Endocrine Toxicity, Immune Checkpoint Inhibitor
Conditions
Brief summary
Immune checkpoint inhibitor (ICI) includes agents that block cytotoxic T-cell-associated antigen 4 (CTLA-4), programmed cell death protein 1 (PD-1), and programmed cell death protein ligand 1 (PD-L1). Since the FDA-approval of the CTLA-4 inhibitor ipilimumab in 2011, ICI drugs have emerged as a powerful new tool in the treatment for several advanced cancers. Now indications for ICI have expanded dramatically due to their efficacy and include a wide array of cancer types. However, the administration of ICI, whereas, carry the risk of developing immune-related adverse events (irAEs) and may lead to serious and even fatal events. Endocrine dysfunctions are among the most common irAEs that have been reported in clinical trials with ICI, including thyroid dysfunction, hypopituitarism, primary adrenal insufficiency (PAI) and insulin-deficient diabetes (ICI-DM). However, it is difficult to acquire a complete picture of irAEs from randomized controlled trials (RCTs) due to limitations in the study design and realistic practicalities.
Interventions
None listed
Sponsors
Nanjing Medical University
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 88 Years
Healthy volunteers
No
Inclusion criteria
* Cancer patients who received one dose or more of PD-1/PD-L1 inhibitors
Exclusion criteria
* Insufficient reported details * Patients younger than 18 years old * in a double-blind study where treatment allocation cannot be resolved
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| irAEs | through study completion, an average of 2 year | Immune Checkpoint Inhibitors Induced Endocrine Immune related Adverse Events |
Countries
China
Outcome results
None listed