Clinical usefulness of serum sialyl SSEA-1 antigen levels in patients with epithelial ovarian cancer. Comparative effectiveness of sialyl SSEA-1 and CA 125

The serum levels of sialyl SSEA-1 antigen, a type 2 chain carbohydrate antigen detected using the monoclonal antibody FH-6, were elevated in 47.2% of patients with epithelial ovarian cancer, with the percent positivity increasing with the clinical stage. Of the histological type, it is interesting to note the relatively high sensitivity in patients with mucinous adenocarcinoma and clear cell carcinoma in contrast with the CA 125 antigen levels. Although the percentage of patients with ovarian cancer who had elevated sialyl SSEA-1 antigen levels is lower than that observed with elevated CA 125 antigen levels, the false-positive rate is significantly low in the sialyl SSEA-1 test. Serial sialyl SSEA-1 antigen levels obtained during follow-up were strong predictors of clinical outcome. The combined determination possible with sialyl SSEA-1 and CA 125 did not markedly increase the detection rate because of the overlap in the positivity. However, increased levels of both serum sialyl SSEA-1 antigen and CA 125 antigen indicated the presence of malignancies in pregnant women associated with ovarian tumors.     

Clinical use of CA 125 and its combination assay with other tumor marker in patients with ovarian carcinoma

The serum levels of CA 125 and CA 19-9 were determined by an immunoradiometric assay employing the monoclonal antibody OC 125 and anti-CA 19-9 antibody in 88 patients with ovarian carcinoma. When a cut-off value of CA 125 was set below 35 U/ml in the control group, serum elevated levels of CA 125 were found in 86.7% of the patients with surgically demonstrable ovarian serous cystadenocarcinoma, in 100% (4/4 cases) of clear-cell carcinoma, in 50% (2/4 cases) of endometrioid carcinoma, in 100% (5/5 cases) of undifferentiated carcinoma, and in 80% of the recurrent cases. Using a cut-off value of 37 U/ml, serum elevated levels of CA 19-9 were detected in 68.2% of mucinous cystadenocarcinoma, in 28.9% of serous cystadenocarcinoma, in 75% (3/4 cases) of metastatic ovarian carcinoma, and in 37.5% of the recurrent cases. A statistical analysis of the combination assay using CA 125, CA 19-9, tissue polypeptide antigen (TPA), immunosuppressive acidic protein (IAP), ferritin and CEA was carried out by multivariate method (discriminatory analysis) in 45 patients with ovarian carcinoma and 50 healthy subjects. As a result before treatment, positive rates of a single tumor marker were 79.7% with CA 125, 42.7% with CA-19-9, 73.1% with IAP, 61.7% with TPA, 64.3% with ferritin and 25.4% with CEA, respectively. A combination assay of these markers was useful for detecting identification of ovarian carcinoma, by which it gave a higher accuracy of ovarian cancer detection.     

The clinical usefulness of the measurement of serum sialyl SSEA-1 antigen levels in patients with gynecologic diseases: as respects the comparative effectiveness of sialyl SSEA-1 and CA125

Increased concentrations of serum Sialyl SSEA-1 antigen, which belongs to type 2 chain carbohydrate antigens and is defined by a new monoclonal antibody FH-6, were observed in 47.2% of patients with ovarian cancer. The Sialyl SSEA-1 test may not be of use in detecting ovarian cancer in the early stages, because the positivity gradually increased with the clinical stages. However, the measurement of the Sialyl SSEA-1 concentrations was a useful tool to use in making a prognosis. The sialyl SSEA-1 and CA125 combination test was not useful in increasing sensitivity because of overlapping of the positivity. Increases in both serum Sialyl SSEA-1 and CA125 indicated the presence of malignancies associated with ovarian tumors in pregnant women. On the other hand, the Sialyl SSEA-1 test showed significantly low false positivity for non-neoplastic diseases except endometriosis.     

