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Clinical significance of CA19-9 in diagnosis of digestive tract tumors
Ji Zong Zhao,Bo Heng Wu
Subject headings Digestive system neoplasms; CA19-9; tumor related antigen; stomach neoplasms; colorectal neoplasms; pancreatic neoplasms; esophageal neoplasms
Zhao JZ, Wu BH. Clinical significance of CAa-a 19-9aa in diagnosis of digestive tract tumors. China Nati J New Gastroenterol, 1997;3(4):253-254
To evaluate the clinical value of CA19-9
in diagnosing and
differentiating the gastrointestinal tumors and in monitoring
the patients treated surgically.
METHODS Gastric cancer(n=70), colorectal cancer (n=90), pancreatic cancer (n=7), esophageal cancer (n=10), benign disorder (n=30), and normal adults (n=111) as control were studied. Fasting blood samples were obtained from each patient and normal adult. The serum CA19-9 concentration was measured with radioimmunoassay.
RESULTS The mean CA19-9 level in gastric cancer (170.69kU/L±91.45kU/L) and in colorectal cancer (87.21kU/L±39.55kU/L) was significantly higher than that in the control (11.254kU/L±6.00kU/L). Compared with the normal adults, the CA19-9 level was much higher in pancreatic cancer patients (1266.58kU/L±521.31kU/L) (P＜0.01). However, the CA19-9 concentrations in non recurrent gastric (12.63kU/L±3.62kU/L) and colorectal cancers (14.14kU/L±3.26kU/L) and benign disorders (14.23kU/L±2.60kU/L) were similar to the control. The differences were not statistically significant (P＞0.05). The demarcation value of CA19-9 between the negative and positive was ＜31.0kU/L. The sensitivity of CA19-9 for gastric, colorectal, pancreatic and esophageal cancers and gastrointestinal benign disorders was 47.3%, 50.0%, 83.3%, 20.0% and 0%, respectively. The specificity of CA19-9 for digestive system malignant diseases was all 100%.
CA19-9 antigen isolated by Koprowski and co-workers［1］in 1979, is a lacto N-fucopentaose Ⅱ like substance and one of the tumorassociated antigens present in serum in the mucin fraction. Close attention has been paid to the role of CA19-9 in the diagnosis of digestive tract tumors［2,3］. After strictly inspecting the quality of CA19-9 antigen kit, we assayed serum CA19-9 levels in 207 patients with gastrointestinal diseases and 111 normal adults as control. The aim of this study is to evaluate the clinical significance of CA19-9 in diagnosis of digestive tract tumors.
MATERIALS AND METHODS
CA19-9 McAb solid phase IRMA kit (Tianjin SYTRON Biotech Inc.) FT-613 automatic counter of 125I radioimmunoassay (Beijing)
Normal CA19-9 value
We determined CA19-9 concentration in the sera of 111 normal adults
Serum samples were obtained from 207 patients with malignant and benign diseases
The mean serum CA19-9 concentration in 111 normal adults from Guangzhou area was 11.254kU/L±6.006kU/L. The difference of CA19-9 value among normal adults has no statistically significance with age and sex (P＞0.05). The demarcation value of CA19-9 between the negative and positive was ＜31.0kU/L in our laboratory. The serum CA19-9 concentrations in patients with malignant and benign diseases are listed in Table 1. Table 2 shows the evaluational indexes of CA19-9 in diagnosing some of the gastrointestinal tumors.
Table 1 Serum CA19-9 concentration in patients and normal adults
vs normal adults, bP＜0.01
vs normal adults; P.R=positive rate.
Table 2 The evaluational indexes in diagnosis of gastrointestinal benign and malignant diseases with CA19-9
|Preoperation and recurrence||55||26||47.3||100.0||65.9||100.0||50.8|
|Preoperation and recurrence||66||33||50.0||100.0||65.6||100.0||47.6|
|GI benign disorders||30||0||0.0||100.0||78.7||787|
Sensitivity, Sp: Specificity, Ac: Accuracy, +PV: Positive predictive value, －PV:
Negative predictive value.
