Cetuximab plus RT linked with high toxicity in head and neck cancer
Source: www.cancernetwork.com Author: Anna Azvolinsky, PhD The combination of radiation therapy plus the EGFR inhibitor cetuximab had higher rates of acute toxicity among patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN) compared with radiation therapy plus the chemotherapy cisplatin, according to results of a phase II trial based in Italy. Efficacy was similar with both combination therapies. According to Stefano Maria Magrini, MD, professor of radiotherapy at the Università degli Studi di Brescia in Italy, and colleagues, this is the first clinical trial to directly compare radiation therapy plus cetuximab to a chemoradiation regimen for SCCHN. The results of the randomized trial are published in the Journal of Clinical Oncology. Cetuximab was approved in combination with radiation therapy by the US Food and Drug Administration in 2006 for the treatment of unresectable SCCHN. Despite a goal of recruiting 130 patients, only 70 patients were recruited between 2011 and 2014. The 1- and 2-year overall survival rates were 75% and 68% in the cetuximab arm compared with 78% in the cisplatin arm. The 1- and 2-year local control rates were 64% and 53% in the cetuximab arm and 84% and 80% in the cisplatin arm, yet the differences between arms were not statistically significant (P = .073), reflecting the inadequate statistical power of the relatively small trial. Compliance in both treatment arms was relatively low. Only 28% of patients in the cetuximab arm and 20% of patients in the cisplatin arm received at least 7 cycles [...]