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. 2025 Dec 9:231:116050.
doi: 10.1016/j.ejca.2025.116050. Epub 2025 Oct 20.

International expert consensus on the clinical integration of circulating tumor cells in solid tumors

Eleonora Nicolò  1 , Carolina Reduzzi  2 , Jean-Yves Pierga  3 , Paola Gazzaniga  4 , Nikolas H Stoecklein  5 , Valeria Denninghoff  6 , Dominic G Rothwell  7 , Johann S De Bono  8 , Dario Marchetti  9 , Evi Lianidou  10 , Sabine Riethdorf  11 , Daniele Generali  12 , Paul Hofman  13 , Lorenzo Gerratana  14 , Peter Kuhn  15 , Jean Paul Thiery  16 , Michail Ignatiadis  17 , Francois-Clement Bidard  18 , Anthony Lucci  19 , Sabine Kasimir-Bauer  20 , Maria Jose Serrano  6 , Massimo Cristofanilli  2
Affiliations

International expert consensus on the clinical integration of circulating tumor cells in solid tumors

Eleonora Nicolò et al. Eur J Cancer. .

Erratum in

Abstract

Background: Circulating tumor cells (CTCs) are a versatile biomarker in solid tumors. Extensive research supports their clinical relevance and led to regulatory approval in breast, prostate, and colorectal cancers. However, clinical adoption remains limited mainly due to the lack of consensus and standardized technologies. Additionally, CTC research lacks unified direction. To address these gaps, an international expert panel was established to assess the current and future clinical utility of CTCs.

Methods: A panel of 11 CTC experts identified key areas of controversy, informing a structured survey distributed to 55 international multidisciplinary experts. Consensus was predefined as ≥ 70 % agreement. Areas without consensus were discussed in a virtual meeting, leading to final statements on the clinical integration of CTCs.

Results: Thirty-seven experts completed the survey. Consensus was reached on the clinical utility of CTCs for prognosis and treatment monitoring in metastatic breast (BC) and prostate (PC) cancers, including AR-V7 testing in metastatic castration-resistant PC for therapy selection. In other tumors, CTCs remain investigational. Experts agreed that while clinical utility is not yet established in early-stage disease, CTCs show promise in early BC, especially combined with cell-free DNA (cfDNA) for minimal residual disease detection. CellSearch® is currently the only platform with high-level evidence for clinical use, though emerging technologies are promising. Key challenges include improving detection sensitivity/specificity, standardizing workflows, generating robust data, and clinician education. Experts emphasized shifting from enumeration to phenotypic and molecular characterization, particularly for treatment guidance, and highlighted the complementary role of CTCs and cfDNA, advocating for integrated liquid biopsy approaches.

Conclusions: This consensus offers practical guidance for clinical integration of CTCs and outlines strategic research priorities to unlock their full potential in precision oncology.

Keywords: Biomarker; Breast cancer; Circulating tumor cells; Clinical utility; Consensus statement; Liquid biopsy; Prostate cancer; Solid tumors.

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Conflict of interest statement

Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Eleonora Nicolò: Young Committee Member of the International Society of Liquid Biopsy (ISLB). Uncompensated member of Precision Medicine Action for Cancer (PMAC) Board of Directors. Carolina Reduzzi: Young Committee Chair of the International Society of Liquid Biopsy (ISLB). Uncompensated member of Precision Medicine Action for Cancer (PMAC) Board of Directors. Research support: Menarini Silicon Biosystems, Angle plc, Tethis SpA, Qiagen. Jean-Yves Pierga: Consulting or Advisory Role: Daiichi Sankyo, AstraZeneca, Menarini/Stemline, Gilead Sciences, Novartis, Lilly, MSD, Roche, ExactSciences. Travel grants: Gilead, Roche, Astra Zeneca, Novartis, Lilly. Paola Gazzaniga: Research support: Merck Serono, Amgen. Consultant: Menarini Silicon Biosystems, Merck Serono. Nikolas H. Stoecklein: CTC Technology Working Group Lead: European Liquid Biopsy Society (ELBS); Research support: Menarini Silicon Biosystems.Valeria Denninghoff: No conflict of interest. Dominic G. Rothwell: No conflict of interest. Johann S. De Bono: Research support from AstraZeneca, Cellcentric, Crescendo, Daiichi, Immunic Therapeutics, MetaCurUm, Myricx, Nurix, Oncternal, Orion and Sanofi Aventis; honoraria from advisory boards of AbbVie, Acai Therapeutics, Amgen, Amunix, Astellas, Bayer, Bioxcel Therapeutics, Celcuity, Crescendo, Daiichi, Dark Blue Therapeutics, Duke Street Bio, Dunad Therapeutics, Endeavor Biomedicines INC, Genentech-Roche, GSK, Macrogenics, Merck Serono, MetaCurUm, Moma Therapeutics, Myricx, Novartis, Nurix, Nuvation Bio, One-Carbon Therapeutics, Oncternal, Orion, Page Therapeutics, Peptone, Pfizer, Takeda, Tango Therapeutics, Tubulis, GmbH and VIR Biotechnology. ICR employee, named as an inventor, with no financial interest for patent 8822,438, submitted by Janssen that covers the use of abiraterone acetate with corticosteroids. Dario Marchetti: No conflict of interest. Evi Lianidou: No conflict of interest. Sabine Riethdorf: No conflict of interest. Daniele Generali: Honoraria from Novartis, Lilly, AstraZeneca, Roche, Pfizer, Menarini. Research funding from Novartis. Travel, Accommodations, Expenses from Novartis, Roche, Pfizer. Paul Hofman: No conflict of interest. Lorenzo Gerratana: Consulting or Advisory Role: AstraZeneca, Daiichi Sankyo, Eli Lilly, GlaxoSmithKline, Incyte, Novartis, Pfizer, Merck Sharp & Dohme, Menarini Stemline, Abbvie. Travel Expenses: Menarini Stemline, Novartis, Gilead Consulting or Advisory Role: AstraZeneca, Daiichi Sankyo, Eli Lilly, GlaxoSmithKline, Incyte, Novartis, Pfizer, Merck Sharp & Dohme, Menarini Stemline, Abbvie. Travel Expenses: Menarini Stemline, Novartis, Gilead. Peter Kuhn: inventor of enrichment free approaches using fluorescent whole slide imaging with intellectual property rights licensed to diagnostic companies. Jean Paul Thiery, Chief scientist Biosyngen Pte Ltd, Singapore; Co-founder and chairman Biocheetah Pte Ltd, Singapore. Francois-Clement Bidard: Research fundings, Menarini Silicon Biosystems. Advisory boards, Menarini Silicon Biosystems. Michail Ignatiadis Consulting or Advisory Role: Seattle Genetics, Daichi, AstraZeneca, Menarini/Stemline, Gilead Sciences, Rejuveron Senescence Therapeutics, and Novartis. Research grants to my Institute: Roche, Pfizer, Natera Inc, Inivata Inc Travel grants: Gilead, Roche, Astra Zeneca, Novartis. Anthony Lucci: No conflict of interest. Sabine Kazimir-Bauer: No conflict of interest. Maria Jose Serrano: No conflict of interest. Massimo Cristofanilli: Consulting or Advisory role: AstraZeneca/Daiichi Sankyo, BriaCell, Datar Genomics, Menarini Silicon Biosystems, Merck, Olaris, Pfizer, Repare Therapeutics, Celcuity, Lilly, Sermonix Pharmaceuticals, and Syantra. Uncompensated member of Precision Medicine Action for Cancer (PMAC) Board of Directors.

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