Partial Response (PR): Defined as a reduction in the sum of the diameters of target lesions by ≥30% from baseline, in the absence of new lesions. This indicates effective treatment with significant tumor shrinkage.

Stable Disease (SD): Defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease (i.e., the sum of the diameters of target lesions shows a change ranging from a decrease of <30% to an increase of <20%), in the absence of new lesions. This indicates that the disease has not worsened, but a significant reduction in tumor burden has not been achieved.

Progressive Disease (PD): Defined as an increase in the sum of the diameters of target lesions by ≥20% (taking as reference the smallest sum on study), and/or the appearance of one or more new lesions. This signifies treatment failure, necessitating a modification of the therapeutic regimen.

Collect blood samples from patients with small cell lung cancer before receiving immunotherapy combined with chemotherapy.

• Assessment Tool: RECIST 1.1 criteria ;
• Unit of Measure: Number of patients (n) and percentage (%) ;
• Data Aggregation Method: Calculation of proportions of patients in each response category (PR/SD/PD);

Definitions:

• Partial Response (PR): ≥30% reduction in the sum of diameters of target lesions from baseline (absence of new lesions) ;
• Stable Disease (SD): Change in the sum of diameters ranging from <30% reduction to <20% increase (absence of new lesions) ;
• Progressive Disease (PD): ≥20% increase in the sum of diameters (reference: smallest sum recorded) and/or appearance of new lesions ;

• Measurement Tool: Next-generation sequencing (NGS) ;

• Unit of Measure: Standardized expression values (CPM, Counts Per Million) ;

• Data Aggregation Method: Descriptive statistics (mean ± SD or median [IQR]) of expression levels by response groups ;

• Procedure:

  1. Pre-treatment serum collection ;
  2. sEV isolation ;
  3. miRNA extraction ;
  4. NGS sequencing ;
  5. Bioinformatic normalization (CPM) .