Evidence map›Paper›PMID 28275886›Full record

Trial reportJournal of neuro-oncology2017

Comparing available criteria for measuring brain metastasis response to immunotherapy.

Jack M Qian, Amit Mahajan, James B Yu, A John Tsiouris, Sarah B Goldberg, Harriet M Kluger, Veronica L S Chiang

Registry-linked trialAbstract readClinical Trial, Phase IIComparative Study
PubMed Publisher
In one paragraph

Trial report in Journal of neuro-oncology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02085070 (A Phase 2 Study of MK-3475 in Patients With Metastatic Melanoma and Non-Small Cell Lung Cancer With Untreated Brain Metastases), which is not on this map. Cited by 32 papers.

0numbers the graph read from it
0cells of the map it votes in
32citing 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.

NCT02085070 phase2completednot on this map

A Phase 2 Study of MK-3475 in Patients With Metastatic Melanoma and Non-Small Cell Lung Cancer With Untreated Brain Metastases

TypeinterventionalSponsorYale UniversityRan2014 to 2020Enrolled65ConditionsMelanoma, Non-Small Cell Lung Cancer, Brain MetastasesArmsMK-3475
3 · Its place in the literature

Who cites it

32 citing papers in PubMed.

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  3. Long-Term Survival of Patients With Melanoma With Active Brain Metastases Treated With Pembrolizumab on a Phase II Trial.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2019
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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

7 authors.

Jack M QianYale School of Medicine, 333 Cedar St, New Haven, CT, 06510, USA.
Amit MahajanDepartment of Radiology and Biomedical Imaging, Yale School of Medicine, 333 Cedar St, New Haven, CT, 06510, USA.
James B YuDepartment of Therapeutic Radiology, Yale School of Medicine, 333 Cedar St, New Haven, CT, 06510, USA.
A John TsiourisDepartment of Radiology, Weill Cornell Medicine, New York, NY, 10065, USA.
Sarah B GoldbergDepartment of Medicine, Yale School of Medicine, 333 Cedar St, New Haven, CT, 06510, USA.
Harriet M KlugerDepartment of Medicine, Yale School of Medicine, 333 Cedar St, New Haven, CT, 06510, USA.
Veronica L S ChiangDepartment of Therapeutic Radiology, Yale School of Medicine, 333 Cedar St, New Haven, CT, 06510, USA. veronica.chiang@yale.edu.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The response assessment in neuro-oncology (RANO) working group recently proposed standardized response criteria for brain metastases (RANO-BM). We sought to compare RANO-BM to other criteria in an ongoing brain metastasis trial. The first 36 patients enrolled on NCT02085070, an ongoing trial of pembrolizumab for patients with untreated brain metastases, were included in this analysis. As RANO-BM had not been proposed when the protocol was written, response on trial was assessed using an institutional modification of RECIST 1.1 (mRECIST), wherein minimum target brain lesion size was 5 mm in longest diameter and up to five target brain lesions were followed. We here additionally assessed response using standard RECIST 1.1, RANO high-grade glioma (RANO-HGG), and RANO-BM. Comparison between the four criteria sets using cases eligible across the board revealed excellent concordance (kappa statistic > 0.8), with only one discordant case. However, compared to RECIST 1.1 or RANO-BM, using a 5 mm threshold for target brain lesions in mRECIST allowed enrollment of 13 additional patients, five of whom had durable responses. Compared to RANO-HGG, 19 additional patients were enrolled using mRECIST, eight of whom had durable responses. Consequently, this resulted in response rates ranging from 12% with RANO-HGG to 28% with mRECIST. This study supports using a 5 mm threshold for target brain lesions when using high resolution MRI with ≤2 mm slices to facilitate accrual to similar clinical trials and provide earlier access to novel therapies for brain metastasis patients. Concordance among the four criteria studied was otherwise very high.

Indexed as

Treatment OutcomeAdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalBrain NeoplasmsFemaleHumansImmunotherapyMagnetic Resonance ImagingMaleMedical OncologyMiddle AgedAntibodies, Monoclonal, HumanizedAntineoplastic Agents, Immunologicalpembrolizumabanti-PD-1Brain metastasesImmunotherapyRANO-BMRECISTResponse criteria

Identifiers

PMID28275886

What OpenQuestion holds

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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.