Phase II study of capecitabine and cisplatin combination as first-line chemotherapy in Chinese patients with metastatic nasopharyngeal carcinoma

Cisplatin combined with 5-fluorouracil (5-Fu) is widely used in the management of advanced nasopharyngeal carcinoma (NPC). However, catheters and pumps are necessary for the continuous infusion of 5-Fu, which add to the cost, immobility and inconvenience of treatment. Capecitabine, an oral fluoropyrimidine, is a potentially more active and more convenient substitute to 5-Fu. A phase II study was conducted to evaluate the efficacy and safety of a capecitabine and cisplatin combination in metastatic NPC.

In the multicenter, open-label, single-arm phase II study, patients with metastatic NPC who previously received no palliative chemotherapy were enrolled. Patients received oral capecitabine (1,000 mg/m² twice daily from day 1 to 14) and intravenous cisplatin (80 mg/m², day1) every 3 weeks.

A total of 48 patients were enrolled and included in the intention-to-treat analysis of efficacy and adverse events. There were 3 patients (6.3%) with complete response and 27 patients (56.3%) with partial response, giving an overall response rate of 62.5% (95% CI, 49.1–76.4%). The median duration of response in the 30 responding patients was 7.5 months (range 1.4–22.4 months). With a median follow-up period of 13.3 months (range 2.3–50 months), the median time to progression and median overall survival for all patients were 7.7 months (95% CI, 6.3–9.2 months) and 13.3 months (95% CI, 9.4–17.2 months), respectively. Toxicities were moderate and manageable. Grade 3/4 toxicities included neutropenia (14.6%), anemia (4.2%) and thromocytopenia (2.1%), nausea (8.3%), vomiting (10.4%), diarrhea (8.3%), stomatitis (6.3%) and hand–foot syndrome (HFS) (4.2%).

The combination of capecitabine and cisplatin is active and well tolerated as a first-line therapy for patients with metastatic NPC.