Diagnostic performance of a new highly sensitive thyroglobulin immunoassay.

The determination of serum thyroglobulin (Tg) is commonly used for detecting the presence of residual thyroid tissue or cancer recurrence in patients treated for differentiated thyroid cancer (DTC). The aim of the study was to evaluate the performance characteristics of a recently introduced fully automated chemiluminescent immunoassay, based on four monoclonal antibodies and which produces results in 40 min. Analytical sensitivity (0.01 micro g/l) was computed from 20 replicates of the zero calibrator and of the 'Tg-free' sample pool. Functional sensitivity (0.1 micro g/l at 20 coefficients of variation percent) was determined from the imprecision profile obtained by assaying ten serum pools. The reliability of the measurements in the low concentration range (Tg<1 micro g/l) has been checked by progressive dilution with the 'Tg-free' serum of a sample pool at 5.27 micro g/l; measured values were very close to the expected values (recovery 100-133%).Cut-off at the 99th percentile in DTC stage I 'disease-free' treated patients (n=53) was 0.16 micro g/l. Tg measurement in basal conditions during L-thyroxine suppression therapy and 5 days after recombinant human TSH stimulation was performed in 22 patients with DTC. In 80% of patients with basal Tg<0.1 micro g/l (12/15), Tg remained<0.1 micro g/l after stimulation, and in all of these Tg was<1 micro g/l. Our results have indicated the optimal analytical and clinical performance of this Tg immunoassay and encourage further studies on larger populations of patients with DTC.

Serum preoperative vascular endothelial growth factor (VEGF) in epithelial ovarian cancer: relationship with prognostic variables and clinical outcome.

Substantial experimental and clinical evidence links tumor growth, progression and metastatic potential with neoangiogenesis. This process is modulated by several angiogenic growth factors, such as vascular endothelial growth factor (VEGF). Little data are currently available on serum VEGF levels in cancer patients. In the present retrospective investigation preoperative serum VEGF was higher in 53 patients with epithelial ovarian cancer than in 25 patients with benign ovarian disease as controls (median, range: 229.7, 23.5-1807.5 pg/ml versus 140.3, 14.7-1038.7 pg/ml, p = 0.034). With regard to FIGO stage, antigen values were significantly elevated in stage III-IV (p = 0.027) but not in stage I-II ovarian cancer patients when compared to controls. In patients with advanced disease preoperative serum VEGE was significantly related to the presence of ascites (p = 0.013), but not to common prognostic variables, response to chemotherapy and survival. In conclusion, preoperative serum VEGF assay reflects tumor progression and ascites generation in epithelial ovarian cancer, but it seems to have a limited predictive and prognostic value in patients with advanced disease.

Preoperative serum E-cadherin assay in patients with ovarian carcinoma.

E-cadherin is a 120-kDa transmembrane glycoprotein involved in the calcium dependent adhesion of epithelial cells. Soluble E-cadherin fragment levels have been found to be significantly elevated in patients with different malignancies when compared to healthy controls (Katayama M. et al. Br. J. Cancer 69, 580-585, 1994). The aim of this paper was to assess the clinical relevance of preoperative serum E-cadherin assay in patients with ovarian carcinoma. E-cadherin was measured with a solid phase enzyme immunoassay based on a sandwich method using two mouse monoclonal anti-human E-cadherin antibodies. Preoperative serum E-cadherin levels were higher in 55 patients with ovarian carcinoma than in 31 patients with benign ovarian disease as controls, even though the difference did not reach the statistical significance (median value, range: 6615 ng/ml, 444-26,092 ng/ml versus 5531 ng/ml, 1548-12668 ng/ml, p = 0.063). However, the subset of the 36 patients with FIGO stage III-IV ovarian carcinoma had significantly higher antigen levels (median value, range: 7205 ng/ml, 444-26,092 ng/ml) when compared to controls (p = 0.039). Among patients with advanced ovarian carcinoma, preoperative serum E-cadherin correlated neither with the common clinico-pathological prognostic variables nor with the response to chemotherapy and survival. Our data seem to show that the preoperative serum E-cadherin assay does not offer useful clinical information for the management of patients with ovarian carcinoma.

