16502 Background: The cisplatin-5-fluorouracil (5-FU) combination is the current standard of treatment in head and neck cancer. However, this regimen is not devoid of toxicity, and it is not confortable, because its administration requires a central vein access for the continuous infusion (c.i.) of 5-FU. Capecitabine is an oral fluoropyrimidine, whose activity, mimic of c.i. 5-FU, is well known in malignancies as colorectal cancer and breast cancer. We are investigating the efficacy and tolerability of cisplatin and capecitabine combination in advanced head and neck cancer. Methods: Patients (pts) with untreated metastatic, recurrent, or inoperable head and neck cancer were enrolled. Eligibility criteria were: squamous histology, age 18 to 75 yrs, at least one measurable lesion according to RECIST criteria, ECOG performance status </=2, normal laboratory values. Pts received capecitabine (2,000 mg/m(2)/day, days 1 to 14) and cisplatin (100 mg/m(2), day 1) every 3 weeks. Results: Since June 2004, 25 pts were enrolled: 22 were male and 3 female; median age was 56 yrs (46–79 yrs). Primitive sites of disease were: 9 pts (36%) laryngeal, 5 pts (20%) oropharyngeal, 2 pts (8%) hypopharingeal, 4 pts(16%) rhynopharingeal, and 5 pts (20%) oral cavity. Two pts with lymphonode recurrence of laryngeal carcinomas achieved a complete response (8%) and 10 pts (40%) had partial response. Stable disease was observed in 6 pts (24%), and 7 pts (28 %) had progressive disease. By the intent-to-treat analysis, the overall response rate was 48% (95% CI, 30–65). At a median follow-up of 9.5 months (4.8–26.1 months) median TTP was 3.5 months (95% CI, 1.3–5.8), and median OS was 12.4 months (95% CI, 6.3–18.5). A total of 99 cycles of chemotherapy was delivered with a median of 5 cycles per pt (range 1- 6). Grade 3 neutropenia, anemia, and thrombocytopenia, were observed in 17%, 13%, and 1% of cycles respectively. Grade 4 anemia was observed in 2 pts (8%). With regard to non hematological toxicity, grade 3–4 asthenia, nausea and vomiting, stomatitis, diarrhoea and PPD were observed in 12%, 12%, 8%, 4% and 4% of pts, respectively. Conclusions The combination regimen of capecitabine and cisplatin showed a good antitumor activity with mild toxicity in patients with advanced head and neck cancer. No significant financial relationships to disclose.