265例乳腺癌手术前后血清CA15-3和CEA检测分析

[目的]探讨乳腺癌手术前后血清糖类抗原15．3（CA15—3）和癌胚抗原（CEA）测定的临床意义。[方法]取265例乳腺癌病例外周静脉血，采用电化学发光免疫分析fECLIA）检测术前及术后CA15—3、CEA水平。[结果]术前已发生转移者23例，CA15—3增高18例，CEA增高10例，阳性率分别为78-3％、43．5％；术后无复发转移组201例，CA15—3增高2例（0．99％）、复发转移组41例，CA15-3增高33例，CEA增高27例，阳性率分别为80．5％和65．9％。[结论]血清CA15-3和CEA的动态检测可作为乳腺癌术后随访的监测指标，CA15-3水平的变化有助于预测肿瘤转移及其治疗效果的判定。     

Clinical evaluation of potential usefulness of CEA, CA 15-3, and MCA in follow-up of breast cancer patients

The potential usefulness of MCA, CA 15-3 and CEA in monitoring of breast cancer patients was evaluated in 135 female patients with histologically confirmed breast cancer. The patients were classified into two groups as follows: group of patients with no evidence of disease, NED; and group of patients with progressive disease, PD. In total, 2106 measurements of CEA, CA 15-3, and MCA were performed using an enzyme immunoassay. Serum levels of all three markers in the NED group differed significantly from those of patients with PD. The observed differences in the sensitivity and specificity of CEA, CA 15-3, and MCA tests were not significant. The serum concentrations of a particular marker correlated well with the concentrations of the other two markers, except when CEA was correlated with MCA or CA 15-3 in NED group patients. The elevation of tumor markers preceded by some 7 months the clinical evidence of dissemination, and marker levels reflected at a high percentage the response to therapy in PD patients. Therefore, this clinical study confirmed that MCA, CA 15-3 and also CEA are suited to discriminate between disease and disease-free periods, and also validated the usefulness of markers for treatment response monitoring.     

CEA与CA15-3联合检测在乳腺癌诊断中的临床意义

目的：探讨癌胚抗原（carcinoembryo antigen,CEA）与肿瘤相关糖类抗原15-3（carbohydrate antigen15-3,CA15-3）联合检测在乳腺癌诊断中的应用价值。方法：采用电化学发光方法检测116例乳腺癌患者与94例乳腺良性肿瘤患者血清中CEA与CA15-3水平并进行统计学分析。结果：乳腺癌患者血清中CEA与CA15-3水平明显高于乳腺良性肿瘤对照组（P〈0.01）;二者联合检测诊断敏感性显著提高（P〈0.05）;治疗后CEA与CA15-3含量与治疗前相比显著无明显变化（P〉0.05）。结论：CEA与CA15-3联合检测可提高乳腺癌诊断敏感性,对临床诊断与疗效评价有一定的应用价值。     

超声BI-RADS联合血CA15-3和CEA在乳腺肿物诊断中的价值研究

目的 探讨超声BI-RADS与血CA15-3和CEA联合检测在乳腺肿物中的诊断价值。方法 选择2019年6月—2019年12月乳腺肿物患者111例,以病理结果为金标准,分析超声BI-RADS、血CA15-3和CEA联合对乳腺肿物诊断的敏感性及准确性。结果 病理示良性病变43例,乳腺癌68例。与良性病变患者相比,乳腺癌患者血CA15-3和CEA均升高(P＜0.05)。乳腺癌患者CA15-3和CEA呈正相关。超声BI-RADS、血CA15-3和CEA联合对乳腺癌诊断的敏感性达到73.5%,准确性升高至83.8%,AUC提高到0.957,均高于三者各自单独使用时的诊断效果。结论 超声BI-RADS、血CA15-3和CEA联合检测是一种提高乳腺肿物诊断敏感性和准确率的有效方法。     

