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.


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.
Meliani
Enrico
E
Department of Urology, Ospedale S. Maria Annunziata, Bagno a Ripoli, Italy. carini@unifi.it
Lapini
Alberto
A
Serni
Sergio
S
Corvino
Cristoforo
C
Carini
Marco
M
D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000633:toxicity*; D002295:Carcinoma, Transitional Cell / Q000188:drug therapy* / Q000601:surgery; D017024:Chemotherapy, Adjuvant / Q000009:adverse effects; D002945:Cisplatin / Q000633:toxicity*; D015653:Cystectomy / Q000379:methods*; D003841:Deoxycytidine / Q000031:analogs & derivatives* / Q000633:toxicity*; D004359:Drug Therapy, Combination; D006801:Humans; D008875:Middle Aged; D016896:Treatment Outcome; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy* / Q000601:surgery; D000093542:Gemcitabine
D000970:Antineoplastic Agents; D003841:Deoxycytidine; D002945:Cisplatin; D000093542:Gemcitabine