A case of breast cancer metastatic to the head of the pancreas

A case of breast cancer that metastasized to the head of the pancreas 6 years and 8 months after mastectomy is reported. The pancreas head metastasis was associated with general fatigue and obstructive jaundice. The serum levels of CEA, CA15-3 and NCC-ST-439, tumor markers of breast cancer, were within normal limits, but CA15-3 was immunohistochemically demonstrated in the resected metastatic lesion, in a manner similar to lobular carcinoma of the breast.     

A case of breast cancer metastatic to the tail of the pancreas

Breast cancer metastasis to pancreas is rarely seen. There have been only 6 cases described in the literature. We present the seventh case of a 54-year-old woman with breast cancer that metastasized to the tail of the pancreas 4 years and 4 months after radical mastectomy. Although the serum levels of CA15-3 and TPA had gradually increased without symptoms, it was difficult to establish the diagnosis before contrast-enhanced abdominal CT scan was performed. Immunohistochemical staining using E-cadherin was positive, proving that the breast cancer was ductal rather than lobular in origin. CA15-3 immunohistochemically stained positive in the resected pancreas lesion. Positive monoclonal staining by GCDFP-15 (gross cystic disease fluid protein-15) in the pancreas tumor also confirmed it breast cancer origin. Investigation of chemokine/chemokine receptors may clarify a new mechanism of metastasis to the pancreas from breast cancer.     

乳腺癌患者血清CA15—3检测的临床意义

采用放射免疫法检测１８０例乳腺疾病患者血清ＣＡ１５－３水平，其中乳腺良性疾病４２例，乳腺癌术前５１例，乳腺癌术后无复发转移者７３例，乳腺癌术后有复发或转移者１４例。ＣＡ１５－３阳性率分别为９．５％、２７．５％、５．５％、８５．７％。结果显示，乳腺癌术后有复发或转移者的阳性率明显高于无复发转移者（Ｐ＜０．０１）。血清ＣＡ１５－３检测对乳腺癌术前诊断意义不大，而对乳腺癌术后复发和转移的监测有重要价值。     

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CEA CA15-3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.     

核素骨显像联合肿瘤标记物检测对乳腺癌骨转移的诊断价值

目的：观察核素骨显像联合肿瘤标记物对乳腺癌骨转移的诊断价值。方法选择乳腺癌患者82例,按照核素骨显像结果分为转移组43例及未转移组39例,另选取40例健康体检女性作为对照组。观察核素骨显像以及肿瘤标记物检测结果,并对其诊断价值进行考察。结果转移组血清CA125、CA15-3及CEA表达水平及阳性率显著高于未转移组及对照组,骨转移灶数目≤2患者血清CA125、CA15-3以及CEA表达水平及阳性率均显著低于骨转移灶数目＞2的患者,差异均具有统计学意义（P＜0．05）。且随着骨转移分级程度的升高,患者乳腺癌相关肿瘤标记物CA125、CA15-3及CEA表达水平及阳性率均呈升高趋势,各分级间差异有统计学意义（ P＜0．05）。结论核素骨显像联合肿瘤标记物检测可提高诊断敏感性,对于乳腺癌骨转移的诊断具有重要的参考价值。     

肿瘤标志物在乳腺癌术后复发转移监测中的应用价值

目的：探讨肿瘤标志物在乳腺癌术后复发转移监测中的应用价值。方法：用多肿瘤标志物系统对121例乳腺癌术后患者（其中包括49例术后复发转移患者及72例术后无复发转移患者）血清样本的12项肿瘤标志物（CA19—9、NSE、CEA、CA242、Ferritin、B—HCG、AFP、F—PSA、PSA、CA125、HGH、CA15—3）的表达水平进行测定,Logistic回归分析与ROC曲线法评价肿瘤标志物在复发转移中的应用价值。结果i乳腺癌术后复发转移组与无复发转移组的蛋白芯片阳性率差异显著（P〈0．05）。与无复发组测定结果比较,CA19—9、CEA、Ferritin、CA125、CA15—3的表达水平及阳性率差异具有统计学意义（P〈0．05）。Logistic回归分析筛选CEA、CA125、CA15—3为监测乳腺癌术后复发转移的有效指标,ROC曲线法三者曲线下面积为0．813、0．808、0．772。CEA、CA125、CA15—3联合监测乳腺癌术后复发转移的敏感性与芯片相同（81．6％）,特异性与准确性高于芯片（95．8％VS92．7％,90．1％VS87．6％）。结论：CEA、CA125、CA153联合检测可能作为临床监测乳腺癌术后复发转移优化方案。     

