RANCHO MIRAGE, CaliforniaCetuximab (Erbitux) plus concurrent chemoradiotherapy (CRT) appears to be feasible and effective in many patients with locally advanced squamous-cell head and neck cancer, and may improve local-regional control, Mohan Suntharalingam, MD, and colleagues said at the 2007 Multidisciplinary Head and Neck Cancer Symposium (abstract 5).
Dr. Suntharalingam, of the University of Maryland Medical Center, Baltimore, reported preliminary data from a phase II trial that will enroll about 60 patients. To date, 21 patients have entered the study, and 18 have completed treatment and were available for toxicity and response analysis. All had locally advanced disease (30% T4, 95% N2-3). Mean follow-up time was about 10 months after completion of therapy.
Patients were treated with cetuximab at a loading dose of 400 mg/m2 followed by 250 mg/m2 weekly. Chemotherapy consisted of weekly doses of paclitaxel 40 mg/m2 and carboplatin to AUC 2. Patients also received radiotherapy at 1.8 Gy/d to a total of 70.2 Gy.
All patients completed planned radiotherapy, and 66% received all planned doses of cetuximab. There were no grade 4 toxicities, but grade 3 toxicities included mucositis (89%), infield skin desquamation (11%), dysphagia (17%), fever (11%), and leukopenia (17%).
Dr. Suntharalingam told ONI that the main new toxicity observed with the regimen was rash associated with cetuximab. Rash is currently treated with antibiotic ointment and Benadryl (diphenhydramine) cream, with special attention to skin problems that appear within the radiation field.
Fever was the most common reason patients were hospitalized in the early months of the trial. The researchers soon realized that the fever was associated with cetuximab and rarely indicated other problems, such as infection.
"The most common reasons for hospitalization have been fever and dehydration," Dr. Suntharalingam said. Currently, patients are hospitalized less quickly for fever, since the cetuximab-related fevers typically resolve without intervention, and patients are being counseled on ways to prevent dehydration.