Health Care Professional survey on understanding of key risk minimisation measures related to interstitial lung disease (ILD) / pneumonitis with Trastuzumab Deruxtecan treatment

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Name of medicine:
  ENHERTU
• Study drug International non-proprietary name (INN) or common name:
  TRASTUZUMAB DERUXTECAN
• Anatomical Therapeutic Chemical (ATC) code:
  (L01FD04) trastuzumab deruxtecan

  trastuzumab deruxtecan
• Medical condition to be studied:
  Breast cancer

  Interstitial lung disease

  Pneumonitis

Population studied

• Short description of the study population:
  The population to be surveyed in the selected countries comprised physicians who were prescribers; or potential prescribers of T-DXd.
• 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:
  0

Study design details

• Study design:
  This is a cross-sectional, multi-national survey conducted among physicians who are prescribers; or potential prescribers of T-DXd in a selection of European countries where T-DXd is marketed.
• Main study objective:
  To assess physicians’ awareness, knowledge, and implementation of additional risk minimisation measures related to the risk, early detection, diagnosis and management of interstitial lung disease (ILD)/pneumonitis.
• Setting:
  The survey was conducted among office and hospital-based physicians in European countries; approximately 12 months after the distribution of EM for T-DXd.
• Outcomes:
  The primary outcome of the aRMMs for T-DXd will be evaluated as effective if all of the following success criteria are met (1.-3.): 1. Proportion of physicians being aware of the important identified risk of ILD/pneumonitis, 2. Proportion of physicians knowledgeable about the important risk of ILD/pneumonitis, 3. Proportion of physicians answering the implementation questions correctly. Physicians’ awareness of ILD/pneumonitis risk and its related minimisation measures, awareness of having received the education material, measure physicians’ knowledge on the requirement for treatment modifications in case of suspected ILD/pneumonitis, assess whether physicians implement the measure (addressing the recommended talking points, distribution of patient alert card).
• Data analysis plan:
  The statistical results of the physicians’ survey data will be presented in one report, by country and combined. In addition, selected analyses will be stratified by physicians’ prescribing status (prescriber vs. potential prescriber) and, if applicable, by specialty. It is aimed to consider weighting of results with respect to country and physician specialty to account for under- or overrepresentation of participants. The unweighted and weighted results for parameters related to study objectives will be presented. Data will be analysed descriptively. Continuous variables will be presented by their number (of valid cases), mean, standard deviation, median, first and third quartiles (Q1, Q3), minimum, and maximum. Categorical variables will be tabulated with absolute and relative frequency per category. Percentages will be calculated over the number of observations with available (non-missing) data. Confidence intervals (CIs) of 95% will be calculated for weighted results as appropriate.

Documents

Study report

EUPAS46367_Report Abstract_May 2024.pdf