Evidence map›Paper›PMID 40833744›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2026

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

Andrea Botticelli, Chiara Cremolini, Simone Scagnoli, Mauro Biffoni, Sara Lonardi, Lorenzo Fornaro, Valentina Guarneri, Ugo De Giorgi, Paolo Antonio Ascierto, Giovanni Blandino and 36 more

Abstract readMulticenter StudyClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Article
  2. Review
  3. Liquid biopsy in solid tumours: expert opinion paper of the European society of pathology.Virchows Archiv : an international journal of pathology · 2026
    Review
  4. Review
  5. Article
  6. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

46 authors.

Andrea BotticelliDepartment of Radiological, Oncological and Pathological Sciences, Sapienza Università di Roma, Rome, Italy.ORCID 0000-0002-6425-9893
Chiara CremoliniDepartment of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy.ORCID 0000-0002-0520-4841
Simone ScagnoliDepartment of Radiological, Oncological and Pathological Sciences, Sapienza Università di Roma, Rome, Italy.ORCID 0000-0003-4943-5622
Mauro BiffoniDepartment of Oncology and Molecular Medicine, Italian National Institute of Health (ISS), Rome, Italy.ORCID 0000-0002-1304-9060
Sara LonardiDepartment of Oncology, Veneto Institute of Oncology IOV-IRCCS, Padua, Italy.ORCID 0000-0002-7593-8138
Lorenzo FornaroDivision of Medical Oncology, Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa University Hospital, Pisa, Italy.ORCID 0000-0002-0187-5904
Valentina GuarneriDepartment of Oncology, Veneto Institute of Oncology IOV-IRCCS, Padua, Italy.ORCID 0000-0002-2375-8397
Ugo De GiorgiIRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola, Italy.ORCID 0000-0001-7520-2908
Paolo Antonio AsciertoIstituto Nazionale Tumori IRCCS Fondazione "G. Pascale", Naples, Italy.ORCID 0000-0002-8322-475X
Giovanni BlandinoTranslational Oncology Research Unit, IRCCS Istituto Nazionale Tumori Regina Elena (IRE), Rome, Italy.ORCID 0000-0002-6970-2241
Giulia D'AmatiDepartment of Radiological, Oncological and Pathological Sciences, Sapienza Università di Roma, Rome, Italy.ORCID 0000-0002-6959-691X
Massimo AgliettaCandiolo Cancer Institute FPO Istituto di Ricovero e Cura a Carattere Scientifico Candiolo, Candiolo, Italy.ORCID 0000-0002-2255-7972
Pierfranco ConteS. Camillo Hospital IRCCS, Venice, Italy.ORCID 0000-0002-5210-5344
Edoardo CriminiDivision of New Drugs and Early Drug Development for Innovative Therapies, European Institute of Oncology, IRCCS, Milan, Italy.ORCID 0000-0002-1869-0607
Maurizio CeracchiCMV STAT S.r.l., Rome, Italy.ORCID 0000-0003-1877-9238
Simona PisegnaDepartment of Experimental Medicine, Sapienza University of Rome, Rome, Italy.ORCID 0000-0002-6910-9528
Sofia VerkhovskaiaDepartment of Oncology, IDI-IRCCS, Rome, Italy.ORCID 0009-0008-2599-807X
Roberto BordonaroMedical Oncology Unit -ARNAS Garibaldi, Catania, Italy.ORCID 0000-0001-5005-0880
Sergio BracardaOncologia Medica Traslazionale, Azienda Ospedaliera Santa Maria di Terni, Terni, Italy.ORCID 0000-0002-0703-2959
Giovanni ButturiniHepatopancreatobiliary (HPB) Surgery, Pederzoli Hospital, Verona, Italy.ORCID 0000-0002-9172-4885
Lucia Del MastroIRCSS Ospedale Policlinico San Martino, UO clinica Oncologia Medica, Genoa, Italy.ORCID 0000-0002-9546-5841
Andrea DeCensiDepartment of Medicine and Medical Oncology Unit E.O. Ospedali Galliera, Genoa, Italy.ORCID 0000-0003-2635-4491
Agnese FabbriDepartment of Oncology, Central Hospital of Santa Rosa-Belcolle, Viterbo, Italy.ORCID 0000-0002-3357-6343
Elisabetta FenocchioCandiolo Cancer Institute FPO Istituto di Ricovero e Cura a Carattere Scientifico Candiolo, Candiolo, Italy.ORCID 0000-0001-6679-0955
