A phase II study of combination chemotherapy with capecitabine and cisplatin in patients with metastatic or recurrent squamous cell carcinoma of the head and neck

The purpose of this study was to assess the efficacy and toxicity of capecitabine and cisplatin (XP) combination chemotherapy in patients with metastatic or recurrent squamous cell carcinoma of the head and neck (SCCHN). The chemotherapy regimen consisted of capecitabine 1250 mg/m2 orally twice a day on day 1 to day 14 and cisplatin 60 mg/m2 i.v. on day 1. Each cycle was repeated every 3 weeks up to a maximum of six cycles. By intent-to-treat analysis, the overall response rate was 50% [complete response, 0/36; partial response, 18/36; 95% confidence interval (CI) 32% to 67%]. The median progression-free survival was 3.7 months (95% CI 2.1–5.3 months), and the median response duration was 4.9 months. The median overall survival and 1-year survival rate were 10.3 months (95% CI 8.5–12.1 months) and 43.3%, respectively. The common grade 3 or 4 nonhematologic adverse events were anorexia (8.8%), fatigue (4.4%), diarrhea (4.4%), stomatitis (3.6%), and the hand–foot syndrome (1.5%). The most common grade 3 or 4 hematologic adverse event was neutropenia (14.6%), followed by anemia (1.5%). There was no treatment-related death. The XP combination regimen has antitumor activity and acceptable safety profile in patients with metastatic or recurrent SCCHN.