Consensus report of the national cancer institute clinical trials planning meeting on pancreas cancer treatment.
Journal Article (Journal Article;Review)
Pancreatic ductal adenocarcinoma (PDAC) is the fourth leading cause of cancer mortality, despite significant improvements in diagnostic imaging and operative mortality rates. The 5-year survival rate remains less than 5% because of microscopic or gross metastatic disease at time of diagnosis. The Clinical Trials Planning Meeting in pancreatic cancer was convened by the National Cancer Institute's Gastrointestinal Cancer Steering Committee to discuss the integration of basic and clinical knowledge in the design of clinical trials in PDAC. Major emphasis was placed on the enhancement of research to identify and validate the relevant targets and molecular pathways in PDAC, cancer stem cells, and the microenvironment. Emphasis was also placed on developing rational combinations of targeted agents and the development of predictive biomarkers to assist selection of patient subsets. The development of preclinical tumor models that are better predictive of human PDAC must be supported with wider availability to the research community. Phase III clinical trials should be implemented only if there is a meaningful clinical signal of efficacy and safety in the phase II setting. The emphasis must therefore be on performing well-designed phase II studies with uniform sets of basic entry and evaluation criteria with survival as a primary endpoint. Patients with either metastatic or locally advanced PDAC must be studied separately.
Full Text
Duke Authors
Cited Authors
- Philip, PA; Mooney, M; Jaffe, D; Eckhardt, G; Moore, M; Meropol, N; Emens, L; O'Reilly, E; Korc, M; Ellis, L; Benedetti, J; Rothenberg, M; Willett, C; Tempero, M; Lowy, A; Abbruzzese, J; Simeone, D; Hingorani, S; Berlin, J; Tepper, J
Published Date
- November 20, 2009
Published In
Volume / Issue
- 27 / 33
Start / End Page
- 5660 - 5669
PubMed ID
- 19858397
Pubmed Central ID
- PMC7587401
Electronic International Standard Serial Number (EISSN)
- 1527-7755
Digital Object Identifier (DOI)
- 10.1200/JCO.2009.21.9022
Language
- eng
Conference Location
- United States