Preclinical Rationale for the Phase III Trials in Metastatic Pancreatic Cancer: Is Wishful Thinking Clouding Successful Drug Development for Pancreatic Cancer?

Thota, Ramya; Maitra, Anirban; Berlin, Jordan D.

doi:10.1097/mpa.0000000000000753

Cited by 12Pancreatic and Hepatic Oncology ResearchPancreatitis Pathology and TreatmentStatistical Methods in Clinical Trials

Preclinical Rationale for the Phase III Trials in Metastatic Pancreatic Cancer: Is Wishful Thinking Clouding Successful Drug Development for Pancreatic Cancer?

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Thota, Ramya, Maitra, Anirban, Berlin, Jordan D.·2017·Pancreas

DOI 10.1097/mpa.0000000000000753PMC PMC5242389

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Abstract

Prior phase III trials in advanced pancreatic cancer have been predominantly unsuccessful. In this review, we attempt to understand how past preclinical data were translated into phase III clinical trials in metastatic pancreatic cancer as described in the article. A systematic literature review conducted through the MEDLINE, Embase, and Cochrane Central Register of Controlled Trials databases, from January 1997 to June 2015 using key words-phase III clinical trials, metastatic/advanced pancreatic adenocarcinoma or pancreatic cancer identified 30 randomized controlled trials (RCTs) that met criteria. The trials were limited to RCTs in the first-line treatment of patients with metastatic pancreatic cancer. The success rate of first-line phase III studies in advanced pancreatic cancer was only 13%. In 60% of the RCTs, no preclinical experiments were referenced in biologically cognate pancreatic models. Nine (30%) of the RCTs were designed based on preclinical evidence from in vitro cell lines alone without additional in vivo validation in xenograft models. It remains uncertain how strongly the preclinical data influence the development of clinical regimens but so far the studies developed based on more solid preclinical evidence have been successful.

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There have been calls to reform PDAC drug development and to revise the criteria for advancing agents into larger trials.
“This has led to calls to revamp how drug development is furthered for this disease, and to redefine the thresholds needed for agents to move forward to larger phase trials281,282.”
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[69]Kanzawa F In vitro interaction between gemcitabine and other anticancer drugs using a novel three-dimensional model Semin Oncol 1997 24 suppl 7 7 16 SN 1997 9194474

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Authors: Thota, R., Maitra, A., & Berlin, J. D.
Affiliations: The University of Texas MD Anderson Cancer Center (US)
Corresponding author: Berlin, Jordan D.
ORCID: Thota, Ramya
Maitra, Anirban
Berlin, Jordan D.
Venue: Pancreas
Publisher: Ovid Technologies (Wolters Kluwer Health)
Published: 2017-02
Volume: 46
Issue: 2
Pages: 143-150
ISSN: 0885-3177 (ISSN-L)
DOI: 10.1097/mpa.0000000000000753
PMC: PMC5242389
OpenAlex: W2577776321
Cited by: 12
References: 104
Citations by year: 2026: 1 · 2024: 1 · 2023: 1 · 2021: 5 · 2020: 1 · 2019: 1 · 2018: 1 · 2017: 1
FWCI: 0.11
Type: journal article
Language: en
Open access: green
www.ncbi.nlm.nih.gov
Locations: Pancreas (publishedVersion)
PubMed (publishedVersion)
Europe PMC (PubMed Central) (acceptedVersion)
PubMed Central (acceptedVersion)
Funders: National Cancer Institute (P30CA068485)
Topics: Health Sciences › Medicine › Oncology › Pancreatic and Hepatic Oncology Research
Health Sciences › Medicine › Surgery › Pancreatitis Pathology and Treatment
Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Keywords: metastatic pancreatic cancer, pancreatic ductal adenocarcinoma, first-line therapy, randomized controlled trials, xenograft models, in vitro cell lines, trial design, preclinical evidence
MeSH terms: Animals, Antineoplastic Combined Chemotherapy Protocols, Drug Screening Assays, Antitumor, Drug Therapy, Humans, Neoplasm Metastasis, Pancreatic Neoplasms, Randomized Controlled Trials as Topic, Clinical Trials, Phase III as Topic

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Preclinical Rationale for the Phase III Trials in Metastatic Pancreatic Cancer: Is Wishful Thinking Clouding Successful Drug Development for Pancreatic Cancer?

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