Does risk for ovarian malignancy algorithm excel human epididymis protein 4 and ca125 in predicting epithelial ovarian cancer: A meta-analysis
Tóm tắt
Risk for Ovarian Malignancy Algorithm (ROMA) and Human epididymis protein 4 (HE4) appear to be promising predictors for epithelial ovarian cancer (EOC), however, conflicting results exist in the diagnostic performance comparison among ROMA, HE4 and CA125. Remote databases (MEDLINE/PUBMED, EMBASE, Web of Science, Google Scholar, the Cochrane Library and ClinicalTrials.gov) and full texts bibliography were searched for relevant abstracts. All studies included were closely assessed with the QUADAS-2 (Quality Assessment of Diagnostic Accuracy Studies-2). EOC predictive value of ROMA was systematically evaluated, and comparison among the predictive performances of ROMA, HE4 and CA125 were conducted within the same population. Sensitivity, specificity, DOR (diagnostic odds ratio), LR ± (positive and negative likelihood ratio) and AUC (area under receiver operating characteristic-curve) were summarized with a bivariate model. Subgroup analysis and sensitivity analysis were used to explore the heterogeneity. Data of 7792 tests were retrieved from 11 studies. The overall estimates of ROMA for EOC predicting were: sensitivity (0.89, 95% CI 0.84-0.93), specificity (0.83, 95% CI 0.77-0.88), and AUC (0.93, 95% CI 0.90-0.95). Comparison of EOC predictive value between HE4 and CA125 found, specificity: HE4 (0.93, 95% CI 0.87-0.96) > CA125 (0.84, 95% CI 0.76-0.90); AUC: CA125 (0.88, 95% CI 0.85-0.91) > HE4 (0.82, 95% CI 0.78-0.85). Comparison of OC predictive value between HE4 and CA125 found, AUC: CA125 (0.89, 95% CI 0.85-0.91) > HE4 (0.79, 95% CI 0.76-0.83). Comparison among the three tests for EOC prediction found, sensitivity: ROMA (0.86, 95%CI 0.81-0.91) > HE4 (0.80, 95% CI 0.73-0.85); specificity: HE4 (0.94, 95% CI 0.90-0.96) > ROMA (0.84, 95% CI 0.79-0.88) > CA125 (0.78, 95%CI 0.73-0.83). ROMA is helpful for distinguishing epithelial ovarian cancer from benign pelvic mass. HE4 is not better than CA125 either for EOC or OC prediction. ROMA is promising predictors of epithelial ovarian cancer to replace CA125, but its utilization requires further exploration.
Tài liệu tham khảo
Brown PO, Palmer C: The preclinical natural history of serous ovarian cancer: defining the target for early detection. PLoS Med. 2009, 6: e1000114-10.1371/journal.pmed.1000114.
Davis HM, Zurawski VR, Bast RC, Klug TL: Characterization of the CA 125 antigen associated with human epithelial ovarian carcinomas. Cancer Res. 1986, 46: 6143-6148.
Bast RC, Badgwell D, Lu Z, Marquez R, Rosen D, Liu J, Baggerly KA, Atkinson EN, Skates S, Zhang Z, et al: New tumor markers: CA125 and beyond. Int J Gynecol Cancer. 2005, 15: 274-281. 10.1111/j.1525-1438.2005.00441.x.
Niloff JM, Klug TL, Schaetzl E, Zurawski VR, Knapp RC, Bast RC: Elevation of serum CA125 in carcinomas of the fallopian tube, endometrium, and endocervix. Am J Obstet Gynecol. 1984, 148: 1057-1058.
Park Y, Lee JH, Hong DJ, Lee EY, Kim HS: Diagnostic performances of HE4 and CA125 for the detection of ovarian cancer from patients with various gynecologic and non-gynecologic diseases. Clin Biochem. 2011, 44: 884-888. 10.1016/j.clinbiochem.2011.04.011.
Yurkovetsky Z, Skates S, Lomakin A, Nolen B, Pulsipher T, Modugno F, Marks J, Godwin A, Gorelik E, Jacobs I, et al: Development of a multimarker assay for early detection of ovarian cancer. J Clin Oncol. 2010, 28: 2159-2166. 10.1200/JCO.2008.19.2484.
