title: A phase II trial of carboplatin/vinorelbine with pegfilgrastim support for the treatment of patients with advanced non-small cell lung cancer.
abstract: BACKGROUND
  The impact of chemotherapy dose delivery has not been well studied in patients with non-small cell lung cancer (NSCLC). Overlapping hematologic toxicities commonly limit planned dose intensity of combination chemotherapy regimens. A phase II study investigating carboplatin and vinorelbine, supported by pegfilgrastim, in the treatment of patients with advanced NSCLC was performed.
  
  
  METHODS
  Chemotherapy-naïve patients with locally advanced or metastatic NSCLC were treated with carboplatin area under the curve (AUC) 6 mg/ml per minute intravenously on day 1 and vinorelbine 30 mg/m2 intravenously on days 1 and 8 every 3 weeks for four planned cycles. Pegfilgrastim was administered on day 9 of each cycle as a 6-mg subcutaneous injection. The primary endpoint was incidence of cycle 1 febrile neutropenia. Secondary endpoints included incidence of grade 3/4 hematologic and nonhematologic toxicities, delivered dose intensity, and overall survival.
  
  
  RESULTS
  Thirty patients (21 men, 9 women) with a median age of 61 years (range, 43-79) were enrolled. Of 120 planned patient cycles, 101 (84%) were completed. There was one episode of cycle 1 febrile neutropenia. Overall response rate was 27%. Median dose delivered for vinorelbine was 17.2 mg/m2 per week, representing a delivered dose intensity of 86%. Median survival was 9.4 months (95% confidence interval: 6.1-18.0) with a 3-year survival rate of 20%.
  
  
  CONCLUSIONS
  This regimen of carboplatin and vinorelbine with pegfilgrastim support was associated with a low rate of febrile neutropenia and good maintenance of planned dose intensity. Although response and survival are similar to other chemotherapy regimens in advanced NSCLC, studies optimizing chemotherapy delivery in this setting may help inform treatment approaches in patients with earlier stage disease.
authors.affiliation: Ruth and Herman Albert Thoracic Oncology Program, Duke University Medical Center, Durham, North Carolina 27710, USA.
authors.forename: Richard F
authors.initials: RF
authors.lastname: Riedel
authors.forename: Carolyn
authors.initials: C
authors.lastname: Andrews
authors.forename: Jennifer
authors.initials: J
authors.lastname: Garst
authors.forename: Frank
authors.initials: F
authors.lastname: Dunphy
authors.forename: James E
authors.initials: JE
authors.lastname: Herndon
authors.forename: Susan
authors.initials: S
authors.lastname: Blackwell
authors.forename: Sally
authors.initials: S
authors.lastname: Barbour
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Crawford
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D019540:Area Under Curve; D016190:Carboplatin / Q000008:administration & dosage; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy; D003131:Combined Modality Therapy; D005260:Female; D000069585:Filgrastim; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use*; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy / Q000556:secondary; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000188:drug therapy; D011092:Polyethylene Glycols; D011379:Prognosis; D011994:Recombinant Proteins; D015996:Survival Rate; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage
chemical_list: D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; C455861:pegfilgrastim; D011092:Polyethylene Glycols; D014747:Vinblastine; D016190:Carboplatin; D000069585:Filgrastim