ORLANDO — Patients with metastatic colorectal cancer who have mild skin reactions or no reactions at all when treated with standard doses of cetuximab can be safely treated with escalated doses of cetuximab to achieve an improved tumor response, according to a randomized trial presented at a symposium on gastrointestinal cancers sponsored by the American Society of Clinical Oncology.
Increasing the cetuximab dose boosted the response rate in these patients, Dr. Eric Van Cutsem, professor of medicine at University Hospital Gasthuisberg, Leuven, Belgium, said at the symposium, also sponsored by the AGA Institute, the American Society for Therapeutic Radiology and Oncology, and the Society of Surgical Oncology. Positive responses to cetuximab, an epidermal growth factor receptor blocker that inhibits the growth of EGFR-expressing tumors, correlate with the intensity of the associated skin reaction.
The EVEREST trial sought to determine whether escalating the dose in EGFR-expressing patients with metastatic colorectal cancer who had no or slight skin reactions when treated with a standard dose would cause them to develop the acnelike rash that indicates they are benefiting from the drug, said Dr. Van Cutsem, speaking on behalf of the EVEREST investigators.
The study randomized 45 patients who had failed to exhibit a skin reaction greater than grade 1 to continue a cetuximab dose of 250 mg/m
Outcomes in these two arms were compared with those of 77 patients who were ineligible for randomization because they had demonstrated more severe skin reactions when treated with the standard regimen. This group, arm C, continued to receive their standard treatment.
After 24 weeks of treatment, arm B patients had a higher complete response rate than those in arm A (30% vs. 13%, respectively), while patients in arm C had a 34% complete response rate.
Dr. Van Cutsem disclosed that he is a consultant or adviser for Sanofi-Aventis, Roche, Pfizer, and Merck.
Cetuximab dose escalation in patients with no or mild skin reaction on standard dose treatment may improve response. DR. VAN CUTSEM