乳腺癌组织中Cath-D、c-erbB-2的表达及其与肿瘤标志物水平、淋巴结转移的相关性

目的观察乳腺癌患者病理组织中Cath-D、c-erbB-2的表达情况,并分析其与淋巴结转移、肿瘤标志物水平的相关性。方法选取接受手术治疗的乳腺癌患者为研究对象,同时选取同期接受手术治疗的乳腺纤维腺瘤患者为对照。观察乳腺癌(有、无淋巴转移组)、乳腺纤维腺瘤患者组织切片Cath-D、c-erbB-2阳性表达情况,比较乳腺癌(有、无淋巴转移组)、乳腺纤维腺瘤患者血清肿瘤标志物水平的差异,分析淋巴结转移的乳腺癌患者Cath-D、c-erbB-2阳性表达与肿瘤标志物水平的相关性。结果乳腺癌组患者的组织切片Cath-D、c-erbB-2阳性表达率均高于乳腺纤维腺瘤组(χ²=51.796、70.090,P均<0.001);有淋巴结转移的乳腺癌患者组织切片Cath-D、c-erbB-2阳性表达率高于无淋巴结转移组。乳腺癌组患者血清CEA、CA15-3、CA125水平高于乳腺纤维腺瘤组(t=52.270、58.784、76.349,P<0.001);乳腺癌组有淋巴结转移组患者血清CEA、CA15-3、CA125水平高于无淋巴结转移组(t=16.681、27.880、23.216,P<0.001)。有淋巴结转移的乳腺癌患者Cath-D、c-erbB-2阳性表达率与血清CEA、CA15-3、CA125水平正相关。结论乳腺癌患者病理组织中Cath-D、c-erbB-2阳性表达率较高,且与淋巴结转移和肿瘤标志物水平相关。     

Metastasis of breast cancer to a uterine leiomyoma

Metastasis of breast cancer to a uterine leiomyoma is rare. We review the clinicopathological features of breast cancer metastasis to a uterine leiomyoma and discuss possible effective treatment. We describe a case of a woman who presented with abdominal discomfort after undergoing mastectomy for breast cancer. At the time of mastectomy, imaging showed osseous metastases involvement to the right kidney. The patient underwent total abdominal hysterectomy with bilateral salpingo-oophorectomy. Microscopic examination disclosed carcinoma of breast origin localized within the leiomyoma. To date, the patient is alive and asymptomatic after treatment with anastozole and capecitabine for 11 months. Per reports in the literature, abnormal uterine bleeding or a rapidly growing leiomyoma may be symptomatic of breast cancer metastasis to a uterine leiomyoma, especially if a patient has a previous diagnosis of invasive ductal carcinoma of the breast. Palliative hysterectomy can potentially improve prognosis in patients whose cancer is restricted to a uterine leiomyoma with or without involvement of lymph nodes, and may offer relief of genital tract symptoms in patients who have widespread involvement of non-life-threatening metastases.     

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。     

Clinical Evaluation of an Immunoradiometric Assay for CA15-3 Antigen Associated With Human Mammary Carcinomas: Comparison With Carcinoembryonic Antigen

