Uno Masaya, Matsuo Rie, Maezawa Naoki, Kato Tomoyasu
Division of Genecology, National Cancer Center Hospital, Tokyo, Japan.
Department of Clinical Laboratory, National Cancer Center Hospital, Tokyo, Japan.
Obstet Gynecol Sci. 2023 Jul;66(4):290-299. doi: 10.5468/ogs.23024. Epub 2023 Jun 28.
We evaluated the usefulness of human epididymis protein 4 (HE4), a tumor marker, during and after treatment in patients with ovarian cancer (OC).
We included Japanese patients newly diagnosed with OC treated at the National Cancer Center Hospital between 2014 and 2021. The HE4 levels were measured in the serum stored during diagnosis. To evaluate the concordance between HE4 and the imaging results, we employed sequential pairs of blood sampling points and the results of imaging examinations. We compared the timing of the elevated HE4 levels, imaging diagnoses, and elevated cancer antigen 125 (CA125) levels in patients with recurrence. The Ethics Review Committee of our institution (2021-056) reviewed this study.
Forty-eight patients with epithelial OC were eligible for enrollment. The sensitivity, specificity, and positive and negative predictive values of HE4 (criterion, 70 pmol/L) for disease progression during the follow-up period were 79.4%, 59.1%, 32.5%, and 92.0%, respectively (time point, n=317). We evaluated the relationship between HE4 and CA125 variability and disease status (recurrence or no recurrence). For recurrence, the sensitivity and negative predictive value of HE4 (criterion, 70 pmol/L), CA125 (criterion, 35 U/mL), and combination of HE4 and CA125 were 77.8%, 85.2%, and 92.6% and 75.0%, 82.6%, and 88.9%, respectively (n=48). Among the 27 patients who exhibited recurrence, 16 and nine showed earlier increased HE4 levels than the relevant imaging and CA125 levels, respectively.
HE4 may be a valuable marker for follow-up during and after OC therapy. A complementary role for HE4 and CA125 measurements was suggested for follow-up observations.
我们评估了肿瘤标志物人附睾蛋白4（HE4）在卵巢癌（OC）患者治疗期间及治疗后的作用。
我们纳入了2014年至2021年期间在国立癌症中心医院接受治疗的新诊断为OC的日本患者。在诊断时储存的血清中测量HE4水平。为了评估HE4与影像学结果之间的一致性，我们采用了连续的采血点对和影像学检查结果。我们比较了复发患者中HE4水平升高、影像学诊断和癌抗原125（CA125）水平升高的时间。我们机构的伦理审查委员会（2021 - 056）审查了这项研究。
48例上皮性OC患者符合纳入标准。随访期间HE4（标准值，70 pmol/L）对疾病进展的敏感性、特异性、阳性预测值和阴性预测值分别为79.4%、59.1%、32.5%和92.0%（时间点，n = 317）。我们评估了HE4与CA125变异性及疾病状态（复发或未复发）之间的关系。对于复发，HE4（标准值，70 pmol/L）、CA125（标准值，35 U/mL）以及HE4与CA125联合检测的敏感性和阴性预测值分别为77.8%、85.2%、92.6%和75.0%、82.6%、88.9%（n = 48）。在出现复发的27例患者中，分别有16例和9例的HE4水平升高早于相关影像学和CA125水平。
HE4可能是OC治疗期间及治疗后随访的有价值标志物。建议在随访观察中HE4和CA125检测发挥互补作用。