The clinical value of sialyl SSEA-1 antigen in patients with gynecologic tumors

In order to estimate the clinical significance of sialyl SSEA-1 antigen, the antigen was measured with an "FH-6" Otsuka Kit in sera from patients with various gynecologic tumors. Among the patients with uterine malignancies and benign ovarian tumors, the incidence of elevated sialyl SSEA-1 antigen levels was very low. However, among the patients with ovarian malignancies, serum sialyl SSEA-1 antigen was significantly increased in the following order: clinical stage I (40%), stage II (67%) and stage III (75%). The serum antigen values were also correlated with the effect of treatment. In addition, high antigen values were also observed in all 14 malignant ovarian cyst fluids tested. The immunohistochemical localization of sialyl SSEA-1 antigen was determined by an immunoperoxidase method using FH-6 monoclonal antibody. A weak positive reaction was observed in normal glands of female genital tracts. However, the intense staining was shown on the mocus materials or on the luminal surface of some malignant glands as well as in the cytoplasm of some adenocarcinoma cells of gynecologic malignancies, although there were few positive cases or positive cells. Thus, sialyl SSEA-1 antigen appears to be a useful marker in the diagnosis of ovarian malignancies.     

Serum CA125 and CA19-9 levels in adenocarcinoma of the uterine cervix and endometrial carcinoma

The changes in serum CA125, CA19-9, CEA, Ferritin, TPA, IAP and LDH concentrations were measured in 22 primary cases and 7 recurrent cases of adenocarcinoma of the uterine cervix and endometrial carcinoma in order to examine the clinical usefullness of CA125 and CA19-9 as a tumor marker. Localization of CA125 and CA19-9 was also examined in adenocarcinoma, normal endocervix and endometrium immunohistochemically. 1. Twenty-seven percent of primary cases had increased serum CA125 and CA19-9 which decreased rapidly after operation or chemotherapy, reflecting reduction of the tumor mass. 2. In these cases, CA125 or CA19-9 was localized in carcinoma tissues immunohistochemically. On the other hand, in normal endocervical and endometrial glands, CA125 was localized, but CA19-9 was not. 3. In most recurrent cases, serum CA125 and CA19-9 increased early and markedly, compared with the other markers. 4. The change in serum Ferritin, CEA, TPA, IAP and LDH didn't reflect clinical courses such as operation and chemotherapy. In recurrent cases they increased even more slowly and slightly than CA125 or CA19-9. These results show that CA125 and CA19-9 are useful tumor markers in the management of adenocarcinoma of the uterine cervix and endometrial carcinoma, especially in advanced or recurrent cases.     

Combination assay of CA125, TPA, IAP, CEA, and ferritin in serum for ovarian cancer

The levels of CA125, TPA, IAP, CEA, and ferritin in the serum were measured simultaneously in 68 healthy nonpregnant females and 133 patients with various gynecological diseases, and were subjected to statistical discriminant analysis for the diagnosis of ovarian cancer. The usefulness and the limits for diagnosis of various gynecological diseases were investigated for each tumor marker. Also, the diagnostic usefulness of the stepwise discriminant analysis employing the values of these five tumor markers in the serum in cases of ovarian cancer was compared with that of CA125 measurements alone. Because the frequency of cases with an elevated serum CA125 level increased more specifically in the ovarian cancer group than those of other tumor makers in the serum, this parameter was considered to be more useful for the diagnosis of ovarian cancer than the levels of the other tumor markers. The frequencies of cases with the elevated serum CA125 levels, however, also increased in the groups of patients with endometriosis and at an early stage of normal pregnancy more than in the group of healthy nonpregnant females. In the ovarian cancer patients, the discriminant analysis employing the values of CA125 and four other tumor markers in sera was more useful for early diagnosis, differential diagnosis, early detection of recurrences, and the determination of complete remission after therapy than the measurement of the serum CA125 level alone.     

