Multicenter observational study for correlation between tumor mutation burden and immunotherapy efficacy of advanced non-small cell lung cancer with malignant pleural effusion
Method of Research: 1. ⅢB-Ⅳ NSCLC patients, tumor mutation burden (TMB) was tested by the 448 gene panel with pleural effusion and tissue sample, to observed mutation characteristics;Tissue and pleural effusion cell precipitation:TMB (Next generation sequencing, 448 gene panel;Average sequencing depth: above 5000×) 2. The date of blood routine examination(neutrophils to lymphocytes ratio (NLR)) and serological tumor maker of NSCLC were collected before treatment;the The results of Programmed death ligand 1 (PDL1) expression level were collected also; 3. Collected Imaging(CT)and pathological data before treatment; 4. Immunotherapy was applied for 8 weeks to evaluate the efficacy; 5. The tumor mutation burden of pleural effusion was tested again for the patients of hyper-progression after immunotherapy, the mutation characteristics and changes were observed, the molecular mutation change before and after treatment were evaluated, and the correlation with immunotherapy was analyzed.Hyper-progression (HPD) were defined as tumor growth rate excess of 50% compared to baseline CT scans prior to treatment initiation.The patient underwent imaging examination (chest CT or pet-ct) at 2 months (8 weeks) after 3 full doses of immunotherapy drugs. 6. The date of blood routine examination(neutrophils to lymphocytes ratio (NLR)) and serological tumor maker of NSCLC were collected after treatment; 7. Imaging, CT and pathological data of patients after treatment were collected
Study Type
OBSERVATIONAL
Enrollment
300
Non-Intervention
Objective response rate (ORR) of NSCLC patients with malignant pleural effusion who were received immunotherapy
The relationship between tumor mutation burden and objective response rate in NSCLC patients
Time frame: 2021
Progression-free survival (PFS) of NSCLC patients with malignant pleural effusion who were received immunotherapy
The relationship between tumor mutation burden and progression-free survival in NSCLC patients
Time frame: 2021
Overall survival (OS) of NSCLC patients with malignant pleural effusion who were received immunotherapy
The relationship between tumor mutation burden and overall survival in NSCLC patients
Time frame: 2022
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