title: Phase II NCCTG trial of oral topotecan and paclitaxel with G-CSF (filgrastim) support in patients with previously untreated extensive-stage small cell lung cancer.
abstract: OBJECTIVE
  To determine the efficacy and toxicity of oral topotecan and paclitaxel in untreated patients with extensive stage small cell lung cancer (SCLC).
  
  
  METHODS
  Thirty-eight patients received 1.75 mg/m2 of oral topotecan days 1 to 5 and 175 mg/m2 paclitaxel IV over 3 hours on day 5 (after topotecan) every 4 weeks for 6 cycles. Subcutaneous G-CSF at a dose of 5 microg/kg was then given 24 to 48 hours after the last dose of chemotherapy and daily for 10 days.
  
  
  RESULTS
  All 38 patients were available for toxicity and response analysis. A median of 5 treatment cycles was given, with a range of 1 to 7 cycles. Seventeen (45%) patients received at least 6 cycles of treatment. The most common severe adverse events were neutropenia (42.1%), leukopenia (34.2%), thrombocytopenia (18.4%), nausea (18.4%), diarrhea (13.2%), and fatigue (13.2%). Two grade 5 treatment-related evens were seen. The median overall survival was 9.1 month (95% CI: 7.5-13.0 months), with a 1-year survival estimate of 44.7% (95% CI: 31.4-63.7%) and a 2-year survival rate of 5.3% (95% CI: 1.4-20.3%). The median time to progression was 5.0 months (95% CI: 3.8-6.6 months), with a 1-year progression-free rate of 5.8% (95% CI: 1.5-22.2%) and a 2-year progression-free rate of 2.9% (95% CI: 0.4-19.9%). The estimated confirmed response rate was 52.9%.
  
  
  CONCLUSIONS
  This regimen has shown similar antitumor activity to that achieved with standard therapy. Because of unacceptable toxicity and cost, we do not recommend this regimen in a palliative setting.
authors.affiliation: Mayo Clinic and Mayo Foundation, Rochester, MN 55905, USA.
authors.forename: Julian R
authors.initials: JR
authors.lastname: Molina
authors.forename: James R
authors.initials: JR
authors.lastname: Jett
authors.forename: Nathan
authors.initials: N
authors.lastname: Foster
authors.forename: Bradley S
authors.initials: BS
authors.lastname: Lair
authors.forename: Thomas J
authors.initials: TJ
authors.lastname: Carroll
authors.forename: Henry D
authors.initials: HD
authors.lastname: Tazelaar
authors.forename: Shauna
authors.initials: S
authors.lastname: Hillman
authors.forename: James A
authors.initials: JA
authors.lastname: Mailliard
authors.forename: Albert M
authors.initials: AM
authors.lastname: Bernath
authors.forename: Daniel
authors.initials: D
authors.lastname: Nikcevich
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D018288:Carcinoma, Small Cell / Q000188:drug therapy*; D018450:Disease Progression; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage; D006801:Humans; D007262:Infusions, Intravenous; D007279:Injections, Subcutaneous; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage; D016019:Survival Analysis; D019772:Topotecan / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D016179:Granulocyte Colony-Stimulating Factor; D019772:Topotecan; D017239:Paclitaxel