Alexandra Morell, Anne Stoklosa, Alexandra Blackman, Youngeun Armbuster, Rachael Rowswell-Turner, M Craig Miller, Richard G Moore
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The objective of this study was to assess the utility of serum HE4 levels as a biomarker for monitoring patients on PARP inhibitors and to compare HE4 performance parameters to those of serum CA125 levels.</p><p><strong>Methods: </strong>A retrospective chart review was performed evaluating patients on PARP inhibitors for ovarian cancer. Patients were included if they received a PARP inhibitor for at least 2 months and had at least 3 serial serum HE4 measurements during treatment. Changes in the serum CA125 and HE4 levels between measurements and over time were calculated and correlated with disease status. The null hypothesis was that HE4 was inferior to CA125.</p><p><strong>Results: </strong>A total of 102 patients with 103 treatment periods and 1554 evaluable serum samples were evaluated. Of these patients, 55 (53.9%) experienced a change in disease status while receiving PARP inhibitor treatment. An analysis using increases from serum baselines of ≥25.0% for HE4 and ≥15.0% for CA125 to indicate a change in disease status showed the accuracy of HE4 was 89.4% compared to 79.1% for CA125 (p < .001), indicating HE4 is not inferior to CA125 for monitoring disease status. Concordance comparison of HE4 accuracy over CA125 was 1.130 (McNemar's test p < .001), again indicating HE4 was not inferior to CA125. HE4 was shown not to be inferior to CA125 for monitoring patients with ovarian cancer on PARP inhibitors. An analysis using an increase from baseline of ≥25% for HE4 provided the highest accuracy for monitoring patients on PARP inhibitors.</p>","PeriodicalId":14097,"journal":{"name":"International Journal of Gynecological Cancer","volume":" ","pages":"102682"},"PeriodicalIF":4.7000,"publicationDate":"2025-09-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"The utility of the novel biomarker HE4 for monitoring epithelial ovarian cancer during PARP inhibitor treatment.\",\"authors\":\"Alexandra Morell, Anne Stoklosa, Alexandra Blackman, Youngeun Armbuster, Rachael Rowswell-Turner, M Craig Miller, Richard G Moore\",\"doi\":\"10.1016/j.ijgc.2025.102682\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>Poly(ADP-ribose) polymerase (PARP) inhibitor maintenance therapy is commonly used in patients with ovarian cancer. Prior studies have reported that serum cancer antigen 125 (CA125) poorly predicts disease progression for patients on PARP inhibitors. Human epididymal protein 4 (HE4) is a serum biomarker cleared by the United States (US) Food and Drug Administration (FDA) for monitoring disease in patients with ovarian cancer. The objective of this study was to assess the utility of serum HE4 levels as a biomarker for monitoring patients on PARP inhibitors and to compare HE4 performance parameters to those of serum CA125 levels.</p><p><strong>Methods: </strong>A retrospective chart review was performed evaluating patients on PARP inhibitors for ovarian cancer. Patients were included if they received a PARP inhibitor for at least 2 months and had at least 3 serial serum HE4 measurements during treatment. Changes in the serum CA125 and HE4 levels between measurements and over time were calculated and correlated with disease status. The null hypothesis was that HE4 was inferior to CA125.</p><p><strong>Results: </strong>A total of 102 patients with 103 treatment periods and 1554 evaluable serum samples were evaluated. Of these patients, 55 (53.9%) experienced a change in disease status while receiving PARP inhibitor treatment. An analysis using increases from serum baselines of ≥25.0% for HE4 and ≥15.0% for CA125 to indicate a change in disease status showed the accuracy of HE4 was 89.4% compared to 79.1% for CA125 (p < .001), indicating HE4 is not inferior to CA125 for monitoring disease status. Concordance comparison of HE4 accuracy over CA125 was 1.130 (McNemar's test p < .001), again indicating HE4 was not inferior to CA125. HE4 was shown not to be inferior to CA125 for monitoring patients with ovarian cancer on PARP inhibitors. An analysis using an increase from baseline of ≥25% for HE4 provided the highest accuracy for monitoring patients on PARP inhibitors.</p>\",\"PeriodicalId\":14097,\"journal\":{\"name\":\"International Journal of Gynecological Cancer\",\"volume\":\" \",\"pages\":\"102682\"},\"PeriodicalIF\":4.7000,\"publicationDate\":\"2025-09-27\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"International Journal of Gynecological Cancer\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1016/j.ijgc.2025.102682\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"OBSTETRICS & GYNECOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"International Journal of Gynecological Cancer","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.ijgc.2025.102682","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"OBSTETRICS & GYNECOLOGY","Score":null,"Total":0}
The utility of the novel biomarker HE4 for monitoring epithelial ovarian cancer during PARP inhibitor treatment.
Objective: Poly(ADP-ribose) polymerase (PARP) inhibitor maintenance therapy is commonly used in patients with ovarian cancer. Prior studies have reported that serum cancer antigen 125 (CA125) poorly predicts disease progression for patients on PARP inhibitors. Human epididymal protein 4 (HE4) is a serum biomarker cleared by the United States (US) Food and Drug Administration (FDA) for monitoring disease in patients with ovarian cancer. The objective of this study was to assess the utility of serum HE4 levels as a biomarker for monitoring patients on PARP inhibitors and to compare HE4 performance parameters to those of serum CA125 levels.
Methods: A retrospective chart review was performed evaluating patients on PARP inhibitors for ovarian cancer. Patients were included if they received a PARP inhibitor for at least 2 months and had at least 3 serial serum HE4 measurements during treatment. Changes in the serum CA125 and HE4 levels between measurements and over time were calculated and correlated with disease status. The null hypothesis was that HE4 was inferior to CA125.
Results: A total of 102 patients with 103 treatment periods and 1554 evaluable serum samples were evaluated. Of these patients, 55 (53.9%) experienced a change in disease status while receiving PARP inhibitor treatment. An analysis using increases from serum baselines of ≥25.0% for HE4 and ≥15.0% for CA125 to indicate a change in disease status showed the accuracy of HE4 was 89.4% compared to 79.1% for CA125 (p < .001), indicating HE4 is not inferior to CA125 for monitoring disease status. Concordance comparison of HE4 accuracy over CA125 was 1.130 (McNemar's test p < .001), again indicating HE4 was not inferior to CA125. HE4 was shown not to be inferior to CA125 for monitoring patients with ovarian cancer on PARP inhibitors. An analysis using an increase from baseline of ≥25% for HE4 provided the highest accuracy for monitoring patients on PARP inhibitors.
期刊介绍：
The International Journal of Gynecological Cancer, the official journal of the International Gynecologic Cancer Society and the European Society of Gynaecological Oncology, is the primary educational and informational publication for topics relevant to detection, prevention, diagnosis, and treatment of gynecologic malignancies. IJGC emphasizes a multidisciplinary approach, and includes original research, reviews, and video articles. The audience consists of gynecologists, medical oncologists, radiation oncologists, radiologists, pathologists, and research scientists with a special interest in gynecological oncology.
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