Evidence map›Paper›PMID 36477181›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2023

Clinical Features Associated with Outcomes and Biomarker Analysis of Dabrafenib plus Trametinib Treatment in Patients with BRAF-Mutant Melanoma Brain Metastases.

James S Wilmott, Hussein Tawbi, Johnathan A Engh, Nduka M Amankulor, Brindha Shivalingam, Hiya Banerjee, Ismael A Vergara, Hansol Lee, Peter A Johansson, Peter M Ferguson and 8 more

Open access · bronzeAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
1.4field-weighted citation impact, top 19% 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

8 citing papers in PubMed, 16 citations in OpenAlex.

  1. A Review on Melanoma Brain Metastases.Current pharmaceutical design · 2026
    Review
  2. Review
  3. Improved Survival and Prognostication in Melanoma Patients With Brain Metastases: An Update of the Melanoma Graded Prognostic Assessment.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2025
    Article
  4. Review
  5. Review
  6. Article
  7. Review
  8. 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

18 authors at 9 institutions in 4 countries.

James S WilmottMelanoma Institute Australia, The University of Sydney, Sydney, New South Wales, Australia.ORCID 0000-0002-6750-5244
Hussein TawbiThe University of Texas MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0003-1942-851X
Johnathan A EnghThe University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.ORCID 0000-0003-4270-309X
Nduka M AmankulorThe University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.ORCID 0000-0001-6217-1954
Brindha ShivalingamMelanoma Institute Australia, The University of Sydney, Sydney, New South Wales, Australia.ORCID 0000-0003-4354-4537
Hiya BanerjeeNovartis Pharmaceuticals Corporation, Basel, Switzerland.ORCID 0000-0003-1158-0330
Ismael A VergaraMelanoma Institute Australia, The University of Sydney, Sydney, New South Wales, Australia.ORCID 0000-0002-2960-2967
Hansol LeeMelanoma Institute Australia, The University of Sydney, Sydney, New South Wales, Australia.ORCID 0000-0002-6270-1203
Peter A JohanssonQIMR Berghofer Medical Research Institute, Brisbane, Queensland, Australia.ORCID 0000-0001-7015-5452
Peter M FergusonMelanoma Institute Australia, The University of Sydney, Sydney, New South Wales, Australia.ORCID 0000-0002-8335-0406
Philippe SaiagDermatology Department, Ambroise Paré Hospital, APHP, Versailles University - Paris-Saclay, Boulogne-Billancourt, France.ORCID 0000-0002-6500-3507
Caroline RobertGustave Roussy and Paris Saclay University, Villejuif, France.ORCID 0000-0002-9493-0238
Jean-Jacques GrobAix-Marseille University, CHU Timone, Marseille, France.ORCID 0000-0002-0667-153X
Lisa H ButterfieldThe University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.ORCID 0000-0002-3439-9844
Richard A ScolyerMelanoma Institute Australia, The University of Sydney, Sydney, New South Wales, Australia.ORCID 0000-0002-8991-0013
John M Kirkwood *The University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.ORCID 0000-0002-3570-4476
Georgina V Long *Melanoma Institute Australia, The University of Sydney, Sydney, New South Wales, Australia.ORCID 0000-0001-8894-3545
Michael A DaviesThe University of Texas MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0002-0977-0912
The University of Sydney · AUUniversity of Pittsburgh Medical Center · USThe University of Texas MD Anderson Cancer Center · USAssistance Publique – Hôpitaux de Paris · FRHôpital de la Timone · FRNovartis (Switzerland) · CHQIMR Berghofer Medical Research Institute · AUUniversité Paris-Saclay · FRUniversity of California, San Francisco · US

Funding

The University of Texas MD Anderson Cancer Center SPORE in MelanomaP50CA221703 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI DAVIES, MICHAEL · 2019 to 2023
$10.3M
NCI NIH HHS P50 CA221703
6 · The paper itself

Abstract

purposeThis study aimed to identify baseline clinical features associated with the outcomes of patients enrolled in the COMBI-MB phase II study of dabrafenib and trametinib treatment in patients with V600 BRAF-mutant metastatic melanoma with melanoma brain metastases (MBM). Exploratory biomarker analysis was also conducted as part of the synergistic COMBI-BRV trial (BRV116521), to identify molecular and immunologic changes associated with dabrafenib in MBMs and extracranial metastases (ECM). PATIENTS AND

methodsPost hoc analysis was performed for baseline features of patients (n = 125) enrolled in COMBI-MB. Analyses were performed to identify baseline clinical features associated with intracranial response rate (ICRR), progression-free survival (PFS), and overall survival (OS). Exploratory biomarker analysis was performed on biospecimen collected in the COMBI-BRV trial in which patients with BRAF-mutant, resectable MBM were treated with dabrafenib for 10 to 14 days prior to craniotomy. Accessible ECM were resected or biopsied at the time of craniotomy. Biospecimens underwent molecular and immunologic profiling for comparative analyses.

resultsIn COMBI-MB baseline treatment with corticosteroids was independently associated with lower ICRR [39% vs. 63%; OR, 0.323; 95 % confidence interval (CI), 0.105-0.996; P = 0.049] and shorter PFS (HR, 1.93; 95% CI, 1.06-3.51; P = 0.031). Additional significant associations identified in the multivariate analysis were improved PFS in patients with a BRAFV600E genotype (HR, 0.565; 95% CI, 0.321-0.996; P = 0.048) and improved OS in patients with Eastern Cooperative Oncology Group 0 (HR, 0.44; 95% CI, 0.25-0.78; P = 0.005).

conclusionsCorticosteroid treatment was associated with reduced ICRR and PFS in COMBI-MB, similar to results with immunotherapy for MBMs. Baseline corticosteroid treatment is a key factor to consider in MBM patient management and clinical trial design/interpretation.

Indexed as

Brain NeoplasmsMelanomaSkin NeoplasmsAntineoplastic Combined Chemotherapy ProtocolsBiomarkersHumansImidazolesMutationOximesProto-Oncogene Proteins B-rafPyridonesPyrimidinonesBiomarkersBRAF protein, humandabrafenibImidazolesOximesProto-Oncogene Proteins B-rafPyridonesPyrimidinonestrametinib

Identifiers

PMID36477181
PMCPMC9898142
OpenAlexW4310958180

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.