Objective: To assess the efficacy and tolerability of a 3-week outpatient schedule of intravenous gemcitabine and cisplatin in patients with locally advanced unresectable or metastatic transitional cell carcinoma of the urothelial tract (TCC).
Patients and methods: A two-stage phase II trial enrolled TCC patients with Karnofsky performance status > or = 60, measurable disease, and adequate organ function. Prior adjunctive chemotherapy was allowed provided it had been completed at least 1 year prior to study entry. Treatment consisted of gemcitabine 1250 mg/m2 iv days 1 and 8 plus cisplatin 70 mg/m2 day 1 iv repeated every 21 days. The primary outcome was the objective response rate.
Results: Thirty patients were enrolled at six Canadian centres. Three complete and 10 partial responses were observed in 29 eligible patients (overall response rate 45% [95%CI, 27-63%]). Three patients had stable disease and 13 had progressive disease. The relative dose-intensities of gemcitabine and cisplatin were 81% and 88%, respectively. Toxicity was primarily hematological, and 60% of patients experienced at least one episode of grade 3 or 4 toxicity. One patient died of neutropenic sepsis and two died of vascular events while on treatment.
Conclusions: The efficacy and tolerability of this schedule are similar to that reported with the standard 4-week schedule of gemcitabine-cisplatin. In the absence of a large randomized trial, the similarity of these results supports the use of this 3-week program in typical TCC patients treated in both community and academic cancer clinic settings.