MONDAY, Jan. 16, 2017 (HealthDay News) -- Addition of cetuximab to chemoradiation (CRT) is associated with a reduction in locoregional failure (LRF) rates in squamous cell carcinoma of the anal canal (SCCAC), according to a study published online Jan. 9 in the Journal of Clinical Oncology.
Assuming a 35 percent LRF rate from historical data, Madhar K. Garg, M.D., from the Montefiore Medical Center in Bronx, N.Y., and colleagues designed a study to detect at least a 50 percent reduction in three-year LRF rate. They enrolled 61 patients with stage I to III SCCAC to CRT (cisplatin, fluorouracil, and radiation therapy to the primary tumor and regional lymph nodes) plus cetuximab (eight once-weekly doses).
The researchers found that the three-year LRF rate was 23 percent by binomial proportional estimate using the prespecified end point and 21 percent by Kaplan-Meier estimate in analysis based on methods that were consistent with historical data. The three-year rates for progression-free and overall survival were 68 and 83 percent, respectively. Thirty-two percent of patients had grade 4 toxicity and 5 percent had treatment-associated deaths.
"Although the addition of cetuximab to chemoradiation for SCCAC was associated with lower LRF rates than historical data with CRT alone, toxicity was substantial, and LRF still occurs in approximately 20 percent, indicating the continued need for more effective and less toxic therapies," the authors write.
Several authors disclosed financial ties to biopharmaceutical companies, including Lilly, which manufactures cetuximab.