The Effectiveness and Safety of Intravesical Docetaxel Instillation for Prevent Bladder Recurrence

The Effectiveness and Safety of Intravesical Docetaxel Instillation After Operation to Prevent Intravesical Recurrence After Radical Nephroureterectomy or Distal Ureterectomy in Upper Urinary Tract Urothelial Carcinoma: A Prospective Study

The investigators evaluated the efficacy of a single early intravesical instillation of doxetaxel in the prevention of bladder recurrence after nephroureterectomy or distal ureterectomy for upper urinary tract urothelial carcinoma (UUT-UC).

Approximately 20% to 50% of patients with upper urinary tract urothelial carcinoma (UUT-UC) experience bladder recurrence after nephroureterectomy. Although many agents have been administered for the prevention of bladder recurrence, the standard prophylactic treatment has yet to be established. A meta-analysis found that a single instillation of chemotherapy immediately after transurethral resection of bladder tumor (TURBT) significantly decreased the risk of recurrence in patients with bladder cancer. Indeed, a single early instillation of Docetaxel was found to reduce the post-TURBT bladder recurrence rate among patients with bladder cancer.

In this prospective, randomized study, the investigators evaluated the efficacy of a single, early, intravesical instillation of Docetaxel in the prevention of bladder recurrence after nephroureterectomy for UUT-UC.

Inclusion Criteria:

• Upper urinary tract urothelial cell carcinoma
• Hb>10g/dL, ANC >1500mm3, Platelet > 100K
• Total bilirubin : 1.5 times lower than the normal upper limit
• AST/ALT: 1.8 times lower than the normal upper limit
• Alkaline phosphatase: 1.8 times lower than the normal upper limit

Exclusion Criteria:

• Concomitant bladder tumor
• Patients diagnosed with bladder cancer within the last 3 years
• Previous history of hypersensitivity to Docetaxel
• Neurogenic Bladder
• Patients who received chemotherapy for cancer within the last 6 months
• Patients with active disease not fit for this study
• ANC <1500mm3
• Pregnant or lactating women
• Patients with severe hepatic dysfunction
• patients with severe renal impairment
• patients with hypersensitivity to mannitol, paraplatin, platinum compounds
• Patients with complications of infection
• Patients suspected of having infectious fever