Evidence map›Paper›PMID 30690930›Full record

Observational studyCancer medicine2019

Efficacy and safety of FOLFIRI/aflibercept in second-line treatment of metastatic colorectal cancer in a real-world population: Prognostic and predictive markers.

Ana Fernández Montes, Nieves Martínez Lago, Marta Covela Rúa, Juan de la Cámara Gómez, Paula González Villaroel, José Carlos Méndez Méndez, Mónica Jorge Fernández, Mercedes Salgado Fernández, Margarita Reboredo López, Guillermo Quintero Aldana and 3 more

Open access · goldAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Cancer medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed
2.5field-weighted citation impact, top 9% of its field
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

22 citing papers in PubMed, 37 citations in OpenAlex.

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  8. Patient profiles as an aim to optimize selection in the second line setting: the role of aflibercept.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2021
    Review
  9. Article
  10. CirculatingJournal of clinical medicine · 2021
    Article
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  12. Review
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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 at 6 institutions in 1 country.

Ana Fernández MontesUniversity Hospital of Ourense, Ourense, Spain.ORCID 0000-0003-4630-5830
Nieves Martínez LagoUniversity Hospital of A Coruña, A Coruña, Spain.
Marta Covela RúaUniversital Hospital Lucus Augusti, Lugo, Spain.
Juan de la Cámara GómezUniversity Hospital Arquitecto Marcide, Ferrol, Spain.
Paula González VillaroelOncological Center of Galicia, A Coruña, Spain.
José Carlos Méndez MéndezUniverity Hospital Álvaro Cunqueiro, Vigo, Spain.
Mónica Jorge FernándezUniversity Hospital Arquitecto Marcide, Ferrol, Spain.
Mercedes Salgado FernándezUniversity Hospital of Ourense, Ourense, Spain.
Margarita Reboredo LópezUniversity Hospital of A Coruña, A Coruña, Spain.
Guillermo Quintero AldanaUniversital Hospital Lucus Augusti, Lugo, Spain.
María Luz Pellón AugustoUniversity Hospital Arquitecto Marcide, Ferrol, Spain.
Begoña Graña SuárezUniversity Hospital of A Coruña, A Coruña, Spain.
Jesús García GómezUniversity Hospital of Ourense, Ourense, Spain.
Complejo Hospitalario de Ourense · ESUniversidade da Coruña · ESComplejo Hospitalario Universitario de Ferrol · ESHospital Universitario Lucus Augusti · ESCentro Oncológico de Galicia · ESUniversity Hospital Complex Of Vigo · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe phase III VELOUR trial demonstrated efficacy with combined FOLFIRI-aflibercept in patients with metastatic colorectal cancer previously treated with oxaliplatin with or without bevacizumab versus placebo. The effect of FOLFIRI-aflibercept in routine clinical practice was evaluated. METHODS/PATIENTS: Overall survival (OS), progression-free survival (PFS), response and safety were analysed for 78 patients treated with FOLFIRI-aflibercept at six GITuD institutions. Exploratory analyses of prognostic and predictive markers of efficacy were performed.

resultsPatients had good general status (PS 0-1 96.2%), tumours were mostly RAS-mutant (75.6%), synchronous (71.8%), and left-sided (71.8%). Prior therapy included bevacizumab (47.4%) and anti-EGFR agents (12.8%). PFS was longer for metachronous than synchronous tumours (11.0 vs 5.0 months, P = 0.028), and for left-colon tumours (7.0 vs 3.0 months, P = 0.044). RAS-mutant status, first-line treatment and primary tumour surgery did not impact PFS. The disease control rate was 70.5%. The most common grade 3/4 toxicities were neutropenia (15.3%), asthenia (10.3%), diarrhea and mucositis (6.4% each). Dysphonia was reported in 39.7% of patients, and grade 3 hypertension in 3.8%. Development of hypertension (any grade) was significantly associated with a reduced risk of progression by multivariate analysis (HR = 2.7; 95%CI 1.3-5.4; P = 0.001).

conclusionsEfficacy with FOLFIRI-aflibercept in a real-life population was in line with results from the pivotal trial and toxicity was manageable with treatment adaptation. Survival outcomes were not impacted by primary tumour location, RAS-mutant status, first-line treatment or primary tumour surgery. Hypertension may be a surrogate marker of efficacy in this patient population.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, PharmacologicalCamptothecinColorectal NeoplasmsFemaleFluorouracilHumansLeucovorinLiver NeoplasmsMaleMiddle AgedReceptors, Vascular Endothelial Growth FactorRecombinant Fusion ProteinsafliberceptBiomarkers, PharmacologicalCamptothecinFluorouracilLeucovorinReceptors, Vascular Endothelial Growth FactorRecombinant Fusion ProteinsafliberceptFOLFIRImetastatic colorectal cancerreal-life studyroutine clinical practiceVELOUR

Identifiers

PMID30690930
PMCPMC6434192
OpenAlexW2913408083

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.