title: Phase II trial of paclitaxel, carboplatin, and topotecan with G-CSF support in previously untreated patients with extensive stage small cell lung cancer: Southwest Oncology Group 9914.
abstract: OBJECTIVE
  This phase II study (S9914) evaluated the efficacy and toxicity of the three-drug combination of paclitaxel, carboplatin, and topotecan with granulocyte colony-stimulating factor support in previously untreated patients with extensive stage small cell lung cancer.
  
  
  METHODS
  Patients with newly diagnosed extensive stage small cell lung cancer received topotecan 1.0 mg/m intravenously on days 1 through 4; paclitaxel 175 mg/m intravenously on day 4, and carboplatin AUC = 5 intravenously on day 4, treatments were repeated every 21 days for a maximum of six cycles. All patients also received granulocyte colony-stimulating factor 5 mug/kg/day beginning on day 5 of each cycle.
  
  
  RESULTS
  A total of 88 patients were enrolled on the study; 79 patients were assessable for survival and toxicity and 74 patients for response. Objective response was observed in 50 patients (68%; 95% confidence interval [CI]: 56%-78%) with nine patients (12%) achieving a complete response. Median progression-free survival was 7 months (95% CI: 6-8 months) and median overall survival was 12 months (95% CI: 11-14 months). The 1- and 2-year survival rates were 48% (95% CI: 37%-59%) and 20% (95% CI: 11%-29%), respectively. The most common toxicities were hematologic. Grade 3 and 4 neutropenia was noted in 17 (22%) and 27 (34%) patients, respectively. Febrile neutropenia developed in only four patients. Two patients (3%) died of treatment-related causes.
  
  
  CONCLUSIONS
  The combination of paclitaxel, carboplatin, and topotecan combined with granulocyte colony-stimulating factor support is an active and reasonably well-tolerated regimen for the treatment of extensive stage small cell lung cancer.
authors.affiliation: Caritas St. Elizabeth's Medical Center of Boston, Boston, MA 02135, USA. phesketh@massmed.org
authors.forename: Paul J
authors.initials: PJ
authors.lastname: Hesketh
authors.forename: Jason
authors.initials: J
authors.lastname: McCoy
authors.forename: Frank R
authors.initials: FR
authors.lastname: Dunphy
authors.forename: James D
authors.initials: JD
authors.lastname: Bearden
authors.forename: Geoffrey R
authors.initials: GR
authors.lastname: Weiss
authors.forename: Jeffrey K
authors.initials: JK
authors.lastname: Giguere
authors.forename: James N
authors.initials: JN
authors.lastname: Atkins
authors.forename: Shaker R
authors.initials: SR
authors.lastname: Dakhil
authors.forename: Karen
authors.initials: K
authors.lastname: Kelly
authors.forename: John J
authors.initials: JJ
authors.lastname: Crowley
authors.forename: David R
authors.initials: DR
authors.lastname: Gandara
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects; D018288:Carcinoma, Small Cell / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology*; D016001:Confidence Intervals; D018572:Disease-Free Survival; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage*; D006801:Humans; D007262:Infusions, Intravenous; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology*; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009361:Neoplasm Invasiveness / Q000473:pathology; D009367:Neoplasm Staging; D009503:Neutropenia / Q000139:chemically induced / Q000517:prevention & control; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D011336:Probability; D011379:Prognosis; D012307:Risk Factors; D016019:Survival Analysis; D019772:Topotecan / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D016179:Granulocyte Colony-Stimulating Factor; D019772:Topotecan; D016190:Carboplatin; D017239:Paclitaxel