CA125检测在卵巢上皮癌诊治监测中的价值探讨

１９９１年１月～１９９５年５月首次入院治疗的原发性卵巢上皮癌患者１５０例，复发性卵巢上皮癌患者２６例，卵巢癌第二次剖腹探查术１５例（共１９１例）。对ＣＡ１２５在卵巢上皮癌中的诊治监测价值进行探讨。结果发现１５０例首次治疗的卵巢上皮癌中，１３０例血ＣＡ１２５＞３５ｕ／ｍｌ，敏感性为８７％，特异性为８０％。其中浆液性上皮癌敏感性最高为９６％。Ｉ、Ⅱ期血ＣＡ１２５值为２１０±１０１ｕ／ｍｌ，Ⅲ、Ⅳ期为３９０±１５０ｕ／ｍｌ，Ｉ、Ⅱ期与Ⅲ、Ⅳ期ＣＡ１２５值之间有显著性等异（ｐ＜０．０５）；２６例复发卵巢癌中２２例血ＣＡ１２５值＞３５ｕ／ｍｌ，敏感性为８５％。１５例二探病人中，４例ＣＡ１２５值二探均为阳性。１１例血ＣＡ１２５值正常者中，６例二探结果为阳性，５例为阴性。提示ＣＡ１２５是目前辅助诊断卵巢上皮癌特别是浆液性腺癌最敏感的肿瘤指标；ＣＡ１２５的动态观察对卵巢上皮癌的治疗选择及预后判断具有重要价值。ＣＡ１２５的检测对二探的选择可提供可靠依据。     

血清CA125水平监测上皮性卵巢癌临床复发的作用

目的：分析血清ＣＡ１２５对上皮性卵巢癌临床复发的监测作用。方法：应用放射免疫法测定血清ＣＡ１２５对经过治疗病情稳定,ＣＡ１２５降到正常的２８例上皮性卵巢患者,定期测定血清ＣＡ１２５水平及其他临床检查项目,直到临床诊断肿瘤复发,分析血清ＣＡ１２５水平与肿瘤复发的关系（以ＣＡ１２５〈３５Ｕ／ｍｌ为正常值）。结果：本组２８例患者中,血清ＣＡ１２５〉３５Ｕ／ｍｌ者１２例,阳性率为４２．９％;血清ＣＡ１２５     

血清ＣＡ１２５水平监测在卵巢癌肿瘤细胞减灭术中的应用价值

目的　探讨血清ＣＡ１２５水平监测在卵巢癌肿瘤细胞减灭术中的应用价值。方法　采用微粒子捕捉免疫发光技术（ＭＥＩＡ）测定７５例卵巢上皮癌患者治疗前、每１周期化疗结束后３周及手术前血清中ＣＡ１２５浓度。计算第１周期化疗后血清ＣＡ１２５下降率。分析术前血清ＣＡ１２５水平及新辅助化疗第１周期化疗后血清ＣＡ１２５下降率与肿瘤细胞减灭术成功率的关系;分析初始血清ＣＡ１２５水平与盆腔淋巴结转移的关系。结果　７５例卵巢上皮癌患者中ＣＡ１２５＞３５Ｕ／ｍｌ者７２例。５６例行新辅助化疗后患者第１周期化疗后血清ＣＡ１２５下降率≥５０％组与＜５０％组理想肿瘤细胞减灭术成功率无差异（Ｐ＝０.１８７）;新辅助化疗后患者术前血清ＣＡ１２５≤２００Ｕ／ｍｌ组与＞２００Ｕ／ｍｌ组理想肿瘤细胞减灭术成功率无差异（Ｐ＝０.０８４）;初诊时血清ＣＡ１２５＞８００Ｕ／ｍｌ组盆腔淋巴结阳性率高于≤８００Ｕ／ｍｌ组（Ｐ＝０.０２６）。结论　初诊时血清ＣＡ１２５＞８００Ｕ／ｍｌ组盆腔淋巴结阳性率高,可以作为选择淋巴结清扫术的参考指标。术前ＣＡ１２５水平及新辅助化疗后患者第１周期化疗后血清ＣＡ１２５下降率对选择卵巢癌肿瘤细胞减灭术的时机无指导意义。     