Serum levels of CA15-3, a mammary tumor associated antigen recognizedby two different murine monoclonal antibodies (115D8 and DF3),were investigated in patients with mammary carcinoma and otherbenign or malignant diseases. The reference value of the serumCA15-3 level was obtained as 24 units/ml at the 99% confidencelimit among healthy individuals (n = 462). Elevation of serumCA15-3 levels was observed in 24.3% of overall patients withmammary carcinoma. Serum CA15-3 levels in breast cancer patientscorrelated with the clinical stage; higher percentages of positivitywere observed in those with advanced breast cancer (stage IV,64.7%, recurrent, 52.4% and metastatic, 70.3%). Furthermore,elevated serum CA15-3 levels in breast cancer patients respondedwell to the effect of therapy. Although the serum CA15-3 testgave percentages of positivity of breast cancer similar to thosefound by the serum CEA test, the serum CA15-3 test revealedlower percentages of posi-tivity than the serum CEA test amongpatients with benign breast lesions, liver cirrhosis or othercarcinomas. These results suggest that the serum CA15-3 antigenlevel provides a very useful marker for diagnosis and clinicalmonitoring of patients with breast cancer.     

三种血清肿瘤标志物联合检测对恶性肿瘤的诊断价值

目的评估血清标志物糖类抗原125（CA125）、糖类抗原15—3（CA15—3）、糖类抗原242（CA242）联合检测对恶性肿瘤诊断的价值。方法对长海医院肿瘤科于2004年9月～2005年9月期间收治的554例恶性肿瘤患者及60例为对照组的健康人的血清进行CA125、CA15—3、CA242检测。结果恶性肿瘤组三种肿瘤标志物检测的阳性率显著高于对照组（P〈0．01）。除鼻咽癌、骨肉瘤及淋巴瘤以外,联合捡测阳性率均大于50％。三种标志物联合检测的阳性率高于CA125、CA15—3、CA242单独检测的阳性率（P〈0．05）;三种标志物联合检测的阳性率高于CA125、CA15—3联合检测的阳性率（P〈0．05）;三种标志物联合检测的阳性率高于CA242、CA15—3联合检测的阳性率（P〈0．05）;三种标志物联合检测的阳性率与CA125、CA242联合检测的阳性率无统计学上的差异（P〉0．05）。联合检测肿瘤标志物的阳性率分别为：荷瘤转移组（77．08％）、荷瘤未转移组（60．05％）、手术后组（53．40％）。结论CA125、CA242联合检测能明显提高肿瘤的检出率。CA15—3的检测对于肿瘤的筛查并不能明显提高肿瘤的检出率,价值有限,但是对胆囊癌、乳腺癌、肺癌的诊断具有重要意义。三种肿瘤标志物联合捡测可为临床判定患者病情状态提供帮助。     

联合检测血清Hcy、CA15-3和FA对乳腺癌的临床价值分析

目的 探讨联合检测血清同型半胱氨酸（Hcy）、糖链抗原15-3（CA15-3）及叶酸（FA）水平在乳腺癌手术前后及复发转移中的临床价值。方法 选择2010年1月至2010年12月间在我院接受手术治疗的原发性乳腺癌患者387例,比较手术前后的血清Hcy、CA15-3及FA水平,根据术后5年的随访结果分为复发组（47例）和未复发组（340例）,比较两组术后的血清Hcy、CA15-3及FA水平,分析复发转移性乳腺癌血清Hcy、CA15-3及FA水平间的相关性。结果 乳腺癌患者术后1个月血清Hcy和CA15-3水平分别为（11.83±4.25） μmol/L和（13.02±3.01）U/ml,低于术前的（17.27±6.82） μmol/L和（37.29±15.92）U/ml,而术后1个月的血清FA水平为（7.84±3.17）ng/ml,高于术前的（5.16±2.36）ng/ml,差异均有统计学意义（P<0.05）;复发组术后1个月的血清Hcy和CA15-3水平分别为（16.08±5.93） μmol/L和（28.41±13.85）U/ml,高于未复发组的（11.92±4.31） μmol/L和（14.25±2.96）U/ml,而复发组FA水平为（5.12±2.21）ng/ml,低于未复发组的（7.85±3.09）ng/ml,差异均有统计学意义（P<0.05）;复发组的血清Hcy、CA15-3及FA的异常率高于未复发组（P<0.05）,且复发转移性乳腺癌患者中,Ⅲ、Ⅳ期患者的Hcy、CA15-3及FA异常率均高于Ⅰ、Ⅱ期,差异有统计学意义（P<0.05）;复发转移性乳腺癌患者血清FA水平与Hcy、CA15-3水平呈负相关（r=-0.286、-0.346,P<0.05）,Hcy和CA15-3水平呈正相关（r=0.402,P<0.05）。结论 复发转移性乳腺癌患者的血清Hcy、CA15-3水平较高,FA水平较低,可能预测乳腺癌患者复发转移。     

