Real-world Treatment Patterns and Clinical Outcomes in Epidermal Growth Factor Receptor(EGFR)-Mutant Unresectable Locally Advanced NSCLC: A Retrospective Multi-center Study
试验速览
- 阶段
- 不适用
- 入组人数
- 450
- 主要终点
- median progression-free survival (mPFS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histologically confirmed NSCLC with adenocarcinoma
- •stage III (AJCC 7th edition)
- •inoperable or refuse surgery
- •EGFR-TKI mutation, specimen from tissue or blood
排除标准
- •the pathology was not adenocarcinoma
- •stage I,II and IV
- •anaplastic lymphoma kinase (ALK) rearrangement
- •no follow-up data achievable
研究组 & 干预措施
Radiation(Chemo-radiation)
Patients in this group had been treated with definitive radiation/Chemo-radiation followed by no treatment until progression.
干预措施: radiation or chemo-radiation (Radiation)
radiation+EGFR-TKI
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.
干预措施: radiation or chemo-radiation (Radiation)
radiation+EGFR-TKI
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.
干预措施: EGFR-TKI Inhibitor (Drug)
EGFR-TKI
Patients in this group had been treated with EGFR-TKI without any other treatment until progression.
干预措施: EGFR-TKI Inhibitor (Drug)
结局指标
主要结局
median progression-free survival (mPFS)
时间窗: 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.
次要结局
- 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)
- 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)
研究者
Luhua Wang
Principal Investigator, Clinical Professor
Chinese Academy of Medical Sciences