EGFR Mutation-Related Tumors, Non Small Cell Lung Cancer, Stage III Non-small-cell Lung Cancer
Conditions
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.
Interventions
RADIATIONradiation or chemo-radiation
standard treatment for stage III lung cancer
DRUGEGFR-TKI Inhibitor
the standard treatment for stage IV lung cancer with EGFR mutation
Sponsors
Chinese Academy of Medical Sciences
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| median progression-free survival (mPFS) | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| median overall survival(mOS) | 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 | 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. |
| failure pattern | 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 | Rate of disease failure in local, regional and distant sites. |
Contacts
Primary ContactLuhua Wang, MD
Backup ContactNan Bi, MD,PhD
Outcome results
None listed