Serum CA 125, carcinoembryonic antigen, and CA 19-9 as tumor markers in borderline ovarian tumors

OBJECTIVES: The goals of this study were to analyze preoperative serum levels of CA 125, carcinoembryonic antigen (CEA), and CA 19-9 in patients with borderline ovarian tumors and to investigate if routine assessment of these markers in follow-up may lead to earlier detection of recurrence. METHODS: For patient identification a database was used, in which data from all patients treated for gynecologic malignancies in the Department of Gynecologic Oncology, University Hospital Groningen, The Netherlands, are compiled. Between 1982 and 1997, 44 patients with borderline ovarian tumors were identified. Clinical data and serum CA-125 and CEA levels were retrieved from the database. CA 19-9 levels were determined in retrospect in available stored preoperative (24 patients) and follow-up (43 patients) serum samples. RESULTS: Preoperative CA 125 levels were elevated in 8 of 33 (24%), CEA levels in 3 of 32 (9%), and CA 19-9 levels in 11 of 24 (46%) cases. In patients with mucinous tumors preoperative CA 19-9 was more frequently elevated (8/14, 57%) than CA 125 (3/20, 15%) (P = 0.02) or CEA (2/18, 11%) (P = 0.02). Complete follow-up serum CA 125, CEA, and CA 19-9 levels were available for 43 of 44 patients. Median follow-up was 84 months (range, 22-204). During follow-up two patients (5%) had recurrent disease. In one patient CA 125 became elevated at the time of recurrence; in the other patient (in retrospect) the CA 19-9 level did not return to normal after surgery, but kept rising, preceding clinical symptoms of recurrence for 13 months. CONCLUSIONS: If one chooses to use serum markers in follow-up of mucinous borderline ovarian tumors CA 19-9 should be included. Measurement of serum tumor markers in the follow-up of patients with borderline ovarian tumors may lead to earlier detection of recurrence in only a very small proportion of patients, while the clinical value of earlier detection of recurrence remains to be established.     

Comparison between tissue and serum content of CA 125, CA 19-9, and carcinoembryonic antigen in ovarian tumors

Tumor markers CA 125, CA 19-9, and carcinoembryonic antigen (CEA) were detected by immunohistochemistry in paraffin embedded tissue samples obtained from two different locations in 35 ovarian tumors. In addition, serum concentrations of these tumor markers were measured before cytoreductive surgery. The staining reaction was heterogeneous in different parts of the tumor as well as within the parenchyma. Of the marker positive tumors, a staining reaction was observed in both tissue samples in only 10 of 22 cases for CA 125, in eight of 13 cases for CEA, and in three of eight cases for CA 19-9. Eighty-one percent of the patients whose tumor was positive for CA 125 also showed elevated serum levels of this marker. A poor correlation was found between tissue and circulating CA 19-9 levels. CEA was detected in 28% of the tumors and seemed to be valuable only for monitoring in rare cases of ovarian cancer. For purposes of selecting a marker for monitoring of patients with ovarian carcinoma, immunohistochemistry has a predictive value for CA 125 only. In order to better define the marker expressed in a tumor, it is necessary to examine at least two samples of different parts of the malignant tissue.     

Sialyl-Tn, sialyl-Lewis Xi, CA 19-9, CA 125, carcinoembryonic antigen, and tissue polypeptide antigen in differentiating ovarian cancer from benign tumors.

Serum sialyl-Tn, sialyl-Lewis Xi, CA 19-9, CA 125, carcinoembryonic antigen (CEA), and tissue polypeptide antigen were measured in 65 women with early-stage ovarian cancer (45 stage I and 20 stage II cases) and 317 with benign pelvic masses. As a single assay, sialyl-Tn showed the best sensitivity and specificity, 46 and 92%, respectively. CA 19-9 detected the greatest number of cancer patients but had the lowest specificity. The combination of sialyl-Tn, CA 125, tissue polypeptide antigen, and CEA seemed to perform the best, with a sensitivity and specificity of 71 and 76%, respectively. The combination of sialyl-Tn, CA 125, and tissue polypeptide antigen gave similar results and may be more cost-effective. However, one-fifth of the patients with early-stage cancer still showed up as false negatives even with use of the six markers in combination. Approaches other than serum assay alone will be needed to detect all malignant pelvic masses at an early stage.     

