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, et al. 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
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