Clinical validation of liquid biopsy-RECIST (LB-RECIST) in metastatic colorectal cancer (mCRC) patients: findings from the PLATFORM-B study
Background: Circulating tumor DNA (ctDNA) variations predict tumor response to systemic treatment (so-called molecular response) earlier than radiological assessment. However, a standardized categorization of molecular response is an unmet clinical need. Liquid biopsy-RECIST (LB-RECIST), based on ag...
| Autores: | , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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| Tipo de recurso: | artículo |
| Estado: | Versión publicada |
| Fecha de publicación: | 2025 |
| País: | España |
| Institución: | Universidad de Barcelona |
| Repositorio: | Dipòsit Digital de la UB |
| OAI Identifier: | oai:diposit.ub.edu:2445/223530 |
| Acceso en línea: | https://hdl.handle.net/2445/223530 |
| Access Level: | acceso abierto |
| Palabra clave: | Tumors Biòpsia Càncer colorectal Marcadors bioquímics Biopsy Colorectal cancer Biochemical markers |
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Clinical validation of liquid biopsy-RECIST (LB-RECIST) in metastatic colorectal cancer (mCRC) patients: findings from the PLATFORM-B studyMartelli, ValentinoVidal, JoanaGibert Fernández, JoanFernández-Rodríguez, Maria ConcepciónLinares, JennifferGarcía-Alfonso, PilarPáez López-Bravo, DavidAlonso Orduña, VicenteGomez-España, Maria AuxiliadoraGuix, MartaSantos Vivas, CristinaDuran, G.Élez, ElenaGarcia Carbonero, RocioFerreiro Monteagudo, ReyesPineda Losada, EstelaSastre, JavierCano, M.T.Manzano, Jose LuisLosa Gaspà, FerranAranda, EnriqueRivera Herrero, FernandoSibilio, AnnaritaToledo, RodrigoTabernero Caturla, JosepSalazar Soler, RamónBellosillo Paricio, BeatrizMontagut Viladot, ClaraTumorsBiòpsiaCàncer colorectalMarcadors bioquímicsTumorsBiopsyColorectal cancerBiochemical markersBackground: Circulating tumor DNA (ctDNA) variations predict tumor response to systemic treatment (so-called molecular response) earlier than radiological assessment. However, a standardized categorization of molecular response is an unmet clinical need. Liquid biopsy-RECIST (LB-RECIST), based on aggregate variant allele frequency (aggVAF; sum of all detected variant allele frequencies in a sample) variations, has been proposed to stratify molecular response. Metastatic colorectal cancer (mCRC) may be an attractive clinical scenario for LB-RECIST clinical implementation; however, specific data on clinical validity is still lacking. Patients and methods: The prospective PLATFORM-B study enrolled 130 mCRC patients who received standard frontline treatment and underwent serial ctDNA analysis at baseline and week 8 of treatment. ctDNA was analyzed by next-generation sequencing (Oncomine Colon cfDNA Assay; Ion Torrent S5). LB-RECIST, both qualitative (changes in ctDNA detection) and quantitative (percentage variations of aggVAF), were used to categorize molecular response, and were correlated with clinical outcomes, including progression-free survival (PFS) and overall survival (OS). Results: ctDNA results were available for 106 patients at baseline and 90 patients at week 8 of treatment. Single timepoint aggVAFWEEK8 >0% showed significantly worse survival outcomes compared to aggVAFWEEK8 = 0% (PFS P < 0.0001; OS P = 0.0069). Complete clearance of ctDNA at week 8 (ctDNA complete response, CCR) demonstrated the best prognostic and predictive values [median (m) OS 41.8 months; mPFS not reached (NR)], similar to persistent undetectable ctDNA (ctDNA non-measurable disease, CND; mOS 41.1 months; mPFS NR). Conversely, patients with ctDNA partial response (CPR) and ctDNA progressive disease (CPD) had the worst clinical outcomes (mOS 16.4 and 25.5 months, and mPFS 12.7 and 11.9 months, respectively). Conclusions: LB-RECIST is prognostic and predictive of clinical outcomes in frontline mCRC. The clinical utility of LB-RECIST to guide early treatment decisions is warranted through interventional trials.Elsevier2025info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://hdl.handle.net/2445/223530Articles publicats en revistes (Ciències Clíniques)reponame:Dipòsit Digital de la UBinstname:Universidad de BarcelonaInglésReproducció del document publicat a: https://doi.org/10.1016/j.esmoop.2025.105760ESMO Open, 2025, vol. 10, num.9https://doi.org/10.1016/j.esmoop.2025.105760cc-by-nc-nd (c) Martelli, Valentino et al., CH, 2025http://creativecommons.org/licenses/by-nc-nd/4.0/info:eu-repo/semantics/openAccessoai:diposit.ub.edu:2445/2235302026-05-27T06:46:51Z |