血清CA125测定对卵巢癌的诊断和治疗的意义

从１９８５年５月～１９８９年５月，作者采用单克隆抗体ＯＣ１２５，以放射免疫固相测定法进行检测人血清ＣＡ１２５抗原。测定结果，确定在本文研究中的血清ＣＡ１２５正常值为６５Ｕ／ｍｌ，≤６５Ｕ／ｍｌ为阴性，＞６５Ｕ／ｍｌ为阳性。卵巢上皮性癌患者的血清ＣＡ１２５水平８１．５％（７５／９２）为阳性，明显高于对照人群的２．５％，其中浆液性癌阳性率高达９３．２％（４１／４４）．根据ＣＡ１２５数值的动态变化来观察对评定疗效、预示复发及指导选择二探术等方面的临床意义，ＣＡ１２５阳性的病例不需要接受二探术，ＣＡ１２５水平与肿瘤变化的符合率达９２．９％。这充分证明ＣＡ１２５＞６５Ｕ／ｍｌ水平，肿瘤病灶＞２ｃｍ者，对化疗的反应差，预后也差。     

卵巢癌相关抗原及抗体检测有助临床诊断

第四军医大学西京医院妇产科副教授田杨顺和北京大学人民医院妇科肿瘤中心冯捷教授等,应用卵巢癌抗原ＣＰ２及卵巢癌抗独特型单克隆抗体６Ｒ１１Ａｂ２联合进行血清中相关抗体检测。他们应用ＥＬＩＳＡ法对９５例恶性卵巢肿瘤、４０例良性卵巢肿瘤及９例子宫内膜异位症患者血清进行卵巢癌相关抗原及抗体的检测,并以５０例正常女性为对照。结果显示,非粘液性卵巢上皮癌与转移性卵巢癌患者抗原阳性率为１００％,明显高于非恶性妇科肿瘤患者的 ６３％（Ｐ＜ ０．０１）,而粘液性卵巢上皮癌、非上皮性卵巢恶性肿瘤、生殖系统其他恶性肿瘤的…     

消化道恶性肿瘤病人血清CA242水平及临床意义初探

作者采用生物素－链亲和素酶联免疫吸附试验方法，对１６４例消化道癌症病人血清ＣＡ２４２水平进行测定。结果，胰腺癌病人血清ＣＡ２４２含量最高（２８６．２±１２５．３Ｕ／ｍｌ），诊断阳性率为７６．９％，特异性为９１．２％；结直肠癌病人为１９３．６±１０６．４Ｕ／ｍｌ，诊断阳性率为６８．９％，特异性为８４．９％；与正常人及其它癌症病人比较，有非常显著性差异（Ｐ＜０．０１）。肝癌组为８６．１±３５．７Ｕ／ｍｌ，胃癌组为３７．６±１６．３Ｕ／ｍｌ，与正常对照组比较亦有显著性差异（Ｐ＜０．０５），但其敏感性仅分别为５８．３％和３２．３％。手术后病情明显缓解的病人，其血清ＣＡ２４２水平明显降低，与病情恶化或复发病人相比，有非常显著性差异（Ｐ＜０．０１）。其它癌症与良性疾病者血清ＣＡ２４２水平无显著性差异（Ｐ＞０．０５）。表明血清ＣＡ２４２水平测定对胰腺癌及结直肠癌的诊断、鉴别诊断、疗效观察和预后评估有一定价值。     

CA—125与子宫内膜抗体测定在子宫内膜异位症诊断中的价值

测定２８例子宫内膜异位症患者及１４例正常健康妇女血清ＣＡ－１２５和子宫膜抗体（ＥＭＡｂ）水平。结果，血清ＣＡ－１２５浓度与子宫内膜异位症临床分期呈正相关，Ⅲ、Ⅳ期子宫内膜异位症患者血清ＣＡ－１２５明显高于对照组；子宫内膜异位症患者血清ＥＭＡｂ明显高于对照组。两者用于子宫内膜异位症诊断的敏感性分别为７１．４３％和８２．１４％，特异性分别为５７．２１％和５７．１４％。     

