title: Gemcitabine monotherapy as second-line treatment in cisplatin-refractory transitional cell carcinoma - prognostic factors for response and improvement of quality of life.
abstract: OBJECTIVE
  i) To evaluate objective response, toxicity, and quality of life (QoL) of gemcitabine monotherapy as second-line treatment in patients with cisplatin-refractory, metastatic transitional cell carcinoma (TCC). ii) To assess prognostic parameters for response to treatment and for improvement of QoL parameters.
  
  
  METHODS
  30 patients were prospectively enrolled in this open-label, nonrandomized multicenter phase II trial. Patients received up to 6 courses of gemcitabine monotherapy (1,250 mg/m(2) on day 1 and 8 of a 21-day course). 28 of 30 patients were available for response evaluation.
  
  
  RESULTS
  Objective response (OR) was seen in 3/28 (11%) of patients (2 complete remissions, 1 partial remission). The mean time to progression (TTP) was 4.9 +/- 3.5 months and mean disease-specific survival time was 8.7 +/- 4.7 months. 13 of 28 patients did not progress (OR + 10 stable diseases), and TTP (8.0 +/- 2.7 months, p < 0.001) as well as survival time (10.2 +/- 3.8 months, p < 0.05) differed significantly from those who showed progressive disease within 18 weeks of treatment. Pain values significantly improved in the group of responders from 4.3 +/- 1.9 to 5.8 +/- 1.3 points (p < 0.05). Response to cisplatin pretreatment was the best prognosticator for the response to gemcitabine.
  
  
  CONCLUSIONS
  Gemcitabine monotherapy as second-line treatment is justified in patients with metastatic TCC who are refractory to cisplatin treatment. Patients with initially OR to cisplatin benefit most from second-line treatment. QoL remains stable during treatment, and pain improves especially in patients with bone metastases.
authors.affiliation: Klinik und Poliklinik für Urologie, Universitätsklinikum Bonn, Germany. peter.albers@ukb.uni-bonn.de
authors.forename: P
authors.initials: P
authors.lastname: Albers
authors.forename: R
authors.initials: R
authors.lastname: Siener
authors.forename: M
authors.initials: M
authors.lastname: Härtlein
authors.forename: M
authors.initials: M
authors.lastname: Fallahi
authors.forename: D
authors.initials: D
authors.lastname: Haeutle
authors.forename: F G E
authors.initials: FG
authors.lastname: Perabo
authors.forename: G
authors.initials: G
authors.lastname: Steiner
authors.forename: J
authors.initials: J
authors.lastname: Blatter
authors.forename: S C
authors.initials: SC
authors.lastname: Müller
mesh_terms: D002295:Carcinoma, Transitional Cell / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage* / Q000009:adverse effects; D003841:Deoxycytidine / Q000008:administration & dosage* / Q000009:adverse effects / Q000031:analogs & derivatives*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D019008:Drug Resistance, Neoplasm; D005500:Follow-Up Studies; D006801:Humans; D009362:Neoplasm Metastasis; D009367:Neoplasm Staging; D011446:Prospective Studies; D015996:Survival Rate; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D002945:Cisplatin; D000093542:Gemcitabine