Journal
GASTROENTEROLOGY
Volume 160, Issue 4, Pages 1373-+Publisher
W B SAUNDERS CO-ELSEVIER INC
DOI: 10.1053/j.gastro.2020.11.052
Keywords
Biomarker; Detection; Pancreatic Cancer
Categories
Funding
- McKee Early Career Investigator in Pancreatic Cancer Research
- National Institutes of Health (NIH) [U01 CA210171]
- Hale Family Center for Pancreatic Cancer Research
- Lustgarten Foundation Dedicated Laboratory program
- Stand Up to Cancer
- NIH [U01 CA210171, P50 CA127003]
- Pancreatic Cancer Action Network
- Noble Effort Fund
- Wexler Family Fund
- Promises for Purple
- MCL [5U01CA196403-05]
- EDRN [5U01CA200468-05]
- MD Anderson Cancer Center GI SPORE [5-P50-CA221707-02]
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CA19-9 serves as an anchor marker for pancreatic cancer early detection, especially with exponentially increasing levels starting 2 years before diagnosis, providing significant value for early diagnosis.
BACKGROUND & AIMS: There is substantial interest in liquid biopsy approaches for cancer early detection among subjects at risk, using multi-marker panels. CA19-9 is an established circulating biomarker for pancreatic cancer; however, its relevance for pancreatic cancer early detection or for monitoring subjects at risk has not been established. METHODS: CA19-9 levels were assessed in blinded sera from 175 subjects collected up to 5 years before diagnosis of pancreatic cancer and from 875 matched controls from the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial. For comparison of performance, CA19-9 was assayed in blinded independent sets of samples collected at diagnosis from 129 subjects with resectable pancreatic cancer and 275 controls (100 healthy subjects; 50 with chronic pancreatitis; and 125 with noncancerous pancreatic cysts). The complementary value of 2 additional protein markers, TIMP1 and LRG1, was determined. RESULTS: In the PLCO cohort, levels of CA19-9 increased exponentially starting at 2 years before diagnosis with sensitivities reaching 60% at 99% specificity within 0 to 6 months before diagnosis for all cases and 50% at 99% specificity for cases diagnosed with early-stage disease. Performance was comparable for distinguishing newly diagnosed cases with resectable pancreatic cancer from healthy controls (64% sensitivity at 99% specificity). Comparison of resectable pancreatic cancer cases to subjects with chronic pancreatitis yielded 46% sensitivity at 99% specificity and for subjects with noncancerous cysts, 30% sensitivity at 99% specificity. For prediagnostic cases below cutoff value for CA19-9, the combination with LRG1 and TIMP1 yielded an increment of 13.2% in sensitivity at 99% specificity (P = .031) in identifying cases diagnosed within 1 year of blood collection. CONCLUSION: CA19-9 can serve as an anchor marker for pancreatic cancer early detection applications.
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