CEA与CA15-3联合检测在乳腺癌诊断中的临床意义

目的:探讨癌胚抗原(carcinoembryo antigen,CEA)与肿瘤相关糖类抗原15-3(carbohydrate antigen15-3,CA15-3)联合检测在乳腺癌诊断中的应用价值。方法:采用电化学发光方法检测116例乳腺癌患者与94例乳腺良性肿瘤患者血清中CEA与CA15-3水平并进行统计学分析。结果:乳腺癌患者血清中CEA与CA15-3水平明显高于乳腺良性肿瘤对照组(P<0.01);二者联合检测诊断敏感性显著提高(P<0.05);治疗后CEA与CA15-3含量与治疗前相比显著无明显变化(P>0.05)。结论:CEA与CA15-3联合检测可提高乳腺癌诊断敏感性,对临床诊断与疗效评价有一定的应用价值。     

Serial Serum HER2 Measurements for the Detection of Breast Cancer Recurrence in HER2-Positive Patients

Purpose

The measurement of serum human epidermal growth factor receptor 2 (HER2) extracellular domain levels is a well-established method for evaluating whether a metastatic HER2-positive breast cancer patient will respond to HER2-targeted treatment. However, little is known about the value of serum HER2 for detecting disease relapse following curative surgical treatment in breast cancer patients. The purpose of this study was to evaluate the sensitivity of serum HER2, carcinoembryonic antigen (CEA), and carcinoma antigen 15-3 (CA 15-3) for the detection of disease recurrence in postoperative breast cancer patients with a primary HER2-positive tumor.

Methods

Serial measurements were taken of serum HER2, CEA, and CA 15-3 levels in patients with primary invasive HER2-positive breast cancer who underwent curative surgical treatment between January 2008 and December 2010. Following treatment, serum HER2 levels were monitored every 6 months using a chemiluminescence immunoassay.

Results

Overall, 264 patients were analyzed in this retrospective study. The median follow-up period was 27.7 months, and 24 patients relapsed during follow-up. The sensitivity of serum HER2, CEA, and CA 15-3 for the detection of disease recurrence was 37.5%, 25.1%, and 12.5%, respectively. Sensitivity increased to 45.8% when all three tumor markers were combined in the analysis. In a subgroup of patients without liver disease, the sensitivity of serum HER2, CEA, and CA 15-3 was 57.1%, 21.4%, and 14.3%, respectively. Of the 264 patients in this study, 80 patients had chronic hepatitis, liver cirrhosis, or abnormal aspartate aminotransferase or alanine aminotransferase levels during the follow-up period. Following the exclusion of these patients, the sensitivity of serum HER2 for the detection of disease recurrence increased to 57.1%.

Conclusion

Serial serum HER2 measurement may be useful for the detection of disease relapse in patients with HER2-positive breast cancer. Abnormal liver function can result in elevated serum HER2 in the absence of disease recurrence.     

Serum CYFRA 21-1 (cytokeratin-19 fragments) is a useful tumour marker for detecting disease relapse and assessing treatment efficacy in breast cancer

The usefulness of serum CYFRA 21-1 (cytokeratin-19 fragments) in monitoring the recurrence of breast cancer and in evaluating therapeutic effects was studied retrospectively. The sera from 173 patients with primary breast cancer or recurrent disease were measured for CYFRA 21-1, carcinoembryonic antigen (CEA), and carbohydrate antigen 15-3 (CA 15-3) levels. The positive rates of serum CYFRA 21-1 for stage IV (n=12) or recurrent disease (n=26) were 83.3 and 84.6%, respectively, while those of serum CEA were 41.7 and 26.9%, and those of serum CA 15-3 were 83.3 and 34.6%. The elevated preoperative levels of serum CYFRA 21-1 decreased to normal levels after curative operation, whereas the levels remained abnormally high after noncurative operation. There was a significantly high frequency of recurrence in patients with elevated levels of serum CYFRA 21-1 preoperatively compared to those with normal levels of the marker preoperatively. The serum CYFRA 21-1 levels were well correlated with response to chemotherapy. The positive rate of serum CYFRA 21-1 alone was higher than that of an assay combining CEA with CA 15-3, in both primary and recurrent cases (28.8 vs 18.8 and 84.6 vs 46.2%, respectively). These observations suggest that serum CYFRA 21-1 may be a reliable marker of recurrence or therapeutic efficacy.     

