Neoadjuvant Chemotherapy in Locally Advanced Bladder Cancer

Neoadjuvant Gemcitabine and Cisplatin in Locally Advanced Bladder Cancer

To evaluate the efficacy and safety of neoadjuvant gemcitabine and cisplatin (gem/cis) in locally advanced bladder cancer.

Patients with locally advanced transitional cell bladder cancer receive 3 cycles of neoadjuvant gemcitabine/cisplatin before radical cystectomy.

Patients with histologically confirmed clinical stage T2-T4a, N0-2 bladder cancer are going to be included. After CT scan of the thorax and abdomen plus MRI of the pelvis patient receive chemotherapy.

Pathologic response rate will be assessed after surgery by the institutional pathologic review. Safety is going to be assessed according to the National Cancer Institute Common Toxicity Criteria (CTC,version 3.0).

Inclusion Criteria:

• 18 years of age
• histologically confirmed stage T2, T3 or T4a urothelial bladder cancer with N0-N2
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
• bone marrow reserve (neutrophil count >1500 cells per μL,platelet count >100 000 per μL) count
• hepatic function (serum bilirubin <2,5 times the upper limit of normal, serum aminotransferase ≤2,5 times the upper limit of normal).
• renal function with a creatinine clearance >60ml/min

Exclusion Criteria:

• metastatic disease
• serious or uncontrolled concurrent medical illness
• pregnancy
• history of other malignancies (with the exception of excised cervical or basal skin or squamous-cell carcinoma)
• non-transitional cell bladder cancer
• creatinine clearance <60ml/min