Evidence map›Paper›PMID 36527039›Full record

Trial reportBMC cancer2022

A phase II study of daily encorafenib in combination with biweekly cetuximab in patients with BRAF V600E mutated metastatic colorectal cancer: the NEW BEACON study.

Martina Eriksen, Per Pfeiffer, Kristoffer Staal Rohrberg, Christina Westmose Yde, Lone Nørgård Petersen, Laurids Østergaard Poulsen, Camilla Qvortrup

Open access · goldAbstract readClinical Trial, Phase II
In one paragraph

Trial report in BMC cancer, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.8field-weighted citation impact, top 25% 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

5 citing papers in PubMed, 8 citations in OpenAlex.

  1. Article
  2. Review
  3. Review
  4. Clinical Medicine Insights. Oncology · 2024
    Review
  5. 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

7 authors at 4 institutions in 1 country.

Martina EriksenDepartment of Oncology, Copenhagen University Hospital (Rigshospitalet), Copenhagen, Denmark. martina.amnitzboell.eriksen@regionh.dk.ORCID http://orcid.org/0000-0002-4700-2615
Per Pfeiffer *Department of Oncology, Odense University Hospital, Odense, Denmark.
Kristoffer Staal Rohrberg *Department of Oncology, Copenhagen University Hospital (Rigshospitalet), Copenhagen, Denmark.
Christina Westmose Yde *Department of Genomic Medicine, Copenhagen University Hospital (Rigshospitalet), Copenhagen, Denmark.
Lone Nørgård Petersen *Department of Oncology, Copenhagen University Hospital (Rigshospitalet), Copenhagen, Denmark.
Laurids Østergaard Poulsen *Department of Oncology, Aalborg University Hospital, Aalborg, Denmark.
Camilla Qvortrup *Department of Oncology, Copenhagen University Hospital (Rigshospitalet), Copenhagen, Denmark.
Copenhagen University Hospital · DKUniversity of Copenhagen · DKAalborg University Hospital · DKOdense University Hospital · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPatients with BRAF V600E mutated metastatic colorectal cancer (mCRC) have a poor prognosis. The introduction of BRAF targeted therapy with encorafenib and weekly administered cetuximab have shown improved survival with a median progression free survival (PFS) of 4.3 months. However, a regimen with cetuximab given every second week may have comparable efficacy and is more convenient for patients. While BRAF targeted therapy is a new standard therapy in pre-treated patients with BRAF V600E mutated mCRC, resistance invariably occurs and is an emerging challenge. The aim of this study is to investigate the efficacy and tolerability of cetuximab given every second week in combination with daily encorafenib and to explore the correlation between markers of resistance and outcome.

methodsThe study is an open label, single arm, phase II study, investigating the efficacy and tolerability of cetuximab given every second week in combination with encorafenib in patients with BRAF V600E mutated mCRC. Furthermore, we will be investigating mechanisms of response and resistance against BRAF targeted therapy though comprehensive genomic profiling on tumor tissue and blood for circulating tumor DNA analysis. A total of 53 patients (19 + 34 in two steps) will be included according to Simon's optimal two stage design. The primary end point of the study is 2 months PFS rate. DISCUSSION: By combining BRAF inhibitor with cetuximab given every second week we can halve the number of visits in the hospital compared to the currently approved regimen with weekly cetuximab. This seems particularly relevant in a group of patients with a median overall survival of 9.3 months. Resistance after initial response to targeted therapy can be either adaptive (e.g., epigenetic, or transcriptomic alterations) or acquired (selective genetic alterations - e.g., activating de novo mutations) resistance. It is of great importance to untangle these complex mechanisms of resistance in patients with BRAF V600E mutated mCRC to improve treatment strategies in the future potentially even further.

trial registrationEU Clinical Trial Register, Eudract no. 2020-003283-10 . Registered on 11 November 2020.

Indexed as

Colonic NeoplasmsColorectal NeoplasmsRectal NeoplasmsAntineoplastic Combined Chemotherapy ProtocolsCarbamatesCetuximabHumansMutationProto-Oncogene Proteins B-rafSulfonamidesBRAF protein, humanCarbamatesCetuximabencorafenibProto-Oncogene Proteins B-rafSulfonamidesBiweekly cetuximabBRAF targeted therapyBRAF V600E mutationColorectal cancerGenomic profilingResistance

Identifiers

PMID36527039
PMCPMC9758813
OpenAlexW4311690624

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

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.