Comparison of breast cancer mucin (BCM) and CA 15-3 in human breast cancer

Summary The Breast Cancer Mucin (BCM) enzyme immunoassay utilizes two monoclonal antibodies (Mab), M85/34 and F36/22, for the identification of a mucin-like glycoprotein in serum of breast cancer patients. We have compared BCM with CA 15-3, another member of the human mammary epithelial antigen family.Serum BCM was evaluated in 151 and CA 15-3 in 134 patients with breast cancer, in 30 normal controls, in 9 pregnant women, and in 13 cancer patients (non-breast). Neither the normal controls nor the pregnant women had BCM levels > 25 U/ml. In contrast, 87 of 115 patients (75%) with metastatic breast cancer had BCM levels > 25 U/ml. All control persons had CA 15-3 levels < 25 U/ml, but 2 out of 9 pregnant women (22%) had levels > 25 U/ml. Seventy-four out of 97 patients (76%) with metastatic breast cancer had CA 15-3 levels > 25 U/ml.A statistically significant correlation was found between BCM and CA 15-3 in the breast cancer patient group (r = 0.883, p < 0.001, n = 134) and in the normal control group (r = 0.743, p < 0.001, n = 30). BCM and CA 15.3 both showed no correlation with CEA in breast cancer patients (r = 0.060, n = 81; and r = 0.146, n = 78, respectively). BCM had a range of sensitivity similar to that of the CA 15-3 RIA.Our results suggest that BCM may be a useful new marker for monitoring the clinical course of patients with breast cancer. Furthermore, in the evaluation of breast cancer patients, marker pands depending on disease stage may be a better choice than any single parameter in the evaluation of breast cancer patients.     

CA15-3和CEA对术后乳腺癌病人随访的临床意义

[目的]探讨肿瘤标记物CA15-3和CEA对术后乳腺癌病人随访的临床意义.[方法]采用放射免疫分析法(RIA)分别测定88例术后乳腺癌病人血清CA15-3、CEA的值.[结果]CA15-3对判断有、无肿瘤负荷(局部复发或远处转移)无显著性差异(P＞0.1),CEA有显著性差异(P＜0.001).两指标联合检测对判别是局部复发,还是远处转移均无显著性差异(P＞0.1).[结论] CEA可作为术后病人常规随访指标,而不推荐常规检查CA15-3.     

Elevated serum ca15-3 levels correlate with positive estrogen receptor and initial favorable outcome in patients who died from recurrent breast cancer

BACKGROUND: The clinical usefulness of circulating tumor markers in breast cancer as recurrence indicators during follow-up or monitoring treatment response is still an open question. There are some patients with normal tumor marker levels who have apparent recurrence foci. In this study, we evaluated the relationships between CEA or CA15-3 levels and clinicopathological factors or outcome in patients who had died from recurrent breast cancer. METHODS: Two hundred-twenty deceased patients who had had recurrent or advanced breast cancer and who had been treated between 1986 and 2000 were enrolled in a retrospective study. Serum CEA and CA 15-3 were measured regularly during the clinical course until death. RESULTS: The rates of CEA and CA15-3 positivity were 41.4% and 50.9% at the time of recurrence, and rose to 67.3% and 76.8% after recurrence, respectively. The CA15-3 and CEA positivity rates significantly correlated with ER and PgR status. Serum CA15-3 status correlated significantly with survival after recurrence. Patients with CA15-3 negativity had poorer prognoses than CA15-3 positive patients. Multivariate analysis revealed that CA15-3 status was one of the significant factors for survival after recurrence. CONCLUSIONS: Tumor markers, especially CA15-3, might reflect the biological characteristics of tumors such as ER or PgR status, and may be useful prognostic predictors in recurrent breast cancer. Elevated CA15-3 levels correlated with positive estrogen receptor and favorable outcome in deceased patients with recurrent breast cancer.     

