title: Randomized phase III intergroup trial of etoposide and cisplatin with or without paclitaxel and granulocyte colony-stimulating factor in patients with extensive-stage small-cell lung cancer: Cancer and Leukemia Group B Trial 9732.
abstract: OBJECTIVE
  To determine, in a randomized comparison, whether the addition of paclitaxel to etoposide and cisplatin improves the time to progression and overall survival in patients with extensive small-cell lung cancer (SCLC) compared with standard etoposide and cisplatin and to compare the regimens' toxicity.
  
  
  METHODS
  Eligible patients (N=587) with untreated extensive SCLC were randomly assigned to receive either cisplatin 80 mg/m2 on day 1 and etoposide 80 mg/m2 on days 1 through 3 administered every 3 weeks for six cycles (EP) or cisplatin 80 mg/m2 on day 1, paclitaxel 175 mg/m2 over 4 hours on day 1, and etoposide 80 mg/m2 on days 1 to 3 followed by recombinant human granulocyte colony-stimulating factor on days 4 to 18 administered every 3 weeks for six cycles (PET).
  
  
  RESULTS
  Reporting of demographics, response, and survival included 565 patients, of whom 282 were randomly assigned to receive EP and 283 were assigned to receive PET. Overall response rates were 68% for the EP arm and 75% for the PET arm. Median failure-free survival time was 5.9 months for the EP arm and 6 months for the PET arm (P = .179). Median overall survival time was 9.9 months for patients on EP and 10.6 months for patients on PET (P = .169). Toxic deaths occurred in 2.4% of the patients on EP and 6.5% of patients on PET.
  
  
  CONCLUSIONS
  PET did not improve the time to progression or survival in patients with extensive SCLC compared with EP alone and was associated with unacceptable toxicity.
authors.affiliation: University of Tennessee, Memphis, TN 31187, USA. hniell@utmem.edu
authors.forename: Harvey B
authors.initials: HB
authors.lastname: Niell
authors.forename: James E
authors.initials: JE
authors.lastname: Herndon
authors.forename: Antonius A
authors.initials: AA
authors.lastname: Miller
authors.forename: Dorothy M
authors.initials: DM
authors.lastname: Watson
authors.forename: Alan B
authors.initials: AB
authors.lastname: Sandler
authors.forename: Karen
authors.initials: K
authors.lastname: Kelly
authors.forename: Randolph S
authors.initials: RS
authors.lastname: Marks
authors.forename: Micheal C
authors.initials: MC
authors.lastname: Perry
authors.forename: Rafat H
authors.initials: RH
authors.lastname: Ansari
authors.forename: Grefory
authors.initials: G
authors.lastname: Otterson
authors.forename: John
authors.initials: J
authors.lastname: Ellerton
authors.forename: Everett E
authors.initials: EE
authors.lastname: Vokes
authors.forename: Mark R
authors.initials: MR
authors.lastname: Green
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D018288:Carcinoma, Small Cell / Q000188:drug therapy* / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage; D018450:Disease Progression; D005047:Etoposide / Q000008:administration & dosage; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000008:administration & dosage; D011446:Prospective Studies; D011994:Recombinant Proteins / Q000008:administration & dosage; D015996:Survival Rate; D013997:Time Factors
chemical_list: D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; D005047:Etoposide; D017239:Paclitaxel; D002945:Cisplatin