Real-world Treatment Patterns and Clinical Outcomes in EGFR-mutant Unresectable Locally Advanced NSCLC

Study Overview
=================
Brief Summary
-----------------
The investigators will obtain a cohort of patients from multiple large cancer centers in China and try to unravel the efficacy of radiotherapy combined with EGFR-TKI, which may provide some evidences for the treatment of stage III-inoperable NSCLC.

Detailed Description
-----------------
The frequency of EGFR mutations in patients with stage III inoperable adenocarcinoma or non-squamous cell carcinoma is 17-31%, which is relatively low. Compared to patients with EGFR wild type, the efficacy of radiotherapy or chemo-radiotherapy may be different in EGFR mutant patients. Some small sample studies showed, compared with patients with EGFR wild type, patients with EGFR mutations have a lower risk of local recurrence and a higher risk of distant metastasis under the standard treatment for stage III lung cancer, which demonstrate the strength of systemic therapy may help. Radiotherapy combined with EGFR-Tyrosine kinase inhibitors(TKI) is a feasible treatment strategy. In view of the low mutation frequency and few prospective research results, the investigators try to explore the survival differences of three treatment strategies used in clinical practice based on the real world data. The investigators will obtain a cohort of patients from multiple large cancer centers in China and try to unravel the efficacy of radiotherapy combined with EGFR-TKI, which may provide some evidences for the further study.

Official Title
-----------------
Real-world Treatment Patterns and Clinical Outcomes in Epidermal Growth Factor Receptor(EGFR)-Mutant Unresectable Locally Advanced NSCLC: A Retrospective Multi-center Study

Conditions
-----------------
Non Small Cell Lung Cancer, Stage III Non-small-cell Lung Cancer, EGFR Mutation-Related Tumors

Intervention / Treatment
-----------------
* Radiation: radiation or chemo-radiation
* Drug: EGFR-TKI Inhibitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histologically confirmed NSCLC with adenocarcinoma stage III (AJCC 7th edition) inoperable or refuse surgery EGFR-TKI mutation, specimen from tissue or blood Exclusion Criteria: the pathology was not adenocarcinoma stage I,II and IV anaplastic lymphoma kinase (ALK) rearrangement no follow-up data achievable

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Radiation(Chemo-radiation)<br>Patients in this group had been treated with definitive radiation/Chemo-radiation followed by no treatment until progression. | Radiation: radiation or chemo-radiation<br>* standard treatment for stage III lung cancer<br>|
| radiation+EGFR-TKI<br>Patients in this group had been treated with one of the following three ways: 1) definitive radiation and concurrent EGFR-TKI followed by EGFR-TKI till progression; 2) EGFR-TKI followed by radiation and continue TKI util progression; 3) radiation and TKI thereafter until progression. | Radiation: radiation or chemo-radiation<br>* standard treatment for stage III lung cancer<br>Drug: EGFR-TKI Inhibitor<br>* the standard treatment for stage IV lung cancer with EGFR mutation<br>* Other names: EGFR-TKI alone;|
| EGFR-TKI<br>Patients in this group had been treated with EGFR-TKI without any other treatment until progression. | Drug: EGFR-TKI Inhibitor<br>* the standard treatment for stage IV lung cancer with EGFR mutation<br>* Other names: EGFR-TKI alone;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| median progression-free survival (mPFS) | The time of half patients who are alive and progression-free after the disease diagnose, estimated by the Kaplan-Maier method and using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. | Tumor scans had been performed at baseline, and every 3 months after the first treatment of EGFR-TKI or the last dose of radiation (whichever occurs first) in 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| median overall survival(mOS) | The time of half patients who are alive after the disease diagnose, estimated by the Kaplan-Maier method and using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. | Tumor scans had been performed at baseline, and every 3 months after the first treatment of EGFR-TKI or the last dose of radiation (whichever occurs first) in 5 years | 
| failure pattern | Rate of disease failure in local, regional and distant sites. | Tumor scans had been performed at baseline, and every 3 months after the first treatment of EGFR-TKI or the last dose of radiation(whichever occurs first) in 5 years |