title: Topotecan therapy in patients with relapsed small-cell lung cancer and poor performance status.
abstract: OBJECTIVE
  Topotecan is generally well tolerated and active in patients with relapsed small-cell lung cancer (SCLC) and poor performance status (PS). In this study, we investigated whether treatment with topotecan is associated with improvement in PS as measured by the rate of conversion from PS 2 to PS 0/1.
  
  
  METHODS
  A retrospective analysis of data from 7 clinical trials (N = 795) investigating topotecan in patients with relapsed SCLC was performed. All patients received topotecan 1.25-1.5 mg/m2 daily on days 1-5 of a 21-day cycle. Demographics were similar for patients with PS 2 and PS 0/1. A total of 152 patients with PS 2 at baseline received 502 cycles (median, 2 cycles; range, 1-14 cycles) of therapy, and 32 (21%) experienced PS improvement to PS 0/1 that lasted for > or = 2 cycles.
  
  
  RESULTS
  Overall, 50% of patients who experienced PS conversion also exhibited an objective antitumor response, compared with 8% of patients with PS 2 who had no improvement in PS and achieved a response. Similarly, median overall survival was longer for patients with PS improvement (37 weeks; 95% confidence interval, 29.6-49.4 weeks) compared with patients with PS 2 who had a response but no PS improvement (10.4 weeks; 95% confidence interval, 8.7-13.6 weeks). A substantial proportion of patients with PS 2 and relapsed SCLC experienced PS improvement during topotecan treatment. These patients had a substantially longer median survival and a higher response rate compared with the overall trial population.
  
  
  CONCLUSIONS
  Improvement in PS appears to be a good indicator of benefit from topotecan therapy.
authors.affiliation: The Mount Sinai Comprehensive Cancer Center, Miami Beach, FL 33140, USA. rlilenbaum@aptiumoncology.com
authors.forename: Rogerio C
authors.initials: RC
authors.lastname: Lilenbaum
authors.forename: Rudolf M
authors.initials: RM
authors.lastname: Huber
authors.forename: Joseph
authors.initials: J
authors.lastname: Treat
authors.forename: Gregory
authors.initials: G
authors.lastname: Masters
authors.forename: Sabine
authors.initials: S
authors.lastname: Kaubitzsch
authors.forename: Stephen
authors.initials: S
authors.lastname: Lane
authors.forename: Paul
authors.initials: P
authors.lastname: Wissel
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D018288:Carcinoma, Small Cell / Q000188:drug therapy* / Q000453:epidemiology / Q000517:prevention & control*; D002986:Clinical Trials as Topic; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D012008:Recurrence; D012189:Retrospective Studies; D015996:Survival Rate; D019772:Topotecan / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D019772:Topotecan