Efficacy and Safety Analysis of ICIs Plus Angiogenesis Inhibitors for Treatment of Advanced NSCLC in Elderly Patients

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.

Official Title
-----------------
Efficacy and Safety Analysis of Immune Checkpoint Inhibitors Plus Angiogenesis Inhibitors for Treatment of Advanced Driver-negative NSCLC in Elderly Patients：A Retrospective Study

Conditions
-----------------
NSCLC

Intervention / Treatment
-----------------
* Drug: Immune checkpoint inhibitors plus angiogenesis inhibitors
* Drug: Immune checkpoint inhibitors without angiogenesis inhibitors


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| IA group<br>Immune checkpoint inhibitors plus angiogenesis inhibitors group | Drug: Immune checkpoint inhibitors plus angiogenesis inhibitors<br>* PD-(L)1-based therapy plus Bevacizumab or Anlotinib<br>|
| NIA group<br>Immune checkpoint inhibitors without angiogenesis inhibitors group | Drug: Immune checkpoint inhibitors without angiogenesis inhibitors<br>* PD-(L)1-based therapy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | PFS was defined as the time from the start of the first immunotherapy until disease progression or death | Up to August 1, 2022 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OS | OS was defined as the time from the start of the first immunotherapy to death from any cause | Up to August 1, 2022 | 
| ORR | ORR refers to the sum of complete response and partial response to treatment | Up to August 1, 2022 | 
| irAEs | Immune-related adverse events were evaluated according to the CTCAE5.0 criteria | Up to August 1, 2022 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Elderly Patient