Stefania GoriDepartment of Oncology, IRCCS Sacro Cuore Don Calabria Hospital, Negrar di Valpolicella, Verona, Italy.ORCID 0000-0001-6320-405X
Giulio MetroMedical Oncology, Santa Maria della Misericordia Hospital, University of Perugia, Perugia, Italy.ORCID 0000-0002-4978-9212
Annamaria PessinoOncologia medica 1, IRCSS Ospedale Policlinico San Martino, Genoa, Italy.ORCID 0000-0001-8040-378X
Daniele PozzessereMedical Oncology Unit, Nuovo Ospedale di Prato-Santo Stefano, Azienda USL Toscana Centro, Prato, Italy.ORCID 0000-0002-6344-7630
Fabio PuglisiDepartment of Medical Oncology, CRO Aviano, National Cancer Institute, IRCCS, Aviano, Italy.ORCID 0000-0003-0573-4938
Stefano TamberiOncology Unit, Santa Maria delle Croci Hospital, Ravenna, Italy.ORCID 0000-0002-7087-9116
Alberto ZambelliOncology Unit ASST Papa Giovanni XXIII, Bergamo, Italy.ORCID 0000-0002-1374-1831
Donatella MarinoDepartment of Oncology, Ordine Mauriziano Hospital, Turin, Italy.ORCID 0000-0001-6565-0870
Ettore CapoluongoDipartimento Di Eccellenza In Medicina Molecolare E Biotecnologie Mediche, Università Federico II, Naples, Italy.ORCID 0000-0002-5647-4059
Federico CappuzzoDivision of Medical Oncology 2, IRCCS Regina Elena National Cancer Institute, Rome, Italy.ORCID 0000-0002-6295-6767
Bruna CerbelliDepartment of Radiological, Oncological and Pathological Sciences, Sapienza Università di Roma, Rome, Italy.ORCID 0000-0001-5419-2309
Giuseppe GianniniDepartment of Molecular Medicine, Sapienza University of Rome, Laboratory Affiliated to Istituto Pasteur Italia, Fondazione Cenci-Bolognetti, Rome, Italy.ORCID 0000-0003-0299-4056
Umberto MalapelleDepartment of Public Health, University Federico II of Naples, Naples, Italy.ORCID 0000-0003-3211-9957
Federica MazzucaOncology Unit, Azienda Ospedaliera Universitaria Sant' Andrea, Rome, Italy.ORCID 0000-0002-6580-286X
Marianna NutiDepartment of Experimental Medicine, Sapienza University of Rome, Rome, Italy.ORCID 0000-0003-1809-1003
Giancarlo PruneriDepartment of Advanced Diagnostics, Fondazione IRCCS Istituto Tumori di Milano, University of Milan, Italy.ORCID 0000-0002-7963-7172
Maurizio SimmacoLaboratory of Clinical Biochemistry, Sant' Andrea University Hospital, Rome, Italy.ORCID 0000-0003-4164-1472
Lidia StrigariDepartment of Medical Physics, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.ORCID 0000-0003-4293-2298
Giuseppe ToniniDepartment of Medicine and Surgery, Università Campus Bio-Medico, Rome, Italy.ORCID 0000-0003-4442-8677
Nello MartiniFondazione ReS, Rome, Italy.ORCID 0009-0007-1014-7611
Giuseppe Curigliano *Division of New Drugs and Early Drug Development for Innovative Therapies, European Institute of Oncology, IRCCS, Milan, Italy.ORCID 0000-0003-1781-2518
Paolo Marchetti *Department of Oncology, IDI-IRCCS, Rome, Italy.ORCID 0000-0002-9064-8761

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThis analysis evaluated the influence of tissue and liquid biopsy concordance on outcomes in patients enrolled in the ROME trial. PATIENTS AND

methodsThe 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.

resultsConcordance 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.

conclusionsThe study highlights the potential value of integrating both biopsy modalities in selected clinical contexts. See related commentary by Saldanha and Siu, p. 7.

Indexed as

Biomarkers, TumorMutationNeoplasmsAdultAgedBiopsyFemaleHigh-Throughput Nucleotide SequencingHumansLiquid BiopsyMaleMiddle AgedPrecision MedicineBiomarkers, Tumor

Identifiers

PMID40833744
PMCPMC12770931

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.