应用ROC曲线分析评价肿瘤标志物糖类抗原15-3、癌胚抗原在乳腺癌诊断与术后监测中的价值

目的评价肿瘤标志物糖类抗原15-3(carbohydrate antigen,CA15-3)、癌胚抗原(carcino-embryonic antigen,CEA)在乳腺癌诊断与术后复发转移判断中的应用价值。方法采用化学发光免疫分析法测定110例乳腺癌患者、50例乳腺良性疾病患者及40例正常对照者的血清CA15-3、CEA水平。组间比较采用χ2检验。用ROC曲线评价CA15-3、CEA在乳腺癌诊断和术后复发转移判断中的应用价值。结果 110例患者中CA15-3和CEA阳性检出率分别为32.7%(36/110)和12.7%(14/110)。I期、II期乳腺癌患者CA15-3、CEA血清含量无明显变化,与良性组和正常对照组相比差异无统计学意义(P0.050)。以43例Ⅲ期、Ⅳ期乳腺癌患者的CA15-3、CEA测定值绘制ROC曲线,分析显示,CA15-3、CEA的ROC曲线下面积(AUC)分别为82.3%、81.1%,95%可信区间分别为0.719～0.929、0.714～0.906。术后复发转移患者CA15-3、CEA阳性检出率分别为85.7%(18/21)、52.4%(11/21),AUC分别为97.8%、89.1%,95%可信区间分别为0.944～1.011、0.790～0.991。结论通过ROC曲线评价可得出,CA15-3、CEA对Ⅲ期、Ⅳ期乳腺癌诊断有临床参考价值,在术后复发转移诊断中有较高的应用价值,可作为乳腺癌术后监测复发转移的有效指标。     

CEA、CA125、CA15-3在吉西他滨治疗乳腺癌化疗前后的表达及意义

目的 探讨血清肿瘤标志物癌胚抗原(CEA)、糖类抗原125(CA125)和糖类抗原15-3(CA15-3)在吉西他滨治疗乳腺癌化疗前后的表达及意义.方法 选取接受吉西他滨药物化疗的70例女性原发性乳腺癌患者,治疗21 d后评价疗效,并用电化学发光免疫分析技术检测患者化疗前后血清中CEA、CA125、CA15-3的浓度并进行比较.结果 患者血清CEA、CA125和CA15-3浓度在吉西他滨化疗后明显降低,差异均有统计学意义(P﹤0.01).且患者血清CEA、CA125和CA15-3浓度与吉西他滨的疗效呈正相关(rs﹥0,P﹤0.05).结论 CEA、CA125、CA15-3对临床诊断乳腺癌的发生发展过程具有重要作用.乳腺癌患者应用吉西他滨化疗可明显降低血清CEA、CA125、CA15-3水平,且3种肿瘤标志物与吉西他滨的化疗疗效具有相关性.     

乳腺癌肿瘤标志物CEA、CA15-3表达水平的临床意义

目的: 探讨血清CEA、CA15-3与乳腺癌临床诊断方面的关系。 方法: 应用微粒子免疫萤光技术对210例乳腺癌患者、75例乳腺良性疾病患者及50例正常对照者血清CEACA15-3表达水平进行检测比较。 结果: CEA、CA15-3在乳腺癌Ⅲ、Ⅳ期中表达明显增高(P<0.005),在Ⅰ、Ⅱ期中表达与正常组及良性疾病组比较无显著性差异(P>0.05)。两种标志物与肿瘤分期、淋巴结受累程度有关,腋淋巴结转移≥4枚或远处脏器转移时CEA、CA15-3浓度明显增高(P<0.005)。两种标志物与肿瘤病理学分型的关系不明显(P>0.05)。乳腺癌术后动态监测CEA、CA15-3对肿瘤远处转移呈高表达(P<0.005),对局部复发CEA无显著性(P>0.05),而CA15-3有指导意义(P<0.005)。 结论: CEA、CA15-3并非乳腺癌早期诊断的理想标志物,但其与肿瘤临床分期、淋巴结转移程度、远处转移关系密切,是乳腺癌术前预测转移及监测术后复发转移与评估乳癌预后的有效指标。     

