title: Single-agent gefitinib in patients with untreated advanced non-small-cell lung cancer and poor performance status: a Minnie Pearl Cancer Research Network Phase II Trial.
abstract: BACKGROUND
  Patients with advanced non-small-cell lung cancer (NSCLC) and poor performance status (PS) are often excluded from trials. Gefitinib is a safe oral agent that may benefit these patients.
  
  
  METHODS
  Seventy-two patients with poor PS and advanced NSCLC were enrolled onto this study of gefitinib 250 mg per day given orally until disease progression, with evaluation at 8 weeks. Eligible patients had no previous chemotherapy, an Eastern Cooperative Oncology Group PS of 2/3, and stage IIIB/IV NSCLC. Quality of life (QOL) and symptom response (SR) scores were calculated using the Functional Assessment of Cancer-Lung questionnaire. Patient characteristics included a median age of 75 years; PS of 2/3; and bronchoalveolar (n=3), adenocarcinoma (n=29), squamous cell (n=21), large-cell (n=11), and unspecified histology (n=6). Mean treatment duration was 4 months (range, 3 days to 18 months), and median duration of follow-up was 12 months. Grade 3/4 toxicities included rash and diarrhea.
  
  
  RESULTS
  Among 70 patients assessed for response, there were 3 partial responses (4%), 32 patients with stable disease (46%), and 18 with progressive disease (26%). Median progression-free survival (PFS) and overall survival (OS) were 3.7 months and 6.3 months, respectively. Six-month and 1-year PFS and OS rates were 35% and 21% and 50% and 24%, respectively. Eighty-two percent and 48% of patients reported improvements or no change in QOL and SR, respectively.
  
  
  CONCLUSIONS
  Gefitinib demonstrates modest efficacy and is well tolerated as initial therapy in advanced NSCLC for patients with poor PS.
authors.affiliation: Sarah Cannon Research Institute and Tennessee Oncology, PLLC, Nashville, TN 37203, USA. dspigel@tnonc.com
authors.forename: David R
authors.initials: DR
authors.lastname: Spigel
authors.forename: John D
authors.initials: JD
authors.lastname: Hainsworth
authors.forename: Emily R
authors.initials: ER
authors.lastname: Burkett
authors.forename: Howard A
authors.initials: HA
authors.lastname: Burris
authors.forename: Denise A
authors.initials: DA
authors.lastname: Yardley
authors.forename: Melodie
authors.initials: M
authors.lastname: Thomas
authors.forename: Suzanne F
authors.initials: SF
authors.lastname: Jones
authors.forename: Natalie R
authors.initials: NR
authors.lastname: Dickson
authors.forename: Daniel C
authors.initials: DC
authors.lastname: Scullin
authors.forename: James E
authors.initials: JE
authors.lastname: Bradof
authors.forename: James R
authors.initials: JR
authors.lastname: Rubinsak
authors.forename: Joseph E
authors.initials: JE
authors.lastname: Brierre
authors.forename: F Anthony
authors.initials: FA
authors.lastname: Greco
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy / Q000503:physiopathology; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D018287:Carcinoma, Large Cell / Q000188:drug therapy / Q000503:physiopathology; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000503:physiopathology*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy / Q000503:physiopathology; D018572:Disease-Free Survival; D005260:Female; D000077156:Gefitinib; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000503:physiopathology*; D008297:Male; D008875:Middle Aged; D011597:Psychomotor Performance / Q000187:drug effects*; D011788:Quality of Life; D011799:Quinazolines / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D011799:Quinazolines; D000077156:Gefitinib