The Impact of Concordance between Liquid and Tissue Biopsy for Actionable Mutations: Insights from the ROME Trial.
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Botticelli Andrea, Cremolini Chiara, Scagnoli Simone, Biffoni Mauro, Lonardi Sara, Fornaro Lorenzo, Guarneri Valentina, De Giorgi Ugo, Ascierto Paolo Antonio, Blandino Giovanni, D'Amati Giulia, Aglietta Massimo, Conte Pierfranco, Crimini Edoardo, Ceracchi Maurizio, Pisegna Simona, Verkhovskaia Sofia, Bordonaro Roberto, Bracarda Sergio, Butturini Giovanni, Del Mastro Lucia, DeCensi Andrea, Fabbri Agnese, Fenocchio Elisabetta, Gori Stefania, Metro Giulio, Pessino Annamaria, Pozzessere Daniele, Puglisi Fabio, Tamberi Stefano, Zambelli Alberto, Marino Donatella, Capoluongo Ettore, Cappuzzo Federico, Cerbelli Bruna, Giannini Giuseppe, Malapelle Umberto, Mazzuca Federica, Nuti Marianna, Pruneri Giancarlo, Simmaco Maurizio, Strigari Lidia, Tonini Giuseppe, Martini Nello, Curigliano Giuseppe, Marchetti Paolo
Аннотация
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 (4.05 months) groups. PFS followed a similar pattern, with the longest PFS in the T + L group (4.93 months) versus 3.06 months in tissue-only and 2.07 months in liquid-only groups.
CONCLUSIONS: The study highlights the potential value of integrating both biopsy modalities in selected clinical contexts. See related commentary by Saldanha and Siu, p. 7.