Long-term prognostic study of carcinoembryonic antigen (CEA) and carbohydrate antigen 15-3 (CA 15-3) in breast cancer

Background  Tumor markers are frequently used for screening and monitoring in oncology. We investigated the use of preoperative tumor marker (carcinoembryonic antigen [CEA] and carbohydrate antigen [CA] 15-3) levels in estimating the prognosis of breast cancer patients. Methods  We conducted a retrospective study in patients who underwent breast cancer surgery at National Cancer Center Hospital between 1975 and 1994 and whose serum CEA (n = 1663) and CA 15-3 (n = 1500) levels were measured prior to operation. When we excluded patients with stage IV disease from the study, the CEA level was within the normal range in 1470 patients, while 150 patients had an elevated CEA level. For CA 15-3, 1395 patients were within the normal range, while 70 patients exhibited an elevated level. Results  The 5-year and 10-year survival rates for patients with normal CEA levels were 87% and 76%, respectively. However, the 5-year and 10-year survival rates for patients with elevated CEA levels were 76% and 65%, respectively. At both time points, patients with normal CEA levels had higher survival rates (P < 0.05). The 5-year and 10-year survival rates for the patients with normal CA 15-3 levels were 86% and 76%, respectively, while only 71% and 52% patients with elevated CA 15-3 levels survived at 5 and 10 years, respectively. These differences were also significant (P < 0.05). However, there were no significant differences in disease-free survival (DFS) according to CEA or CA 15-3 levels. Conclusion  There was a positive correlation between CEA levels and CA 15-3 levels and patient prognosis. Thus, the levels of these tumor markers may help to determine prognosis in breast cancer patients.     

Relationships among serum CA15-3 tumor marker, TNM staging, and estrogen and progesterone receptor expression in benign and malignant breast lesions

Serum tumor marker CA15-3 is widely used in follow-up for assessment of breast cancer prognosis. The aim of this study was to evaluate levels among healthy females and patients, to assess differences with tumor stage and grade, and to determine the relationship with estrogen and progesterone receptor expression. One hundred and thirty six Jordanian females were enrolled in this study: Forty-five were healthy females; seventy-two were diagnosed with breast cancer and nineteen diagnosed with benign breast lesions. Elevated serum CA15-3 level was significantly observed among breast cancer patients (37.95±6.65) compared to both healthy (14.97±0.8) and benign females (12.30±1.55), but no significant association was detected between serum CA15-3 level and age of cancer onset, menarche age, menopause age, parity and BMI. Decreased CA15-3 level was significantly associated with hormone therapy and oral contraceptive consumption among breast cancer patients. Significantly elevated CA15-3 serum levels were found among grade II, III and stage II and III breast cancer females compared to normal healthy females. Elevated CA15-3 serum levels were also found among ER+/PR+ (54.242±7.89) and ER+/PR- (37.08±8.22) compared to healthy control females.     

血清TPS和CA15-3水平变化与乳腺癌的关系及其临床意义

目的：探讨血清组织多肽特异性抗原（TPS）和癌抗原15－3（CA15－3）水平检测对乳腺癌的临床应用价值。方法：采用酶联免疫吸附法，分别在治疗前后测定173例乳腺癌和69例乳腺良性疾病患者血清TPS和CA15－3水平。结果：乳腺癌组患者TSP和CA15－3水平及检测阳性率均明显高于乳腺良性疾病和正常对照组（P＜0．01），CA15－3水平随临床分期的进展明显升高，而TPS即使在临床I期也有高水平的表达，乳腺癌患者经有效治疗后其血清TPS和CA15－3水平均明显降低，尤其是单纯根治术或加用放疗的患者降低幅度更为明显，乳腺癌复发患者血清TPS和CA15－3均明显升高，尤其是TPS升高幅度较为显著，结论：TPS和CA15－3联合检测可明显提高乳腺癌的阳性检出率，对乳腺癌早期诊断，病情判断，疗效评估和复发监测等均有重要价值，而动态监测其水平变化的临床价值更为可靠。     

