Evidence map›Paper›PMID 38203214›Full record

Trial reportInternational journal of molecular sciences2023

A Phase II Exploratory Study to Identify Biomarkers Predictive of Clinical Response to Regorafenib in Patients with Metastatic Colorectal Cancer Who Have Failed First-Line Therapy.

Karen Gambaro, Maud Marques, Suzan McNamara, Mathilde Couetoux du Tertre, Cyrla Hoffert, Archana Srivastava, Anna Schab, Thierry Alcindor, Adrian Langleben, Lucas Sideris and 5 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase II
In one paragraph

Trial report in International journal of molecular sciences, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01949194 (A Phase II Exploratory Study to Identify Biomarkers Predictive of Clinical Response to Regorafenib in Patients With Metastatic Colorectal Cancer Who Have Failed First-line Therapy), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.2field-weighted citation impact, top 29% 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.

NCT01949194 phase2unknown statusnot on this map

A Phase II Exploratory Study to Identify Biomarkers Predictive of Clinical Response to Regorafenib in Patients With Metastatic Colorectal Cancer Who Have Failed First-line Therapy

TypeinterventionalSponsorGerald BatistRan2013 to 2018Enrolled48ConditionsMetastatic Colorectal CancerArmsRegorafenib
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 citations in OpenAlex.

  1. Review
  2. 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

15 authors at 8 institutions in 1 country.

Karen GambaroCanadian National Centres of Excellence-Exactis Innovations, Montreal, QC H3T 1Y6, Canada.
Maud MarquesCanadian National Centres of Excellence-Exactis Innovations, Montreal, QC H3T 1Y6, Canada.
Suzan McNamaraCanadian National Centres of Excellence-Exactis Innovations, Montreal, QC H3T 1Y6, Canada.
Mathilde Couetoux du TertreCanadian National Centres of Excellence-Exactis Innovations, Montreal, QC H3T 1Y6, Canada.
Cyrla HoffertCanadian National Centres of Excellence-Exactis Innovations, Montreal, QC H3T 1Y6, Canada.
Archana SrivastavaCanadian National Centres of Excellence-Exactis Innovations, Montreal, QC H3T 1Y6, Canada.
Anna SchabCanadian National Centres of Excellence-Exactis Innovations, Montreal, QC H3T 1Y6, Canada.
Thierry AlcindorMcGill University Health Centre, Montreal, QC H4A 3J1, Canada.
Adrian LanglebenSt. Mary's Hospital, Montreal, QC H3T 0A2, Canada.
Lucas SiderisHôpital Maisonneuve Rosemont, Montreal, QC H1T 2M4, Canada.ORCID 0000-0002-9326-4392
Mahmoud AbdelsalamThe Moncton Hospital, Moncton, NB E1C 6Z8, Canada.
Mustapha TehfeHematology-Oncology, Oncology Center-Centre Hospitalier de l'Université de Montreal, Montreal, QC H2X 0C1, Canada.ORCID 0000-0002-1380-5110
Felix CoutureHôtel-Dieu de Québec, Quebec, QC G1R 2J6, Canada.
Gerald BatistSegal Cancer Centre-Jewish General Hospital, Montreal, QC H3T 1E2, Canada.
Petr KavanSegal Cancer Centre-Jewish General Hospital, Montreal, QC H3T 1E2, Canada.
Jewish General Hospital · CAQuebec - Clinical Research Organization in Cancer · CACentre Hospitalier de l’Université de Montréal · CAHôpital Maisonneuve-Rosemont · CAHôtel-Dieu de Québec · CAMcGill University Health Centre · CAMoncton Hospital · CASt Mary's Hospital Centre · CA

Funding

Bayer (Canada) 0
6 · The paper itself

Abstract

Single-agent regorafenib is approved in Canada for metastatic colorectal cancer (mCRC) patients who have failed previous lines of therapy. Identifying prognostic biomarkers is key to optimizing therapeutic strategies for these patients. In this clinical study (NCT01949194), we evaluated the safety and efficacy of single-agent regorafenib as a second-line therapy for mCRC patients who received it after failing first-line therapy with an oxaliplatin or irinotecan regimen with or without bevacizumab. Using various omics approaches, we also investigated putative biomarkers of response and resistance to regorafenib in metastatic lesions and blood samples in the same cohort. Overall, the safety profile of regorafenib seemed similar to the CORRECT trial, where regorafenib was administered as ≥ 2 lines of therapy. While the mutational landscape showed typical mutation rates for the top five driver genes (APC, KRAS, BRAF, PIK3CA, and TP53), KRAS mutations were enriched in intrinsically resistant lesions. Additional exploration of genomic-phenotype associations revealed several biomarker candidates linked to unfavorable prognoses in patients with mCRC using various approaches, including pathway analysis, cfDNA profiling, and copy number analysis. However, further research endeavors are necessary to validate the potential utility of these promising genes in understanding patients' responses to regorafenib treatment.

Indexed as

Colonic NeoplasmsProto-Oncogene Proteins p21(ras)PyridinesBiomarkersHumansPhenylurea CompoundsBiomarkersPhenylurea CompoundsProto-Oncogene Proteins p21(ras)Pyridinesregorafenibacquired resistance (ARES)biomarkersintrinsic resistance (IRES)metastatic colorectal cancer (mCRC)progression-free survival (PFS)regorafenib

Identifiers

PMID38203214
PMCPMC10778949
OpenAlexW4389935684

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

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.