Serum levels of six tumor markers in patients with benign and malignant gynecological disease

Summary We studied the pretreatment serum levels of 6 tumor markers in gynecological patients with and without malignant disease. The tumor markers were carcinoembryonic antigen (CEA), tissue polypeptide antigen (TPA), ferritin, Schwangerschaftsprotein 1 (SP₁), Schwangerschaftsprotein 3 (SP₃) and cancer antigen 125 (CA125). The results were as follows: (1) Serum CA125 and TPA levels were raised in 81% and 57% of patients with ovarian serous cystadenocarcinoma: CEA and SP₃, in 52% and 43% respectively of patients with ovarian mucinous cystadenocarcinoma; CA125, TPA and SP₃, in 76%, 48% and 48% respectively of patients with other ovarian malignancies; and TPA and SP₃, in 56% and 40% respectively of patients with endometrial carcinoma. (2) Serum levels of TPA, ferritin and CA125 were more often raised with advancing stages of malignant disease. (3) Serum TPA levels were elevated in 55% of patients with stage I endometrial carcinoma, and serum SP₃ levels were elevated in 35% of patients with a stage I malignant ovarian neoplasm and in 45% of patients with endometrial carcinoma. (4) One of the 6 tumor markers showed a raised level in 84% of patients with gynecologic malignancy as against 56% in those with benign gynecologic diseases.     

Diagnostic usefulness of stepwise discriminant analysis employing the values of CA125, TPA, IAP, CEA and ferritin in sera measured simultaneously for gynecological malignant neoplasms

The values for CA125, TPA, IAP, CEA, and ferritin in sera were measured simultaneously in 68 healthy nonpregnant females and 133 patients with various gynecological diseases, and examined by stepwise discriminant analysis. The usefulness and the limits for diagnosis of various gynecological diseases were investigated for each tumor marker. Also, the diagnostic usefulness of stepwise discriminant analysis employing the values for five tumor markers in sera was studied for gynecological malignancies compared with that of measuring serum CA125 alone. Because the mean values for CA125 in sera were increased specifically in the ovarian cancer patient group compared with those of other tumor markers in sera, the measurement of serum CA125 was considered to be more useful in diagnosing ovarian cancer than that of the other tumor markers. The mean values for CA125 in sera, however, were also increased more significantly in the groups of patients with endometriosis and normal pregnancies than in the group of healthy nonpregnant females (p less than 0.005). In the stepwise discriminant analysis employing the values for CA125 and four other tumor markers in sera, the diagnostic usefulness of each tumor marker was demonstrated in the early diagnosis, the differential diagnosis, and the determination of complete remission after several therapies for ovarian cancers.     

Serum CA125 in malignant ovarian tumor--periodical monitoring and correlation with other tumor markers

CA125 is a new unique tumor marker for epithelial ovarian cancer, and its clinical use has recently increased considerably. We have periodically monitored 14 cases of ovarian cancer (7 cases of serous cystadenocarcinoma, 4 cases of clear cell carcinoma, 1 case of endometrioid carcinoma and 1 case of metastatic ovarian cancer) using CA125, before and after surgery, during chemotherapy, and in follow-up. The serum CA125 was measured with a radioimmunoassay kit. As a result of this monitoring, we have discovered the following facts: The ten cases in which the titer of CA125 dropped to 35U/ml, which is cut off, by 60 days after surgery, when we had finished 2 courses of chemotherapy, showed good progress. In contrast to this, in the other cases, the degree of CA125 was still high 60 days after the surgery and did not drop after that. In these 4 cases, the tumor growth was found. It was therefore concluded that with this method a prognosis could be made much earlier than with the current system, and that relapse could be detected far earlier. We have also examined the mutual relations between CA125 and other tumor markers, IAP, TPA, HBDH, CEA, Ferritin, alpha 1AT, ESR, and LDH. Although we could see some usefulness in periodic monitoring with IAP, unlike CA125 it did not reflect the condition of a disease. The coefficients of correlations between CA125 and other tumor markers are as follows: IAP 0.5268, TPA 0.4541, HBDH 0.4551, CEA 0.2942, Ferritin -0.1005, alpha 1AT 0.5321, ESR -0.0619, LDH 0.5994.(ABSTRACT TRUNCATED AT 250 WORDS)     

