Gemcitabine plus cisplatin in adjuvant regimen for bladder cancer. Toxicity evaluation.

Objective: To evaluate the toxicity of gemcitabine and cisplatin combination therapy in adjuvant regimen after radical cystectomy for muscle invasive bladder cancer.

Patients And Methods: Forty patients underwent radical cystectomy for pT2b-pT4 N0-N2 transitional cell carcinoma of the urinary bladder. They had not received prior systemic chemotherapy and were scheduled to receive gemcitabine 1,000 mg/m(2) on days 1, 8, and 15 and cisplatin 70 mg/m(2) on day 1 of a 28-day cycle, for 4 cycles. All toxicities were evaluated by World Health Organization toxicity criteria.

Results: No toxic deaths occurred. All patients experienced transitory alopecia. 12/40 (30%) patients did not experience any toxicity except for alopecia. 23/40 (57.5%) had hematologic toxicity; 1/40 (2.5%) thrombocytopenia grade 4, and 3/40 (7.5%) granulocytopenia grade 3. All nonhematologic toxicities (21/40, 52.5%), including neurotoxicity, constipation and diarrhea, nausea and vomiting were less than grade 3.

Conclusions: Gemcitabine plus cisplatin is a well-tolerated combination therapy with a good clinical safety profile, ethically justifiable in adjuvant regimen for bladder cancer.