Stieber Petra, Molina Rafael, Chan Daniel W, Fritsche Herbert A, Beyrau Ralf, Bonfrer Jean M G, Filella Xavier, Gornet Terrie G, Hoff Torsten, Jäger Wolfram, van Kamp Gerard J, Nagel Dorothea, Peisker Klaus, Sokoll Lori J, Troalen Frédéric, Untch Michael, Domke Ingrid
Klinikum der Universität München -Grosshadern-, Institut für Klinische Chemie, Munich, Germany.
Clin Lab. 2003;49(1-2):15-24.
The aim of the present study was to evaluate the clinical performance of the CA 15-3 assay on Elecsys systems in an international multicenter study (11 centers). A total of 1326 single samples (272 apparently healthy individuals, 34 pregnant women, 308 benign diseases, 273 cancers other than breast, 439 breast cancer) and 538 serial samples of 98 breast cancer patients during follow-up were analyzed. 95% of values in healthy individuals were below 25 kU/L, and 88% in benign breast diseases, respectively. In malignant breast disease at primary diagnosis the value distribution of Elecsys CA 15-3, sensitivity at 95% specificity, as well as the areas under the curve in ROC analysis were clearly correlated to tumor stages: UICC I to IV 88 to 25% of values < 25 kU/L, sensitivity 7 to 78%, areas under the curve 0.53 to 0.94. During follow-up, sensitivity/specificity for detection of recurrences were 90%/71%. In metastatic disease clinical progression/response to therapy were indicated in 91%/78% of patients at a specificity of 92%/78%. The findings indicate that the Elecsys CA 15-3 assay is very suitable in routine work for detection of recurrences as well as for therapy control in metastatic breast cancer.
本研究的目的是在一项国际多中心研究（11个中心）中评估Elecsys系统上CA 15-3检测的临床性能。共分析了1326份单次样本（272名貌似健康的个体、34名孕妇、308例良性疾病、273例非乳腺癌的癌症、439例乳腺癌）以及98例乳腺癌患者随访期间的538份系列样本。健康个体中95%的值低于25 kU/L，良性乳腺疾病中这一比例为88%。在原发性诊断的恶性乳腺疾病中，Elecsys CA 15-3的值分布、95%特异性时的敏感性以及ROC分析中的曲线下面积与肿瘤分期明显相关：国际抗癌联盟（UICC）I至IV期，88%至25%的值<25 kU/L，敏感性7%至78%，曲线下面积0.53至0.94。在随访期间，检测复发的敏感性/特异性为90%/71%。在转移性疾病中，在特异性为92%/78%时，91%/78%的患者显示出临床进展/对治疗的反应。这些结果表明，Elecsys CA 15-3检测在常规工作中非常适合用于检测转移性乳腺癌的复发以及治疗监测。
