Adding erlotinib to the standard chemoradiation treatment for locally advanced squamous cell carcinoma of the head and neck (SCCHN) did not increase treatment toxicity, but neither did it significantly increase complete response rate or progression-free survival.

The combination of cisplatin and radiotherapy is the standard treatment for locally advanced SCCHN. Erlotinib is a small-molecule inhibitor of epidermal growth factor receptor (EGFR), which is a therapeutic target in this type of cancer.

To evaluate whether erlotinib could enhance conventional SCCHN therapy, Neil Hayes, MD, MPH, of the University of North Carolina (UNC) Lineberger Cancer Center in Chapel Hill, North Carolina, and colleagues randomized 204 patients with locally advanced disease to cisplatin plus radiotherapy, with or without the addition of erlotinib. Patients were enrolled between December 2006 and October 2011.


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As the investigators reported in Journal of Clinical Oncology, complete response rate was 52% in the erlotinib group, compared with 40% in the standard-treatment arm. No difference in progression-free survival was seen between the groups over a median follow-up of 26 months.

Although more cases of rash were seen among erlotinib users, the two treatment arms did not differ in terms of rates of other grade 3 or 4 toxicities.

These results by no means signal the end of the road for EGFR inhibitors in SCCHN, commented Hayes in a statement from UNC Health Care. “Since the study was initially designed, it is interesting to note that novel theories have emerged about subgroups of patients who might be more likely to benefit from the specific [chemotherapy and biologic] therapies under consideration. Future investigations will clearly rely more on patients selected by the molecular tumor characteristics.”