title: Rational drug sequencing of paclitaxel, gemcitabine and carboplatin in patients with untreated stage IV and select stage IIIB non-small cell lung cancer.
abstract: BACKGROUND
  To conduct a phase II study evaluating the efficacy of rationally sequenced paclitaxel, gemcitabine, and carboplatin in patients with stage IV or select stage IIIB non-small cell lung cancer (NSCLC).
  
  
  METHODS
  Patients with select stages IIIB (pleural effusion) and IV NSCLC with an ECOG performance status of 0-1 and no prior chemotherapy for their disease were eligible to participate. Treatment was delivered as follows: paclitaxel at 70 mg/m2 followed by gemcitabine at 300 mg/m2 on day 1, with carboplatin (AUC 5) on day 2 of a 28-day cycle. Response was assessed after every two cycles of therapy. The primary endpoint of this trial was response rate, with secondary endpoints of time to progression and 1 year overall survival.
  
  
  RESULTS
  Twenty patients were enrolled on protocol, one of whom never received chemotherapy. The median number of cycles delivered was 3 (range 0-8). A partial response rate of 42% (8/19; 95% CI: 20-67%) and a stable disease rate of 11% (2/19; 95% CI: 1-33%) were observed. The median overall survival time was 9.6 months (95% CI: 4.6-16.6), with a 1 year overall survival rate of 42.1% (95% CI: 24.9-71.3%). Eight patients (42%) stopped treatment due to toxicity.
  
  
  CONCLUSIONS
  Paclitaxel followed by gemcitabine and then carboplatin is an active, albeit complex, regimen in the treatment of patients with advanced NSCLC with insufficient advantage to justify continuation of this regimen.
authors.affiliation: Division of Oncology, Department of Medicine, Cancer Institute of New Jersey, Robert Wood Johnson Medical School, University of Medicine and Dentistry of New Jersey, 195 Little Albany Street, New Brunswick, NJ 08903, United States. sovakmi@umdnj.edu
authors.forename: Mika A
authors.initials: MA
authors.lastname: Sovak
authors.forename: Stuart
authors.initials: S
authors.lastname: Lutzker
authors.forename: Ling
authors.initials: L
authors.lastname: Zheng
authors.forename: Lisa
authors.initials: L
authors.lastname: Guensch
authors.forename: Margaret
authors.initials: M
authors.lastname: Joyce
authors.forename: Susan
authors.initials: S
authors.lastname: Schwartz
authors.forename: Yujun
authors.initials: Y
authors.lastname: Wu
authors.forename: Joseph
authors.initials: J
authors.lastname: Aisner
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D018450:Disease Progression; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D010996:Pleural Effusion / Q000188:drug therapy / Q000473:pathology; D016019:Survival Analysis; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D016190:Carboplatin; D017239:Paclitaxel; D000093542:Gemcitabine