Objective: To evaluate efficacy and safety of a scheme using gemcitabine radiotherapy plus cetuximab to treat LAHNC.
Design: Phase 2 study.
Patients: Nineteen patients (age range, 18-50 years) with LAHNC and 1 with recurrent cancer were enrolled, with confirmed epidermoid carcinoma (Karnofsky performance score >70%); normal renal, hepatic, and hematologic functions; without previous oncologic treatment (CT, RT); or surgically inoperable disease; or patients with operable disease who did not consent to surgery. Expression of epidermal growth factor receptor was not evaluated. Radiotherapy was 200 cGy/d for 5 weeks until 70 Gy was received. The initial dose of cetuximab was 400 mg/m2, followed by 250 mg/m2 weekly until completion of radiotherapy. The dosage of gemcitabine was 50 mg/m2 for weeks 1, 2, 4, 5, and 7.
Granados M, Aguilar JL, Lavín AJ, Frías M, Maldonado F, Luna K, Cruz JC, Morán A, Martínez JL, de la Garza J. P052 Phase 2 Study: Concurrent Gemcitabine Radiotherapy With Cetuximab in Locally Advanced Head and Neck Cancer (LAHNC). Arch Otolaryngol Head Neck Surg. 2006;132(8):875-876. doi:10.1001/archotol.132.8.875-c