Assessment of the prognostic relevance of serum anti-p53 antibodies in epithelial ovarian cancer.

The objective of this study was to assess the prognostic relevance of preoperative serum anti-p53 antibodies in epithelial ovarian cancer. These autoantibodies were detected with a new generation enzyme-linked immunosorbent assay in blood samples preoperatively drawn from 86 patients with this malignancy. Serum anti-p53 antibodies were found in 3 (10.0%) of the 30 patients with stage I-II and 15 (26.8%) of the 56 patients with stage III-IV epithelial ovarian cancer (P = 0.09). We assessed in detail 44 patients with stage III-IV disease who underwent six cycles of first-line platinum-based chemotherapy. A pathological complete response at second-look was achieved by none of the 15 patients with serum anti-p53 antibodies compared to 24.1% of the 29 patients without autoantibodies (P = 0.09). However, the preoperative serum anti-p53 antibody status had no prognostic relevance for progression-free survival and survival. In conclusion, the assessment of preoperative serum anti-p53 antibodies seems to have a limited clinical value in the management of patients with advanced epithelial ovarian cancer.

Serum anti-p53 antibodies in the follow-up of patients with advanced ovarian carcinoma.

Serum anti-p53 antibodies have been detected in different human malignancies, including ovarian carcinoma. In the present investigation these autoantibodies were retrospectively measured with a new ELISA (Immunotech, Marseilles, France) before first surgery and subsequently at different times during the course of disease from 40 patients with advanced ovarian carcinoma. Anti-p53 antibodies were preoperatively found in 15 (37.5%) patients. With regard to the follow-up of these 15 patients, anti-p53 antibodies were detected in 87.8% of the 41 samples drawn when there was clinical evidence of disease compared to 57.1% of the 14 samples collected when there was no clinical evidence of tumor (p = 0.037). As for the 25 patients whose serum originally scored negative, the autoantibodies were found only in 1.8% of the 113 samples obtained during the follow-up, independently of the status of disease. In conclusion, anti-p53 antibodies are often detected in serum from patients with advanced ovarian carcinoma. However, the serial measurement of these autoantibodies does not seem to give useful clinical information for the follow-up of these patients.

Serum macrophage colony-stimulating factor (M-CSF) levels in patients with epithelial ovarian cancer.

The preoperative macrophage colony-stimulating factor (M-CSF) levels were measured in serum samples from 56 patients with epithelial ovarian cancer and 68 patients with benign ovarian disease who had undergone laparotomy. M-CSF values were significantly higher in the former (median, range: 2.18, 0.70-10.00 ng/ml versus 1.19, 0.17-5.54 ng/ml, P < 0.0001), and were not significantly related to stage, histology, grade of differentiation, age, and residual disease after first surgery. M-CSF concentrations were also measured in 163 serum samples drawn from patients with stage III-IV epithelial ovarian cancer at different times since the first surgery. M-CSF values were higher in the 81 samples from patients with clinically evident disease than in the 82 samples from patients with no clinical evidence of disease (median, range: 2.13, 0.60-10.00 ng/ml versus 1.05, 0.40-10.00 ng/ml, P < 0.0001). M-CSF levels before second-look laparotomy were similar in the 18 patients who showed persistent disease at surgical reevaluation and in the 11 patients who achieved pathological complete response (median, range: 1.26, 0.70-3.27 ng/ml versus 0.94, 0.46-4.23 ng/ml, P = NS). M-CSF concentrations were raised (> or = 1.70 ng/ml) only in 1 (14.3%) of the 7 samples from patients with clinically evident disease and serum CA125 < 35 U/ml, and only in 5 (38.5%) of the 13 samples from patients with positive second-look findings and serum CA125 < 35 U/ml. In conclusion, serum M-CSF levels correlated with the clinical status of disease in patients with epithelial ovarian cancer. However, the concomitant determination of serum M-CSF seems to add little to the CA125 assay alone in the monitoring of patients with this malignancy.

The serum assay of soluble CD44 standard (sCD44-st), CD44 splice variant 5 (sCD44-v5), and CD44 splice variant 6 (sCD44-v6) in patients with cervical cancer.

