O'Reilly David, O'Grady Anthony, Hayes Conor, Piggott Laura, Keane Ruaidhri, Fitzpatrick Orla M, Conroy Michael, Aretz Nicholas Kruseman, Synnott David, Dillon Rachel, Dowling Gavin P, Ryan Daniel J, O'Brien Emmet, Morgan Ross, Breathnach Oscar, Grogan Liam, Morris Patrick, Greally Megan, Teo Minh Yuen, Murphy Adrian, Ryan Gillian, Counihan Ian, Ryan Cliona, Barrett Helen, O'Shea Ann-Marie, Cuffe Sinead, Korpanty Grzegorz, Prior Lisa, Barr Martin P, Finn Stephen, O'Brien Cathal, McCarron Sarah, Cummins Rob, Toomey Sinead, Dowling Catríona M, Glavey Siobhan, Hennessy Bryan T, Sorensen Jan, Bennett Kathleen, Nadarajan Parthiban, Doyle Brendan, Naidoo Jarushka
Beaumont RCSI Cancer Centre, Beaumont Hospital, Dublin, Ireland.
Department of Pathology, Beaumont RCSI Cancer Centre, Dublin, Ireland.
Eur J Cancer. 2025 Jul 25;225:115582. doi: 10.1016/j.ejca.2025.115582. Epub 2025 Jun 17.
We report a pilot clinical trial investigating the feasibility of liquid biopsy genotyping (LBG) at the time of radiological suspicion of advanced NSCLC, incorporating a micro-cost model (MCM). (PLAsma Genomic Testing in Advanced NSCLC; The PLAN trial, ClinicalTrials.gov Identifier: NCT05542485).
Patients with a radiologic suspicion of stage III-IV lung cancer were recruited from four cancer centres in Ireland between August 2023 and July 2024. LBG was performed using the Archer LiquidplexTM NGS assay. The MCM considered staff time, consumables and capital costs and savings from avoidance of repeat tissue biopsy genotyping (TBG) or inappropriate systemic therapy such as immunotherapy for EGFR + NSCLC.
A total of 138 patients were enrolled in the study with 38 excluded from the primary analysis (Squamous=16; SCLC = 22). Of patients that were eligible, LBG was completed in 100 % (100/100). TBG was completed in 68 % (68/100; insufficient tissue 20 %; 20/100; declining ECOG PS 12 %; 12/100). Repeat tissue biopsies were avoided in 12 % (12/100) of patients due to available LBG reports. The median calendar days from LBG to receipt of genomic report was 21 days shorter for LBG (z = -6.8, p < 0.01) versus TBG, as a median (range: 1-104 days). For evaluable paired cases with both TBG and LBG available (n = 68), concordance was 90 % (61/68). LBG resulted in detection of 5 actionable variants. LBG (€1135) was less than half the cost of TBG (€2404). LBG also resulted in overall cost savings of €20,288 (reduced TBG; use of immunotherapy).
LBG reduces the time to genomic diagnosis in patients with newly diagnosed NSCLC compared to tissue genotyping, identifies actionable variants not reported in tissue, and results in overall cost savings.
我们报告了一项试点临床试验，该试验在放射学怀疑为晚期非小细胞肺癌（NSCLC）时研究液体活检基因分型（LBG）的可行性，并纳入了微观成本模型（MCM）。（晚期NSCLC的血浆基因组检测；PLAN试验，ClinicalTrials.gov标识符：NCT05542485）。
2023年8月至2024年7月期间，从爱尔兰的四个癌症中心招募了放射学怀疑患有III-IV期肺癌的患者。使用Archer LiquidplexTM NGS检测法进行LBG。MCM考虑了人员时间、耗材和资本成本，以及避免重复组织活检基因分型（TBG）或不适当的全身治疗（如EGFR+NSCLC的免疫治疗）所节省的费用。
共有138名患者纳入研究，38名被排除在主要分析之外（鳞状细胞癌=16；小细胞肺癌=22）。在符合条件的患者中，LBG完成率为100%（100/100）。TBG完成率为68%（68/100；组织不足20%；20/100；东部肿瘤协作组体能状态评分下降12%；12/100）。由于有可用的LBG报告，12%（12/100）的患者避免了重复组织活检。从LBG到收到基因组报告的中位日历天数，LBG（z=-6.8,p<0.01）比TBG短21天，中位时间为（范围：1-104天）。对于可评估的同时有TBG和LBG结果的配对病例（n=68），一致性为90%（61/68）。LBG检测到5个可操作的变异。LBG（1135欧元）不到TBG（2404欧元）成本的一半。LBG还带来了20288欧元的总体成本节省（减少TBG；使用免疫治疗）。
与组织基因分型相比，LBG缩短了新诊断NSCLC患者的基因组诊断时间，识别出组织中未报告的可操作变异，并实现了总体成本节省。
