Clinical Trial
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Cisplatin and gemcitabine administered every two weeks in patients with locally advanced or metastatic urothelial carcinoma and impaired renal function.

BACKGROUND: Cisplatin-based combination chemotherapy is the mainstay of treatment for locally advanced or metastatic urothelial carcinoma. However, standard dose schedule of cisplatin cannot be used in patients with impaired renal function. We evaluated the safety and efficacy of gemcitabine and a split dose administration of cisplatin in patients with renal dysfunction.

PATIENTS AND METHODS: Patients with locally advanced or metastatic urothelial carcinoma with creatinine clearance between 35 and 59 ml/min received gemcitabine 2500 mg/m(2) and cisplatin 35 mg/m(2) on day 1 and day 15 for an every 28 day schedule.

RESULTS: Between March 2004 and November 2009, 38 patients were treated. Median creatinine clearance was 49 ml/min. Median number of cycles per patient was 3 (1-7). There were 15 partial responses (39%) and 12 patients had stable disease (31%). Median progression free survival and overall survival were 3.5 and 8.5 months (mo), respectively. Grade 3-4 haematological toxicities were: neutropenia 9%, anaemia 6% and thrombocytopenia 16%. No patient developed renal toxicity.

CONCLUSIONS: Biweekly gemcitabine and cisplatin is an active and feasible regimen in this subset of patients and could be an option for unfit patients. However, results seem not to be superior to those obtained with carboplatin based regimens in this population of patients.

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