The pretreatment serum levels of soluble CD44 standard (sCD44st), CD44 splice variant 5 (sCD44-v5), and CD44 splice variant 6 (sCD44-v6) were retrospectively measured in 37 patients with untreated cervical cancer and in 36 patients with benign gynecological diseases as controls. Median sCD44-st levels were significantly higher in patients with cervical cancer than in controls (547 ng/ml, range 244-880 ng/ml versus 400.5 ng/ml, range 217-723 ng/ml, p = 0.004), whereas sCD44-v5 and sCD44-v6 concentrations were significantly lower in the former (34 ng/ml, range 0-140 ng/ml versus 44 ng/ml, range 11-109 ng/ml, p = 0.038; and 37 ng/ml, range 1-191 ng/ml versus 52.5 ng/ml, range 11-173 ng/ml, p = 0.007, respectively). sCD44-st, sCD44-v5, and sCD44-v6 levels were not related to FIGO stage and histologic type. Moreover, among patients with stage Ib-IIa cervical cancer, the preoperative levels of these glycoproteins correlated with neither the common prognostic variables nor the clinical outcome. Therefore, the serum assay of sCD44-st, sCD44-v5, and sCD44-v6 seems to have no clinical relevance for the management of patients with cervical cancer.

Serum assay of soluble CD44 standard (sCD44-st), CD44 splice variant v5 (sCD44-v5), and CD44 splice variant v6 (sCD44-v6) in patients with epithelial ovarian cancer.

Different variants of the cell adhesion molecule CD44 have been involved in malignant transformation and cancer metastasis. In the present investigation we assessed the preoperative serum levels of soluble CD44 standard (sCD44-st), sCD44 splice variant 5 (sCD44-v5), and sCD44 splice variant 6 (sCD44-v6) in 51 patients with ovarian cancer. Median preoperative sCD44-st, sCD44v5, and sCD44-v6 levels were 417 ng/ml (range, 240- > 602 ng/ml), 78 ng/ml (range, 5-314 ng/ml), and 86 ng/ml (range, 1-243 ng/ml), respectively. No significant relationship was detected between sCD44-st concentrations and the common clinicopathological variables. Conversely, sCD44-v5 and sCD44-v6 levels were significantly lower in FIGO stage III-IV than in stage I disease (p < 0.0001 and p = 0.001, respectively). Moreover, with regard to advanced ovarian cancer, sCD44-v5 levels were lower in patients with poorly differentiated (G3) than in those with moderately (G2) or well (G1) differentiated tumors (p = 0.038), as well as in patients whose residual disease was > 2 cm than in those with smaller residuum (p = 0.025). Similarly, sCD44-v6 levels were lower in patients with large residual disease (p = 0.05). The median value of serum sCD44-v6 was lower in patients with G3 than in those with G1-G2 tumor, but the difference was not significant. In conclusion, sCD44-st, sCD44-v5, and sCD44-v6 are detectable in sera from patients with epithelial ovarian cancer. A reduction in preoperative sCD44-v5 and sCD44-v6 levels seems to be associated with advanced, poorly differentiated tumors and with large residual disease after first surgery, and it might reflect an increased biological aggressiveness of the malignancy.

Preoperative serum antibodies against the p53 protein in patients with ovarian and endometrial cancer.

Antibodies against the p53 protein were measured with a sandwich-type enzyme-linked immunosorbent assay in blood samples preoperatively collected from 30 patients with ovarian cancer and 30 patients with endometrial cancer. Anti-p53 antibodies were detected in 33.3% of patients with ovarian cancer, comprising 22.2% of the 9 patients with stage I-II disease, 30.8% of the 13 patients with stage III disease, and 50.0% of the 8 patients with stage IV disease. Anti-p53 antibodies were found in none of the 4 patients with well differentiated tumors and in 38.5% of the 26 patients with moderately or poorly differentiated tumors. Among the 21 patients with stage III-IV disease, a complete clinical response to front-line platinum-based chemotherapy was obtained by 46.2% of the 13 patients without anti-p53 antibodies and 25.0% of the 8 patients with anti-p53 antibodies. Antibodies against the p53 protein were detected in only 6.7% of patients with endometrial cancer. The low incidence of anti-p53 antibodies in patients with endometrial cancer seems to suggest that the serum assay of these autoantibodies has a limited clinical relevance in the management of this malignancy. On the other hand in patients with ovarian cancer the incidence of serum anti-p53 antibodies is relatively high, and, moreover, it seems to increase with tumor stage and grade and seems to be associated with a lower response rate to chemotherapy. However, the small number of patients did not allow us to obtain statistically significant differences.

