Cancer
Conditions
Brief summary
Although immune checkpoint inhibitors (ICIs) have proved effective in treating many cancers, patients receiving ICIs may experience immune-related adverse events (irAEs). Little evidence exists on the safety of resuming these treatments after an irAE. Our objective was to investigate the safety of ICI rechallenge after an irAE using the WHO pharmacovigilance database
Interventions
DRUGImmune Checkpoint Modulator
identification of cases of immune-related adverse events due to immune checkpoint inhibitors. Among these cases, identification and description of those with immune checkpoint inhibitor rechallenge.
Sponsors
University Hospital, Caen
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Case reported in the World Health Organization (WHO) database (VigiBase) of individual safety case reports at the time of the extraction, * consecutive individual case safety reports present in VigiBase reporting an irAEs associated to at least one immune checkpoint inhibitor.
Exclusion criteria
* Chronology not compatible between the drug and the toxicity.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of occurrence of second immune-related adverse events (irAEs) | Number of case reported in the World Health Organization (WHO) of individual safety case reports, through study completion (an average of 2 months). | percentage of cases experiencing a second irAE among the rechallenged cases |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Description of cases experiencing an initial irAEs | Number of case reported in the World Health Organization (WHO) of individual safety case reports, through study completion (an average of 2 months).. | description of clinical features of cases experiencing an initial irAEs |
| Description of the rechallenge cases | Number of case reported in the World Health Organization (WHO) of individual safety case reports, through study completion (an average of 2 months).. | description of clinical features of the rechallenged cases |
| Description of the clinical features of cases experiencing a second irAEs | Number of case reported in the World Health Organization (WHO) of individual safety case reports, through study completion (an average of 2 months).. | Description of the clinical features of cases experiencing a second irAEs |
Countries
France
Contacts
Primary ContactJoachim Alexandre, MD
Outcome results
None listed