title: Symptom improvement in lung cancer patients treated with erlotinib: quality of life analysis of the National Cancer Institute of Canada Clinical Trials Group Study BR.21.
abstract: OBJECTIVE
  This report describes the quality of life (QOL) findings of a randomized placebo controlled study of erlotinib, an epidermal growth factor receptor inhibitor, in patients with non-small-cell lung cancer (NSCLC).
  
  
  METHODS
  This double-blind phase III trial randomly assigned 731 patients with NSCLC who had progressed after prior chemotherapy to erlotinib 150 mg daily or placebo, with survival as the primary study outcome. QOL was assessed by European Organisation for Research and Treatment of Cancer QLQ-C30 and the lung cancer module QLQ-LC13. The primary end points for QOL analysis were time to deterioration of three common lung cancer symptoms: cough, dyspnea, and pain.
  
  
  RESULTS
  Survival was significantly longer (hazard ratio, 0.70; P < .0001) in the erlotinib arm. Compliance with QOL was 87% at baseline and more than 70% during treatment. Patients receiving erlotinib had significantly longer median time to deterioration for all three symptoms (4.9 v 3.7 months for cough [P = .04]; 4.7 v 2.9 months for dyspnea [P = .04], and 2.8 v 1.9 months for pain [P = .03]). QOL response analyses showed that 44%, 34%, and 42% of patients receiving erlotinib had improvement in these three symptoms, respectively. This was accompanied by a significant improvement in the physical function (31% erlotinib v 19% placebo, P = .01), and global QOL (35% v 26%, P < .0001). Patients with complete or partial response were more likely to have improvement in the QOL response than patients with stable or progressive disease (P < .01).
  
  
  CONCLUSIONS
  Erlotinib not only improves survival in previously treated patients with NSCLC, but also improves tumor-related symptoms and important aspects of QOL.
authors.affiliation: Princess Margaret Hospital/University Health Network, University of Toronto, Toronto, Ontario, Canada. andrea.bezjak@rmp.uhn.on.ca
authors.forename: Andrea
authors.initials: A
authors.lastname: Bezjak
authors.forename: Dongsheng
authors.initials: D
authors.lastname: Tu
authors.forename: Lesley
authors.initials: L
authors.lastname: Seymour
authors.forename: Gary
authors.initials: G
authors.lastname: Clark
authors.forename: Aleksandra
authors.initials: A
authors.lastname: Trajkovic
authors.forename: Mauro
authors.initials: M
authors.lastname: Zukin
authors.forename: Joseph
authors.initials: J
authors.lastname: Ayoub
authors.forename: Sergio
authors.initials: S
authors.lastname: Lago
authors.forename: Ronaldo
authors.initials: R
authors.lastname: de Albuquerque Ribeiro
authors.forename: Alexandra
authors.initials: A
authors.lastname: Gerogianni
authors.forename: Arnold
authors.initials: A
authors.lastname: Cyjon
authors.forename: Jonathan
authors.initials: J
authors.lastname: Noble
authors.forename: Francis
authors.initials: F
authors.lastname: Laberge
authors.forename: Raymond Tsz-Tong
authors.initials: RT
authors.lastname: Chan
authors.forename: David
authors.initials: D
authors.lastname: Fenton
authors.forename: Joachim
authors.initials: J
authors.lastname: von Pawel
authors.forename: Martin
authors.initials: M
authors.lastname: Reck
authors.forename: Frances A
authors.initials: FA
authors.lastname: Shepherd
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002170:Canada; D002289:Carcinoma, Non-Small-Cell Lung / Q000150:complications / Q000188:drug therapy*; D003371:Cough / Q000209:etiology / Q000517:prevention & control; D004311:Double-Blind Method; D004417:Dyspnea / Q000209:etiology / Q000517:prevention & control; D000069347:Erlotinib Hydrochloride; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000150:complications / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D010146:Pain / Q000209:etiology / Q000517:prevention & control; D047428:Protein Kinase Inhibitors / Q000627:therapeutic use; D011788:Quality of Life; D011799:Quinazolines / Q000009:adverse effects / Q000627:therapeutic use*; D011795:Surveys and Questionnaires; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D047428:Protein Kinase Inhibitors; D011799:Quinazolines; D000069347:Erlotinib Hydrochloride