| dc.title.none.fl_str_mv |
Clinical validation of liquid biopsy-RECIST (LB-RECIST) in metastatic colorectal cancer (mCRC) patients: findings from the PLATFORM-B study |
| title |
Clinical validation of liquid biopsy-RECIST (LB-RECIST) in metastatic colorectal cancer (mCRC) patients: findings from the PLATFORM-B study |
| spellingShingle |
Clinical validation of liquid biopsy-RECIST (LB-RECIST) in metastatic colorectal cancer (mCRC) patients: findings from the PLATFORM-B study Martelli, Valentino Tumors Biòpsia Càncer colorectal Marcadors bioquímics Tumors Biopsy Colorectal cancer Biochemical markers |
| title_short |
Clinical validation of liquid biopsy-RECIST (LB-RECIST) in metastatic colorectal cancer (mCRC) patients: findings from the PLATFORM-B study |
| title_full |
Clinical validation of liquid biopsy-RECIST (LB-RECIST) in metastatic colorectal cancer (mCRC) patients: findings from the PLATFORM-B study |
| title_fullStr |
Clinical validation of liquid biopsy-RECIST (LB-RECIST) in metastatic colorectal cancer (mCRC) patients: findings from the PLATFORM-B study |
| title_full_unstemmed |
Clinical validation of liquid biopsy-RECIST (LB-RECIST) in metastatic colorectal cancer (mCRC) patients: findings from the PLATFORM-B study |
| title_sort |
Clinical validation of liquid biopsy-RECIST (LB-RECIST) in metastatic colorectal cancer (mCRC) patients: findings from the PLATFORM-B study |
| dc.creator.none.fl_str_mv |
Martelli, Valentino Vidal, Joana Gibert Fernández, Joan Fernández-Rodríguez, Maria Concepción Linares, Jenniffer García-Alfonso, Pilar Páez López-Bravo, David Alonso Orduña, Vicente Gomez-España, Maria Auxiliadora Guix, Marta Santos Vivas, Cristina Duran, G. Élez, Elena Garcia Carbonero, Rocio Ferreiro Monteagudo, Reyes Pineda Losada, Estela Sastre, Javier Cano, M.T. Manzano, Jose Luis Losa Gaspà, Ferran Aranda, Enrique Rivera Herrero, Fernando Sibilio, Annarita Toledo, Rodrigo Tabernero Caturla, Josep Salazar Soler, Ramón Bellosillo Paricio, Beatriz Montagut Viladot, Clara |
| author |
Martelli, Valentino |
| author_facet |
Martelli, Valentino Vidal, Joana Gibert Fernández, Joan Fernández-Rodríguez, Maria Concepción Linares, Jenniffer García-Alfonso, Pilar Páez López-Bravo, David Alonso Orduña, Vicente Gomez-España, Maria Auxiliadora Guix, Marta Santos Vivas, Cristina Duran, G. Élez, Elena Garcia Carbonero, Rocio Ferreiro Monteagudo, Reyes Pineda Losada, Estela Sastre, Javier Cano, M.T. Manzano, Jose Luis Losa Gaspà, Ferran Aranda, Enrique Rivera Herrero, Fernando Sibilio, Annarita Toledo, Rodrigo Tabernero Caturla, Josep Salazar Soler, Ramón Bellosillo Paricio, Beatriz Montagut Viladot, Clara |
| author_role |
author |
| author2 |
Vidal, Joana Gibert Fernández, Joan Fernández-Rodríguez, Maria Concepción Linares, Jenniffer García-Alfonso, Pilar Páez López-Bravo, David Alonso Orduña, Vicente Gomez-España, Maria Auxiliadora Guix, Marta Santos Vivas, Cristina Duran, G. Élez, Elena Garcia Carbonero, Rocio Ferreiro Monteagudo, Reyes Pineda Losada, Estela Sastre, Javier Cano, M.T. Manzano, Jose Luis Losa Gaspà, Ferran Aranda, Enrique Rivera Herrero, Fernando Sibilio, Annarita Toledo, Rodrigo Tabernero Caturla, Josep Salazar Soler, Ramón Bellosillo Paricio, Beatriz Montagut Viladot, Clara |
| author2_role |
author author author author author author author author author author author author author author author author author author author author author author author author author author author |
| dc.subject.none.fl_str_mv |
