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.