An International, Non-Interventional, Post-Authorization Long-Term Safety Study of Lutathera®, in Patients with Unresectable or Metastatic, Well-Differentiated, Somatostatin Receptor Positive, Gastroenteropancreatic Neuroendocrine Tumours (SALUS Study)

Study type

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

  Drug utilisation

  Safety study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Drug interaction study, Long term safety study

Study drug and medical condition

• Name of medicine:
  LUTATHERA
• Additional medical condition(s):
  Unresectable or Metastatic, Well-Differentiated, Somatostatin Receptor Positive, Gastroenteropancreatic Neuroendocrine Tumours

Population studied

• 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

• Main study objective:
  To assess the incidence and nature of potential long term second primary malignancies, including solid tumours and haematological neoplasia, in patients with unresectable or metastatic, well-differentiated, somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours.
• Outcomes:
  Incidence and type of a second primary cancer (a solid tumour or an haematological cancer). a. AEs and SAEs related to Lutathera b. AEs/SAEs of special interest related to Lutathera as outlined in the RMP. c. mortality (all causes) d. new AEs/SAEs related to Lutathera, in particular those related to the safety concerns classified as “missing information” in the RMP e. Impact of tumour location at baseline on the safety profile. f. Description of Lutathera use patterns
• Data analysis plan:
  The primary analysis population will be the population of all eligible patients included in the study. The Full Analysis Set will consist of all evaluable subjects who have received any part of a Lutathera treatment. Patients who consented for the SALUS study are intended to be followed up to 7 years from the start of the study, regardless of incidence of second malignancy, unless they die or they are lost-to-follow-up. Stratified or subgroup analysis might be considered if deemed relevant. All analyses will be performed for all countries and sites together. Categorical variables will be described by counts n and % on each category. Continuous variables will be described by mean, standard deviation, median, interquartile and min-max ranges. No imputation will be performed on missing data. Instead, missing data can be reported as an independent category.

Documents

Study, other information

Centers involved in study EUPAS25735