Circulating Tumor Cell Predicts Response to EGFR-TKI in Treatment-naive Advanced Non-small Cell Lung Cancer Patients With Sensitive EGFR Mutations

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Abstract RATIONALE: Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) are the standard treatment for advanced non-small cell lung cancer (NSCLC) patients harboring sensitive EGFR mutations. Traditional imaging methods are used to evaluate the response to antitumor therapy by measuring tumor size as the main criterion, based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. However, these methods have limitations of being inflexible and lagging to assess therapeutic response. There are clinical needs to supplement current RECIST criteria and to identify therapeutic response as early as possible for the implementation of individualized treatment plan in the whole-course management for advanced NSCLC patients. METHODS: This was a prospective, multi-center study. From December 2021 to June 2023, advanced NSCLC patients who underwent first-line third-generation EGFR-TKI were enrolled from Shanghai Chest Hospital, Shanghai Pulmonary Hospital and Hebei Medical University Fourth Affiliated Hospital in China. At baseline and 1 month of EGFR-TKI therapy, bloods were collected and CTC analysis was performed according to standard operating procedures by CTC sorting system with EGFR-immunolipid magnetic balls and Vimentin-immunolipid magnetic balls. Relationships between CTC and the efficacy of EGFR-TKI therapy were analyzed. This study was conducted in accordance with the provisions of the Declaration of Helsinki and was approved by the Ethics Committee of Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine. Informed consent documents were obtained from all patients. Statistical analysis was performed with SPSS statistical software, version 24.0(IBM-SPSS, Inc., Chicago, IL, USA). Chi-square test or Fisher exact probability method were used for comparison and statistical significance was defined as two-sided P < 0.05. RESULTS: A total of 131 patients and their CTC detection results were included and analysed. The clinical stages were mainly stage IV (96.9%). It was found that the number of CTCEGFR after EGFR-TKI treatment was correlated with the efficacy after 1 and 3 months of EGFR-TKI treatment (P=0.007; P=0.032). Patients with reduced number of CTCEGFR were more likely to obtain RECIST-PR after 3 months of EGFR-TKI therapy (P=0.030). The total number of CTCtotal after EGFR-TKI treatment was correlated with the efficacy after 3 months of EGFR-TKI treatment (P=0.035). Patients with reduced number of CTCtotal were more likely to obtain RECIST-PR for the best efficacy of EGFR-TKI treatment (P=0.025)(Table1). CONCLUSIONS: It indicated that CTC count and dynamic changes might provide some clues to predict the therapeutic effect to EGFR-TKI as a potential biomarker, serving as a supplement to RECIST 1.1.

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