术前测定血清CA125、CA199、CA724、CEA和GM-CSF在鉴别附件包块性质中的作用

探讨术前测定患者血清CA12 5、CA19 9、CA72 4、CEA和GM -CSF水平在鉴别附件包块良恶性质中的作用。方法 :74例附件包块患者术前 1周内采外周血 ,用固相免疫放射法测定各种肿瘤标志物浓度 ,并与术后组织学诊断比较。计算各标志物单独和联合应用诊断卵巢癌的相应诊断参数。结果 :( 1)CA12 5(临界值 70U/ml)鉴别卵巢肿瘤性质的敏感性和特异性分别为 85 71%和 82 61% ,CA19 9(临界值 30U/ml)分别为 4 2 86%和 73 33% ,CA72 4 (临界值 3 8U/ml)分别为 53 57%和 90 90 % ,CEA(临界值 5ng/ml)分别为 4 6 4 3%和 4 8 89% ;( 2 )联合应用肿瘤标志物 :CA12 5联合CA19 9的敏感性和特异性分别为 89 2 9%和 73 33% ;CA12 5联合CA72 4的敏感性和特异性分别为 89 2 9%和 75 56% ;CA12 5联合CEA的敏感性和特异性分别为 92 86%和 4 0 0 0 % ;( 3)如果去除 9例子宫内膜异位症 ,CA12 5、CA19 9、CA72 4和CEA的特异性分别增至 89 19% ,80 55% ,94 2 9%和4 7 2 2 %。结论 :此项研究应用的肿瘤标志物中以CA12 5最为敏感。将CA12 5临界值定为 70U/ml时诊断效果最佳。CA72 4的特异性最高 ,但诊断卵巢癌的敏感性低。CEA的诊断价值有限 ,GM -CSF则无价值。CA12 5与其他肿瘤标志物联合检测时诊断的特异性会部分丧失。?     

Differential diagnosis of ovarian cancer, benign ovarian tumor and endometriosis by a combination assay of serum sialyl SSEA-1 antigen and CA125 levels

We used a combination assay of serum sialyl SSEA-1 antigen (SLX) and CA125 levels, and evaluated the clinical usefulness of this technique for a differential diagnosis of ovarian cancer, benign ovarian tumor and endometriosis. In 82 patients with ovarian tumors, the sera of 20 (64.5%) of 31 with ovarian cancer and 15 (48.4%) of the 31 with endometriosis (endometrial cyst) were positive for both SLX and CA125, but serum SLX level was 5 U/ml or less in these 14 SLX- and CA125-positive patients with endometriosis. The sera of 16 (80.0%) patients with benign ovarian tumor were negative for both tumor markers. The sera of 3 (9.7%) of 31 with ovarian cancer and the sera of 2 (6.5%) of 31 with endometriosis were negative for both markers. The diagnostic accuracy (true positive rate X true negative rate) of the combination assay for ovarian cancer was 49.0% when the cutoff value of the serum SLX was 38 U/ml but improved to 78.5% when the value was set at 50 U/ml. When the cutoff value of serum SLX was set at 50 U/ml and that of serum CA125 at 35 U/ml, 27 of 37 patients who were positive only for CA125 had endometriosis. From the above observations, a combination assay of serum SLX and CA125 is a promising method for the differential diagnosis of malignant and benign ovarian tumors. Our results also suggest that to improve the diagnostic accuracy, the cutoff value of the serum SLX level should be 50 U/ml for ovarian tumors alone.     

