Retrospective analysis of satraplatin in patients with metastatic urothelial cancer refractory to standard platinum-based chemotherapy

Background: Satraplatin is an oral platinum analogue with antitumor activity in cisplatin-resistant cells lines. The activity of satraplatin in patients with metastatic cancers of the urothelial tract refractory to standard platinum agents has not previously been reported. Methods: We previously reported a phase I study of the safety and pharmacokinetics of satraplatin in patients with refractory solid tumors and varying degrees of renal impairment. Given that the majority of patients enrolled in the study had metastatic cancers of the urothelial tract, and all patients were treated with a uniform dose and schedule, we performed a retrospective analysis to describe the activity of satraplatin in this cohort. Results: A total of 12 patients with metastatic cancers of the urothelial tract were enrolled. The majority (83%) had transitional cell carcinomas, whereas 2 patients (17%) had adenocarcinomas. All patients were treated previously with platinum agents; 6 patients (50%) had previously received cisplatin and 8 patients (67%) had previously received carboplatin. Patients were treated with a median of 1.5 cycles of satraplatin (range, 1-4). There were no objective responses; 1/12 (8%) patients experienced transient stable disease and 11/12 (92%) experienced disease progression as best response. Conclusions: Treatment with satraplatin in patients with metastatic cancers of the urothelial tract who had progressed on standard platinum-based chemotherapy resulted in negligible antitumor activity. These conclusions are limited by the retrospective nature of the analysis and the phase I population from which the data were derived. The activity of satraplatin in patients with metastatic cancers of the urothelial tract who have been less heavily pretreated is unknown.