Impact of gemcitabine and cisplatin with radiotherapy in locally advanced or metastatic transitional cell carcinoma of urinary bladder

ABSTRACT

The primary object of this study is to evaluate the efficacy and safety of Gemcitabine and Cisplatin along with radiotherapy in transitional cell carcinoma of urinary bladder. Patients and Twenty patients with locally advanced or metastatic TCC of urinary bladder were enrolled during the 22-months period from January, 1999 to October, 2000 and followed up till March 2002.Three patients received 4 cycles, five patients received 5 cycles and twelve patients received 6 cycles of Gemcitabine 1250mg / m2 on day 1 and day 8 and Cisplatin 80mg / m2 on day 1; administered every 3 weeks. No patient received prior chemotherapy, radiotherapy or surgery. However, four patients received prior intravesical chemotherapy. All patients received radiotherapy after completion of chemotherapy regimen. Nineteen patients achieved complete response at the end of the treatment. The complete response rate was 95%. The confidence interval was at 95%, level of confidence ranged from 85% to 100%. Median duration of clinical benefit was 21 months. Six patients [30%] were documented neutropenia, three patients [15%] documented thrombocytopenia. No life threatening toxicity was observed. Gemcitabine and Cisplatin along with radiotherapy in locally or metastatic Transitional cell carcinoma of urinary bladder, exhibited pronounced response rate among all the patients. The toxicity profile remained extremely low and disease free survival enhanced. The above investigation may further be continued at a larger scale encompassing a wide band of subjects: