Evidence map›Paper›PMID 40338282›Full record

Trial reportClinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico2025

Predictive factors of efficacy for FTD/TPI plus bevacizumab in refractory metastatic colorectal cancer patients: a subanalysis of the Spanish cohort from the SUNLIGHT phase III trial.

Gemma Soler, Cristina Grávalos, Fernando Rivera, María José Safont, Anna C Virgili, Manuel Valladares-Ayerbes, Reyes Ferreiro-Monteagudo, María José Ortiz-Morales, Eduardo Polo-Marques, Irina Kornusova-Bersheva and 3 more

Abstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Gemma SolerMedical Oncology Department, Institut Catalá d'Oncologia (ICO), Badalona·Applied Research Group in Oncology (B·ARGO), Institut d'Investigació en Ciències de la Salut Germans Trias i Pujol (IGTP), De Can Ruti Camí de les Escoles s/n, 08916, Badalona, Barcelona, Spain. gsoler@iconcologia.net.ORCID http://orcid.org/0009-0007-4111-1726
Cristina Grávalos12 de Octubre University Hospital, Madrid, Spain.
Fernando RiveraMarqués de Valdecilla University Hospital, IDIVAL, Santander, Spain.
María José SafontGeneral University Hospital Consortium of Valencia, Valencia University, Valencia, Spain.
Anna C VirgiliHospital de la Santa Creu i Sant Pau, Barcelona, Spain.
Manuel Valladares-AyerbesVirgen del Rocío University Hospital, Sevilla, Spain.
Reyes Ferreiro-MonteagudoRamón y Cajal University Hospital, Madrid, Spain.
María José Ortiz-MoralesReina Sofía University Hospital, IMIBIC, UCO, Córdoba, Spain.
Eduardo Polo-MarquesMiguel Servet University Hospital, Zaragoza, Spain.
Irina Kornusova-BershevaDepartment of Medical Affairs, Servier Laboratories, Madrid, Spain.
Elsa SoustreDepartment of Medical Affairs, Servier Laboratories, Madrid, Spain.
Weiyu YaoDepartment of Biostatistics, Servier Pharmaceuticals LLC, Boston, MA, USA.
Elena ÉlezVall d'Hebron University Hospital and Institute of Oncology (VHIO), Universitat Autònoma de Barcelona, Barcelona, Spain.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe addition of bevacizumab to trifluridine-tipiracil (FTD/TPI) therapy improves outcomes in patients with refractory metastatic colorectal cancer (CRC). However, predictive factors of efficacy for FTD/TPI when used in combination with bevacizumab are not yet fully recognized.

methodsPatients included in the Spanish cohort of the SUNLIGHT trial were evaluated. The primary endpoint of this post-hoc exploratory subanalysis was overall survival (OS). Secondary endpoints included progression-free survival (PFS), disease control rate (DCR), safety and the assessment of potential predictive factors of efficacy for FTD/TPI plus bevacizumab, such as age, KRAS mutational status, the incidence of neutropenia, patient prognosis, and prior administration of bevacizumab.

resultsA total of 115 patients were analysed, 58 receiving FTD/TPI and 57 FTD/TPI plus bevacizumab. The median OS was 8.5 vs. 10.6 months (p = 0.254), respectively, and the median PFS was 2.4 vs. 4.7 months (p < 0.0001), respectively. Severe neutropenia affected 20% more patients in the experimental arm than in the control arm (51% vs. 31%, respectively). The univariate analysis showed that a benefit of adding bevacizumab to FTD/TPI in terms of PFS was observed in all previously defined patient subgroups and was accompanied by DCR of 69% for FTD/TPI plus bevacizumab vs. 45% in arm of FTD/TPI alone.

conclusionsThe addition of bevacizumab to FTD/TPI tends to improve OS probably due to the reduced number of patients included in this cohort and significantly improved PFS in all patient subgroups with metastatic CRC. Prospective studies are needed to confirm these results and to find out additional predictive factors that help us to discriminate which patients would benefit most from FTD/TPI plus bevacizumab.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsColorectal NeoplasmsAdultAgedAged, 80 and overBevacizumabCohort StudiesDrug CombinationsFemaleHumansMaleMiddle AgedPrognosisProgression-Free SurvivalPyrrolidinesSpainBevacizumabDrug CombinationsPyrrolidinesThymineTrifluridinetrifluridine tipiracil drug combinationUracilAgingDigestive tumoursPrognosisTargeted therapiesVascular endothelial growth factors

Identifiers

PMID40338282

What OpenQuestion holds

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Registered trials

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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.