Evidence map›Paper›PMID 37402581›Full record

Trial reportJournal for immunotherapy of cancer2023

Nivolumab and ipilimumab with concurrent stereotactic radiosurgery for intracranial metastases from non-small cell lung cancer: analysis of the safety cohort for non-randomized, open-label, phase I/II trial.

Mehmet Altan, Yan Wang, Juhee Song, James Welsh, Chad Tang, Nandita Guha-Thakurta, George R Blumenschein, Brett W Carter, Jeffrey S Wefel, Amol J Ghia and 17 more

Erratum issuedOpen access · goldAbstract readClinical Trial, Phase IIClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal for immunotherapy of cancer, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 20 papers.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed
5.9field-weighted citation impact, top 3% 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

20 citing papers in PubMed, 23 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

27 authors at 1 institution in 1 country.

Mehmet AltanDepartment of Thoracic Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.ORCID 0000-0001-9229-156X
Yan WangDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Juhee SongDepartment of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
James WelshDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Chad TangDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.ORCID 0000-0002-5915-1327
Nandita Guha-ThakurtaDepartment of Neuroradiology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
George R BlumenscheinDepartment of Thoracic Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Brett W CarterDepartment of Thoracic Imaging, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Jeffrey S WefelDepartment of Neuro-Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Amol J GhiaDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Debra N YeboaDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Mary Frances McAleerDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Caroline ChungDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Kristina D WoodhouseDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Susan L McGovernDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Chenyang WangDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Betty Y S KimDepartment of Neurosurgery, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Jeffrey S WeinbergDepartment of Neurosurgery, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Tina M BriereDepartment of Radiation Physics, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Yasir Y ElaminDepartment of Thoracic Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Xiuning LeDepartment of Thoracic Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Tina CasconeDepartment of Thoracic Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Marcelo V NegraoDepartment of Thoracic Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.ORCID 0000-0001-8938-6699
Ferdinandos SkoulidisDepartment of Thoracic Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Renata FerrarottoDepartment of Thoracic Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
John V HeymachDepartment of Thoracic Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Jing LiDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA jing.li@mdanderson.org.
The University of Texas MD Anderson Cancer Center · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
NCI NIH HHS P30 CA016672
6 · The paper itself

Abstract

backgroundUp to 20% of patients with non-small cell lung cancer (NSCLC) develop brain metastasis (BM), for which the current standard of care is radiation therapy with or without surgery. There are no prospective data on the safety of stereotactic radiosurgery (SRS) concurrent with immune checkpoint inhibitor therapy for BM. This is the safety cohort of the phase I/II investigator-initiated trial of SRS with nivolumab and ipilimumab for patients with BM from NSCLC. PATIENTS AND

methodsThis single-institution study included patients with NSCLC with active BM amenable to SRS. Brain SRS and systemic therapy with nivolumab and ipilimumab were delivered concurrently (within 7 days). The endpoints were safety and 4-month intracranial progression-free survival (PFS).

resultsThirteen patients were enrolled in the safety cohort, 10 of whom were evaluable for dose-limiting toxicities (DLTs). Median follow-up was 23 months (range 9.7-24.3 months). The median interval between systemic therapy and radiation therapy was 3 days. Only one patient had a DLT; hence, predefined stopping criteria were not met. In addition to the patient with DLT, three patients had treatment-related grade ≥3 adverse events, including elevated liver function tests, fatigue, nausea, adrenal insufficiency, and myocarditis. One patient had a confirmed influenza infection 7 months after initiation of protocol treatment (outside the DLT assessment window), leading to pneumonia and subsequent death from hemophagocytic lymphohistiocytosis. The estimated 4-month intracranial PFS rate was 70.7%.

conclusionConcurrent brain SRS with nivolumab/ipilimumab was safe for patients with active NSCLC BM. Preliminary analyses of treatment efficacy were encouraging for intracranial treatment response.

Indexed as

Brain NeoplasmsCarcinoma, Non-Small-Cell LungLung NeoplasmsRadiosurgeryCombined Modality TherapyHumansIpilimumabNivolumabIpilimumabNivolumabImmune Checkpoint InhibitorsNon-Small Cell Lung CancerRadiotherapy

Identifiers

PMID37402581
PMCPMC10335483
OpenAlexW4383092604

What OpenQuestion holds

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LicenceCC BY-NC
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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.