Measurement of a monoclonal-antibody-defined antigen (CA 19-9) in the sera of patients with malignant and nonmalignant diseases comparison with carcinoembryonic antigen

Abstract

Immunoradiometric assay (IRMA) using monoclonal antibody for colon cancer cell surface antigen (CA19-9) was compared with carcinoembryonic antigen (CEA) with regard to sensitivity and specificity in 730 patients. In the 341 patients who had no evidence of malignant disease, CA19-9 levels ranged between 4. 5 to 49 U/ml. Specificity of CA19-9 at a cutoff of 20 U/ml was similar to that of CEA at a cutoff of 5.0 ng/ml; CA19-9 was more sensitive than CEA in pancreatic cancer, whereas CEA was more sensitive than CA19-9 in breast, colon, and gastric cancer. Of 17 patients with pancreatic cancer, 13 had elevated levels of CA19-9 (sensitivity, 76%). whereas only 8 had elevated levels of CEA (sensitivity, 47%) and 15 had elevated levels of either CEA or CA19-9 (sensitivity, 88%). These findings suggest that, like CEA, CA19-9 is detectable in nonmalignant diseases and is not specific for gastrointestinal tumors, and has higher sensitivity than CEA only in pancreatic cancer. However, further prospective studies are required to verify its value in the diagnosis and management of pancreatic cancer. Cancer 56977-283, 1985. LTHOUGH carcinoembryonic antigen (CEA) has A been the most widely studied'-3 and used marker in human cancer, it lacks the specificity and sensitivity required for early detection of malignan~y.~ Clinically, it is used only as an indicator of recurrence or as a monitor of therapy in known cancer More recently, hybridoma technology* has renewed interest in more specific tumor markers. Koprowski et al. developed a monoclonal antibody to colon cancer cell surface antigen in 19799 and later showed that this antibody reacted with sialylated lacto-N-fuco-pentoase 11. l o In early clinical studies, this same antibody has been found to be both highly sensitive and specific in identifying gastrointestinal adenocarcinoma.'1*'2 A radiometric assay using this antibody has been made available for inves-tigational purposes (along with the necessary reagents) by Centocor (Philadelphia).'' In this report we present our results with this assay, including comparison with CEA, in patients with malignant and nonmalignant diseases. Materials and Methods Immimoradiometric Assay for CA19-9 Details of the CA19-9 assay have been described previously. Briefly, antibody coated beads were incu-bated with standards and unknowns (100 pl) in 25 well reaction trays for 3 hours at 37°C. The beads were then washed and 200 ~l of radiolabeled iodine 125 ('251) anti-CA19-9 (approximately 100,OOO cpm) was added to each bead. The beads were incubated for 3 hours at room temperature, followed by aspiration and washing, after which they were transferred into 12 X 75 mm tubes and counted in a gamma counter. The lowest 277

Carbohydrate antigen 19-9 as a serum marker of hepatocellular carcinoma: Comparison with alpha-foetoprotein

“…Indirect confirmation of our finding and that of previous workers that CA 19-9 is frequently not expressed by HCC is provided by the observation of Atkinson et al (1982) that only one of 11 HCCs examined with immunoperoxidase staining was positive for CA 19-9. Our finding of raised serum concentrations of CA 19-9 in patients with a variety of non-gastrointestinal tumours confirms the observation of Gupta et al (1985) that CA 19-9 is not specific for gastrointestinal tumours.…”

“…The present investigation has shown elevated CA 19-9 values to be present appreciably more often in southern African Blacks with HCC. Although this level of sensitivity as a marker is less than that described in carcinoma of the pancreas, it is comparable with that obtained with other gastro-intestinal carcinomas (Koprowski et al, 1981;Del Villano et al, 1983;Kuusela et al, 1984;Jalanko et al, 1984;Satake et al, 1985;Gupta et al, 1985;Schmiegel et al, 1985). The specificity of CA 19-9 in differentiating HCC from various benign hepatic diseases with which it might be confused clinically was 71%, with a predictive value of a positive test of 80.5% and of a negative test of 39.9%.…”

Intralobar Pulmonary Sequestration and Increased Serum CA 19-9

“…The most common clinical features are fever and cough due to various bacteria and occasionally uncommon pathogens such as Mycobacterium tuberculosis and fungus [1][2][3][4] . The presence of high levels of CA 19-9 is usually considered to strongly suggest malignant pancreatic-biliary or gastrointestinal disease, but this serum marker may also increase in a number of non-malignant diseases [5] . In patients with PS, an increase in serum CA 19.9 has been reported anecdotally [3][4][5][6] .…”

“…High CA 19-9 levels are considered strongly suggestive of malignancy of the pancreas, biliary system or gastrointestinal tract. However, slight increases in this marker (usually not more than four to five times the normal limit) are reported in several non-malignant diseases such as chronic hepatitis, primary biliary cirrhosis [5,6] and primary sclerosing cholangitis [7] . An increase in CA 19-9 has been rarely reported in some cases of PS [2,3] .…”

Intralobar Pulmonary Sequestration Presenting Increased Serum CA19-9 and CA125.

“…As far as we know, there is no report indicating whether this area changes into a homogeneousopacity. CA19-9 is a sialyl lewis A antigen, and is a tumor marker of the choledochal, pancreatic, gastrointestinal tracts, and lung caner (2,3). In benign pulmonary diseases such as bronchial ectasia, pulmonary fibrosis or pulmonary sequestration, CA19-9 is occasionally elevated in serum (4).…”