Serum levels of soluble receptors for tumor necrosis factor (p55 and p75 sTNFr) in endometrial cancer.

The pretreatment serum levels of the soluble receptors for tumor necrosis factor (p55 and p75 sTNFr) were retrospectively measured in 38 patients with endometrial cancer and 55 patients with benign uterine diseases as controls. Serum p55 and p75 sTNFr levels were significantly higher in patients with endometrial cancer (median = 2.4 ng/ml, range = 1.4-6.8 ng/ml, and median = 7.1 ng/ml, range = 2.5-19.5 ng/ml, respectively) than in controls (median = 1.7 ng/ml, range = 0.5-4.0 ng/ml, p < 0.0001, and median = 5.2 ng/ml, range = 2.6-21.9 ng/ml, p = 0.03, respectively). In the former, serum p55 and p75 sTNFr values correlated with the extent of disease (stage III-IV versus I-II: p = 0.04 and p = 0.03, respectively). Among the 23 patients with stage I endometrial cancer who underwent initial surgery, the preoperative serum levels of both receptors correlated with the histologic grade and myometrial invasion but not with the clinical outcome. In conclusion, a stage-dependent release of the soluble receptors for TNF into the bloodstream occurs in patients with endometrial cancer.

Serum levels of soluble receptors for tumor necrosis factor (p55 and p75 sTNFr) in patients with cervical cancer.

The pretreatment serum levels of the soluble receptors for tumor necrosis factor (p55 and p75 sTNFr) were retrospectively measured in 54 patients with cervical cancer and in 55 patients with benign uterine disease as controls. Serum mean (+/- standard deviation) concentrations of both p55 and p75 sTNFr were higher in patients with cervical cancer than in controls (2.6+/-1.3 vs 1.9+/-0.7 ng/ml, p<0.0001, and, respectively, 7.8+/-4.3 vs 5.9+/-3.0 ng/ml, p=0.009). Both receptor levels were significantly higher in patients with stage IIb-IV than in those with stage I-IIa cervical cancer or with cervical intraepithelial neoplasia (CIN) 3. Among the 31 patients with stage I-IIa disease who underwent initial surgery, the preoperative serum p55 and p75 sTNFr values correlated neither with the common prognostic variables nor with the clinical outcome. In conclusion, serum p55 and p75 sTNFr levels are significantly elevated in patients with cervical cancer. However, the serum measurement of these soluble receptors seems to be of limited clinical value for the management of patients with this malignancy.

Preoperative serum intercellular adhesion molecule-1 (ICAM-1) and E-selectin (endothelial cell leukocyte adhesion molecule, ELAM-1) in patients with epithelial ovarian cancer.

The serum levels of intercellular adhesion molecule-1 (ICAM-1) and E-Selectin (endothelial cell leukocyte adhesion molecule, ELAM-1) were retrospectively measured in serum samples drawn at diagnosis from 66 patients with epithelial ovarian cancer and 128 patients with benign ovarian masses. The preoperative serum ICAM-1 levels were higher in the former group (p < 0.0001), while serum E-Selectin concentrations were similar in the two groups (p = NS). Among patients with epithelial ovarian cancer, neither serum ICAM-1 nor E-selectin levels correlated with FIGO stage and with histologic type. The serum assay of ICAM-1 and E-Selectin seems to have limited value in the management of patients with epithelial ovarian cancer.

Serum levels of tumor necrosis factor (TNF), soluble receptors for TNF (55- and 75-kDa sTNFr), and soluble CD14 (sCD14) in epithelial ovarian cancer.