Tumors Biòpsia Càncer colorectal Marcadors bioquímics Tumors Biopsy Colorectal cancer Biochemical markers |
| topic |
Tumors Biòpsia Càncer colorectal Marcadors bioquímics Tumors Biopsy Colorectal cancer Biochemical markers |
| description |
Background: Circulating tumor DNA (ctDNA) variations predict tumor response to systemic treatment (so-called molecular response) earlier than radiological assessment. However, a standardized categorization of molecular response is an unmet clinical need. Liquid biopsy-RECIST (LB-RECIST), based on aggregate variant allele frequency (aggVAF; sum of all detected variant allele frequencies in a sample) variations, has been proposed to stratify molecular response. Metastatic colorectal cancer (mCRC) may be an attractive clinical scenario for LB-RECIST clinical implementation; however, specific data on clinical validity is still lacking. Patients and methods: The prospective PLATFORM-B study enrolled 130 mCRC patients who received standard frontline treatment and underwent serial ctDNA analysis at baseline and week 8 of treatment. ctDNA was analyzed by next-generation sequencing (Oncomine Colon cfDNA Assay; Ion Torrent S5). LB-RECIST, both qualitative (changes in ctDNA detection) and quantitative (percentage variations of aggVAF), were used to categorize molecular response, and were correlated with clinical outcomes, including progression-free survival (PFS) and overall survival (OS). Results: ctDNA results were available for 106 patients at baseline and 90 patients at week 8 of treatment. Single timepoint aggVAFWEEK8 >0% showed significantly worse survival outcomes compared to aggVAFWEEK8 = 0% (PFS P < 0.0001; OS P = 0.0069). Complete clearance of ctDNA at week 8 (ctDNA complete response, CCR) demonstrated the best prognostic and predictive values [median (m) OS 41.8 months; mPFS not reached (NR)], similar to persistent undetectable ctDNA (ctDNA non-measurable disease, CND; mOS 41.1 months; mPFS NR). Conversely, patients with ctDNA partial response (CPR) and ctDNA progressive disease (CPD) had the worst clinical outcomes (mOS 16.4 and 25.5 months, and mPFS 12.7 and 11.9 months, respectively). Conclusions: LB-RECIST is prognostic and predictive of clinical outcomes in frontline mCRC. The clinical utility of LB-RECIST to guide early treatment decisions is warranted through interventional trials. |
| publishDate |
2025 |
| dc.date.none.fl_str_mv |
2025 |
| dc.type.none.fl_str_mv |
info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion |
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article |
| status_str |
publishedVersion |
| dc.identifier.none.fl_str_mv |
https://hdl.handle.net/2445/223530 |
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https://hdl.handle.net/2445/223530 |
| dc.language.none.fl_str_mv |
Inglés |
| language_invalid_str_mv |
Inglés |
| dc.relation.none.fl_str_mv |
Reproducció del document publicat a: https://doi.org/10.1016/j.esmoop.2025.105760 ESMO Open, 2025, vol. 10, num.9 https://doi.org/10.1016/j.esmoop.2025.105760 |
| dc.rights.none.fl_str_mv |
cc-by-nc-nd (c) Martelli, Valentino et al., CH, 2025 http://creativecommons.org/licenses/by-nc-nd/4.0/ info:eu-repo/semantics/openAccess |
| rights_invalid_str_mv |
cc-by-nc-nd (c) Martelli, Valentino et al., CH, 2025 http://creativecommons.org/licenses/by-nc-nd/4.0/ |
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openAccess |
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application/pdf |
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Elsevier |
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Elsevier |
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Articles publicats en revistes (Ciències Clíniques) reponame:Dipòsit Digital de la UB instname:Universidad de Barcelona |
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Universidad de Barcelona |
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Dipòsit Digital de la UB |
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Dipòsit Digital de la UB |
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