Real-world Safety and Efficacy Data of Checkpoint Inhibitors in Patients With Cancer and Underlying Autoimmune Disease: the Experience of the Hellenic Cooperative Oncology Group
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 126
- Locations
- 1
- Primary Endpoint
- progression-free survival
Study Overview
Brief Summary
Patients with cancer and concurrent autoimmune diseases (AID) have been universally excluded from clinical trials evaluating immunotherapy. Data on the safety and efficacy of checkpoint inhibitors in patients with underlying AID is limited. The investigators performed a retrospective multicenter review of medical records of patients with diverse tumor types and underlying AID who received checkpoint inhibitors at Departments of Oncology, affiliated with the Hellenic Cooperative Oncology Group (HeCOG). The primary endpoint was progression-free survival (PFS).
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18 years or older
- •Patients with cancer
- •Patients with autoimmune disease
- •Treated at HeCOG-affiliated Departments of Oncology
- •Early-stage or metastatic
Exclusion Criteria
- •diagnosis of the autoimmune disease after initiation of immunotherapy
Outcomes
Primary Outcomes
progression-free survival
Time Frame: Through the completion of the study, for an average of 6 months
Secondary Outcomes
No secondary outcomes reported
