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Updated: Jun 24, 2026
Semi-automatic PD-L1 Characterization and Enumeration of Circulating Tumor Cells from Non-small Cell Lung Cancer Patients by Immunofluorescence
Published on: August 14, 2019
Circulating Tumor DNA is Associated With Pathologic Response and Survival Outcomes in Patients With Non-Small Cell
Qian Song1, Shijie Shang2, Zijun Zhai3
1Shandong Provincial Key Laboratory of Precision Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, Shandong, China.
Background:
Circulating tumor DNA (ctDNA) has emerged as a robust biomarker for tumor burden and survival outcome prediction, but its role in neoadjuvant immunotherapy for non-small cell lung cancer (NSCLC) remains unclear.
Methods:
PubMed, Web of Science, and Embase databases, as well as major international meetings (ASCO and ESMO), were systematically searched through February 2026. Clinical trials reporting patients with stage IA-IIIB NSCLC receiving neoadjuvant immunotherapy and documenting ctDNA levels together with outcome data, including pathologic complete response (pCR), major pathologic response (mPR), event-free survival (EFS), and overall survival (OS), were included.
Results:
Twelve studies comprising 10 clinical trials with 381 patients were included. Patients with ctDNA clearance had improved pCR (OR, 0.14; 95%CI, 0.05-0.40; I2=37.3%) and mPR (OR, 0.25; 95%CI, 0.07-0.85; I2=57%). This association was also observed in the subgroup receiving neoadjuvant chemoimmunotherapy for pCR (OR, 0.16; 95%CI, 0.05-0.49). ctDNA clearance was significantly associated with improved EFS (HR, 0.31; 95%CI, 0.21-0.46) and OS (HR, 0.31; 95%CI, 0.13-0.74). Pooled sensitivity for pCR prediction was 0.92 (95%CI, 0.79-1.00), specificity was 0.52 (95%CI, 0.44-0.59), positive predictive value was 0.49 (95%CI, 0.40-0.58), and negative predictive value was 0.92 (95%CI, 0.76-1.00). Significant heterogeneity was observed in diagnostic performance.
Conclusions:
ctDNA clearance before surgery correlates with pathologic response and survival outcomes in patients with NSCLC undergoing neoadjuvant immunotherapy. However, the prognostic utility of ctDNA clearance is limited by low specificity and substantial heterogeneity.
