biochimica clinica

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RASSEGNE - Reviews

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Biochimica Clinica 2013; 37(3) 179-189

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Serum human epididymis protein 4 vs. carbohydrate antigen 125 for ovarian cancer diagnosis: a systematic review

AUTORI

Simona Ferraro1, Federica Braga1, Monica Lanzoni2, Patrizia Boracchi2, Elia Mario Biganzoli2, Mauro Panteghini1
1Laboratorio Analisi Chimico-Cliniche, Azienda Ospedaliera “Luigi Sacco", and Cattedra di Biochimica Clinica e Biologia Molecolare Clinica, Università degli Studi, Milano
2Sezione di Statistica Medica e Biometria, Università degli Studi, Milano, and Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy

ABSTRACT

Human epididymis protein 4 (HE4) measurements in serum have been proposed for improving the specificity of laboratory identification of ovarian cancer (OC). This study sought to critically revise the available literature on the comparison between the diagnostic accuracy of HE4 and carbohydrate antigen 125 (CA-125) to provide evidence of HE4 additional clinical value. Literature search was undertaken on electronic databases and references from retrieved articles, and articles analyzed according to predefined criteria. Meta-analyses for HE4 and CA-125 biomarkers with odds ratio (OR), diagnostic sensitivity, specificity, positive (LR+) and negative (LR–) likelihood ratios as effect sizes were performed. Sixteen articles were originally included in meta-analyses, but two for HE4 and one for CA-125 were eliminated as outliers. Furthermore, for HE4 a publication bias was detected. ORs for both HE4 (37.2, 95% CI: 19.0-72.7, adjusted for publication bias) and CA-125 (15.4, 95% CI: 10.4-22.8) were significant, although in a heterogeneous set of studies (P <0.0001). By combining sensitivity and specificity, the overall LR+ and LR– were 13.0 (95% CI: 8.2-20.7) and 0.23 (95% CI: 0.19-0.28) for HE4 and 4.2 (95% CI: 3.1-5.6) and 0.27 (95% CI: 0.23-0.31) for CA-125, respectively. HE4 measurement seems to be superior to CA-125 in terms of diagnostic performance for identification of OC in women with suspected gynecological disease. Due to the high prevalence of OC in post-menopausal women and the need of data focused on early tumor stages, more studies tailored on these specific subsets are needed.

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