title: Results of the Southwest Oncology Group phase II evaluation (study S0031) of ZD1839 for advanced transitional cell carcinoma of the urothelium.
abstract: METHODS
  Prognosis (inception cohort).
  
  
  METHODS
  1b.
  
  
  OBJECTIVE
  To evaluate the epidermal growth factor receptor (EGFR)-targeted agent ZD1839 in patients who failed one previous chemotherapeutic regimen for metastatic transitional cell carcinoma (TCC), and to correlate patterns of response with the expression of EGFR.
  
  
  METHODS
  Thirty-one patients with metastatic TCC of the urothelial tract were treated with ZD1839 500 mg oral daily. Patients were required to have a pretreatment biopsy to assess EGF expression.
  
  
  RESULTS
  The median progression-free survival was 2 months, with only two patients (6.5%) surviving past 6 months with no disease progression. Thirty patients were evaluable for toxicity; there was grade 4 cerebrovascular ischaemia and an increase in creatinine level. All patients were evaluable for response, with one confirmed partial response (3%; 95% confidence interval, CI, 0-17%) in a patient with pulmonary metastases. All patients have died, and the estimated median (95% CI) survival is 3 (2-7) months.
  
  
  CONCLUSIONS
  ZD1839 is ineffective as a second-line agent for urothelial carcinoma.
authors.affiliation: Genitourinary Cancer Program, Columbia University, NewYork, NY 10032, USA. dpp5@columbia.edu
authors.forename: Daniel P
authors.initials: DP
authors.lastname: Petrylak
authors.forename: Catherine M
authors.initials: CM
authors.lastname: Tangen
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Van Veldhuizen
authors.forename: J Wendall
authors.initials: JW
authors.lastname: Goodwin
authors.forename: Przemyslaw W
authors.initials: PW
authors.lastname: Twardowski
authors.forename: James N
authors.initials: JN
authors.lastname: Atkins
authors.forename: Shaker R
authors.initials: SR
authors.lastname: Kakhil
authors.forename: Marianne K
authors.initials: MK
authors.lastname: Lange
authors.forename: Mahesh
authors.initials: M
authors.lastname: Mansukhani
authors.forename: E David
authors.initials: ED
authors.lastname: Crawford
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002295:Carcinoma, Transitional Cell / Q000188:drug therapy*; D005260:Female; D000077156:Gefitinib; D006801:Humans; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D011799:Quinazolines / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome; D014571:Urologic Neoplasms / Q000188:drug therapy*; D019459:Urothelium
chemical_list: D000970:Antineoplastic Agents; D011799:Quinazolines; D000077156:Gefitinib