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Erschienen in: Annals of Surgical Oncology 8/2013

01.08.2013 | Pancreatic Tumors

Borderline Resectable Pancreatic Cancer: Need for Standardization and Methods for Optimal Clinical Trial Design

verfasst von: MD Matthew H. G. Katz, MD Robert Marsh, MD Joseph M. Herman, PhD Qian Shi, MD Eric Collison, MD Alan P. Venook, MD Hedy L. Kindler, MD Steven R. Alberts, MD Philip Philip, MD Andrew M. Lowy, MD Peter W. T. Pisters, MD Mitchell C. Posner, MD Jordan D. Berlin, MD Syed A. Ahmad

Erschienen in: Annals of Surgical Oncology | Ausgabe 8/2013

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Abstract

Background

Methodological limitations of prior studies have prevented progress in the treatment of patients with borderline resectable pancreatic adenocarcinoma. Shortcomings have included an absence of staging and treatment standards and pre-existing biases with regard to the use of neoadjuvant therapy and the role of vascular resection at pancreatectomy.

Methods

In this manuscript, we review limitations of studies of borderline resectable PDAC reported to date, highlight important controversies related to this disease stage, emphasize the research infrastructure necessary for its future study, and present a recently-approved Intergroup pilot study (Alliance A021101) that will provide a foundation upon which subsequent well-designed clinical trials can be performed.

Results

We identified twenty-three studies published since 2001 which report outcomes of patients with tumors labeled as borderline resectable and who were treated with neoadjuvant therapy prior to planned pancreatectomy. These studies were heterogeneous in terms of the populations studied, the metrics used to characterize therapeutic response, and the indications used to select patients for surgery. Mechanisms used to standardize these and other issues that are incorporated into Alliance A021101 are reviewed.

Conclusions

Rigorous standards of clinical trial design incorporated into trials of other disease stages must be adopted in all future studies of borderline resectable pancreatic cancer. The Intergroup trial should serve as a paradigm for such investigations.
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Metadaten
Titel
Borderline Resectable Pancreatic Cancer: Need for Standardization and Methods for Optimal Clinical Trial Design
verfasst von
MD Matthew H. G. Katz
MD Robert Marsh
MD Joseph M. Herman
PhD Qian Shi
MD Eric Collison
MD Alan P. Venook
MD Hedy L. Kindler
MD Steven R. Alberts
MD Philip Philip
MD Andrew M. Lowy
MD Peter W. T. Pisters
MD Mitchell C. Posner
MD Jordan D. Berlin
MD Syed A. Ahmad
Publikationsdatum
01.08.2013
Verlag
Springer US
Erschienen in
Annals of Surgical Oncology / Ausgabe 8/2013
Print ISSN: 1068-9265
Elektronische ISSN: 1534-4681
DOI
https://doi.org/10.1245/s10434-013-2886-9

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