title: Phase II Clinical Trial of Gefitinib for the Treatment of Chemonaïve Patients with Advanced Non-small Cell Lung Cancer with Poor Performance Status.
abstract: BACKGROUND
  Patients with advanced non-small cell lung cancer (NSCLC) have no curative treatment options; therefore, improving their quality of life (QOL) is an important goal. Gefitinib, an epidermal growth factor receptor (EGFR) inhibitor, is a safe oral agent that may be of benefit to a specific population of NSCLC.
  
  
  METHODS
  A Phase II clinical trial included chemonaïve patients with advanced NSCLC and poor performance status (PS). Response rate, progression-free survival, overall survival, QOL using the Functional Assessment of Cancer Therapy - Lung (FACT-L) questionnaire, and Trial Outcome Index (TOI) were evaluated.
  
  
  RESULTS
  Twelve out of 19 enrolled patients were evaluable. The median age for the evaluable patients was 68.8 years (59.7-74.6). Out of all the patients, 7 (58.3%) had adenocarcinoma and 5 (41.7%) had squamous cell carcinoma. The median duration of treatment was 62.5 days (26.5-115.0) in the evaluable patients. Grade 3/4 toxicities included fatigue, rash, diarrhea, and nausea. One patient had partial response, eight patients had stable disease (SD), and three patients progressed. The median overall survival for the evaluable population was 4.9 months (2.3-16). The median progression-free survival was 3.7 months (1.9-6.6). TOI was marginally associated with the overall survival, with a hazard ratio of 0.92 (95% confidence interval: 0.84, 1.0) (P = 0.061). FACT-L score and the TOI were highly correlated (r = 0.96, P < 0.0001). TOI scores were higher in African Americans compared to Caucasians and increased with age.
  
  
  CONCLUSIONS
  Our results suggest that gefitinib use in patients with NSCLC and poor PS may improve the QOL of older patients and African American patients.
authors.affiliation: University of Cincinnati, Cincinnati, OH, USA.
authors.forename: Nagla Abdel
authors.initials: NA
authors.lastname: Karim
authors.affiliation: University of Illinois at Urbana-Champaign, IL, USA.
authors.forename: Salma
authors.initials: S
authors.lastname: Musaad
authors.affiliation: Cleveland Clinic Foundation, Cleveland, OH, USA.
authors.forename: Ahmad
authors.initials: A
authors.lastname: Zarzour
authors.affiliation: University of Tennessee Cancer Institute, Memphis, TN, USA.
authors.forename: Sadanand
authors.initials: S
authors.lastname: Patil
authors.affiliation: King Saud bin Abdul-Aziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Kingdom of Saudi Arabia.
authors.forename: Abdul Rahman
authors.initials: AR
authors.lastname: Jazieh
keywords: advanced non-small cell lung cancer; gefitinib; poor performance status; quality of life