Japanese REal-world data for treatment of afatinib (GIotrif®) in first-line setting and Subsequent Therapies for patients with advanced EGFR mutation-positive lung adenocarcinoma (J-REGISTER)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name:
  GIOTRIF
• Study drug International non-proprietary name (INN) or common name:
  AFATINIB
• Anatomical Therapeutic Chemical (ATC) code:
  (L01EB03) afatinib

  afatinib
• Medical condition to be studied:
  Lung carcinoma cell type unspecified stage IV

  EGFR gene mutation

Population studied

• Short description of the study population:
  Patients with EGFR mutation- positive NSCLC.
• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Estimated number of subjects:
  1000

Study design details

• Study design:
  This was a non-interventional, multi-center study from existing data of patients treated with afatinib as the first-line treatment. The study involved secondary use of data which was extracted retrospectively once patients were enrolled into this study
• Main study objective:
  The primary objective is to confirm TOT related to afatinib treatment as first-line therapy(TOT1) in patients with EGFR mutation-positive NSCLC.
• Setting:
  This NIS study enrolled 857 patients at 40 sites in Japan. Patients information was chosen for patients treated with afatinib in the first-line setting in each study site after its launch on 7 May 2014 on a regular basis. In first round of data extraction, the data was extracted retrospectively once patients were enrolled into this study. A second round of data extraction was performed for additional follow-up one year after completion of first round data extraction. The data extraction was started on 01 Apr 2021 and ended on 07 Nov 2022
• Outcomes:
  1.TOT from the start of afatinib until end of subsequent therapies in the second-line setting or death by any cause 2.TOT from start of the second-line treatment until end of the second-line treatment or death by any case (TOT2) 3.overall survival 4.survival rate at 18 and 36 months 5.time to initial dose reduction of afatinib 6.proportion of patients with dose modifications of afatinib
• Data analysis plan:
  TOT with afatinib (TOT1)will be analysed using Kaplan-Meier method, and the median along with two-sided 95% confidence interval (CI) will be displayed