Monitoring human ovarian carcinoma with a combination of CA 125, CA 19-9, and carcinoembryonic antigen

CA 125 and CA 19-9 are antigenic determinants associated with human epithelial ovarian carcinomas. Murine monoclonal antibodies have been raised against these determinants, and immunoradiometric assays have been developed to monitor antigen levels in the serum of cancer patients. This study was undertaken to determine whether concomitant measurement of CA 125, CA 19-9, and carcinoembryonic antigen would provide a more precise correlation with tumor progression or regression than could be obtained with any single assay. Among 105 patients with surgically demonstrable epithelial ovarian carcinoma, serum CA 125 levels were elevated (greater than 35 U/ml) in 83%, CA 19-9, levels (greater than 37 U/ml) in 17%, and carcinoembryonic antigen levels (greater than or equal to 2.5 ng/ml) in 37%. Within individual samples, no correlation was found among values for the three markers, but patients with elevated CA 19-9 levels also had increased levels of CA 125. At least one of the three markers was elevated in 90% of the subjects. When 41 patients were monitored serially over 2 to 60 months, alterations in CA 125 levels correlated with disease progression or regression in 94% of instances, whereas alterations in CA 19-9 levels correlated in 33% and alterations in carcinoembryonic antigen levels in 25% of instances. Concomitant measurement of CA 125, CA 19-9, and carcinoembryonic antigen did not prove superior to measurement of CA 125 alone in the monitoring of patients with epithelial ovarian carcinoma.     

CA125 expression at clinical diagnosis by ovarian carcinoma not detected through antecedent serum CA125 screening

At the time of clinical presentation with ovarian carcinoma, 85% of women have an elevated serum level of the CA125 antigen, but the duration of the preclinical phase of expression of CA125 is unknown. From the database of The Royal London Hospital ovarian cancer screening project, 19 women were identified who had a serum CA125 level <30 IU ml⁻¹, measured between 2 and 24 months prior to their clinical diagnosis of ovarian cancer. Histological sections of tumor removed from these women were reviewed. In 17 cases tumor tissue was immunocytochemically stained for CA125 expression. Tumor blocks of 40 women presenting clinically with ovarian cancer with known preoperative CA125 levels were also stained for CA125 expression. The serum CA125 level at the time of diagnosis was available in six of the 19 screening study cases, four of which had levels> 30 IU ml⁻¹. In five of the 13 cases with unknown serum CA125 levels, ovarian tumor tissue expressed CA125. Among the 40 controls, 24 tumors expressed CA125 and all 24 had a serum level greater than 47 IU ml⁻¹. An annual screening test using serum levels of CA125 at a cut-off of 30 IU ml⁻¹, cannot detect all cases of ovarian cancer that express the antigen at the time of clinical diagnosis. The development of a panel of complementary tumor markers will be necessary to provide a test with a higher sensitivity for the detection of preclinical ovarian cancer.     

Comparison between serum CA 125 and CA 19-9 assays and tissular OC 125 and 1116NS 19-9 reactivity in malignant and benign ovarian tumors.

This preliminary study included 25 patients with primary epithelial ovarian cancer (EOC) (18 serous, 3 serous-mucinous, 1 endometrioid, 2 undifferentiated carcinomas and 1 malignant Brenner carcinoma); 2 patients with borderline ovarian tumors and 20 patients with benign ovarian tumors (9 benign cystic teratomas, 6 serous cystoadenomas and 5 mucinous cystoadenomas). Blood samples for the measurement of CA 125 and CA 19-9 were drawn from all patients before surgery. Serum CA 125 (Reference Value-RV = 65 U/ml) and CA 19-9 (RV = 40 U/ml) were measured with IRMAs using the monoclonal antibodies (MoAbs) OC 125 and 1116NS 19-9. The same antigens were detected on paraffin-embedded tissue sections by immunocytochemistry with the avidin-biotin complex method employing the same MoAbs used for serum IRMAs. Among the 25 patients with EOC serum CA 125 levels were elevated in 20: tissular OC 125 reactivity was observed in 15 (75%) of them. Of the 5 EOC patients with normal CA 125 levels, 4 showed OC 125 reactivity. Only 2 of the 25 EOC patients had elevated serum CA 19-9 levels: one of them had tissular 1116 NS 19-9 reactivity. Among the 23 patients with normal serum CA 19-9 levels only 5 had immunocytochemical reactivity for this antigen. The 2 patients with borderline ovarian tumors had negative serum CA 125 and CA 19-9 assay: tissular OC 125 reactivity was observed in both patients, while 1116 NS 19-9 reactivity was detected in only one.(ABSTRACT TRUNCATED AT 250 WORDS)     

