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Evaluation of a Serologic Marker, CA19-9, in the Diagnosis of Pancreatic Cancer

Douglas K. Pleskow, MD; Harvey J. Berger, MD; John Gyves, MD; Elaine Allen, PhD; Arlene McLean, PhD; and Daniel K. Podolsky, MD
[+] Article, Author, and Disclosure Information

Request for Reprints: Daniel K. Podolsky, MD, Chief, Gastrointestinal Unit, Massachusetts General Hospital, Fruit Street, Boston, MA 02114.

Current Author Addresses: Dr. Podolsky: Gastrointestinal Unit, Massachusetts General Hospital, Boston, MA 02114.

Drs. Berger, Gyves, Allen, and McLean: Centocor Inc., Malvern, PA 19355.

Dr. Pleskow: New England Deaconess Hospital, Boston, MA 02215.

©1989 American College of PhysiciansAmerican College of Physicians

Ann Intern Med. 1989;110(9):704-709. doi:10.7326/0003-4819-110-9-704
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Study Objective: To determine the utility of the serologic marker CA19-9 in the diagnosis of pancreatic cancer in patients suspected of having a pancreatic disorder.

Design: Blinded study of frozen pedigreed serum samples collected at time of diagnostic evaluation with follow-up review at a mean of 8 years.

Setting: A general university teaching hospital serving both primary and referral patient populations.

Measurements and Main Results: Sera collected prospectively from 1978 to 1980 from 261 patients undergoing imaging studies of the pancreas (ultrasound, computed tomography, endoscopic retrograde cholangiopancreatography) for a variety of symptoms were assayed for CA19-9 levels, and the results were compared with earlier determinations of other potential markers for pancreatic cancer. In 54 patients ultimately shown to have pancreatic cancer, the CA19-9 assay showed a sensitivity of 70% with a median value of 349 u/mL (normal < 70 u/mL) and range, 7.3 to 2 859 964 u/mL, whereas specificity of the marker in this population was 87%. The positive predictive value was 59%, and the negative predictive value was 92%. Results of CA19-9 testing in the small group of patients with definitive staging information showed no difference in sensitivity between patients with local/regional disease (n = 6) and those with distant metastases (n = 14), 50% compared with 71% (P= 0.613).

Conclusion: CA19-9 was found to be a more sensitive and specific marker of pancreatic cancer than other serologic markers and should be a useful test in the patient with suspected pancreatic disease. Annals of Internal Medicine. 1989;110:704-709.


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