Evidence map›Paper›PMID 36367377›Full record

ArticleThe oncologist2023

Tumor Growth Rate Informs Treatment Efficacy in Metastatic Pancreatic Adenocarcinoma: Application of a Growth and Regression Model to Pivotal Trial and Real-World Data.

Celine Yeh, Mengxi Zhou, Keith Sigel, Gayle Jameson, Ruth White, Rachael Safyan, Yvonne Saenger, Elizabeth Hecht, John Chabot, Stephen Schreibman and 7 more

Open access · goldAbstract read
In one paragraph

Article in The oncologist, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
1.0field-weighted citation impact, top 21% 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

8 citing papers in PubMed, 10 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

17 authors at 8 institutions in 2 countries.

Celine YehDepartment of Medicine, Columbia University Irving Medical Center, New York, NY, USA.
Mengxi ZhouDepartment of Medicine, Division of Hematology/Oncology, Columbia University Herbert Irving Comprehensive Cancer Center, New York, NY, USA.
Keith SigelDepartment of Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, USA.ORCID 0000-0002-4051-4861
Gayle JamesonDepartment of Medical Oncology/Hematology, HonorHealth Research Institute, Scottsdale, AZ, USA.
Ruth WhiteDepartment of Medicine, Division of Hematology/Oncology, Columbia University Herbert Irving Comprehensive Cancer Center, New York, NY, USA.
Rachael SafyanDepartment of Medicine, Division of Hematology/Oncology, Columbia University Herbert Irving Comprehensive Cancer Center, New York, NY, USA.
Yvonne SaengerDepartment of Medicine, Division of Hematology/Oncology, Columbia University Herbert Irving Comprehensive Cancer Center, New York, NY, USA.
Elizabeth HechtDepartment of Radiology, Weill Cornell Medicine, New York, NY, USA.
John ChabotDepartment of Medicine, Division of Hematology/Oncology, Columbia University Herbert Irving Comprehensive Cancer Center, New York, NY, USA.
Stephen SchreibmanDepartment of Medicine, Division of Hematology/Oncology, Columbia University Herbert Irving Comprehensive Cancer Center, New York, NY, USA.
Béata JuzynaR&D UNICANCER, Fédération Nationale des Centres de Lutte Contre le Cancer, Paris, France.
Marc YchouDepartment of Medical Oncology, Institut Régional du Cancer de Montpellier (ICM), Montpellier, France.
Thierry ConroyDepartment of Medical Oncology, Institut de Cancérologie de Lorraine, Vandoeuvre-lès-Nancy Cedex, France.
Tito FojoDepartment of Medicine, Division of Hematology/Oncology, Columbia University Herbert Irving Comprehensive Cancer Center, New York, NY, USA.
Gulam A ManjiDepartment of Medicine, Division of Hematology/Oncology, Columbia University Herbert Irving Comprehensive Cancer Center, New York, NY, USA.
Daniel Von HoffVirginia G. Piper Cancer Center Clinical Trials, HonorHealth Research Institute, Scottsdale, AZ, USA.
Susan E BatesDepartment of Medicine, Division of Hematology/Oncology, Columbia University Herbert Irving Comprehensive Cancer Center, New York, NY, USA.
Columbia University Irving Medical Center · USCornell University · USHonorHealth · USIcahn School of Medicine at Mount Sinai · USInstitut de Cancérologie de Lorraine · FRInstitut de Recherche en Cancérologie de Montpellier · FRLa Ligue Contre le Cancer · FRTranslational Genomics Research Institute · US

Funding

FDA HHS R01 FD006108
6 · The paper itself

Abstract

backgroundMethods for screening agents earlier in development and strategies for conducting smaller randomized controlled trials (RCTs) are needed.

methodsWe retrospectively applied a tumor growth model to estimate the rates of growth of pancreatic cancer using radiographic tumor measurements or serum CA 19-9 values from 3033 patients with stages III-IV PDAC who were enrolled in 8 clinical trials or were included in 2 large real-world data sets.

resultsg correlated inversely with OS and was consistently lower in the experimental arms than in the control arms of RCTs. At the individual patient level, g was significantly faster for lesions metastatic to the liver relative to those localized to the pancreas. Regardless of regimen, g increased toward the end of therapy, often by over 3-fold.

conclusionsGrowth rates of PDAC can be determined using radiographic tumor measurement and CA 19-9 values. g is inversely associated with OS and can differentiate therapies within the same trial and across trials. g can also be used to characterize changes in the behavior of an individual's PDAC, such as differences in the growth rate of lesions based on metastatic site, and the emergence of chemoresistance. We provide examples of how g can be used to benchmark phase II and III clinical data to a virtual reference arm to inform go/no go decisions and consider novel trial designs to optimize and accelerate drug development.

Indexed as

AdenocarcinomaPancreatic NeoplasmsHumansTreatment Outcomepancreatic cancersurvival biomarkerstumor growth rate

Identifiers

PMID36367377
PMCPMC9907043
OpenAlexW4308773416

What OpenQuestion holds

Textmetadata
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.