title: A phase I/II trial of weekly docetaxel and gefitinib in elderly patients with stage IIIB/IV non-small cell lung cancer.
abstract: BACKGROUND
  Phase III trials in elderly patients with advanced (stage IIIB/IV) non-small cell lung cancer (NSCLC) reveal treatment with single agent chemotherapy improves survival. The role of double agent therapy in this patient population is an area of investigation.
  
  
  METHODS
  A phase I/II trial was performed in elderly patients (age>or=70 years) with stage IIIB/IV disease and Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. Patients were treated with gefitinib 250 mg daily. Patients received docetaxel on a treatment schedule of days 1, 8, 15 of an every 28 days schedule. The phase I portion of the trial consisted of dose escalation docetaxel from 30 to 36 mg/m2 using a three patient cohort design. The trial design contained continuous monitoring for excessive toxicity with pre-selected toxicity boundaries.
  
  
  RESULTS
  Twenty-six patients were evaluable for efficacy and toxicity analysis. The median age was 75.5 years. The majority of the patients had stage IV disease (85%), ECOG functional status of 0-1 (81%), were male (65%), and current or former smokers (88%). Eleven patients experienced National Cancer Institute Common Toxicity Criteria grades 3-5 non-hematologic toxicity during the first cycle. The toxicity was determined to be unexpected, and the trial was discontinued. Overall response rate (complete+partial responses) was 31%, and the median survival was 6.5 months (95% confidence interval (CI) (3.6-9.0)), and estimated 1-year survival rate was 27% (95% CI (13-55%)).
  
  
  CONCLUSIONS
  The combination of weekly docetaxel and gefitinib had activity; however, unexpected toxicity was observed in the elderly patient population.
authors.affiliation: Department of Hematology/Oncology, University of North Carolina, Chapel Hill, NC 27599-7305, USA. Thomas_Stinchcombe@med.unc.edu
authors.forename: Thomas E
authors.initials: TE
authors.lastname: Stinchcombe
authors.forename: Petra
authors.initials: P
authors.lastname: Bůzková
authors.forename: Janak
authors.initials: J
authors.lastname: Choksi
authors.forename: Mark
authors.initials: M
authors.lastname: Taylor
authors.forename: Kamal
authors.initials: K
authors.lastname: Bakri
authors.forename: Heidi
authors.initials: H
authors.lastname: Gillenwater
authors.forename: Maureen
authors.initials: M
authors.lastname: Tynan
authors.forename: Andrea
authors.initials: A
authors.lastname: Mears
authors.forename: Paul E
authors.initials: PE
authors.lastname: Jones
authors.forename: Mark A
authors.initials: MA
authors.lastname: Socinski
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality; D000077143:Docetaxel; D004334:Drug Administration Schedule; D005260:Female; D000077156:Gefitinib; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D009367:Neoplasm Staging; D011799:Quinazolines / Q000008:administration & dosage / Q000009:adverse effects; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D011799:Quinazolines; D043823:Taxoids; D000077143:Docetaxel; D000077156:Gefitinib