Evidence map›Paper›PMID 31996388›Full record

ArticleClinical cancer research : an official journal of the American Association for Cancer Research2020

Immune Checkpoint Blockade in Combination with Stereotactic Body Radiotherapy in Patients with Metastatic Pancreatic Ductal Adenocarcinoma.

Changqing Xie, Austin G Duffy, Gagandeep Brar, Suzanne Fioravanti, Donna Mabry-Hrones, Melissa Walker, Cecilia Monge Bonilla, Bradford J Wood, Deborah E Citrin, Elizabeth M Gil Ramirez and 9 more

Erratum issuedOpen access · greenAbstract readClinical Trial, Phase I
In one paragraph

Article in Clinical cancer research : an official journal of the American Association for Cancer Research, 2020. 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 63 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
63citing papers in PubMed, 6 pooled it
4.9field-weighted citation impact, top 4% 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

63 citing papers in PubMed, 6 syntheses or guidelines pooled it, 98 citations in OpenAlex.

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3 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

19 authors at 3 institutions in 1 country.

Changqing XieGastrointestinal Malignancy Section, Center for Cancer Research, NCI, NIH, Bethesda, Maryland.
Austin G DuffyGastrointestinal Malignancy Section, Center for Cancer Research, NCI, NIH, Bethesda, Maryland.
Gagandeep BrarHematology/Oncology Fellowship Program, National Heart, Lung, and Blood Institute, NCI, NIH, Bethesda, Maryland.
Suzanne FioravantiGastrointestinal Malignancy Section, Center for Cancer Research, NCI, NIH, Bethesda, Maryland.
Donna Mabry-HronesGastrointestinal Malignancy Section, Center for Cancer Research, NCI, NIH, Bethesda, Maryland.
Melissa WalkerGastrointestinal Malignancy Section, Center for Cancer Research, NCI, NIH, Bethesda, Maryland.
Cecilia Monge BonillaGastrointestinal Malignancy Section, Center for Cancer Research, NCI, NIH, Bethesda, Maryland.
Bradford J WoodRadiology and Imaging Sciences, Center for Cancer Research, NIH, Bethesda, Maryland.
Deborah E CitrinRadiation Oncology Branch, Center for Cancer Research, NCI, NIH, Bethesda, Maryland.
Elizabeth M Gil RamirezRadiation Oncology Branch, Center for Cancer Research, NCI, NIH, Bethesda, Maryland.
Freddy E EscorciaRadiation Oncology Branch, Laboratory of Molecular Radiotherapy, Center for Cancer Research, NCI, NIH, Bethesda, Maryland.ORCID 0000-0002-0727-3242
Bernadette ReddRadiology and Imaging Sciences, Center for Cancer Research, NIH, Bethesda, Maryland.
Jonathan M HernandezSurgical Oncology Program, Center for Cancer Research, NCI, NIH, Bethesda, Maryland.
Jeremy L DavisSurgical Oncology Program, Center for Cancer Research, NCI, NIH, Bethesda, Maryland.
Billel GasmiLaboratory of Pathology, Center for Cancer Research, NCI, NIH, Bethesda, Maryland.
David KleinerLaboratory of Pathology, Center for Cancer Research, NCI, NIH, Bethesda, Maryland.ORCID 0000-0003-3442-4453
Seth M SteinbergBiostatistics and Data Management Section, Center for Cancer Research, NIH, Bethesda, Maryland.
Jennifer C JonesLaboratory of Pathology, Center for Cancer Research, NCI, NIH, Bethesda, Maryland.ORCID 0000-0002-9488-7719
Tim F GretenGastrointestinal Malignancy Section, Center for Cancer Research, NCI, NIH, Bethesda, Maryland. tim.greten@nih.gov.ORCID 0000-0002-0806-2535
Center for Cancer Research · USNational Cancer Institute · USNational Heart Lung and Blood Institute · US

