Clinic for Oral & Maxillofacial Surgery, Berlin, Germany;
Clinic and Policlinic for Haematology and Oncology, Berlin
Objective: The purpose of this phase 2 trial was to investigate for the first time the efficacy and toxic effects of oxaliplatin combined with folinic acid (FA) and 5-fluorouracil (5-FU) in patients with recurrent squamous cell carcinoma of the head and neck in advanced stage of disease.
Design: Thirty-six patients with recurrent/metastatic disease with a median age of 59 years were enrolled. Patients received oxaliplatin (85 mg/m2) and FA (200 mg/m2), followed by 5-FU (2000 mg/m2) as 24-hour continuous infusion on day 1 and 15 in a 4-week cycle. On days 8 and 22, FA (200 mg/m2) and 5-FU (2000 mg/m2) were administered without oxaliplatin, followed by 2 weeks without cytotoxic treatment.
Raguse JD, Bier J, Oettle H. P016 Oxaliplatin, Folinic Acid, and 5-Fluorouracil (OFF) in Recurrent Advanced Head and Neck Cancer: A Phase 2 Trial. Arch Otolaryngol Head Neck Surg. 2006;132(8):869. doi:10.1001/archotol.132.8.869-b