Weekly Cisplatin, Infusional High-Dose 5-Fluorouracil and Leucovorin for Advanced, Recurrent and Metastatic Cervical Carcinoma

BACKGROUND: To evaluate the effectiveness and toxicity of infusional cisplatin and weekly 24-hour infusion of high- dose fluorouracil plus leucovorin (P-HDFL) for the treatment of patients with stage IVB, recurrent and metastatic carcinoma of the cervix. PATIENTS AND METHODS: A phase II study of P-HDFL in stage IVB, recurrent and metastatic carcinoma of cervix was initiated in January 2001. As of March 2007, a total of 21 patients were enrolled. Of these, 16 were evaluable for response. RESULTS: The overall objective response rate was 25% [95% confidence interval (CI ), 1.2-48.8%] with none achieving complete response. The median progression-free survival and overall survival for all 21 patients was 2.3 months (95% CI, 1.2-4.3 months) and 10.5 months (95% CI, 4.6-17.4 months) , respectively. Toxicity was tolerable. The main problems were nausea/ vomiting and anemia. CONCLUSION: P-HDFL appears to be a moderately effective regimen with low toxicity for treating patients with advanced, recurrent and metastatic cervical cancer