Funding

Anatomic Pathology Residency ProgramZIEBC011384 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI BARR, FREDERIC · 2011 to 2025
$26.8M
Center for Interventional OncologyZIDBC011242 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI WOOD, BRADFORD J · 2009 to 2025
$18.7M
Office of Collaborative BiostatisticsZIDSC007202 · NCI · DIVISION OF CLINICAL SCIENCES - NCI · PI CHOO-WOSOBA, HYOYOUNG · 2009 to 2025
$14.5M
Postmortem PathologyZICBC010685 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI KLEINER, DAVID ERWIN · 2009 to 2025
$14.3M
Targeting mechanisms of radiation resistanceZIABC011552 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI CITRIN, DEBORAH · 2014 to 2025
$12.2M
Novel Combinations of Radiation and ImmunotherapyZIABC011503 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI JONES, JENNIFER · 2013 to 2025
$5.3M
Clinical protocols for the treatment of GI cancerZIABC011343 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI GRETEN, TIM · 2010 to 2025
$4.8M
Immune suppressor mechanisms in patients with GI cancerZIABC011344 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI GRETEN, TIM · 2010 to 2025
$2.2M
Evaluating outcomes for patients with primary-metastatic gastrointestinal cancerZIABC011861 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI HERNANDEZ, JONATHAN · 2019 to 2025
$166k
Interventional OncologyZIACL040015 · CLC · CLINICAL CENTER · PI WOOD, BRADFORD · 2009 to 2025
$0k
Navigation Tools for Image Guided Minimally invasive TherapiesZIACL040011 · CLC · CLINICAL CENTER · PI WOOD, BRADFORD · 2009 to 2025
$0k
Intramural NIH HHS ZIA BC011343
6 · The paper itself

Abstract

purposeThe effectiveness of immune checkpoint inhibitors (ICI) is limited in pancreatic ductal adenocarcinoma (PDAC). We conducted a phase I study to evaluate the safety of ICI with stereotactic body radiation therapy (SBRT) in patients with metastatic PDAC. PATIENTS AND

methodsPatients enrolled must have received at least one line of prior systemic chemotherapy for metastatic disease. Cohorts A1 and A2 received durvalumab every 2 weeks plus either 8 Gy in one fraction of SBRT on day 1 or 25 Gy in five fractions on day -3 to +1. Cohorts B1 and B2 received durvalumab plus tremelimumab every 4 weeks and either 8 Gy in one fraction of SBRT on day 1 or 25 Gy in five fractions on day -3 to +1. ICIs were continued until unacceptable toxicity or disease progression. The primary objective was the safety and feasibility of treatment. Objective response was assessed in lesions not subjected to SBRT.

resultsFifty-nine patients were enrolled and 39 were evaluable for efficacy. No dose-limiting toxicities were seen. The most common adverse event was lymphopenia. Two patients achieved a partial response (one confirmed and the other unconfirmed). The overall response rate was 5.1%. Median PFS and OS was 1.7 months [95% confidence intervals (CI), 0.8-2.0 months] and 3.3 months (95% CI, 1.2-6.6 months) in cohort A1; 2.5 months (95% CI, 0.1-3.7 months) and 9.0 months (95% CI, 0.5-18.4 months) in A2; 0.9 months (95% CI, 0.7-2.1 months) and 2.1 months (95% CI, 1.1-4.3 months) in B1; and 2.3 months (95% CI, 1.9-3.4 months) and 4.2 months (95% CI, 2.9-9.3 months) in B2.

conclusionsThe combination of ICI and SBRT has an acceptable safety profile and demonstrates a modest treatment benefit in patients with metastatic PDAC.

Indexed as

AdultAgedAged, 80 and overAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Pancreatic DuctalCohort StudiesFemaleFollow-Up StudiesHumansImmune Checkpoint InhibitorsLymphatic MetastasisMaleMiddle AgedPancreatic NeoplasmsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizeddurvalumabImmune Checkpoint Inhibitorstremelimumab

Identifiers

PMID31996388
PMCPMC8284008
OpenAlexW3004059930

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.