A phase II trial of 5-fluorouracil and cisplatinum in recurrent or metastatic nasopharyngeal carcinoma

Background: A phase II clinical trial of the combination of5-fluorouracil (5-FU) and cisplatinum (CDDP) was conducted in24 patients (pts) with recurrent or metastatic nasopharyngealcarcinoma. None of the patients had prior chemotherapy and allbut 4 had prior radiotherapy. Patients and methods: 5-FU was administered by intravenous (i.v.)infusion at a dose of 1000 mg/m² daily on days 1 to 5 and i.v.infusion of CDDP at a dose of 100 mg/m2 in divided doses ondays 1 to 3 of each 21-day cycle. Pts were examined for responseafter every two cycles. Of 24 pts accrued, 21 had measurabledisease. Three had only bone metastases and were evaluable fortoxicity and survival. Results: Thirteen pts had partial response and three achievedcomplete response, for an overall response rate of 66% (95%confidence interval 59% to 93%). Median time to progressionfor all patients was 8 months (range 4 to 28+ months) and mediansurvival for all patients was 11 months. Grades 3 to 4 toxicitiesincluded granulocytopenia (10 pts). There was no treatment-relatedmortality. Average relative dose intensity was 0.8. Conclusion: This combination is highly effective with acceptabletoxicity. The duration of response tended to be brief. Its rolein the neoadjuvant and adjuvant setting in patients with poorprognostic features should be further studied. 5-fluorouracil, cisplatinurn, nasopharyngeal carcinoma