We have determined the normal referential value of CA19-9 (11.254kU/L±6.006kU/L) with solid phase IRMA kit (Tianjin SYTRON) in 111 normal adults from Guangzhou area. This result was similar to the results tested with solid phase radioimmunoassay kits of Abbott Company and ORIS Company, (France). The demarcation value of CA19-9 between the negative and positive was ＜31.0kU/L. This value was a little lower than that provided by the kit (＜34.0kU/L).
The results showed that the serum CA19-9 levels in the patients with gastric cancer (55), colorectal cancer (66) and some postoperatively recurrent cancer were significantly higher than those of normal adults. The sensitivity of CA19-9 in diagnosing gastric and co-lorectal- cancers was 47.7% and 50.0% and the specificity and positive predictive value were all 100%. None of the 30 patients with benign disorders of gastrointestinal tract had a higher serum CA19-9 level than the normal referential value. The sensitivity and specifity of CA19-9for benign disorders were 0% and 100%, respectively. This indicated that CA19-9 is a high specific tumor marker in diagnosing gastric and colorectal cancers, and will play an important role in the differentiation of benign and malignant diseases of digestive tract.
It is worth notice that of 39 patients with gastric cancer or co-lorectal-cancer who had no recurrent tumor postoperatively, no one had a higher CA19-9 level than normal referenial value. The mean value of CA19-9 of the 39 patients was similar to the normal ref
Elevated serum CA19-9 levels have been found in many different malignant diseases. The test seems expecially promising for detection of pancreatic cancer, as more than 80% of these patients showed increased serum CA19-9 concentration［4,5］, therefore it may be a good tumor marker in diagnosing pancreatic cancer and monitoring the patients treated surgically［6］. We assayed the CA19-9 levels in patients with pancreatic cancer, and the serum CA19-9 concentration was ＞85kU/L in 6 ＞110kU/L in 5 patients, ＞1900kU/L in 3 patients and 3200kU/L in one patient. The sensitivity, speciticity, accuracy, positive and negative predictive values were 83.3%, 100%, 97.3%, 100%, 96.8%, respectively.
The incidence of pancreatic cancer is increasing worldwide. The Japanese Cancer Register in 1987 reported that the 5-year survival rates in 177 resected cases of T1 stage, 783 resected cases of T2 stage, 463 resected cases of T3 stage and 304 resected cases of T4 stage cancer were 39.8%, 21.7%, 14.3% and 13.4% respectively［7］. These results indicate that it is important to diagnose early stage pancreatic cancer so as to improve the prognosis. However, by the current diagnostic methods, it is difficult to diagnose pancreatic cancer in early stage, and to distinguish it from benign condition which resembles pancreatic cancer in many aspects. Although only 7 patients with pancreatic cancer received the CA19-9 test in this study, the results still showed that the CA19-9 test seems to be a useful additional tool in the diagnosis of pancreatic cancer.
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(CAa-a 19-9aa) in serum of patients with malignant and non-malignant diseases, comparison with carcinoembryonic antigen.
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marker in pancreatic cancer. Br J Cancer, 1986;53(2):197-202
5 tSteinberg WM, Gelfand R, Anderson KK, Glenn J, Kurtzman SH, Sindelar WF, et al. Comparison of the senstivity and specificity
of CAa-a 19-9 and Carcinoembryonic antigen assays in detecting cancer of pancreas. Gastroenterology, 1986;90(2):343-349
6 tTian FZ, Appert HE, Myles J, Howard JM. Prognostic value of serum CAa-a 19-9 levels in pancreatic adenocarcinoma.
Ann Surg, 1992;215(4):350-355
7 tJapanese Pancreas Society. Report of Japanese pancrcatic cancer register. Sendai: Japanese Pancreas Society, 1987
First Affiliated Hospital, SUN Yat
Sen University of Medical Sciences,
Guangzhou 510080, China
Correspondence to Dr. Ji Zong Zhao, male, was born on Jan. 22, 1945 in Guangzhou, graduated from Department of Laboratory Medical Sciences, Guangzhou Medical Collage, Laboratorian in Charge, engaged in laboratory diagnostic study on clinical chemistry and immunology, having 15 papers published.
Received 1996-09-06 Revised 1996-10-05