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1126 The game-changing role of HE4 and CA 125 in the follow-up setting in advanced ovarian and fallopian tube cancer – CEEGOG OX-01 study
  1. Jiri Presl1,
  2. Pavel Havelka2,
  3. Vit Weinberger3,
  4. Petra Ovesna4,
  5. Ladislav Masak5,
  6. Filip Frühauf6,
  7. Marcin Jedryka7,
  8. Branislav Bystricky8,
  9. Aleksandra Strojna9,
  10. Natalya Volodko10,
  11. Olga Matylevich11,
  12. Petra Herbolotva12,
  13. Vladimir Kalist2,
  14. Eliska Gazarkova3,
  15. Jan Kostun1,
  16. Barbora Chaloupková2,
  17. Vendula Smoligova1,
  18. Markéta Hrabalova2,
  19. Peter Linkesch2 and
  20. Libor Viktora3
  1. 1Department of Gynecology and Obstetrics, University Hospital Pilsen, Charles University, Faculty of Medicine in Pilsen, Pilsen, Czech Republic
  2. 2Department of Gynecology and Obstetrics, KNTB a.s Zlin, Zlin, Czech Republic
  3. 3University Hospital Brno, Medical Faculty of Masaryk University, Brno, Czech Republic
  4. 4Institute of Biostatistics and Analyses, Masaryk University Faculty of Medicine, Brno, Czech Republic
  5. 5Department of Gynecological Oncology, St. Elizabeth Cancer Institute, Bratislava, Slovakia
  6. 6Department of Obstetrics, Gynecology and Neonatology First Faculty of Medicine, Charles University and General University Hospital in Prague, Prague, Czech Republic
  7. 7Gynecological Oncology Department, Lower Silesian Oncology, Pulmonology and Hematology Center, Wroclaw, Wroclaw Medical University, Wroclaw, Poland
  8. 8Department of Oncology, Faculty Hospital, Trencin, Slovakia and Alexander Dubcek University of Trencin Faculty of Healthcare, Trencin, Slovakia
  9. 9Department of Gynecology and Gynecologic Oncology, Evangelische Kliniken Essen-Mitte, Essen, Germany
  10. 10State Oncological Regional Treatment and Diagnostic Center, Lviv, Ukraine
  11. 11Gynecologic Oncology Division, NN Alexandrov National Cancer Centre, Minsk, Belarus
  12. 12Department of Gynecology and Obstetrics, Faculty of Medicine in Pilsen, Charles University, Pilsen, Department of Gynecology and Obstetrics, Jihlava Hospital, Jihlava, Czech Republic

Abstract

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.

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