期刊
JOURNAL OF THORACIC ONCOLOGY
卷 16, 期 5, 页码 807-816出版社
ELSEVIER SCIENCE INC
DOI: 10.1016/j.jtho.2021.01.1617
关键词
ALK; CTCs; Immunocytochemistry; FISH; Lung adenocarcinoma
资金
- National Institute of Cancer (INCa PHRC) [STALKLUNG01 13-APN-01]
- Canceropole PACA
- Conseil Departemental des Alpes-Maritimes
Circulating tumor cells (CTCs) can serve as a complementary tool for detecting ALK gene rearrangements and show promise in real-time patient monitoring and improving molecularly guided therapy in the studied population.
Introduction: Patients with advanced-stage NSCLC whose tumors harbor an ALK gene rearrangement benefit from treatment with multiple ALK inhibitors (ALKi). Approximately 30% of tumor biopsy samples contain insufficient tissue for successful ALK molecular characterization. This study evaluated the added value of analyzing circulating tumor cells (CTCs) as a surrogate to ALK tissue analysis and as a function of the response to ALKi. Methods: We conducted a multicenter, prospective observational study (NCT02372448) of 203 patients with stage IIIB/IV NSCLC across nine French centers, of whom 81 were ALK positive (immunohistochemistry or fluorescence in situ hybridization [FISH]) and 122 ALK negative on paraffin-embedded tissue specimens. Blood samples were collected at baseline and at 6 and 12 weeks after ALKi initiation or at disease progression. ALK gene rearrangement was evaluated with CTCs using immunocytochemistry and FISH analysis after enrichment using a filtration method. Results: At baseline, there was a high concordance between the detection of an ALK rearrangement in the tumor tissue and in CTCs as determined by immunocytochemistry (sensitivity, 94.4%; specificity 89.4%). The performance was lower for the FISH analysis (sensitivity, 35.6%; specificity, 56.9%). No significant association between the baseline levels or the dynamic change of CTCs and overall survival (hazard ratio = 0.59, 95% confidence interval: 0.24-1.5, p = 0.244) or progression-free survival (hazard ratio = 0.84, 95% confidence interval: 0.44-1.6, p = 0.591) was observed in the patients with ALK-positive NSCLC. Conclusions: CTCs can be used as a complementary tool to a tissue biopsy for the detection of ALK rearrangements. Longitudinal analyses of CTCs revealed promise for real-time patient monitoring and improved delivery of molecularly guided therapy in this population. (C) 2021 International Association for the Study of Lung Cancer. Published by Elsevier Inc. All rights reserved.
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