Clinical value of sialyl SSEA-1 antigen in patients with ovarian cancer

The efficacy of sialyl SSEA-1 antigen (SLX), a tumor-associated carbohydrate antigen, as a test for gynecological cancer was investigated. The test was found to be positive in 64.5% of all patients with ovarian cancers; this rate is lower than that obtained with CA 125. On the other hand, relatively few false-positive results were observed. Tests were false-positive in 25.0% of patients with endometrial cysts; 25.0% of women in the first trimester of pregnancy and 0.0% of menstruating woman had false-positive results. These percentages were lower than those for CA 125. It is concluded that SLX is a tumor marker with inferior sensitivity and high specificity, compared with CA 125. Since positive tests with SLX in patients with ovarian cancer mostly overlapped the positive tests for CA 125, the usefulness of a combination assay was considered to be low. The SLX test was positive in 18.6 and 25.0% of patients with cervical cancer and endometrial cancer, respectively, and it was concluded that SLX is useless as a serum tumor marker for uterine cancer.     

CA 125, placental alkaline phosphatase, and tissue polypeptide antigen in the monitoring of ovarian carcinoma. A comparative study of three different tumor markers

Three different tumor markers, placental alkaline phosphatase (PLAP), tissue polypeptide antigen (TPA), and cancer antigen 125 (CA 125), were measured in serum samples obtained during chemotherapy in 57 ovarian carcinoma patients. At the start of chemotherapy, 37, 63, and 77% had elevated serum values of PLAP, TPA, and CA 125, respectively. During chemotherapy, changing PLAP serum levels reflected disease regression and, later, progression in only 2 patients. TPA serum levels reflected the disease course in 15 patients and CA 125 in 28 patients. Rising CA 125 values predicted disease progression in 12 patients for a median of 2 months. At second-look laparotomy, all 11 patients with pathological complete response were marker negative. In the remaining 46 patients with residual or progressive disease, 27, 50, and 61% had elevated serum levels of PLAP, TPA, and CA 125, respectively. None of the markers reflected microscopic disease or pure carcinomatosis. For management decisions, CA 125 was clearly the most useful of the markers. In this study no further information was gained from the other two markers.     

Assessment of biological variation and analytical imprecision of CA 125, CEA, and TPA in relation to monitoring of ovarian cancer.

OBJECTIVES: Changes in serial tumor marker results during monitoring of patients with ovarian cancer are due not only to deterioration or amelioration of the patient's condition, but also to preanalytical sources of variation (CPP), total random analytical error, and within-subject normal biological variation. The aim of the study was to assess (i) the analytical imprecision (CVA) and the average inherent intra- and interindividual biological variation (CVTI and CVG, respectively) for CA 125, CEA, and TPA in a group of healthy women; (ii) the significance of changes in serial results of each marker; and (iii) the index of individuality. METHODS: The study group consisted of 31 healthy women. Sixteen blood samples from each subject were collected in four series over a period of approximately 1 year. Data analysis was based on ANOVA. The index of individuality was calculated as ((CV2A + CV2TI)/CV2G)1/2 and the critical difference for a change between two consecutive concentrations as radical2xZx(CV2P + CV2A + CV2TI)1/2 (Z = 1.65 for unidirectional and 1.96 for bidirectional changes, P 相似文献