A case of breast cancer metastatic to the pituitary gland

A case of breast cancer that developed pituitary metastasis 22 years after mastectomy is reported. The pituitary metastasis was associated with hypopituitarism, impairment of the visual field and later diabetes insipidus. The serum levels of CA15-3 and NCC-ST-439, tumor markers of breast cancer, were increased, and CA15-3 (DF3) and NCC-ST-439 were demonstrated in the resected pituitary metastatic lesion immunohistochemically.     

A case of postoperative rapid brain metastasis originating from stage II a cervical adenosquamous cell carcinoma

Cerebralmetastases from primary cervical carcinomas are very rare with a repeated incidence of 0. 5-1. 2% in various studies. A 46-year-old woman was initially diagnosed and treated for FIGO clinical stage II a cervical carcinoma. She was two gravid, two para. When 40 years old, she had a right hemicolectomy and chemotherapy, due to colon cancer. Her mother also had colon cancer, cervical cancer, and stomach cancer. She had habitually smoked ten/day for 26 years. First, she went to the outpatient clinic, due to abnormal vaginal bleeding. She had a biopsy of her cervix and was diagnosed with cervical cancer. She underwent a radical hysterectomy, bilateral salpingo-oophorectomy and pelvic lymphadenectomy. Pathological diagnosis was adenosquamous cell carcinoma of uterine cervix with extensive LVSI and pelvic lymph node metastasis (right internalil iac LN), myometrial invasion (depth 10 mm), anterior vaginal wall metastasis, but no metastasis of vaginal stump. She came to our hospital for radiotherapy. The woman received concurrent chemoradiotherapy(CCRT)with weekly CDDP 30 mg/m2 as adjuvant therapy. Shortly after CCRT, she was diagnosed with multiple metastases to the bone, liver, lung, and brain. She received palliative radiotherapy and eventually died four months after being diagnosed. The extremely rapid progression of this patient's disease is unusual. To our knowledge, this is one of the most aggressive cases of cervical adenosquamous cell carcinoma documented.     

多种肿瘤标志物蛋白芯片检测系统(C-12)对老年肺癌转移诊断的临床价值研究

目的:利用多种肿瘤标志物蛋白芯片检测系统(C-12)检测老年肺癌患者各项肿瘤标志物的水平,并探讨C-12对老年肺癌患者是否发生转移的临床监测价值。方法:利用多种肿瘤标志物蛋白芯片检测系统检测年龄50岁以上的正常对照组(n=31)、肺部良性疾病组(n=23)、肺癌未转移组(n=24)以及肺癌转移组(n=33)血清12种肿瘤标志物水平并计算阳性率。结果:肺癌未转移组血清CA19-9、CEA、CA242、AFP、CA125和CA15-3的水平明显高于正常对照组(P<0.05),而肺癌转移组血清CA19-9、NSE、CEA、CA242、Fe蛋白、β-HCG、AFP、CA125、HGH和CA15-3这10项肿瘤标志物水平均显著高于正常对照组(P<0.05)。肺癌转移组与肺癌未转移组相比,CA19-9、CEA、CA242、Fe蛋白、CA15-3这5项肿瘤标志物水平和阳性率均明显升高(P<0.05)。结论:联合检测血清CA19-9、CEA、CA242、Fe蛋白、CA15-3的水平可以作为老年肺癌患者发生转移的辅助诊断指标。     

CA 15-3 (Mucin-1) and Physiological Characteristics of Breast Cancer from Lahore,Pakistan

