.15; P = .53). However, the rate of disease-free survival was significantly lower among patients randomized to edrecolomab monotherapy than among those randomized to chemotherapy (53.0% vs 65.5%; hazard ratio, 0.62; CI, 0.53 to 0.73; P < .0001). Hypersensitivity reactions occurred in 452 patients (25%) receiving edrecolomab, resulting in treatment discontinuation in 71 patients (4%). The addition of edrecolomab to chemotherapy did not increase incidence of neutropenia, diarrhea, or mucositis.
We concluded that, while edtrecolomab was well tolerated, its addition to fluorouracil and folinic acid chemotherapy for the treatment of resected stage III colon cancer does not enhance overall or disease-free survival. Further, edrecolomab monotherapy is associated with significantly shorter overall and disease-free survival than fluorouracil and folinic acid chemotherapy.
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