title: A randomized phase II trial of oral topotecan versus docetaxel in the second-line treatment of non-small-cell lung cancer.
abstract: BACKGROUND
  This randomized phase II trial evaluated the efficacy and toxicity of oral topotecan compared with intravenous docetaxel in the second-line treatment of patients with non-small-cell lung cancer (NSCLC).
  
  
  METHODS
  Eighty patients were randomized to receive topotecan (2 mg per day or 2.5 mg per day fixed dose for 5 of 7 days for 2 weeks) or docetaxel (75 mg/m2) every 21 days. Thirty-nine patients received 138 cycles of topotecan.
  
  
  RESULTS
  The overall response rate (RR; ORR) was 8%, median time to progression (TTP) was 1.6 months, median survival was 8.4 months, and the 1- and 2-year survival rates were 36% and 13%, respectively, for patients receiving topotecan. Forty-one patients were randomized, but only 38 patients were actually treated with 136 cycles of docetaxel. The ORR was 8% (7% intent to treat RR), median TTP was 1.4 months, median survival was 7.6 months, and the 1- and 2-year survival rates were 29% and 13%, respectively, for patients receiving docetaxel.
  
  
  CONCLUSIONS
  Oral topotecan appears to be active and well tolerated when administered as a fixed dose daily for 5 of every 7 days for 2 weeks every 21 days and might provide another treatment alternative for patients with advanced-stage NSCLC.
authors.affiliation: Sarah Cannon Research Institute, Nashville, TN 37203, USA. suzanne.jones@scresearch.net
authors.forename: Suzanne
authors.initials: S
authors.lastname: Jones
authors.forename: Dana
authors.initials: D
authors.lastname: Thompson
authors.forename: John
authors.initials: J
authors.lastname: Barton
authors.forename: Jeff
authors.initials: J
authors.lastname: Patton
authors.forename: Dianna
authors.initials: D
authors.lastname: Shipley
authors.forename: F Anthony
authors.initials: FA
authors.lastname: Greco
authors.forename: David
authors.initials: D
authors.lastname: Spigel
authors.forename: Jeff
authors.initials: J
authors.lastname: Infante
authors.forename: Howard A
authors.initials: HA
authors.lastname: Burris
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D018450:Disease Progression; D000077143:Docetaxel; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D019772:Topotecan / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D043823:Taxoids; D000077143:Docetaxel; D019772:Topotecan