Background: High incidence of breast cancer and its fatal effect has reached an alarming stage across theglobe, including the third world countries. Many factors have been reported to be associated with the developmentof breast cancer but detailed structural and functional information is missing. CA 15-3 is one of the knownpotential tumor marker of breast cancer; however little is known about structure and functional site of thisprotein. Present study aims to investigate the functional role of CA 15-3 in breast cancer, especially in developmentand metastasis. Material and Methods: Hundred female breast cancer patients confirmed by histopathologicalreports were included in the study. Their physiological characters were recorded in a performa. Enzyme linkedimmunosorbent assay (ELISA) technique was used to estimate serum CA 15-3 level. Immunohistochemistry wasdone for estrogen (ER), progesterone (PR) and Her2/neu receptors expression. Results: The study revealed thedetails of physiological characteristics of female breast cancer. Mean age was 37.72±5.99 and 55.05±7.28 yearsand serum CA 15-3 (MUC1) level was 60.47±8.59 and 63.17±4.58 U/ml in pre and post-menopause respectively,and both groups of women had sedentary life style. Their receptor status especially of progesterone, estrogen andHER-2/neu were positive in 50% of premenopausal women and 65% of postmenopausal women. Conclusion:There are multiple physiological factors promoting breast cancer. High serum CA 15-3 level and hormonalimbalance of ER, PR and Her2/neu appears to be the main cause of breast cancer. It may be possible that thefunctional sites of these proteins may be altered which may increase the chances of metastasis in breast cancer.     

血清肿瘤抗原15-3、恶性肿瘤特异性生长因子、骨桥蛋白和肿瘤抗原125联合检测在乳腺癌诊断和治疗中的价值

 【摘要目的　探讨血清肿瘤标志物[肿瘤抗原15-3（CA15-3）、恶性肿瘤特异性生长因子（TSGF）、骨桥蛋白（OPN）和肿瘤抗原125（CA125）]联合检测在乳腺癌诊断和治疗中的价值。方法　采用电化学发光法检测患者血清CA15-3和CA125、化学比色法检测TSGF及酶联免疫吸附试验法检测OPN水平,乳腺癌组（187例）与乳腺疾病良性对照组（50例）患者比较,分析各标志物与乳腺癌临床分期和复发转移的关系。对45例复发者比较血清肿瘤标志物与钼靶X线检出时间的差异。结果　乳腺癌组患者血清CA15-3、CA125、TSGF和OPN明显高于良性对照组（P＜0.01）;乳腺癌高分期（Ⅲ、Ⅳ期）组[四项指标分别为（83.21±28.67）、（89.13±32.42）、（278.66±137.23）U／ml和（97.4±11.7）ng／ml]明显高于良性对照组[（14.01±3.23）、（13.12±9.23）、（46.15±3.12）U／ml和（30.12±12.91）ng／ml]和低分期（Ⅰ、Ⅱ期）组[（60.03±19.35）、（58.21±17.46）、（155.79±113.11）U／ml和（77.5±10.81）ng／ml]（P＜0.05）;淋巴结转移组与无转移组、复发组与无复发组间差异有统计学意义（P＜0.05）;CA15-3、TSGF、OPN和CA125联合检测的敏感度为96.3 %（180／187）,特异度为80.0 %（40／50）;复发组血清肿瘤标志物检测比钼铑双靶X线检测出肿块时间平均早2个月。结论　CA15-3、TSGF、OPN和CA125血清学联合检测是乳腺癌早期诊断和监控复发转移的较好指标,有利于临床早期发现、早期干预。     

Variation of Tumor Markers in 277 Breast Cancer Cases

Introduction and purpose: Breast cancer is the most frequently diagnosed cancer in women in the world, Advances ‍in paraclinical methods have resulted in dramatic changes in determining the survival of patients. Serial evaluation ‍of serum levels of tumor markers is one of these methods. ‍Methods: During 1993-2002, 277 cases with breast cancer after mastectomy were included in this cross sectional ‍study. Data were extracted from the patients records. Characteristics of the patients associated with serum levels of ‍tumor markers like CEA,CA15-3 and receptor markers like ER,PR with P53,Cathepsin-D and HER -2 were evaluated. ‍Results: The most common involved age was in the 4th decade, accounting for 43.3%of the total. Most of the ‍cases (54.3%) had stage II disease; Ductal carcinoma with frequency of 83.3% was the most common pathology ‍involved and bone metastasis with 59% was prominent. There were elevated serum levels of CEA and CA15-3 in ‍50.6% and 41.7%, respectively. There was no statistical relation between serum levels of these markers with disease ‍stage (CEA: pearson chi-square = 0.133 CAl5-3: Pearson chi-square = 0.064). There was a great increase in serum ‍level of tumor markers during relapse (CEA P = 0.000 CA15-3 P = 0.000). ‍Discussion and Conclusions: Because diagnosis of breast cancer is generally at advanced stage in our country, ‍serum levels of tumor markers demonstrate great differences from those published for the Western world. It seems, ‍however, that serum levels of tumor markers might be reliable for predicting relapses.     

