A European team determined the effect of adding edrecolomab to the combination of fluorouracil and folinic acid in the adjuvant treatment of patients with resected stage III colon cancer.
Edrecolomab is a murine monoclonal antibody to the cell-surface glycoprotein 17-1A, which is expressed on epithelial tissues and on various carcinomas.
A total of 2761 patients from 27 countries were included in the trial.
After surgery, the patients were randomly assigned to 1 of 3 regimens. These were edrecolomab plus fluorouracil-folinic acid (combination therapy, n = 912), fluorouracil-folinic acid alone (chemotherapy, n = 927), or edrecolomab alone (edrecolomab monotherapy, n = 922).
Patients were assessed for survival and disease recurrence after surgery.
The researchers assessed whether combination therapy improved overall survival relative to chemotherapy.
They also tested whether edrecolomab monotherapy was non-inferior to chemotherapy in terms of disease-free survival.
|3-year overall survival:|
Combination therapy: 75%
Median follow-up time was 26 months.
The 3-year overall survival on combination therapy was no different from that on chemotherapy (75% vs 76%, hazard ratio 0·94).
It was discovered that disease-free survival was significantly lower on edrecolomab monotherapy than on chemotherapy (53% vs 66%, 0·62).
Hypersensitivity reactions occurred in 25% of patients receiving edrecolomab, causing treatment discontinuation in 4%.
The addition of edrecolomab to chemotherapy did not increase neutropenia, diarrhea, or mucositis.
Professor Cornelis J. A. Punt, of the University Medical Center St. Radboud, Nijmegen, Netherlands, said on behalf of the group, "The addition of edrecolomab to fluorouracil and folinic acid in the adjuvant treatment of resected stage III colon cancer does not improve overall or disease-free survival.
"Furthermore, edrecolomab monotherapy is associated with significantly shorter overall and disease-free survival than fluorouracil and folinic acid and is therefore an inferior treatment option."
"However, edrecolomab is well tolerated and its addition to fluorouracil and folinic acid does not increase the toxicity of chemotherapy," it was concluded.