title: Gemcitabine plus cisplatin in adjuvant regimen for bladder cancer. Toxicity evaluation.
abstract: 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.
authors.affiliation: Department of Urology, Ospedale S. Maria Annunziata, Bagno a Ripoli, Italy. carini@unifi.it
authors.forename: Enrico
authors.initials: E
authors.lastname: Meliani
authors.forename: Alberto
authors.initials: A
authors.lastname: Lapini
authors.forename: Sergio
authors.initials: S
authors.lastname: Serni
authors.forename: Cristoforo
authors.initials: C
authors.lastname: Corvino
authors.forename: Marco
authors.initials: M
authors.lastname: Carini
mesh_terms: 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
chemical_list: D000970:Antineoplastic Agents; D003841:Deoxycytidine; D002945:Cisplatin; D000093542:Gemcitabine