Prognostic Significance of Circulating Tumor Cells and SerumCA15-3 Levels in Metastatic Breast Cancer,Single CenterExperience,Preliminary Results

Background: Breast cancer is the second leading cancer causing death in women. Circulating tumor cellsare among the prognostic factors while tumor markers are of diagnostic value and can be used for follow-up.The aim of this study was to investigate the correlation between the prognostic significance of the serum CA15-3levels, number of circulating tumor cells and histopathological tumor factors. Materials and Methods: Thirtypatients recently diagnosed with breast cancer were included in the study. Number of circulating tumor cells andserum CA15-3 level were assessed when metastasis was detected and diagnostic value was assessed. Presence ofassociations with estrogen and progesterone receptors, c-erbB2, Ki-67 proliferation index and histological gradewere also evaluated. Results: Median overall survival of the patients with serum CA15-3 levels of >108 ng/dlwas 19 months whereas for those with a low serum level it was 62 months. Median overall survival for CTC≥5vs CTCConclusions: Prognostic significance of the CTC count and CA15-3 levels in metastaticbreast cancer patients was demonstrated.     

Comparison of circulating CA15-3 and carcinoembryonic antigen levels in patients with breast cancer

An immunoradiometric assay (IRMA) has been used to determine circulating levels of the breast cancer-associated antigen, CA15-3. Of 1,050 normal control subjects, serum from 99 (9.4%) had CA15-3 antigen levels greater than 22 U/mL, while that from 58 (5.5%) and 14 (1.3%) had levels greater than 25 U/mL and 30 U/mL, respectively. In contrast, 115 of 158 patients (73%) with metastatic breast cancer had CA15-3 levels greater than 22 U/mL. Thirteen of 26 patients (50%) with only local metastases, 27 of 34 (79%) of those with only bone metastases, and 20 of 24 (83%) with hepatic metastases had CA15-3 levels greater than 22 U/mL. Furthermore, nine of 31 patients (29%) with primary breast cancer had CA15-3 levels greater than 22 U/mL. CA15-3 and carcinoembryonic antigen (CEA) levels were compared for the same patient population. Significantly more patients with metastatic breast cancer had elevated CA15-3 levels than had elevated CEA levels (P less than .001). Furthermore, the CA15-3 IRMA was more sensitive than the CEA assay in patients with only bone metastases, as well as those with only local metastases. Significantly more patients with primary carcinoma of the breast also had elevated CA15-3 than had elevated CEA levels (P less than .02). CA15-3 levels were greater than 22 U/mL in patients with nonmalignant conditions, including five of 25 patients (20%) with benign breast diseases, and 23 of 52 patients (44%) with benign liver diseases. Furthermore, CA15-3 levels were also greater than 22 U/mL in 24 of 54 patients (44%) with gastrointestinal (GI) malignancies, 12 of 17 patients (71%) with bronchogenic carcinoma, and 29 of 44 patients (66%) with epithelial ovarian carcinoma. Serial CA15-3 levels correlated with clinical disease course. Nineteen of 21 patients (91%) with tumor progression had at least a 25% increase in CA15-3 levels. Conversely, seven of nine patients (78%) with tumor regression had at least a 50% decrease in CA15-3 levels. Among 27 patients with stable disease, 16 (59%) had levels that did not vary by more than +/- 25% of the original CA15-3 levels. These results indicate that the CA15-3 antigen is a sensitive marker for the evaluation and monitoring of patients with breast cancer.