Circulating CA 15-3 levels in the postsurgical follow-up of breast cancer patients and in non-malignant diseases

Summary Circulating CA 15-3 antigen levels were evaluated in patients with benign diseases and breast cancer patients with no clinical evidence of disease after surgery (NED). Patients with breast cancer NED were followed for tumor recurrence or death during a median of 12.9 months (range 1 to 25 months). CA 15-3 and carcinoembryonic antigen (CEA) were compared in the same breast cancer NED patient population. Elevated CA 15-3 levels (>40 U/ml) were observed in 38 of 1220 patients with benign diseases (3.1%) and in 25 of 350 breast cancer NED patients (7.1%). Elevations of CEA (>5ng/ml) were observed in 23 patients with breast cancer NED (6.5%). Benign diseases that produced significant elevations of CA 15-3 were chronic hepatitis (42.9%), liver cirrhosis (13.3%), sarcoidosis (16.7%), tuberculosis (9.7%), and systemic lupus erythematosous (6.7%).In breast cancer NED, initial elevations of CA 15-3 were observed in 12 of the 297 patients that remained free of disease during the follow-up, and in 13 of the 40 patients that relapsed (4.0% vs. 32.5%, p<0.001). Initial CEA levels were elevated in 16 patients that remained NED and in 7 patients that relapsed (5.3% vs. 17.5%, p<0.001). Serial determinations of CA 15-3 in patients continuously NED showed persistent elevations in 4 cases. Three of these exhibited concomitant benign diseases. In relapsing patients, serial tumor marker determinations showed that elevations of CA 15-3 before any other clinical evidence of recurrence occurred significantly more frequently than elevations of CEA (45% vs. 25%, p<0.001). Overall, two or more serial elevated values of CA 15-3 were observed in 7 cases, and 6 of them (85%) eventually relapsed. Median survival from study entry was 18.3 months in patients with breast cancer NED that had initial elevated CA 15-3, compared to 25+ months in those with negative CA 15-3 (p<0.0001).We conclude that circulating levels of CA 15-3 antigen can be elevated in some patients with nonmalignant diseases, and that serial determinations of CA 15-3 may be useful in the postsurgical follow-up of patients with breast cancer when specific types of benign diseases that may cause elevations of the antigen are excluded. Additionally, CA 15-3 is more sensitive than CEA in the early diagnosis of breast cancer recurrences, and the simultaneous assay of CEA does not add information to that of CA 15-3 alone.     

Combined measurement of serum sialyl Lewis X with serum CA15-3 in breast cancer patients

BACKGROUND: Serum CA15-3 has been one of the most reliable tumor markers used in monitoring breast cancer patients; however, its sensitivity in detecting metastases is limited. To increase its sensitivity, the combined measurement of other tumor markers with CA15-3 was investigated. METHODS: Serum CA15-3, carcinoembryonic antigen (CEA) and sialyl Lewis X (CSLEX) were simultaneously measured in a prospective series of 455 postoperative breast cancer patients with or without metastasis. The diagnostic parameters sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy for detecting metastases were compared. The correlation of values between pairs of tumor markers was analyzed. The efficacy of combined measurement of two different tumor markers was also evaluated. RESULTS: The sensitivity for detecting metastases was 61.5, 56.9 and 52.3%; specificity was 97.2, 93.6 and 96.2%; PPV was 78.4, 59.7 and 69.4%; NPV was 93.8, 92.9 and 92.4%; and accuracy was 92.1, 88.8 and 89.9% for CA15-3, CEA and CSLEX, respectively. The values for CA15-3 were significantly correlated with those for CEA (P < 0.001) but not those for CSLEX. The combined measurement of CSLEX and CA15-3 increased the sensitivity by 17.0% but that of CEA and CA15-3 increased the sensitivity by only 10.8%. All diagnostic parameters for the combined measurement of CSLEX and CA15-3 were higher than those for the combined measurement of CEA and CA15-3. CONCLUSIONS: These findings suggest that CSLEX may be more useful than CEA in combination with CA15-3 in monitoring breast cancer patients. The results of this study suggest that CSLEX may be more useful than CEA in combination with CA15-3 in monitoring breast cancer patients.     

