Assessment of Real-World Outcomes Associated with Afatinib (Gilotrif) Use in Patients with Solid Tumors Harboring NRG1 Gene Fusions (Afatinib (Gilotrif) Use in Solid Tumors Harboring)

Study type

• Study topic:
  Human medicinal product

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

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name, other:
  Gilotrif
• Medical condition to be studied:
  Neoplasm

Population studied

• Short description of the study population:
  Approximately 20 or more unique providers will participate in this research study. ; Providers who meet the following criteria will be eligible to participate:; 1) Are board-certified oncologist/hematologist.; 2) Have treated/are treating at least one eligible patient with an NRG1 fusion-positive solid tumor.; 3) Are able to participate in research approved by an external institutional review board (IRB).; 4) Agree to participate in data quality assurance/control processes.; Providers will be asked to select eligible patients chronologically, starting with the first patient who first initiated any line of afatinib or chemotherapy, on or after 01/01/2017 through 03/31/2020.; Inclusion Criteria:; • Adults, 18 years of age or older, at the time of diagnosis with any solid tumor.; • Confirmed NRG1 gene fusion in any solid tumor.; • Initiated afatinib or other systemic therapy (in any line of therapy) for treatment of a solid tumor with NRG1 gene fusion on or after 01/01/2017 through 03/31/2020.; • Followed up for ≥3 months after initiation of afatinib or other systemic therapy (unless deceased prior to 3 months of follow-up).; Exclusion Criteria:; • Treatment with any TKI/ErbB-directed therapy other than afatinib
• 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)
• Special population of interest:
  Pregnant women

  Other
• Special population of interest, other:
  Solid tumor
• Estimated number of subjects:
  110

Study design details

• Main study objective:
  Characteristics of patients with NRG1 gene fusion-positive solid tumors treated with afatinib, and the characteristics of those treated with another systemic therapy
• Outcomes:
  ORR, DOCB, DOR, TOT, TTP, PFS, OS, AE
• Data analysis plan:
  Demographic and clinical characteristics were reported via descriptive analyses, including counts and frequencies for dichotomous and categorical variables, while measures of centrality (mean, median) and spread (min, max, standard deviation, interquartile range, as appropriate) were used for continuous variables. These characteristics were described at the time of initial diagnosis of advance/metastatic disease and at the time of initiation of each line of therapy received. For disease response, the point estimate for ORR and associated 95% confidence interval were calculated for each cohort. The Kaplan-Meier method was used to estimate any time to event outcome including DOR, DOCB, TOT, TTP, PFS, and OS to account for any right censoring (e.g. patient had not discontinued therapy, patient had not progressed or died). Incidence and severity of AEs were summarized and displayed in number/percentage. All safety endpoints were analyzed descriptively.