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Group name EquipeMY
Item Type Journal Article
Title Tumor Growth Rate Informs Treatment Efficacy in Metastatic Pancreatic Adenocarcinoma: Application of a Growth and Regression Model to Pivotal Trial and Real-World Data
Creator Yeh et al.
Author Celine Yeh
Author Mengxi Zhou
Author Keith Sigel
Author Gayle Jameson
Author Ruth White
Author Rachael Safyan
Author Yvonne Saenger
Author Elizabeth Hecht
Author John Chabot
Author Stephen Schreibman
Author Marc Ychou
Author Thierry Conroy
Author Tito Fojo
Author Gulam A. Manji
Author Daniel Von Hoff
Author Susan E. Bates
Abstract BACKGROUND: Methods for screening agents earlier in development and strategies for conducting smaller randomized controlled trials (RCTs) are needed. METHODS: We 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. RESULTS: g 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. CONCLUSIONS: Growth 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.
Publication The Oncologist
Volume 28
Issue 2
Pages 139-148
Date 2023-02-08
Journal Abbr Oncologist
Language eng
DOI 10.1093/oncolo/oyac217
ISSN 1549-490X
Short Title Tumor Growth Rate Informs Treatment Efficacy in Metastatic Pancreatic Adenocarcinoma
Library Catalog PubMed
Extra PMID: 36367377 PMCID: PMC9907043
Tags Adenocarcinoma, Humans, Pancreatic Neoplasms, survival biomarkers, Treatment Outcome, tumor growth rate
Date Added 2023/06/08 - 15:09:23
Date Modified 2024/10/10 - 16:24:25
Notes and Attachments PubMed entry (Attachment)
Texte intégral (Attachment)
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