title: Effects of erlotinib first-line maintenance therapy versus placebo on the health-related quality of life of patients with metastatic non-small-cell lung cancer.
abstract: BACKGROUND
  Maintenance therapy can delay progression and prolong survival in metastatic non-small-cell lung cancer (mNSCLC). As treatment for mNSCLC is non-curative, its impact on patient health-related quality of life (HRQoL) is an important consideration. SATURN (Sequential Tarceva in Unresectable NSCLC) was a randomised, double-blind, placebo-controlled, multicentre study investigating the impact of erlotinib maintenance therapy on HRQoL in patients with locally advanced or recurrent NSCLC.
  
  
  METHODS
  Eligible patients who had previously completed four cycles of platinum-based chemotherapy were randomised 1:1 to receive erlotinib 150 mg/day or placebo until disease progression, unacceptable toxicity or death. Patient HRQoL was assessed using the Functional Assessment of Cancer Therapy-Lung questionnaire, in terms of time to symptom progression (TSP), time to deterioration (TTD) in Trial Outcome Index (TOI) and TTD. Exploratory analysis was based on time to analgesia and appearance of key symptoms (pain, cough and dyspnoea).
  
  
  RESULTS
  Compared with placebo, erlotinib maintenance therapy prolonged progression-free and overall survival by 41% and 23%, respectively. At baseline, HRQoL measures were comparable between the two treatment groups. Maintenance therapy with erlotinib did not impact on deterioration in HRQoL: TSP (hazard ratio [HR]=0.91 [95% confidence interval (CI) 0.74-1.12]; n=785), TTD in TOI (HR=1.06 [95% CI 0.87-1.31]; n=781) and TTD in HRQoL (HR=0.96 [95% CI 0.79-1.16]; n=776). Time to pain and time to analgesic use were significantly delayed in patients receiving erlotinib compared with placebo (HR=0.61 [95% CI 0.42-0.88]; p=0.0080 and HR=0.66 [95% CI 0.46-0.94]; p=0.0199, respectively). A non-significant trend towards delayed time to cough and time to dyspnoea (HR=0.77 [95% CI 0.49-1.21] and HR=0.75 [95% CI 0.48-1.17], respectively) was also observed.
  
  
  CONCLUSIONS
  Erlotinib maintenance therapy significantly extends progression-free survival without compromising patient HRQoL in comparison with placebo, with some improvement in symptoms.
authors.affiliation: Korányi National Institute for TB and Pulmonology, Budapest, Hungary. juhasz@koranyi.hu
authors.forename: Erzsébet
authors.initials: E
authors.lastname: Juhász
authors.forename: Joo-Hang
authors.initials: JH
authors.lastname: Kim
authors.forename: Gaëlle
authors.initials: G
authors.lastname: Klingelschmitt
authors.forename: Stefan
authors.initials: S
authors.lastname: Walzer
mesh_terms: D000368:Aged; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D003967:Diarrhea / Q000139:chemically induced; D018450:Disease Progression; D004311:Double-Blind Method; D000069347:Erlotinib Hydrochloride; D005076:Exanthema / Q000139:chemically induced; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D060046:Maintenance Chemotherapy; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D047428:Protein Kinase Inhibitors / Q000627:therapeutic use; D011788:Quality of Life; D011799:Quinazolines / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D047428:Protein Kinase Inhibitors; D011799:Quinazolines; D000069347:Erlotinib Hydrochloride