title: A randomized phase II trial of first-line treatment with gemcitabine, erlotinib, or gemcitabine and erlotinib in elderly patients (age ≥70 years) with stage IIIB/IV non-small cell lung cancer.
abstract: BACKGROUND
  Single-agent gemcitabine is a standard of care for elderly patients with advanced non-small cell lung cancer, but novel therapies are needed for this patient population.
  
  
  METHODS
  We performed a noncomparative randomized phase II trial of gemcitabine, erlotinib, or the combination in elderly patients (age ≥70 years) with stage IIIB or IV non-small cell lung cancer. Patients were randomized to arms: A (gemcitabine 1200 mg/m on days 1 and 8 every 21 days), B (erlotinib 150 mg daily), or C (gemcitabine 1000 mg/m on days 1 and 8 every 21 days and erlotinib 100 mg daily). Arms B and C were considered investigational; the primary objective was 6-month progression-free survival.
  
  
  RESULTS
  Between March 2006 and May 2010, 146 eligible patients received protocol therapy. The majority of the patients (82%) had stage IV disease, 64% reported adenocarcinoma histology, 90% reported current or previous tobacco use, and 28% had a performance status of 2. The 6-month progression-free survival rate observed in arms A, B, and C was 22% (95% confidence interval [CI] 11-35), 24% (95% CI 13-36), and 25% (95% CI 15-38), respectively; the median overall survival observed was 6.8 months (95% CI 4.8-8.5), 5.8 months (95% CI 3.0-8.3), and 5.6 months (95% CI 3.5-8.4), respectively. The rate of grade ≥3 hematological and nonhematological toxicity observed was similar in all three arms. The best overall health-related quality of life response did not differ between treatment arms.
  
  
  CONCLUSIONS
  Erlotinib or erlotinib and gemcitabine do not warrant further investigation in an unselected elderly patient population.
authors.affiliation: Division of Hematology/Oncology, Multidisciplinary Thoracic Oncology Program, Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina 27599-7, USA. Thomas_Stinchcombe@med.unc.edu
authors.forename: Thomas E
authors.initials: TE
authors.lastname: Stinchcombe
authors.forename: Amy H
authors.initials: AH
authors.lastname: Peterman
authors.forename: Carrie B
authors.initials: CB
authors.lastname: Lee
authors.forename: Dominic T
authors.initials: DT
authors.lastname: Moore
authors.forename: Jennifer L
authors.initials: JL
authors.lastname: Beaumont
authors.forename: Daniel S
authors.initials: DS
authors.lastname: Bradford
authors.forename: Kamal
authors.initials: K
authors.lastname: Bakri
authors.forename: Mark
authors.initials: M
authors.lastname: Taylor
authors.forename: Jeffrey M
authors.initials: JM
authors.lastname: Crane
authors.forename: Garry
authors.initials: G
authors.lastname: Schwartz
authors.forename: Thomas A
authors.initials: TA
authors.lastname: Hensing
authors.forename: Edwin
authors.initials: E
authors.lastname: McElroy
authors.forename: Harvey B
authors.initials: HB
authors.lastname: Niell
authors.forename: Harry D
authors.initials: HD
authors.lastname: Harper
authors.forename: Sridhar
authors.initials: S
authors.lastname: Pal
authors.forename: Mark A
authors.initials: MA
authors.lastname: Socinski
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000473:pathology; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000069347:Erlotinib Hydrochloride; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008137:Longitudinal Studies; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D009367:Neoplasm Staging; D011799:Quinazolines / Q000008:administration & dosage; D015996:Survival Rate; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D011799:Quinazolines; D003841:Deoxycytidine; D000069347:Erlotinib Hydrochloride; D000093542:Gemcitabine