Oxaliplatin, folinic acid and 5-fluorouracil (OFF) in patients with recurrent advanced head and neck cancer: a phase II feasibility study.

The purpose of this phase II trial was to investigate the efficacy and toxicity of oxaliplatin combined with folinic acid (FA) and 5-FU in patients with recurrent squamous cell carcinoma of the head and neck (scchn) in advanced stage of disease. Thirty-six patients with recurrent/metastatic disease with median age of 59 years were enrolled. Patients received oxaliplatin (85mg/m(2)) and FA (200mg/m(2)) followed by 5-FU (2000mg/m(2)) as 24h continuous infusion on day 1 and 15 in a 4-week cycle. On day 8 and 22 FA (200mg/m(2)) and 5-FU (2000mg/m(2)) were administered without oxaliplatin followed by two weeks without cytotoxic treatment. Toxic effects, length of survival and tumour response were assessable in 33/36 patients. The overall response was 60.6% with 7 (21.2%) complete responders (CR) and 13 (39.4%) partial responders (PR). Eight patients (24.2%) showed stable disease (SD) and 5 (15.2%) progressed. The median time to progression (TTP) was 8.1 month (range 2-14) and median overall survival was 10.8 months (range 5-16). The 1-year survival rate was 43.2%. The incidence of haematological toxicity was low but mild paraesthesias occurred in all patients received more then 3 cycles of cytotoxic therapy and dose reduction was necessary in two patients due to diarrhoea grade 3. In this small phase II study the combination of oxaliplatin, FA and 5-FU (OFF) demonstrated relative to the standard regimen of cisplatin and 5-FU a high antitumoural activity in previously treated scchn with favourable toxicity profile.