The preoperative serum levels of tumor necrosis factor (TNF), soluble receptors for TNF (55- and 75-kDa sTNFr), and soluble CD14 (sCD14) were retrospectively measured in 66 patients with epithelial ovarian cancer and in 59 patients with benign ovarian masses. The preoperative serum TNF and sCD14 levels were higher in patients with epithelial ovarian cancer than in those with benign ovarian disease (P = 0.001 and P < 0.0001, respectively). Among patients with advanced malignancy, preoperative serum TNF and sCD14 correlated with neither the common prognostic variables nor the clinical outcome of patients. The preoperative serum 55- and 75-kDa sTNFr levels were higher in patients with epithelial ovarian cancer than in those with benign ovarian disease (P < 0.0001 and P = 0.02, respectively). Among patients with advanced malignancy, preoperative serum 55- and 75-kDa sTNFr correlated with FIGO stage (IV vs III, P = 0.008 and P = 0.01, respectively) and with the clinical outcome of patients. Among patients followed after surgery and chemotherapy for advanced epithelial ovarian cancer, 55- and 75-kDa sTNFr levels were significantly higher in the samples drawn from patients with clinical evidence of disease when compared to those from patients without clinical evidence of disease; conversely, TNF and sCD14 levels were similar in the two groups. In conclusion, the preoperative serum levels of TNF, 55- and 75-kDa sTNFr, and sCD14 were significantly higher in patients with epithelial ovarian cancer than in those with benign ovarian disease. The measurement of serum TNF and sCD14 seemed to be of limited clinical value for the management of patients with advanced epithelial ovarian cancer. Conversely, the assay of serum 55- and 75-kDa sTNFr might have a potential clinical relevance, for both prognostic purposes and assessment of disease status.

Determination of serum levels of different cytokeratins in patients with uterine malignancies.

Tissue polypeptide antigen (TPA), TPS, Cyfra 21-1, Cytokeratins 8-18 (CTKRS 8-18), SCC and CA 125 were measured in blood samples drawn at diagnosis from 43 patients with endometrial cancer, 47 with cervical cancer, 11 with cervical intraepithelial neoplasia (CIN), and 236 with benign uterine disease as controls. The cut-off values for all antigens were chosen at the 95th percentile of the standard Gaussian variate of controls; these limits were 98 U/L for TPA, 127 U/L for TPS, 1.6 ng/mL for Cyfra 21-1, 1.2 ng/mL for CTKRS 8-18, 48 U/mL for CA 125, and 2.8 ng/mL for SCC. TPA had the same sensitivity as SCC for squamous cell carcinoma of the cervix (42%) and a higher sensitivity than CA 125 for endometrial cancer (40% vs 12% respectively). TPA was more sensitive than TPS for both cervical (40% vs 13%) and endometrial cancer (40% vs 21%). TPA and SCC had a higher sensitivity than Cyfra 21-1 (34%) and CTKRS 8-18 (27%) for squamous cell carcinoma of the cervix. In conclusion, as for soluble cytokeratin fragments, the serum TPA seems to be the most reliable marker for the management of cervical and endometrial cancer.

Serum interleukin-6 levels in uterine malignancies. Preliminary data.

Interleukin-6 (IL-6) was measured with an enzyme-immunoassay in blood samples drawn at diagnosis from 37 patients with endometrial cancer, 36 with cervical cancer, 9 with cervical intraepithelial neoplasia (CIN) and 68 with benign uterine disease. The minimal detectable dose of IL-6 was 3 pg/mL. Detectable serum IL-6 levels were found in 9% of patients with benign uterine diseases, 11% of patients with CIN, 44% of patients with cervical cancer and 11% of patients with endometrial cancer. As regards cervical cancer, serum IL-6 levels > 3 pg/mL were found in 36.0% of 25 patients with stage Ib-IIa disease and in 64% of 11 patients with stage IIb-IV disease. As regards endometrial cancer, serum detectable IL-6 levels were observed in 0% of 30 patients with stage I-II disease and in 57% of 7 patients with stage III-IV disease (p = 0.0005). These preliminary data suggest that IL-6 may be involved in the progression of uterine malignancies.

