2019 Volume 68 Issue 4 Pages 644-649
HE4 is a new ovarian tumor marker that has been clinically used in Japan since April 2017, and the level of HE4 is less elevated than that of CA125 in gynecological benign diseases, the menstrual period and pregnancy. The aim of this study was to assess the variations of the levels of the tumor markers HE4 and CA125 among pre- and postmenopausal healthy Japanese volunteers. During the first examination, we compared the measured CA125 and HE4 levels in 62 pre- and postmenopausal women. The CA125 levels exceeded the reference level in four premenopausal women. One was pregnant, and the other three women had CA125 levels that declined to below the reference level at 5 to 7 days after their menstruation. This result suggests that the CA125 level was affected by pregnancy and menstruation. In contrast, none of the women showed HE4 levels that exceeded the reference level. This suggests that the HE4 level was hardly affected by pregnancy or menstruation. There were statistically significant differences in both HE4 and CA125 levels between pre- and postmenopausal women. In the second examination, HE4 and CA125 measurements were conducted once every two to three days in a month. Among nine premenopausal women, the CV of CA125 level was 21.47% and the CV of HE4 level was 8.90%. The SD of within-subject variation of HE4 level were 2.7 pmol/L for premenopausal women, 3.2 pmol/L for postmenopausal women, and 2.6 pmol/L for men. None of the women showed HE4 levels that exceeded the reference level. These results suggest that HE4 is a more stable tumor marker than CA125, and its level is hardly affected by pregnancy or menstruation.
