Background: Ovarian, fallopian tube, and primary peritoneal cancers often share clinical characteristics and are typically diagnosed at advanced stages due to nonspecific symptoms. The utility of tumor markers, particularly CA125 and HE4, in the diagnosis and follow-up of these cancers remains an area of active investigation.Objectives: The CEEGOG (Central and Eastern European Gynecologic Oncology Group) OX-01 study aimed to evaluate HE4’s role alongside CA125 in follow-up for advanced-stage ovarian, fallopian tube, and primary peritoneal cancers. It assessed the potential for detecting recurrence using marker elevation and imaging methods, examining the necessity of dynamic monitoring and current cut-off values’ accuracy for early relapse detection.Methods: In this multicenter prospective cohort study, 117 eligible patients with Stage III–IV cancers were included. Patients had elevated CA125 or HE4 at diagnosis and achieved complete remission after first-line treatment. HE4 and CA125 levels were monitored every 3–4 months in the first two years and every six months thereafter. CT scans were performed if markers exceeded set thresholds or increased by over 20%.Results: During a median follow-up of 13.7 months, 73% of patients relapsed. Median HE4 levels were significantly higher in relapsed patients. A 10 IU/mL increase from baseline in CA125 had a sensitivity of 83% and specificity of 93%, while a 15 pmol/L increase in HE4 had a sensitivity of 74% and specificity of 92% for predicting relapse up to three months before CT scan detection.Conclusions: The study found that dynamic changes in HE4 and CA125 levels, rather than predefined cut-off values, are crucial for early relapse detection. These markers may offer a significant lead time over imaging, potentially enabling earlier intervention. Further research is needed to validate these findings.
背景：卵巢癌、输卵管癌及原发性腹膜癌常具有相似的临床特征，且因症状非特异性通常诊断时已属晚期。肿瘤标志物，特别是CA125和HE4，在这些癌症的诊断与随访中的应用价值仍是当前研究的热点。 目的：中欧及东欧妇科肿瘤学组（CEEGOG）OX-01研究旨在评估HE4与CA125在晚期卵巢癌、输卵管癌及原发性腹膜癌随访中的作用。该研究通过标志物升高及影像学方法评估了检测复发的可能性，并探讨了动态监测的必要性以及现有截断值对早期复发检测的准确性。 方法：在这项多中心前瞻性队列研究中，纳入了117例符合条件的III–IV期癌症患者。所有患者在诊断时CA125或HE4水平升高，并在接受一线治疗后达到完全缓解。前两年每3–4个月监测一次HE4和CA125水平，之后每六个月监测一次。若标志物超过设定阈值或升高超过20%，则进行CT扫描。 结果：在中位随访13.7个月期间，73%的患者出现复发。复发患者的HE4中位水平显著更高。CA125较基线升高10 IU/mL对CT扫描检测前三个月内复发的预测敏感度为83%，特异度为93%；而HE4升高15 pmol/L的敏感度为74%，特异度为92%。 结论：研究发现，HE4和CA125水平的动态变化（而非预设的截断值）对早期复发检测至关重要。这些标志物可能较影像学检查提供更长的预警时间，从而有望实现更早的干预。未来需要进一步研究验证这些发现。
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