Platinum analogue combination chemotherapy: Cisplatin, carboplatin, and methotrexate in patients with metastatic urothelial tract tumors. A phase II trial with evaluation of prognostic factors

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Abstract
Background. Cisplatin is one of the single drugs that has shown the best documented effect in treating patients with locally recurrent or metastatic urothelial cancer. To the authors' knowledge, the effect of the combination of different platinum analogues in treating transitional cell carcinoma has not been evaluated previously neither experimentally nor in clinical studies. Methods. A Phase II trial of carboplatin (200 mg/m2), cisplatin (100 mg/m2), and methotrexate (250 mg/m2) with folinic acid rescue every 3 weeks was performed on 55 previously untreated patients with metastatic or locally recurrent urothelial cell carcinoma. Results. A response (complete response and partial response) was achieved in 21 of 51 evaluable patients (41%; 95% confidence limits, 28‐56%). Twelve patients had no change, whereas 18 had progressive disease. Eight patients (16%) achieved a complete response, and most of these survived more than 2 years. No patient with poor performance (performance status score ≥ 2) or bone metastases achieved a complete response. The median survival for all patients was 8.4 months. Multivariate survival analyses showed that performance status and alkaline phosphatase levels were significant prognostic factors for survival. Conclusion. Combination therapy with cisplatin, carboplatin, and methotrexate is feasible but offers no advantage over other combinations with cisplatin and methotrexate in treating metastatic urothelial cell cancer. It is important to select patients for treatment carefully, and further studies of prognostic factors in these patients are warranted. Cancer 1995;76:1797‐803.