The Impact of Concordance between Liquid and Tissue Biopsy for Actionable Mutations: Insights from the ROME Trial

作者：Andrea Botticelli, Chiara Cremolini, Simone Scagnoli, Mauro Biffoni, Sara Lonardi, Lorenzo Fornaro, Valentina Guarneri, Ugo De Giorgi, Paolo A. Ascierto, Giovanni Blandino, Giulia d’Amati, Massimo Aglietta, PierFranco Conte, Edoardo Crimini, Maurizio Ceracchi, Simona Pisegna, Sofia Verkhovskaia, Roberto Bordonaro, Sergio Bracarda, Giovanni Butturini, Lucia Del Mastro, Andrea DeCensi, Agnese Fabbri, Elisabetta Fenocchio, Stefania Gori, Giulio Metro, Annamaria Pessino, Daniele Pozzessere, Fabio Puglisi, Stefano Tamberi, Alberto Zambelli, Donatella Marino, Ettore Capoluongo, Federico Cappuzzo, Bruna Cerbelli, Giuseppe Giannini, Umberto Malapelle, Federica Mazzuca, Marianna Nuti, Giancarlo Pruneri, Maurizio Simmaco, Lidia Strigari, Giuseppe Tonini, Nello Martini, Giuseppe Curigliano, Paolo Marchetti · 发表于：Clinical Cancer Research · 年份：2025 · DOI：10.1158/1078-0432.ccr-25-0430 · 被引用次数：8 · 研究领域：Cancer Genomics and Diagnostics、Lung Cancer Treatments and Mutations、Statistical Methods in Clinical Trials

PURPOSE: This analysis evaluated the influence of tissue and liquid biopsy concordance on outcomes in patients enrolled in the ROME trial. PATIENTS AND METHODS: The ROME trial, a phase II multicenter study, enrolled 1,794 patients with advanced solid tumors. Next-generation sequencing was performed on tissue and liquid biopsies using FoundationOne CDx and FoundationOne Liquid CDx. A centralized molecular tumor board reviewed results to identify actionable alterations, with 400 patients randomly assigned to tailored therapy (TT) or standard-of-care groups. TT improved objective response rate and progression-free survival (PFS) in the intention-to-treat population. Concordance was defined as the detection of the same druggable alteration in both biopsy types; discordance indicated detection in only one. RESULTS: Concordance was present in 49% of cases, with alterations detected exclusively in tissue (35%) or liquid (16%) biopsies. Patients in the concordant group receiving TT experienced improved survival outcomes. The median overall survival was 11.05 versus 7.70 months in the standard-of-care group [HR = 0.74; 95% confidence interval, 0.51-1.07], and the median PFS was 4.93 versus 2.80 months (HR = 0.55; 95% confidence interval, 0.40-0.76), respectively. In contrast, the survival benefit of TT was less pronounced or absent in patients with discordant results. Overall survival was higher in the T + L group (11.05 months), followed by tissue-only (9.93 months) and liquid-only (...