血清ＣＡ７２-４预测胃癌根治术后复发的临床研究

目的　探讨血清糖链抗原７２-４（ＣＡ７２-４）水平在胃癌根治术后复发患者中的临床价值。方法　动态监测７１例胃癌患者根治术术前、术后至复发的血清ＣＡ７２-４水平,分别记录复发前血清ＣＡ７２-４高于正常组（Ａ组）首次出现ＣＡ７２-４升高值及其距手术时间和距复发时间,以及Ａ组与复发前血清ＣＡ７２-４正常组（Ｂ组）的无病生存期（ＤFＳ）;采用受试者工作特征曲线（ＲＯＣ）计算Ａ组患者６个月内复发的血清ＣＡ７２-４阈值。结果　７１例复发患者中Ａ组为４３例,Ｂ组为２８例,两组的中位ＤＦＳ分别为１８.４个月和２６.９个月（Ｐ＝０.０００）。Ａ组患者首次出现ＣＡ７２-４升高值及其距手术时间和距复发时间分别为（５７.７±２６.８）Ｕ／ｍｌ、１２.４个月和５.２个月。在Ａ组中,首次出现ＣＡ７２ ４升高的６个月内复发者为２６例,中位距复发时间为４.５个月;６个月以上复发者１７例,中位距复发时间为９.５个月,经ＲＯＣ计算６个月内复发的血清ＣＡ７２-４阈值为５６.８Ｕ／ｍｌ（Ａｚ＝０.９４１）。７１例患者复发前首次出现血清ＣＡ７２-４≥５６.８Ｕ／ｍｌ组的中位ＤＦＳ为１７.０个月,低于复发前首次出现血清ＣＡ７２.４升高且<５６.８Ｕ／ｍｌ组的２１.１个月和Ｂ组的２６.９个月（Ｐ＝０.０００）。结论　动态监测血清ＣＡ７２-４水平对胃癌根治术后复发具有早期预测作用,尤其当首次检测血清ＣＡ７２-４升高且≥５６.８Ｕ／ｍｌ时能够较好地预测胃癌的复发。     

血清CA125监测子宫内膜腺癌的临床价值

作者采用放射免疫测定法监测了１００例子宫内膜腺癌的血清ＣＡ１２６水平。结果表明病人的血清ＣＡ１２５水平显著高于健康妇女及子宫内膜不典型增生者。Ⅰ、Ⅱ、Ⅲ、Ⅳ期的阳性率分别为２９．４％、５４．８％、１００；０％及８０．０％，有显著差异。复发者阳性率为１６．６％，未控者阳性率为８７．０％。ＣＡ１２ｓ值随病情变化而变化。阳性组与阴性组的３年生存率分别为６９．０％、９１．０％，有显著差异。作者认为血清ＣＡ１２５水平主要与肿瘤负荷及播散范围有关，可作为正确估计病期、监测病情变化及指示预后的有效指标。     

肿瘤标志物CA15-3的免疫放射分析及其临床应用

目的发展一项新的肿瘤标志物免疫放射分析,并初步评价其临床应用价值。方法从瑞典引进单克隆抗体Ｍａ５５２与Ｍａ６９５,以前者为扑捉抗体,后者为标记抗体,建立一种夹心式的免疫放射分析。将Ｍａ５５２包被于聚苯乙烯小珠上,并以１２５－Ｉ标记Ｍａ６９５单抗。测定为室温下的一步反应。结果标准曲线的Ｂｍａｘ／Ｂ０为８２。本测定的灵敏度为０．３Ｕ／ｍｌ;批内与批间ＣＶ分别为８％与１０％。５０名正常女性血清ＣＡ１５－３值为１１．３±３．９Ｕ／ｍｌ,若以３０Ｕ／ｍｌ为判别的界值,则假阳性率为０％。良性乳腺病４０例,ＣＡ１５－３值９．６±５．８Ｕ／ｍｌ,假阳性率０％。６５例不同病程阶段的乳腺癌患者,疗前血清ＣＡ１５－３水平为８８．４±１５９．６Ｕ／ｍｌ,总阳性率５０．８％。肝转移,特别是骨转移引起显著的血清ＣＡ１５－３升高,阳性率可达１００％（ｎ＝９）。乳腺癌复发的患者ＣＡ１５－３阳性率为８０％（ｎ＝５）。结论新建成的免疫放射分析在乳腺癌的诊断,鉴别诊断,监视转移和复发中有高度的临床应用价值,比ＣＥＡ更好。     

Clinical evaluation of serum sialosyl-Tn antigen levels in comparison with CA 125 levels in gynecologic cancers.

