title: Combination of gemcitabine and paclitaxel as second-line chemotherapy for advanced urothelial carcinoma.
abstract: OBJECTIVE
  The aim of this study was to evaluate the efficacy and toxicities of the gemcitabine and paclitaxel combination regimen as second-line chemotherapy for patients with advanced or metastatic urothelial carcinoma (UC) who have previously been treated with platinum-based chemotherapy for the metastatic disease.
  
  
  METHODS
  Thirty-three patients with advanced or metastatic UC who had received platinum-based chemotherapy were treated with an outpatient gemcitabine and paclitaxel combination regimen. A dose of 180 mg/m(2) paclitaxel was administered by intravenous (IV) infusion on Day 1, and 1000 mg/m(2) gemcitabine was administered by IV on Days 1, 8 and 15.The course was repeated every 28 days. Patients were evaluated after every 2 cycles of therapy using computed tomography.
  
  
  RESULTS
  Of the 33 patients enrolled in this study, 30 could be evaluated to determine treatment efficacy; 10 had an objective response [overall response rate: 33.3%, 95% confidence interval (CI), 19.2-51.2%]. The median overall survival was 11.3 months (95% CI, 7.2-13.6 months). The chemotherapy sensitivity differed with disease site. The response rates of lung and bone metastases were 27% and 14%, and the progressive disease (PD) rates of lung and bone metastases were 13% and 14%, respectively. On the other hand, the response rate of liver metastasis was 14%, and its PD rate was 57%. None of the patients (n = 3) with adrenal metastasis responded to this regimen. Toxicities were mild, and no life-threatening complications occurred.
  
  
  CONCLUSIONS
  Gemcitabine and paclitaxel combination therapy is a tolerable and active regimen for patients with advanced UC after failure of platinum-based chemotherapy.
authors.affiliation: Chiba Cancer Center, Japan.
authors.forename: Takahito
authors.initials: T
authors.lastname: Suyama
authors.forename: Takeshi
authors.initials: T
authors.lastname: Ueda
authors.forename: Satoshi
authors.initials: S
authors.lastname: Fukasawa
authors.forename: Yusuke
authors.initials: Y
authors.lastname: Imamura
authors.forename: Kazuyoshi
authors.initials: K
authors.lastname: Nakamura
authors.forename: Kyoko
authors.initials: K
authors.lastname: Miyasaka
authors.forename: Tomokazu
authors.initials: T
authors.lastname: Sazuka
authors.forename: Ken-ichi
authors.initials: K
authors.lastname: Egoshi
authors.forename: Naoki
authors.initials: N
authors.lastname: Nihei
authors.forename: Masaaki
authors.initials: M
authors.lastname: Hamano
authors.forename: Tomohiko
authors.initials: T
authors.lastname: Ichikawa
authors.forename: Masayuki
authors.initials: M
authors.lastname: Maruoka
mesh_terms: D000310:Adrenal Gland Neoplasms / Q000556:secondary; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002277:Carcinoma / Q000188:drug therapy* / Q000401:mortality* / Q000556:secondary; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D003875:Drug Eruptions / Q000209:etiology; D005260:Female; D006801:Humans; D008113:Liver Neoplasms / Q000556:secondary; D008175:Lung Neoplasms / Q000556:secondary; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage; D010523:Peripheral Nervous System Diseases / Q000139:chemically induced; D011379:Prognosis; D015996:Survival Rate; D013921:Thrombocytopenia / Q000139:chemically induced; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy* / Q000401:mortality*; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D017239:Paclitaxel; D000093542:Gemcitabine