1. ¹Medical Oncology Department, University Hospital 12 de Octubre, Madrid, Spain
2. ²Pathology Department, University Hospital 12 de Octubre, Madrid, Spain
3. ³Radiology Department, University Hospital 12 de Octubre, Madrid, Spain
4. ⁴Otorrhinolaringology Department, University Hospital 12 de Octubre, Madrid, Spain
5. ⁵Radiotherapy Department, University Hospital 12 de Octubre, Madrid, Spain

Correspondence: Dr A Jimeno, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, 1650 Orleans St, Room 162A, Baltimore, 21231 MD, USA. E-mail: ajimeno1@jhmi.edu

⁶These authors equally contributed to this work.

Received 29 July 2004; Revised 21 September 2004; Accepted 22 September 2004; Published online 14 December 2004.

Abstract

The combination of cisplatin and capecitabine was evaluated in patients with recurrent or unresectable squamous cell carcinoma of the head and neck (HNSCC), and outcome parameters were correlated with the expression of thymidine phosphorylase (TP), thymidilate syntetase (TS), vascular endothelial growth factor receptor (VEGFR) 1–3, and microvessel density (MVD). Patients with recurrent or unresectable HNSCC were eligible if they had received prior neoadjuvant chemotherapy, concurrent chemo-radiotherapy, or no prior systemic therapy. Patients received cisplatin (75 mg m^-2 day 1), and capecitabine (2000 mg m^-2 day 1–14) every 3 weeks. A total of 41 patients received 194 cycles. In all, 16 complete responses (39%) and 12 partial responses (29%) were documented, for an overall response rate of 68% (95% CI, 53–80%). Grade 3–4 uncomplicated neutropenia was documented in five subjects. Asthenia, anorexia, hand–foot syndrome, and constipation were the most frequent nonhaematologic events. Median progression-free and overall survival were 6.4 and 12.6 months. Cytoplasmic TP expression was more prevalent in patients with a laryngeal location vs other, and in patients with a recurrence vs primary disease. Microvessel density count was higher in patients with recurrent vs primary disease. The combination of cisplatin and capecitabine is effective in recurrent or unresectable HNSCC, and shows a manageable toxicity.