The serum levels of sialosyl-alpha 2,6GalNAc alpha 1-0-serine/threonine (S-Tn) antigen and CA 125 antigen were measured in 205 patients with gynecologic tumors, including 48 ovarian cancers, 20 endometrial cancers, 29 cervical cancers, 57 benign ovarian tumors, 37 uterine leiomyomas, and 14 adenomyosis. Using a cutoff value of 41 U/ml for S-Tn and 35 U/ml for CA 125, positive findings were obtained in ovarian cancers in 31 of 48 (64.6%) patients with S-Tn antigen, and in 36 of 48 (75%) patients with CA 125. In uterine malignancies, positive findings were obtained in 11 of 49 (22.4%) patients and in 8 of 49 (16.3%) patients with the serum S-Tn and CA 125 antigens, respectively. In ovarian benign tumors, false-positive findings with CA 125 were observed in 16 of 57 (28.1%) patients, but with S-TN antigen in only 3 of 57 (5.3%) patients (P less than 0.01). For the ovarian tumors, excluding patients with recurrent disease, the specificity, positive predictive value, and accuracy of the serum S-Tn antigen level for detecting cancer exceeded that of the serum CA 125. The combined assay of serum S-Tn and CA 125 antigens gave positive results in 38 of 48 (79.2%) patients with ovarian cancers; most of the negative findings were obtained in Stage I disease. A significant decreases in serum S-Tn level was observed after cytoreductive surgery in 14 patients with ovarian cancer (P less than 0.01). Four patients with a subsequent recurrence showed a concomitant rise in serum S-Tn. The cyst fluid and ascitic fluid showed high levels of S-Tn antigen in patients with ovarian cancer, in contrast to findings in patients with benign ovarian tumors. In conclusion, serum S-Tn antigen has limited use in diagnosing early stage ovarian cancer and uterine malignancies, but it can detect with accuracy ovarian cancers when used in a combination assay with CA 125 and can monitor the status of disease after therapy.     

Significance of CA 125 antigen levels in patients with ovarian cancer

CA 125 antigen levels were measured in patients with ovarian cancer (54 cases) by the RIA method using a monoclonal antibody OC 125 and were examined as a marker for ovarian cancer. The upper normal limit of CA 125 of 35 U/ml was derived from the mean value (15.7 U/ml) + 2 SD (9.3 U/ml) of CA 125 in healthy controls. The mean value of CA 125 in patients with ovarian cancer (1160 +/- 1850 U/ml) was statistically (p less than 0.001) higher than those of healthy controls, benign ovarian tumors (28 +/- 20 U/ml) and cervical cancers (226 +/- 526 U/ml). Elevated CA 125 levels were also found in the early stages pregnancy and endometriosis, but these cases did not show such high CA 125 values as those of ovarian cancers. In addition, CA 125 levels were not affected by the menstrual cycle. Among ovarian malignancies, elevated CA 125 values were specifically demonstrated in serous cystadenocarcinoma (positivity 89%) and markedly low in mucinous cystadenocarcinoma (positivity 16%). No positive correlation of CA 125 values with clinical stage (FIGO) were found in any ovarian cancer patients. The rise or fall of CA 125 level was well correlated with the progression or regression observed in cancer patients with positive CA 125 levels. In conclusion, serum CA 125 determinations may be useful in patients with ovarian cancer (except for mucinous type) for diagnosis and for monitoring the results of treatment.     

Diagnosis and follow-up of ovarian cancer 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 diagnosis of ovarian cancer and follow-up of the patient with ovarian cancer. In 28 patients with ovarian tumors, the sera of 8 (66.7%) of 12 with ovarian cancer and 5 (71.4%) of the 7 with endometriosis (endometrial cyst) were positive for both SLX and CA125, but serum SLX level was 50 U/ml or less in all these 5 SLX-and-CA125 positive patients with endometriosis. The sera of all 9 patients with benign ovarian tumor were negative for both tumor markers. No patient with endometriosis was negative for both markers. The diagnostic accuracy (true positive rate X true negative rate) of the combination assay for ovarian cancer was 50.3% when the cut-off value of the serum SLX was 38 U/ml but improved to 81.8% when the value was set at 50 U/ml. From the above observations, a combination assay of serum SLX and CA125 is promising method for the differential diagnosis of malignant and benign ovarian tumors. Our results also suggest that to improve the diagnostic accuracy, the cut-off value of the serum SLX level should be 50 U/ml for ovarian tumors alone. We found following-up two cases of ovarian cancer that the serum SLX level is not affected by the ascites and inflammation. We expect that this combination assay of serum SLX and serum CA125 will be beneficial for diagnosis and follow-up of ovarian cancer.     

