Objective: To evaluate the response rate, progression-free (PFS) and overall survival in patients with recurrent carcinoma of the cervix (RCC) treated with carboplatin (CBDCA; cis-diamine-1, 1-cyclobutane dicarboxylate platinum II) 300 mg/m2 or according to Calverts formula, CBDCA dose [(GFR + 25) x AUC = 51 mg intravenous (iv) day 1 and 5-FU (5-fluorouracil) 1000 mg/m2 iv day 1 to 5, every 4 weeks.
Methods: From June 1989 to October 1992, 25 patients were enrolled in this phase II study. All patients were evaluated for toxicity, response and survival data.
Results: No patients obtained objective response. Eleven patients had stable disease. The median progression-free survival for these patients was 9 months (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 for more than 1 year. Two of these patients survived for more than 4 years. The toxicity was tolerable with bone marrow suppression 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 this combination regimen insufficient and it should not be used in treating RCC.