Elevated serum levels of neopterin and soluble interleukin-2 receptor in patients with ovarian cancer.

Preoperative serum neopterin, soluble interleukin-2 receptor (sIL-2R), and CA125 levels were assayed in 47 patients with ovarian cancer and 113 patients with benign ovarian disease undergoing laparotomy. The cutoff limits of the antigens for the preoperative evaluation of ovarian cancer were fixed according to the Youden plot, using the patients with benign ovarian disease as controls. These limits were 7.9 nmole/liter for neopterin, 71 U/ml for sIL-2R, and 83 U/ml for CA125. The preoperative mean values of serum neopterin and sIL-2R were significantly higher in patients with ovarian cancer than in those with benign ovarian disease. Therefore these tests would seem to be useful in distinguishing benign from malignant ovarian masses. Serum levels of neopterin, sIL-2R, and CA125 above the cutoff limits were detected in 66.0, 78.7, and 76.6% of patients with ovarian cancer. Patients with advanced-stage disease (FIGO > or = III) were significantly more likely to have a higher percentage of elevated values of sIL-2R and CA125, but not neopterin, compared to patients with early-stage disease. However, neopterin was the antigen most often raised in early disease. As for advanced ovarian cancer, preoperative serum sIL-2R levels were higher in patients who developed progressive disease than in those who were progression-free (P = 0.02) after a median follow-up time of 18 months. Furthermore, a trend to higher preoperative serum neopterin values was found in the former patients (P = 0.08). Tumor progression occurred in 3 of 8 (37.5%) patients with low serum preoperative neopterin (< 7.9 nmole/liter) and in 16 of 19 (84.2%) patients with elevated serum neopterin, respectively (P = 0.027). Multivariate analysis on a larger number of patients followed for a longer time is warranted to elucidate the prognostic relevance of these immunologic markers in ovarian cancer. Changes in serum neopterin, sIL-2R, and CA125 levels correlated with the disease course in 50.0, 54.8, and 92.9% of 42 instances, respectively. Moreover, serum CA125 was more sensitive than the other two antigens in the early detection of tumor progression. Therefore serial neopterin and sIL-2R measurements seem to be of limited value in monitoring the disease course in patients with ovarian cancer.

Serum CYFRA 21-1 assay in squamous cell carcinoma of the cervix.

Squamous cell carcinoma antigen (SCC) is the best known marker for squamous cell carcinoma of the cervix as well as of the lung, oesophagus, head and neck and anal canal. Elevated levels of cytokeratin 19-fragments (CYFRA 21-1) have recently been detected in a large proportion of patients with non small cell cancer of the lung, and in particular of those with squamous cell carcinoma. Serum levels of CYFRA 21-1 (cut-off = 1.06 ng/mL) and SCC (cut-off = 2 ng/mL) were measured in blood samples collected before treatment from 15 patients with cervical intraepithelial neoplasia (CIN), 56 patients with cervical cancer, 48 patients with endometrial cancer, and 361 patients with benign uterine diseases. Serum CYFRA 21-1 values in patients with CIN were superimposable on those detected in patients with benign uterine diseases. Conversely, serum CYFRA 21-1 levels were higher in patients with cervical cancer (p < 0.05) and in patients with endometrial cancer (p < 0.05) than in those with benign uterine diseases. There was no significant difference in serum CYFRA 21-1 levels between cervical and endometrial cancer, and, as regards cervical cancer, there was no significant difference in antigen values between squamous cell carcinoma and adenocarcinoma. Among patients with squamous cell carcinoma of the cervix, CYFRA 21-1 values correlated with FIGO stage (stage IIb-IV vs stage Ib-IIa, p = 0.0303). Elevated CYFRA 21-1 levels were found in 20.0% of patients with CIN, in 41.7% of patients with squamous cell carcinoma of the cervix, in 62.5% of patients with adenocarcinoma of the cervix, in 45.8% of patients with endometrial cancer, and in 13% of patients with benign uterine diseases. Serum SCC was more sensitive than serum CYFRA 21-1 for both early and advanced squamous cell carcinoma of the cervix; these preliminary data seem to show that serum CYFRA 21-1 is of limited value for the management of patients with this malignancy.

