Evidence map›Paper›PMID 33811152›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2021

Pilot Clinical Trial of Perioperative Durvalumab and Tremelimumab in the Treatment of Resectable Colorectal Cancer Liver Metastases.

Preeti Kanikarla Marie, Cara Haymaker, Edwin Roger Parra, Young Uk Kim, Rossana Lazcano, Swati Gite, Daniele Lorenzini, Ignacio I Wistuba, Rebecca S Slack Tidwell, Xiaofei Song and 18 more

Open access · bronzeAbstract readClinical Trial
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed, 2 pooled it
3.3field-weighted citation impact, top 5% 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, 2 syntheses or guidelines pooled it, 48 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

28 authors at 1 institution in 1 country.

Preeti Kanikarla Marie *Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Cara Haymaker *Department of Translational Molecular Pathology, The University of Texas MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0002-1317-9287
Edwin Roger ParraDepartment of Translational Molecular Pathology, The University of Texas MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0001-9068-1636
Young Uk KimDepartment of Translational Molecular Pathology, The University of Texas MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0002-2518-0189
Rossana LazcanoDepartment of Translational Molecular Pathology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Swati GiteDepartment of Translational Molecular Pathology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Daniele LorenziniDepartment of Translational Molecular Pathology, The University of Texas MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0002-1425-3354
Ignacio I WistubaDepartment of Translational Molecular Pathology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Rebecca S Slack TidwellDepartment of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0003-3041-8582
Xiaofei SongDepartment of Genomic Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Wai Chin FooDepartment of Pathology, The University of Texas MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0002-0471-4911
Dipen M MaruDepartment of Pathology, The University of Texas MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0002-9134-7709
Yun Shin ChunDepartment of Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Andy FutrealDepartment of Genomic Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Bryan KeeDepartment of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
David MenterDepartment of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Luisa SolisDepartment of Translational Molecular Pathology, The University of Texas MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0002-1253-630X
Ching-Wei TzengDepartment of Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0001-6035-7288
Christine ParseghianDepartment of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0002-2047-097X
Kanwal RaghavDepartment of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Van MorrisDepartment of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0002-4911-2252
Chia-Chi ChangDepartment of Genomic Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0003-0050-1705
Robert JenqDepartment of Genomic Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Alda TamDepartment of Interventional Radiology, The University of Texas MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0002-6065-1556
Chantale BernatchezMelanoma Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0001-5926-3460
Scott KopetzDepartment of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Jean-Nicolas Vauthey *Department of Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0003-4921-5427
Michael J Overman *Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas. moverman@mdanderson.org.ORCID 0000-0001-5377-135X
The University of Texas MD Anderson Cancer Center · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI DIANE BODURKA · 1985 to 2026
$290.8M
Translational Cancer Immune Monitoring and Analysis Center (TCIMAC)U24CA224285 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Gheath Al-Atrash, Cara L Haymaker · 2017 to 2026
$16.7M
Project 3: Inhibiting Oxidative Phosphorylation in Pancreatic CancerP50CA221707 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI KOPETZ, SCOTT · 2019 to 2023
$11.0M
NCI NIH HHS P30 CA016672NCI NIH HHS P50 CA221707NCI NIH HHS U24 CA224285
6 · The paper itself

Abstract

purposeDespite the prognostic importance of immune infiltrate in colorectal cancer, immunotherapy has demonstrated limited clinical activity in refractory metastatic proficient mismatch-repair (pMMR) colorectal cancer. This study explores combining anti-CTLA-4 and an anti-PD-L1 therapy in the preoperative management of resectable colorectal cancer liver metastases with the intent to improve immune responses in this disease setting. PATIENTS AND

methodsPatients with resectable colorectal cancer liver-only metastases received one dose of tremelimumab and durvalumab preoperatively followed by single-agent durvalumab postoperatively. Primary objectives were to determine feasibility and safety.

resultsA total of 24 patients were enrolled between November 2016 and November 2019. Twenty-three patients received treatment [21 pMMR and 2 deficient mismatch-repair (dMMR)] and subsequently 17 (74%; 95% CI: 53%-88%) underwent surgical resection. Grade 3/4 treatment-related immune toxicity and postoperative grade 3/4 toxicity were seen in 5/23 (22%; 95% CI: 10%-44%) and 2/17 (12%; 95% CI: 2%-38%) patients. The median relapse-free survival (RFS) was 9.7 (95% CI: 8.1-17.8) months, and overall survival was 24.5 (95% CI: 16.5-28.4) months. Four patients demonstrated complete pathologic response, two dMMR patients and two POLE mutation patients. Pre- and post-tumor tissue analysis by flow cytometry, immunofluorescence, and RNA sequencing revealed similar levels of T-cell infiltration, but did demonstrate evidence of CD8

conclusionsThis study demonstrates the safety of neoadjuvant combination tremelimumab and durvalumab prior to colorectal cancer liver resection. Evidence for T- and B-cell activation following this therapy was seen in pMMR metastatic colorectal cancer.

Indexed as

AdultAgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedColorectal NeoplasmsDigestive System Surgical ProceduresFeasibility StudiesFemaleHumansInfusions, IntravenousLiver NeoplasmsMaleMiddle AgedNeoadjuvant TherapyPerioperative PeriodPilot ProjectsAntibodies, MonoclonalAntibodies, Monoclonal, Humanizeddurvalumabtremelimumab

Identifiers

PMID33811152
PMCPMC8172528
OpenAlexW3147739291

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.