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Introduction/Background Biomarkers HE4 and CA 125 are elevated in advanced ovarian cancer patients. In diagnostics, they don´t play any crucial role. Thus, ultrasonography can detect ovarian cancer more precisely. They usually rise when the relapse occurs in the follow-up (FU) period. We aimed to determine their significance and value in the follow-up period. Methodology Twelve institutions have been collecting the prospective data for almost seven years. A fixed follow-up protocol with methodology was distributed among all centers, and an online database was a tool for data collection. Of 120 patients, 117 met the inclusion criteria and were analyzed, all had normal postoperative HE4 and CA125 levels, all older than 51. The median FU was 13.7 months. Overall, 85 (73%) patients relapsed. For every FU visit, CA125 and HE4 were measured. CT (chest/abdomen) was performed when markers rose above the standard level. Results The cut-off for HE4 (140 pmol/l postmenopausal women) and CA125 (35 IU/ml) revealed no significance in early relapse detection. The median HE4 level by relapsed patients was 96 pmol/L, whereas without 49 pmol/L. The median CA125 level at evidence of relapse was 76 IU/ml, while in visits without it was 10 IU/ml. For HE4, absolute change from baseline was set up at 15pmol/l, (sensitivity 74%, specificity 92%). For CA 125, absolute change from baseline was set up at 10 IU/ml (sensitivity 83%, specificity 93%). Using these new cut-offs, we detect the recurrence two months before CT confirmation by CA 125 and three months by HE4. Conclusion There are cut-offs for change in HE4 and CA 125 from baseline (even within the normal range) that predict disease relapse in advance. An increase in those markers indicates the risk of relapse up to three months before CT scan. The patient should eventually be closely monitored, and imaging methods should be performed. Disclosures No.
Presl et al. (Fri,) studied this question.