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.
How Should we Manage the Central Vein Access Port System in Outpatient Cancer Chemotherapy when the Port System Can be Flushed, but no Blood Aspirated?
