Single agent paclitaxel as a first-line therapy in advanced urothelial carcinoma: Its efficacy and safety in patients even with pretreatment renal insufficiency

Background: Cisplatin-based chemotherapy is the mainstay of the treatment f or advanced urothelial cancer, but patients with renal insufficiency before therapy are usually contraindicated to receiving platinum-based chemothera py. Paclitaxel is one of the most promising agents against advanced urothel ial carcinoma in recent trials and it can be easily tolerated even in patie nts with compromised renal function. We conducted a study in order to evalu ate the efficacy and safety of paclitaxel as a first-line therapy in advanc ed urothelial carcinoma patients. Methods: Thirteen advanced chemo-naive urothelial carcinoma patients with a median age of 71 years were studied, seven of them demonstrating renal ins ufficiency (pretreatment serum creatinine greater than or equal to1.5 mg/dl ). All 13 patients received a minimum of two cycles of paclitaxel 175 mg/m( 2), delivered by intravenous infusion for 3 h every 3 weeks. Results: Four of the 13 patients responded to treatment, a response rate of 30.8%, with two of these achieving complete remission and two showing part ial responses. The median overall survival period of all 13 patients was ni ne months (95% CI: 6.51-11.49) and our study revealed a statistical tendenc y in the difference of median overall survival time between responders and non-responders (13 months versus 7.5 months, log-rank p = 0.038), although the number of cases was limited. The differences in response rate and media n overall survival time, comparing patients with renal insufficiency and th ose with normal renal function, were not significant. Treatment-related tox icity was mild, with only two (15.4%) patients suffering from grade 3-4 leu kopenia. No treatment-related mortality was noted. Conclusions: Single-agent paclitaxel can be used as a first-line therapy in advanced urothelial carcinoma patients, and is especially suitable for tho se with pretreatment renal insufficiency, since the antitumor activity is s ignificant while toxicity is well tolerated.