Abstract
Background: The aim of this work was to analyze the diagnostic and prognostic value of serum human epididymis protein 4 (HE4) and Risk for Ovarian Malignancy Algorithm (ROMA) in epithelial ovarian cancer (EOC). Methods: Preoperative serum samples of 419 women (140 healthy controls, 131 ovarian benign cysts, 34 endometriosis, and 114 EOC) were tested for CA125 and HE4 using fully automated methods (Abbott ARCHITECT) and validated cutoff values. Results: For the discrimination of benign masses from EOC, in premenopausal women, the sensitivity and specificity were 92.3% and 59.4% for CA125, 84.6% and 94.2% for HE4, and 84.6% and 81.2% for ROMA, whereas in postmenopausal women, the sensitivity and specificity were 94.3% and 82.3% for CA125, 78.2% and 99.0% for HE4, and 93.1% and 84.4% for ROMA. In patients with EOC, elevated CA125, HE4, and ROMA levels were associated with advanced Federation of Gynaecologists and Obstetricians (FIGO) stage, suboptimally debulking, ascites, positive cytology, lymph node involvement, and advanced age (all P ≤ 0.05). Elevated HE4 and ROMA (both P ≤ 0.01), but not CA125 (P = 0.0579), were associated with undifferentiated tumors. In multivariable analysis, elevated HE4 and ROMA (all P≤0.05) were independent prognostic factors for shorter overall, disease-free, and progression-free survival. Conclusions and Impact: This study underlines the high specificity of HE4 in discriminating endometriosis and ovarian benign cysts from EOC and the high sensitivity of CA125 in detecting EOC. We showed HE4 and ROMA as independent prognostic factors. Multicenter studies are needed to draw firm conclusions about the applicability of HE4 and ROMA in clinical practice.
| Original language | English |
|---|---|
| Pages (from-to) | 2496-2506 |
| Number of pages | 11 |
| Journal | Cancer Epidemiology Biomarkers and Prevention |
| Volume | 20 |
| Issue number | 12 |
| DOIs | |
| Publication status | Published - Dec 2011 |
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ASJC Scopus subject areas
- Epidemiology
- Oncology
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Serum human epididymis protein 4 and risk for ovarian malignancy algorithm as new diagnostic and prognostic tools for epithelial ovarian cancer management. / Bandiera, Elisabetta; Romani, Chiara; Specchia, Claudia; Zanotti, Laura; Galli, Claudio; Ruggeri, Giuseppina; Tognon, Germana; Bignotti, Eliana; Tassi, Renata A.; Odicino, Franco; Caimi, Luigi; Sartori, Enrico; Santin, Alessandro D.; Pecorelli, Sergio; Ravaggi, Antonella.
In: Cancer Epidemiology Biomarkers and Prevention, Vol. 20, No. 12, 12.2011, p. 2496-2506.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Serum human epididymis protein 4 and risk for ovarian malignancy algorithm as new diagnostic and prognostic tools for epithelial ovarian cancer management
AU - Bandiera, Elisabetta
AU - Romani, Chiara
AU - Specchia, Claudia
AU - Zanotti, Laura
AU - Galli, Claudio
AU - Ruggeri, Giuseppina
AU - Tognon, Germana
AU - Bignotti, Eliana
AU - Tassi, Renata A.
AU - Odicino, Franco
AU - Caimi, Luigi
AU - Sartori, Enrico
AU - Santin, Alessandro D.
AU - Pecorelli, Sergio
AU - Ravaggi, Antonella
PY - 2011/12
Y1 - 2011/12
N2 - Background: The aim of this work was to analyze the diagnostic and prognostic value of serum human epididymis protein 4 (HE4) and Risk for Ovarian Malignancy Algorithm (ROMA) in epithelial ovarian cancer (EOC). Methods: Preoperative serum samples of 419 women (140 healthy controls, 131 ovarian benign cysts, 34 endometriosis, and 114 EOC) were tested for CA125 and HE4 using fully automated methods (Abbott ARCHITECT) and validated cutoff values. Results: For the discrimination of benign masses from EOC, in premenopausal women, the sensitivity and specificity were 92.3% and 59.4% for CA125, 84.6% and 94.2% for HE4, and 84.6% and 81.2% for ROMA, whereas in postmenopausal women, the sensitivity and specificity were 94.3% and 82.3% for CA125, 78.2% and 99.0% for HE4, and 93.1% and 84.4% for ROMA. In patients with EOC, elevated CA125, HE4, and ROMA levels were associated with advanced Federation of Gynaecologists and Obstetricians (FIGO) stage, suboptimally debulking, ascites, positive cytology, lymph node involvement, and advanced age (all P ≤ 0.05). Elevated HE4 and ROMA (both P ≤ 0.01), but not CA125 (P = 0.0579), were associated with undifferentiated tumors. In multivariable analysis, elevated HE4 and ROMA (all P≤0.05) were independent prognostic factors for shorter overall, disease-free, and progression-free survival. Conclusions and Impact: This study underlines the high specificity of HE4 in discriminating endometriosis and ovarian benign cysts from EOC and the high sensitivity of CA125 in detecting EOC. We showed HE4 and ROMA as independent prognostic factors. Multicenter studies are needed to draw firm conclusions about the applicability of HE4 and ROMA in clinical practice.
AB - Background: The aim of this work was to analyze the diagnostic and prognostic value of serum human epididymis protein 4 (HE4) and Risk for Ovarian Malignancy Algorithm (ROMA) in epithelial ovarian cancer (EOC). Methods: Preoperative serum samples of 419 women (140 healthy controls, 131 ovarian benign cysts, 34 endometriosis, and 114 EOC) were tested for CA125 and HE4 using fully automated methods (Abbott ARCHITECT) and validated cutoff values. Results: For the discrimination of benign masses from EOC, in premenopausal women, the sensitivity and specificity were 92.3% and 59.4% for CA125, 84.6% and 94.2% for HE4, and 84.6% and 81.2% for ROMA, whereas in postmenopausal women, the sensitivity and specificity were 94.3% and 82.3% for CA125, 78.2% and 99.0% for HE4, and 93.1% and 84.4% for ROMA. In patients with EOC, elevated CA125, HE4, and ROMA levels were associated with advanced Federation of Gynaecologists and Obstetricians (FIGO) stage, suboptimally debulking, ascites, positive cytology, lymph node involvement, and advanced age (all P ≤ 0.05). Elevated HE4 and ROMA (both P ≤ 0.01), but not CA125 (P = 0.0579), were associated with undifferentiated tumors. In multivariable analysis, elevated HE4 and ROMA (all P≤0.05) were independent prognostic factors for shorter overall, disease-free, and progression-free survival. Conclusions and Impact: This study underlines the high specificity of HE4 in discriminating endometriosis and ovarian benign cysts from EOC and the high sensitivity of CA125 in detecting EOC. We showed HE4 and ROMA as independent prognostic factors. Multicenter studies are needed to draw firm conclusions about the applicability of HE4 and ROMA in clinical practice.
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UR - http://www.scopus.com/inward/citedby.url?scp=83055178119&partnerID=8YFLogxK
U2 - 10.1158/1055-9965.EPI-11-0635
DO - 10.1158/1055-9965.EPI-11-0635
M3 - Article
C2 - 22028406
AN - SCOPUS:83055178119
VL - 20
SP - 2496
EP - 2506
JO - Cancer Epidemiology Biomarkers and Prevention
JF - Cancer Epidemiology Biomarkers and Prevention
SN - 1055-9965
IS - 12
ER -