Serum soluble interleukin-2 receptor (sIL-2R) assay in cervical and endometrial cancer. Preliminary data.

Pretreatment serum levels of soluble interleukin-2 receptor (sIL-2R), CA 125, and SCC were measured in 183 patients with malignant or benign uterine diseases. Serum sIL-2R levels were higher in the 46 patients with cervical cancer (p < 0.05) or in the 35 patients with endometrial cancer (p < 0.05) than in the 102 patients with benign uterine diseases. Raised serum concentrations of sIL-2R (> or = 50 U/mL), CA 125 (> or = 35 U/mL) and SCC (> or = 2 ng/mL) were found in 50.0%, 15.0% and 67.5% of 40 patients with squamous cell carcinoma of the cervix, respectively. Serum sIL-2R values were > or = 50 U/mL in 83.3% of 6 patients with cervical adenocarcinoma. Elevated serum levels of sIL-2R, CA 125 and SCC were detected in 51.4%, 11.3% and 14.3% of 35 patients with endometrial cancer, respectively. The sensitivity of SCC for squamous cell carcinoma of the cervix was better than that of sIL-2R. On the other hand, we observed that sIL-2R was the most sensitive antigen for endometrial cancer; therefore it could represent a new tumor marker for the management of patients with this malignancy.

Serum soluble interleukin-2 receptor assay in epithelial ovarian cancer.

Preoperative serum soluble interleukin-2 receptor (sIL-2R) and CA 125 levels were measured in 183 patients with ovarian masses undergoing laparotomy. Serum sIL-2R levels were higher in the 54 patients with epithelial ovarian cancer than in the 129 patients with benign ovarian diseases (p < 0.0001). Elevated serum levels of sIL-2R (> or = 71 U/ml) and CA 125 (> or = 83 U/ml) were found in 79.6 and 77.8% of patients with epithelial ovarian cancer, respectively. Serum sIL-2R and CA 125 positivity rates correlated with the FIGO stage (p = 0.0033 and p = 0.0001, respectively). Raised serum levels of sIL-2R and CA 125 were detected in 11.6 and 7.0% of patients with benign ovarian diseases, respectively. The combination sIL-2R or CA 125 had a sensitivity of 88.9%, and the association sIL-2R and CA 125 had a specificity of 98.4% for epithelial ovarian cancer. As for the 16 patients with this malignancy who were serially monitored during and after chemotherapy, changes in sIL-2R and CA 125 levels correlated with the clinical course of disease in 62.3 and 94.3% of 53 instances, respectively. In conclusion, the serum sIL-2R assay could represent a useful adjunctive tool for the differential diagnosis of ovarian masses, while it seems to be of limited benefit for monitoring the response to chemotherapy and follow-up of patients with epithelial ovarian cancer.

Combined evaluation of serum CA 125 and CAM 29 in patients with epithelial ovarian cancer.

We examined 92 patients with epithelial ovarian cancer and 262 patients with benign ovarian diseases undergoing laparotomy. On the basis of a nonparametric method, antigen levels corresponding to prefixed 95% specificity values in a group of 674 women with benign gynecologic diseases were taken as cutoff limits (88.8 U/ml for CA 125 and 13.7 U/ml for CAM 29). Moreover, CA 125 and CAM 29 levels were measured serially during and after chemotherapy in 26 women selected from the patients with advanced epithelial ovarian cancer. At diagnosis, serum CA 125 was as sensitive as serum CAM 29 for nonmucinous tumors, but more sensitive than serum CAM 29 for mucinous tumors. The association of the two markers seemed to give no advantage over the CA 125 assay alone in the diagnosis of epithelial ovarian cancer. In monitoring the response to chemotherapy and follow-up of patients with epithelial ovarian cancer, changes in CA 125 levels correlated with the clinical course of disease better than changes in CAM 29 levels, and the serum CA 125 assay was more reliable than the serum CAM 29 assay in the early detection of tumor progression. In conclusion, serum CAM 29 did not seem to represent a complementary assay to serum CA 125 in the management of patients with epithelial ovarian cancer.