糖类抗原15-3、癌胚抗原、环氧合酶-2联合检测在乳腺癌诊断中的应用

 目的　探讨糖类抗原15-3（CA15-3）、癌胚抗原（CEA）、环氧合酶-2（COX-2）联合检测对乳腺癌早期诊断的应用价值。方法　选择经影像学和病理学诊断为乳腺癌患者53例,同时选择同期良性乳腺病患者61例及同期健康体检者68名,采用电化学发光技术与酶联免疫吸附法（ELISA）分别检测血清CA15-3、CEA、COX-2水平。结果　乳腺癌组CA15-3、CEA、COX-2血清水平分别为（34.67±13.20）U／ml、（7.38±3.87）ng／ml、（43.25±10.87）ng／ml,与良性乳腺病组和健康对照组血清含量比较差异具有统计学意义（均P＜0.01）;CA15-3、CEA、COX-2联合检测将各项指标单独检测的阳性检出率提高至84.9 %（45／53）,其敏感度提高至84.9 %,准确度提高至91.2 %。结论　三项肿瘤标志物联合应用能弥补单项肿瘤标志物临床应用的不足,对提高乳腺癌阳性检出率具有一定意义。     

Serum Human Epididymis Protein-4 (HE4) - A novel Approach to Differentiate Malignant Frombenign Breast Tumors

Background: The lack of sensitivity and specificity of existing diagnostic markers like Carbohydrate Antigen 15-3(CA15-3) and Carcinoembryonic antigen (CEA) in breast cancer stimulates the search for new biomarkers to improve diagnostic sensitivity especially in differentiating benign and malignant breast tumors. Expression of Human epididymal protein 4 (HE4) has been demonstrated in ductal carcinoma of the breast tissue. So we tried to evaluate serum HE4 levels as diagnostic marker in breast cancer patients and to comparatively assess serum HE4, CEA and CA15-3 in breast tumor patients both benign and malignant. Methods: Total 90 female subjects were included in the study. We selected 30 breast cancer cases (Malignant group) and 30 benign breast lump cases (Benign group) based on histopathology report. And other 30 were age matched apparently healthy controls (Control group). HE4, CEA and CA15-3 were analysed in serum samples of all subjects by Electrochemiluminiscence immunoassay method. Results: A significant difference in the median (IQR) of HE4 (pmol/l) was identified among malignant, benign and control groups {62.4(52.6-73.7) vs 49.3(39.8-57.4) vs 52.3(50.6-63.3) P=0.0009} respectively. The cutoff value for prediction of breast cancer was determined at >54.5 pmol/l for HE4, with a sensitivity of 73.3%, specificity of 65.3%, whereas cutoff value of CA 15-3 was >21.24 (U/ml) with a sensitivity of 56.7%, specificity of 74.5%. For CEA at cutoff value >0.99 (ng/ml) the sensitivity and specificity were 96.7 % and 62.7% respectively. AUC for HE4, CA15-3 and CEA were 0.725, 0.644 and 0.857 respectively. Conclusion: Our study demonstrated that serum levels of HE4 were significantly higher in malignant group compared to benign and control groups. There is no significant difference between HE4 levels between benign and control groups. These results indicate that HE4 appears as a useful and highly specific biomarker for breast cancer, which can differentiate between malignant and benign tumors.