A Multicentre, Cohort Study to Assess the Impact on SYMptom Burden and Patient Health-related Quality of Life of Afatinib Treatment in Advanced Non-small Cell Lung Cancer in a Real World Setting in Greece (SYM-Less)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  GIOTRIF
• Medical condition to be studied:
  Non-small cell lung cancer metastatic
• Additional medical condition(s):
  1) any histological type and 2) activating EGFR-mutations

Population studied

• Short description of the study population:
  Patients with locally advanced or metastatic NSCLC harboring Epidermal Growth Factor Receptor (EGFR)-mutations in Greece. Eligible NSCLC patients, for whom the physician has decided to initiate treatment with the study medication (afatinib, GIOTRIF®) will be treated according to the local prescribing information and standard medical practice in terms of visit frequency and types of assessments performed.
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Non-small cell lung cancer patients
• Estimated number of subjects:
  128

Study design details

• Main study objective:
  To evaluate the impact of afatinib therapy on the patient-reported lung cancer-specific symptom burden over 6 months of therapy
• Outcomes:
  6-month symptom improvement rate using the LCSS ASBI questionnaire, 1.LCSS total & domain scores change from enrolment 2.ASBI score change from enrolment 3.Proportion of patients in the EQ-5D dimension levels change from enrolment 4.EQ-VAS score change from enrolment 5.ECOG PS score change from baseline 6.Ratio of afatinib doses actually taken 7.Discrepancy reasons between afatinib doses 8.Treatment discontinuation % of pts 9.Treatment interruption % of pts
• Data analysis plan:
  The study is not aimed to confirm/reject any pre-defined hypotheses,statistical analyses will be of explorative & descriptive nature.Continuous variables will be summarized with the use of descriptive statistical measures (mean, SD, median & extreme values) & categorical/distinct variables will be displayed as frequency tables.The normality of distribution of continuous variables will be examined using the Shapiro-Wilk test in order to determinewhether or not to use parametric methods for the analysis of the sample data.Differences between the mean values of continuous variables will be evaluated using the paired t-test or the non-parametric analogue (i.e.Wilcoxon signed rank test).All statistical tests will be two-sided & will be performed at a 0.05 significance level.The exact p-values will be reported, even for non-significant results, rounded to 3 decimals unless the p-alue is less than 0.001 (P<0.001 will be reported).No adjustment for multiplicity of testing will be performed.