1. ¹Head and Neck Unit, Royal Marsden Hospital, 203 Fulham Road, London, UK
2. ²Department of Statistics, Royal Marsden Hospital, 203 Fulham Road, London, UK
3. ³McElwain Laboratories, Institute for Cancer Research, 15 Cotswold Road, Sutton, UK
4. ⁴Targeted Therapy Laboratory, Institute of Cancer Research, Cancer Research UK Centre for Cell and Molecular Biology, Chester Beatty Laboratories, 237 Fulham Road, London SW3 6JB, UK

Correspondence: Dr KJ Harrington, E-mail: kevinh@icr.ac.uk

Received 10 October 2005; Revised 12 January 2006; Accepted 12 January 2006; Published online 21 February 2006.

Abstract

To assess the level of activity and toxicity of gefitinib (ZD1839, Iressa™) in a population of patients with locally recurrent and/or metastatic head and neck cancer. Patients were recruited into an expanded access programme through the multidisciplinary head and neck clinics at the Royal Marsden and St George's Hospitals. Patients were required to have received at least one course of standard systemic chemotherapy or radiation therapy, or be medically unfit for chemotherapy. Patients were commenced on single-agent gefitinib at a dose of 500 mg day^-1. Clinical, symptomatic and radiological response, time to progression (TTP), survival and toxicity were recorded. A total of 47 patients were enrolled (35 male and 12 female) with a median age of 62 years (range 18–93 years). The observed clinical response rate was 8% with a disease control rate (complete response, partial response, stable disease) of 36%. In all, 34% of patients experienced an improvement in their symptoms. The median TTP and survival were 2.6 and 4.3 months, respectively. Acneiform folliculitis was the most frequent toxicity observed (76%) but the majority of cases were grade 1 or 2. Only four patients experienced grade 3 toxicity of any type (all cases of folliculitis). Gefitinib was well tolerated and yielded symptomatic improvement in one-third of patients. However, this agent appeared to possess limited antitumour activity in this group of patients with head and neck cancer in whom the objective response rate, median TTP and survival were all lower than has been reported in a previous study.