CLINICAL DIAGNOSIS AND TREATMENT OF SMALL OVARIAN TUMOR IN POSTMENOPAUSAL WOMEN

Objective： To investigate the clinical symptom, ultrasonographic scan finding, serum CA125 value, histopathological type and treatment of small ovarian tumor （〈5 cm） in postmenopausal women. Methods： Retrospective analysis was carried out for 52 clinical materials of ovarian tumor cases in women more than one year after menopausal between Jan 1997 and Dec 2004. The largest diameter of the ovarian mass is less than 5 cm. Results： There were 11 ovarian cancers and 1 borderline ovarian tumor among 52 small ovarian tumors （23.1%）. 10 ovarian cancers were epithelial neoplasms and 2 were sex cord-stromal tumors, and 8 cases were in late stage according to FIGO staging system （33.3%）. Compared with benign tumor, there is no significant difference in the onset age, interval after menopausal and duration of history. The main clinical feature is abdominal symptoms, such as abdominal pain and distension in the malignant cases. The patients with benign tumors often showed the ovarian mass during the annual screening or admitted into hospital for other causes. The ultrasonography finding and serum CA125 level showed much difference between benign and malignant cases. Unilocular smooth-walled ovarian cysts mostly were found in benign tumor and the CA125 values were always less than 35 U/ml; but the solid or complex sonographic structures （multilocular, or with a papillary projections on the wall） often indicated a high risk of cancer, especially there was ascites in the pelvic cavity. Serum CA125 level in many cancer cases was elevated （〉35 U/ml）, over 300 U/ml in more than half of the patients. Surgery is still the first choice to treat ovarian cancer, and chemotherapy would be an auxiliary method. Till now, 3 ovarian cancer patients died of complications of cancer and 2 cases had recurrence. Conclusion： Small ovarian tumor in postmenopausal women has a comparatively low malignant occurrence but more in later stage. Many are epithelial carcinoma. If there is complex or parenchymal sonographic structure accompanied with a high serum CA125 level, operation should be considered, while it can be followed up when the ultrasound shows a smooth cyst with normal CA125 value.     

Serum level of the tumor marker CA 125 before second-look laparatomy in primary epithelial ovarian cancer in relation to intraoperative findings

Serum CA 125 levels were evaluated in 76 patients undergoing second-look laparatomy for primary epithelial ovarian cancer. The findings were related to the presence of intraabdominal tumor. CA 125 levels were greater than 35 U/ml in 26 cases in accordance to the intraoperative findings. CA 125 levels less than or equal to 35 U/ml were found in 50 cases out of which 29 were free of tumor, while 21 showed intraabdominal tumors. Thus a CA 125 level greater than 35 U/ml revealed to be a strong predictor of the presence of intraabdominal tumor. Due to low sensitivity monitoring serum CA 125 levels cannot replace second-look laparotomy.     

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.     

血清糖类抗原125和糖类抗原199在卵巢肿瘤诊断中的意义

目的探讨血清糖类抗原125（CA125）和糖类抗原199（CA199）在卵巢肿瘤诊断中的意义。方法采用化学发光法检测2010年1月至2011年12月收治的196例卵巢肿瘤患者（良性肿瘤组140例、交界性肿瘤组13例、恶性肿瘤组43例）和50例健康体检者（对照组）的血清CA125和CA199。比较两种肿瘤标记物单检及联检在卵巢肿瘤诊断中的敏感度和特异度。结果 （1）CA125在卵巢良性肿瘤、交界性肿瘤和恶性肿瘤的表达水平分别为（19.80±13.57）U/ml、（94.59±53.41）U/ml和（759.00±677.26）U/ml,均高于对照组水平（9.94±5.64）U/ml,各组之间差异有统计学意义（P〈0.05）;（2）CA199在卵巢良性肿瘤、交界性肿瘤和恶性肿瘤的表达水平分别为（69.13±72.08）U/ml、（167.70±19.22）U/ml和（184.00±93.26）U/ml,均高于对照组水平（13.42±11.16）U/ml,但各组之间差异无显著意义（P〉0.05）;（3）CA125在卵巢恶性肿瘤诊断中敏感度、特异度为76.7%和90.0%,均高于CA199,两者联合检测并没有明显提高敏感度,反而降低了特异度。结论 CA125可作为卵巢肿瘤诊断的生物指标,而CA199的敏感度和特异度均较低,临床意义不大,两者联合检测并没有比CA125单项检测更具优势。     

CA125-response assessment in epithelial ovarian cancer.

