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

Background: A phase II clinical trial of the combination of 5-fluorouracil (5-FU) and cisplatinum (CDDP) was conducted in 24 patients (pts) with recurrent or metastatic nasopharyngeal carcinoma. None of the patients had prior chemotherapy and all but 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 on days 1 to 3 of each 21-day cycle. Pts were examined for response after every two cycles. Of 24 pts accrued, 21 had measurable disease. Three had only bone metastases and were evaluable for toxicity and survival.

Results: Thirteen pts had partial response and three achieved complete response, for an overall response rate of 66% (95% confidence interval 59% to 93%). Median time to progression for all patients was 8 months (range 4 to 28+ months) and median survival for all patients was 11 months. Grades 3 to 4 toxicities included granulocytopenia (10 pts). There was no treatment-related mortality. Average relative dose intensity was 0.8.

Conclusion: This combination is highly effective with acceptable toxicity. The duration of response tended to be brief. Its role in the neoadjuvant and adjuvant setting in patients with poor prognostic features should be further studied.