Evidence map›Paper›PMID 38040420›Full record

Trial reportJournal for immunotherapy of cancer2023

Multicenter randomized controlled trial of neoadjuvant chemoradiotherapy alone or in combination with pembrolizumab in patients with resectable or borderline resectable pancreatic adenocarcinoma.

Matthew H G Katz, Gina R Petroni, Todd Bauer, Matthew J Reilley, Brian M Wolpin, Chee-Chee Stucky, Tanios S Bekaii-Saab, Rawad Elias, Nipun Merchant, Andressa Dias Costa and 9 more

Open access · goldAbstract readRandomized Controlled TrialMulticenter Study
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. Cited by 33 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed, 5 pooled it
7.6field-weighted citation impact, top 2% 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

33 citing papers in PubMed, 5 syntheses or guidelines pooled it, 33 citations in OpenAlex.

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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

19 authors at 8 institutions in 1 country.

Matthew H G KatzDepartment of Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA mhgkatz@mdanderson.org.ORCID 0000-0003-3870-6968
Gina R PetroniDivision of Translational Research and Applied Statistics, Department of Public Health Sciences, University of Virginia Health System, Charlottesville, Virginia, USA.
Todd BauerDepartment of Surgery, University of Virginia Health System, Charlottesville, Virginia, USA.
Matthew J ReilleyDivision of Hematology and Oncology, Department of Medicine, University of Virginia Health System, Charlottesville, Virginia, USA.ORCID 0000-0002-4725-0459
Brian M WolpinDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.
Chee-Chee StuckyDepartment of Surgery, Mayo Clinic, Rochester, Minnesota, USA.
Tanios S Bekaii-SaabDivision of Hematology and Medical Oncology, Department of Internal Medicine, Mayo Clin, Phoenix, Arizona, USA.
Rawad EliasHartford HealthCare Cancer Institute, Plainville, Connecticut, USA.
Nipun MerchantDepartment of Surgery, University of Miami, Coral Gables, Florida, USA.
Andressa Dias CostaDepartment of Medical Oncology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts, USA.
Patrick LenehanDepartment of Cancer Immunology and Virology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.
Victoire Cardot-RuffinoDepartment of Cancer Immunology and Virology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.
Scott RodigDepartment of Cancer Immunology and Virology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.
Kathleen PfaffCenter for Immuno-Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.
Stephanie K DouganDepartment of Cancer Immunology and Virology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.ORCID 0000-0002-2263-363X
Jonathan Andrew NowakDepartment of Cancer Immunology and Virology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.ORCID 0000-0002-0943-7407
Gauri R VaradhacharyDepartment of Gastrointestinal Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Craig L SlingluffDepartment of Surgery, University of Virginia Health System, Charlottesville, Virginia, USA.ORCID 0000-0002-6664-4373
Osama RahmaDepartment of Medical Oncology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts, USA.
Harvard University · USUniversity of Virginia Health System · USThe University of Texas MD Anderson Cancer Center · USBrigham and Women's Hospital · USHartford Hospital · USMayo Clinic · USMayo Clinic in Arizona · USUniversity of Miami · US

Funding

Medical Scientist Training ProgramT32GM007753 · NIGMS · HARVARD UNIVERSITY (MEDICAL SCHOOL) · PI WALENSKY, LOREN DAVID · 1985 to 2021
$50.0M
Tissue and Pathology ResourcesP50CA127003 · NCI · DANA-FARBER CANCER INST · PI SHIVDASANI, RAMESH A · 2007 to 2023
$33.2M
Medical Scientist Training ProgramT32GM144273 · NIGMS · HARVARD MEDICAL SCHOOL · PI David Shumway Jones, Jacqueline A. Lees · 2022 to 2026
$14.7M
Circulating Biomarker Consortium for Pancreatic Cancer Early DetectionU01CA210171 · NCI · DANA-FARBER CANCER INST · PI Michael H. Rosenthal, Brian Matthew Wolpin · 2016 to 2026
$8.7M
Stromal modulation of pancreatic cancer malignant cell state and therapeutic sensitivityU01CA274276 · NCI · DANA-FARBER CANCER INST · PI Andrew James Aguirre, Stephanie Dougan · 2022 to 2026
$5.1M
CDK4/6 inhibition during CD8 T cell priming potentiates memory formation in mice and humansR01AI158488 · NIAID · DANA-FARBER CANCER INST · PI DOUGAN, STEPHANIE · 2021 to 2025
$2.2M
NCI NIH HHS P50 CA127003NCI NIH HHS U01 CA210171NCI NIH HHS U01 CA274276NIAID NIH HHS R01 AI158488NIGMS NIH HHS T32 GM007753NIGMS NIH HHS T32 GM144273
6 · The paper itself

Abstract

backgroundPancreatic ductal adenocarcinoma (PDAC) is a challenging target for immunotherapy because it has an immunosuppressive tumor microenvironment. Neoadjuvant chemoradiotherapy can increase tumor-infiltrating lymphocyte (TIL) density, which may predict overall survival (OS). We hypothesized that adding programmed cell death protein 1 (PD-1) blockade to chemoradiotherapy would be well tolerated and increase TILs among patients with localized PDAC.

methodsPatients were randomized 2:1 to Arm A (receiving pembrolizumab plus chemoradiotherapy (capecitabine and external beam radiation)) or Arm B (receiving chemoradiotherapy alone) before anticipated pancreatectomy. Primary endpoints were (1) incidence and severity of adverse events during neoadjuvant therapy and (2) density of TILs in resected tumor specimens. TIL density was assessed using multiplexed immunofluorescence histologic examination.

resultsThirty-seven patients were randomized to Arms A (n=24) and B (n=13). Grade ≥3 adverse events related to neoadjuvant treatment were experienced by 9 (38%) and 4 (31%) patients in Arms A and B, respectively, with one patient experiencing dose-limiting toxicity in Arm A. Seventeen (71%) and 7 (54%) patients in Arms A and B, respectively, underwent pancreatectomy. Median CD8

conclusionsAdding pembrolizumab to neoadjuvant chemoradiotherapy was safe. However, no convincing effect on CD8

Indexed as

AdenocarcinomaCarcinoma, Pancreatic DuctalPancreatic NeoplasmsAntibodies, Monoclonal, HumanizedHumansNeoadjuvant TherapyTumor MicroenvironmentAntibodies, Monoclonal, HumanizedpembrolizumabAdjuvants, ImmunologicClinical Trials as TopicCombined Modality TherapyImmune Checkpoint InhibitorsImmunotherapy

Identifiers

PMID38040420
PMCPMC10693876
OpenAlexW4389219193

What OpenQuestion holds

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LicenceCC BY-NC
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.