Gemcitabine and carboplatin in the treatment of transitional cell carcinoma of the urothelium

Abstract

16136 Background: In advanced transitional cell carcinoma (TCC) of the urothelium gemcitabine plus cisplatin (GC) is considered a gold standard chemotherapy regimen. However, treatment with cisplatin is associated with significant toxicity and requires intravenous hydration. Carboplatin is an analogue of cisplatin which at standard doses is less toxic, and does not require hydration. From July 2003 to June 2007, 15 consecutive patients with metastatic TCC of the urothelium were treated with gemcitabine plus carboplatin (GCarbo). Patients were not selected on the basis of poor renal function, poor performance status (PS) or any other adverse feature. Methods: All cases of metastatic TCC of the urothelium referred to a single consultant at Velindre Cancer Centre, South East Wales from July 2003 to date were treated using 3-weekly cycles of gemcitabine 1,200 mg/m2 i.v. days 1 and 8 plus carboplatin AUC 5–6 i.v. day 1. Creatinine clearance was estimated using the Cockroft-Gault formula. Carboplatin dose was calculated using the Calvert formula. All patients were required to have a histological diagnosis of TCC. Survival was calculated from the start of chemotherapy to the date of last contact or death using the Kaplan-Meier method. Treatment was continued for up to 6 cycles. Granulocyte-colony stimulating factors were not routinely used. Patients were transfused if the haemoglobin fell below 9g/dl, or if significant symptoms developed. Results: The median age of all patients was 67 years. In 10/15 (67%) patients the urinary bladder was the primary site. All patients had stage 4 disease. In total, 4/15 (27%) patients had a PS of 0, 8/15 (53%) patients had a PS of 1 and 3/15 (20%) had a PS of 2. Grade 3 or 4 toxicity included neutropenia (47%), anaemia (27%) and thrombocytopenia (20%). Red blood cell transfusions were given to 6/15 (40%) patients. No platelet transfusions were given. No patients required admission for neutropenic pyrexia/sepsis, and there were no treatment-related deaths. The overall response rate was 67%. The median survival was 9 months (95% CI 7.4–10.6), and 1-year survival 42%. Conclusions: GCarbo is well tolerated, and has activity as first- line treatment in metastatic TCC of the urothelium. Results are comparable to other studies using this regimen. No significant financial relationships to disclose.