Purpose: Although cisplatin-based chemotherapy is the standard of care for advanced transitional cell carcinoma, tolerability is a challenging issue in unfit patients. This study was conducted to evaluate the efficacy, toxicity, and tolerability of the combination of gemcitabine and carboplatin in unfit patients with advanced transitional cell carcinoma.
Methods: Thirty-one patients who had advanced transitional cell carcinoma and one of the following clinical features were evaluated: Eastern Cooperative Oncology Group performance status equal or greater than 2, age older the 75 years or estimated glomerular filtration rate less than 60 ml/min. The patients were treated with carboplatin and gemcitabine delivered every 4 weeks.
Results: Of the 31 patients, 71 % had an estimated glomerular filtration rate of less than 60 ml/min, and the remaining patients were treated by this protocol due to poor performance status or age older than 75. The median age of the patients was 74 years old. A total of 162 cycles of treatment were delivered to the patients. The overall response rate was 45.1 %. After the median follow-up of 15 months, the median progression-free survival time was 9.4 months (95 % CI 7.3-11.4) and overall survival time was 20 months (95 % CI 14.9-25.0). Grades 3 and 4 anemia, thrombocytopenia, and neutropenia were observed in 22.6, 6.45, and 6.45 % of patients, respectively. There was no treatment-related mortality in our patient series.
Conclusion: The combination of gemcitabine and carboplatin is effective in elderly patients with advanced transitional cell carcinoma or those unfit for cisplatin-based chemotherapy, with manageable toxicity.