To assess the clinical potential of serial serum CA125 measurements in the follow-up of patients with epithelial ovarian cancer, 74 consecutive unselected patients with histologically confirmed ovarian carcinoma were studied prospectively. There was an 83% concordance between clinical assessment and CA125 assessment of response. The positive predictive values of a rising CA125 for disease progression and a falling CA125 for disease regression were 0.93 and 0.94, respectively. The absolute CA125 values during observations of complete response (mean 96 U/ml; 95% confidence interval; 33 to 128 U/ml), partial response (mean 134 U/ml; 95% confidence interval; 98 to 159 U/ml) and stable or progressive disease (mean 391 U/ml; 95% confidence interval; 282 to 545 U/ml) were significantly different. A randomized study is required to determine whether CA125 monitoring has any benefit in terms of outcome, and particularly survival, in epithelial ovarian cancer.     

Clinical significance of elevation of serum CA125 level in patients with metastatic bladder carcinoma

Objective: To explore the clinical significance of the examination of serum CA125 level of patients with metastatic bladder carcinoma.Methods: Electrochemiluminescance technique was used to examine the serum CA125 concentration of 58 cases with metastatic bladder cancer.30 cases of superficial bladder cancer and 8 cases of other urological diseases were collected as the control group.Results: Serum CA125 level in 39 (67.2%) out of 58 cases ranged from 36.7 U/mL to 1485.6 U/mL (mean 498.3 U/mL), being higher than normal (＜35 U/mL).Serum CA125 level of metastatic bladder cancer patientswas 324.5 U/mL, significantly higher than that in control group (P＜0.001).Serum CA125 level of 10 patients after transurethral resection operation was significantly lower than that before operation (P＜0.05).Serum CA125 level of 16 patients whorefused further treatment significantly increased from 450.4 U/mL, to 505.8 U/mL (P = 0.041) 3 months after discharge from the hospital.Serum CA125 level of 17 patients significantly decreased from 475.8 U/L to 237.9 U/mL (P＜0.001 ) after bilaterallilac-arterial embolism treatment.Conclusion: CA125 may be a valuable marker for the judgment of advanced metastatic bladder cancer.     

Coordinate elevation of serum markers in ovarian cancer but not in benign disease

Effective screening for occult ovarian cancer will require a strategy that is both sensitive and specific. Preliminary data suggest that CA 125 is elevated at diagnosis in a majority of patients with ovarian cancer. Although CA 125 is sufficiently specific to prompt its evaluation as one component of a strategy to detect ovarian cancer in postmenopausal women, a further improvement in specificity would facilitate cost-effective screening. In an attempt to develop a more specific screening strategy, multiple markers were assayed in a panel of sera from 47 patients with ovarian cancer and in a separate panel of sera from 50 individuals with benign disease whose serum CA 125 levels exceeded 35 U/ml. Among the patients with ovarian cancer, elevations of CA 125 (greater than 35 U/ml) were observed in 91%, CA 15-3 (greater than 30 U/ml) in 57%, TAG 72 (greater than 10 U/ml) in 49%, placental alkaline phosphatase (PLAP) in 25%, human milk fat globule protein (HMFG) 1 in 77%, HMFG2 in 62%, and NB/70K in 57%. Among the 50 sera selected from patients with benign disease, CA 125 was more than 35 U/ml in 100% and more than 65 U/ml in 42%. Among those patients with benign disease and elevated CA 125, NB/70K was elevated in 62%, HMFG1 in 26%, and HMFG2 in 12%, whereas TAG 72 and CA 15-3 were elevated in only 6% and 2%, respectively. In addition PLAP appeared promising; elevated enzyme levels were not found in the benign disease group. Among patients with ovarian cancer with CA 125 levels more than 35 U/ml, either TAG 72 or CA 15-3 was elevated in 77%. In the false-positive group, only 6% had elevations of one or the other marker. The CA 125 levels in cancer patients were, however, substantially greater than in patients with benign disease. If sera from patients with ovarian cancer were diluted to a range comparable to that found in benign disease, at least one of the two confirmatory tests was elevated in 63% of the samples from the malignant cases. Consequently, use of CA 15-3 and TAG 72 in combination with CA 125 can increase the apparent specificity of the CA 125 assay for distinguishing malignant from benign disease. Prospective studies will be required to test critically whether the use of additional serum markers in combination with the CA 125 assay would contribute to the specificity of a cost-effective screening strategy for ovarian cancer.