Carboplatin/5-fluorouracil treatment of recurrent cervical carcinoma: a phase II study with long-term follow-up

Objective: To evaluate the response rate, progression-free (PFS) and overal l survival in patients with recurrent carcinoma of the cervix (RCC) treated with carboplatin (CBDCA; cis-diamine-1, 1-cyclobutane dicarboxylate platin um II) 300 mg/m(2) or according to Calverts formula, CBDCA dose [(GFR + 25) x AUC = 5] mg intravenous (iv) day 1 and 5-FU (5-fluoroumcil) 1000 mg/m(2) iv day I to 5, every 3 weeks. Methods: From June 1989 to October 1992., 25 patients were enrolled in this phase II study. All patients were evaluated for toxicity, city, response a nd survival data. Results: No patients obtained objective response. Eleven patients had stabl e disease. The median progression-free survival for these patients was 9 mo nths (range 2 to 38), and the median survival was 17 months (range 3 - 50). For all patients the median overall survival was 11 months (range 2 - 50). Four patients survived fur more than I year. Two of these patients survive d for more than 4 years. The toxicity was tolerable with bone marrow suppre ssion as the major problem. Conclusion: Eleven patients (44%) with RCC obtained stable disease and four patients (16%) survived for more than one year. These poor results make th is combination regimen insufficient and it should not be used in treating R CC.