Efficacy and Safety Analysis of Immune Checkpoint Inhibitors Plus Angiogenesis Inhibitors for Treatment of Advanced Driver-negative NSCLC in Elderly Patients：A Retrospective Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Suzhou Municipal Hospital
- Enrollment
- 79
- Locations
- 1
- Primary Endpoint
- PFS
Study Overview
Brief Summary
Immune checkpoint inhibitors(ICIs) combined with angiogenesis inhibitors may is synergistic in elderly patients with advanced non-small cell lung cancer(NSCLC), however its true efficacy is still unclear. The investigators retrospectively compared clinical efficacy and safety of driver-negative elderly patients with advanced NSCLC treated with ICIs with(or without)angiogenesis inhibitors in the Cancer Center of the Affiliated Suzhou Hospital of Nanjing Medical University.
Detailed Description
The investigators reviewed the medical records of all lung cancer patients in the Cancer Diagnosis and Treatment Center of Suzhou Hospital Affiliated to Nanjing Medical University from January 1, 2019 to December 31, 2021, and a total of 79 patients were enrolled. The subjects were divided into two groups: the group treated with immune checkpoint inhibitors plus antiangiogenic drugs(IA group) and the group treated with immune checkpoint inhibitors without antiangiogenic drugs(NIA group). The data of PFS, OS, ORR, covariates, and Immune-related adverse events (irAEs) were collected through electronic medical records and follow-up. The primary endpoint of the study was PFS, and the secondary endpoints were OS, ORR and irAEs.All enrolled patients were followed up until August 1, 2022.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥65 years old.
- •Stage IV according to the AJCC Cancer grading manual (8th edition).
- •Histologically confirmed NSCLC.
- •No driver mutations.
- •Received at least 2 courses of immunotherapy.
- •Expected survival time > 3 months.
- •No concurrent malignancy.
- •Not participating in a clinical trial.
- •The functions of important organs were basically normal.
- •Sign informed consent.
Exclusion Criteria
- Not provided
Arms & Interventions
IA group
Immune checkpoint inhibitors plus angiogenesis inhibitors group
Intervention: Immune checkpoint inhibitors plus angiogenesis inhibitors (Drug)
NIA group
Immune checkpoint inhibitors without angiogenesis inhibitors group
Intervention: Immune checkpoint inhibitors without angiogenesis inhibitors (Drug)
Outcomes
Primary Outcomes
PFS
Time Frame: Up to August 1, 2022
PFS was defined as the time from the start of the first immunotherapy until disease progression or death
Secondary Outcomes
- OS(Up to August 1, 2022)
- irAEs(Up to August 1, 2022)
- ORR(Up to August 1, 2022)
Investigators
jing xue
Associate chief physician
Suzhou Municipal Hospital