Letters to the Editor

Second-line treatment with docetaxel after failure of a platinum-based chemotherapy in squamous-cell head and neck cancer Second-line chemotherapy does not have a proven impact on survival or on quality of life in head and neck cancer patients. Furthermore, responses are rare and usually of brief duration. Similar figures are also reported for second-line treatment of non-small-cell lung cancer; response rates rarely exceed 10% and median survival is-4 months. However, two recent ran-domized trials suggested a survival benefit when docetaxel, administered as a single agent, was compared with best sup-portive care [1] or to another drug (ifosfamide or vinorelbine) [2], although the response rates obtained in the experimental arms were 5.8 % and 6.7%, respectively. We planned a phase IT trial in order to asses objective activ-ity and toxicity of docetaxel administered as a single agent, at a dose of 80 mg/nf every 21 days, in patients with squamous-cell head and neck cancer, relapsed after treatment with a platinum-based regimen. An optimal two-stage design was used in order to calculate the sample size. For an a error of 0.05 and a ~ error of 0.20, a p l (the target activity level) of 25 % and a pO (the lowest level of activity that is of interest) of 5%, 17 evaluable patients had to be enrolled and at least two responses out of 17 patients should have been found in order to reject the null hypothesis. Inclusion criteria were the following: histologically proven squamous-cell carcinoma of the head and neck; local relapse or metastatic disease not suitable of further loco-regional treatment; leucocytes>3000/ml; platelets>100 OOO/ml; normal renal, hepatic and cardiac function; no concomitant serious medical condition. Patients were staged and periodically evaluated with com-puted tomography (CT) scans of the head and neck region, nasal endoscopy and chest X-ray. Before treatment patients underwent a clinical examination in which performance status was assessed and active symptoms were recorded. Docetaxel 80 rng/m ' was administered over 60 min after a pre-medication consisting of prednisolone 50 mg, 12 and 1 h before treatment