Prognostic Evaluation of HE4 in Cervical Cancer
Author(s)
AMAR RANJAN SINGH, MD, Harshita Dubey, PhD, Utkarsh Dubey, B.Tech..
All India Institute of Medical Sciences, New Delhi, India.
All India Institute of Medical Sciences, New Delhi, India.
OBJECTIVES: Cervical cancer (CC) accounts for 6-29% of all cancers in women in India. There is no biomarker for CC. We evaluated Human Epididymis Protein 4 (HE4) for its diagnostic & prognostic significance.
METHODS: Serum HE4 level was estimated in 87 patients and 63 healthy females (control) for three years. The cut-off value, 64 pmol/L, was set for a positive result (ROC curve analysis). Follow-up was done for overall survival (OS). OS was defined as the time interval between the date of diagnosis and the date of death or last follow-up.
RESULTS: We found that, in CC, 67/87 (77%) patients had elevated levels of HE4, while 20/87 (23%) had low levels of HE4. Out of 67/87 cases, we could reach out to only 35 patients, of whom 9 expired while 26 survived. However, all 20 patients with low HE4 levels were leading a normal life. Elevated HE4 values were associated with advanced-stage disease and pre-menopausal status. In healthy females, 56/63 (88.8%) cases showed low HE4 levels, while 7/63 (11.1%) cases showed elevated HE4 levels.
CONCLUSIONS: In this study, HE4 had a sensitivity of 71.2% and specificity of 88.9% in diagnosing CC. Patients with higher HE4 correlated with shorter survival. Higher HE4 values in healthy women were due to structural genital defects, as control cases were taken from the infertility clinic. The only available study, E. Bignotti et et.al, 2020, complies with our results. These results show that HE4 levels can aid in the diagnosis, therapeutic monitoring, & prediction of clinical outcomes in CC.Keywords: HE4, Cervical cancer, diagnosis
METHODS: Serum HE4 level was estimated in 87 patients and 63 healthy females (control) for three years. The cut-off value, 64 pmol/L, was set for a positive result (ROC curve analysis). Follow-up was done for overall survival (OS). OS was defined as the time interval between the date of diagnosis and the date of death or last follow-up.
RESULTS: We found that, in CC, 67/87 (77%) patients had elevated levels of HE4, while 20/87 (23%) had low levels of HE4. Out of 67/87 cases, we could reach out to only 35 patients, of whom 9 expired while 26 survived. However, all 20 patients with low HE4 levels were leading a normal life. Elevated HE4 values were associated with advanced-stage disease and pre-menopausal status. In healthy females, 56/63 (88.8%) cases showed low HE4 levels, while 7/63 (11.1%) cases showed elevated HE4 levels.
CONCLUSIONS: In this study, HE4 had a sensitivity of 71.2% and specificity of 88.9% in diagnosing CC. Patients with higher HE4 correlated with shorter survival. Higher HE4 values in healthy women were due to structural genital defects, as control cases were taken from the infertility clinic. The only available study, E. Bignotti et et.al, 2020, complies with our results. These results show that HE4 levels can aid in the diagnosis, therapeutic monitoring, & prediction of clinical outcomes in CC.Keywords: HE4, Cervical cancer, diagnosis
Conference/Value in Health Info
2025-09, ISPOR Real-World Evidence Summit 2025, Tokyo, Japan
Value in Health Regional, Volume 49S (September 2025)
Code
RWD306
Topic Subcategory
Reproducibility & Replicability
Disease
SDC: Oncology