Cree I: Improved blood tests for cancer screening: general or specific?. BMC Cancer. 2011, 11: 499-10.1186/1471-2407-11-499.
Kulasingam V, Pavlou MP, Diamandis EP: Integrating high-throughput technologies in the quest for effective biomarkers for ovarian cancer. Nat Rev Cancer. 2010, 10: 371-378. 10.1038/nrc2831.
Lu R, Sun M, Feng J, Gao X, Guo L: Myofibrillogenesis regulator 1 (MR-1) is a novel biomarker and potential therapeutic target for human ovarian cancer. BMC Cancer. 2011, 11: 270-10.1186/1471-2407-11-270.
Kothandaraman N, Bajic VB, Brendan PN, Huak CY, Keow PB, Razvi K, Salto-Tellez M, Choolani M: E2F5 status significantly improves malignancy diagnosis of epithelial ovarian cancer. BMC Cancer. 2010, 10: 64-10.1186/1471-2407-10-64.
Helistrom I, Raycraft J, Hayden-Ledbetter M, Ledbetter JA, Schummer M, McIntosh M, Drescher C, Urban N, Hellstrom KE: The HE4 (WFDC2) protein is a biomarker for ovarian carcinoma. Cancer Res. 2003, 63: 3695-3700.
Drapkin R, von Horsten HH, Lin Y, Mok SC, Crum CP, Welch WR, Hecht JL: Human epididymis protein 4 (HE4) is a secreted glycoprotein that is overexpressed by serous and endometrioid ovarian carcinomas. Cancer Res. 2005, 65: 2162-2169. 10.1158/0008-5472.CAN-04-3924.
Moore RG, Brown AK, Miller MC, Skates S, Allard WJ, Verch T, Steinhoff M, Messerlian G, DiSilvestro P, Granai CO, Bast RC: The use of multiple novel tumor biomarkers for the detection of ovarian carcinoma in patients with a pelvic mass. Gynecol Oncol. 2008, 108: 402-408. 10.1016/j.ygyno.2007.10.017.
Holcomb K, Vucetic Z, Miller MC, Knapp RC: Human epididymis protein 4 offers superior specificity in the differentiation of benign and malignant adnexal masses in premenopausal women. Am J Obstet Gynecol. 2011, 205 (358): e351-e356.
Bandiera E, Romani C, Specchia C, Zanotti L, Galli C, Ruggeri G, Tognon G, Bignotti E, Tassi RA, Odicino F, et al: Serum human epididymis protein 4 and risk for ovarian malignancy algorithm as new diagnostic and prognostic tools for epithelial ovarian cancer management. Cancer Epidemiol Biomarkers Prev. 2011, 20: 2496-2506. 10.1158/1055-9965.EPI-11-0635.
Van Gorp T, Cadron I, Despierre E, Daemen A, Leunen K, Amant F, Timmerman D, De Moor B, Vergote I: HE4 and CA125 as a diagnostic test in ovarian cancer: prospective validation of the risk of ovarian malignancy algorithm. Br J Cancer. 2011, 104: 863-870. 10.1038/sj.bjc.6606092.
Moore RG, McMeekin DS, Brown AK, DiSilvestro P, Miller MC, Allard WJ, Gajewski W, Kurman R, Bast RC, Skates SJ: A novel multiple marker bioassay utilizing HE4 and CA125 for the prediction of ovarian cancer in patients with a pelvic mass. Gynecol Oncol. 2009, 112: 40-46. 10.1016/j.ygyno.2008.08.031.
Montagnana M, Danese E, Ruzzenente O, Bresciani V, Nuzzo T, Gelati M, Salvagno GL, Franchi M, Lippi G, Guidi GC: The ROMA (Risk of Ovarian Malignancy Algorithm) for estimating the risk of epithelial ovarian cancer in women presenting with pelvic mass: is it really useful?. Clin Chem Lab Med. 2011, 49: 521-525.
Stroup DF, Berlin JA, Morton SC, Olkin I, Williamson GD, Rennie D, Moher D, Becker BJ, Sipe TA, Thacker SB: Meta-analysis of observational studies in epidemiology: a proposal for reporting. Meta-analysis Of Observational Studies in Epidemiology (MOOSE) group. JAMA. 2000, 283: 2008-2012. 10.1001/jama.283.15.2008.
Lijmer JG, Mol BW, Heisterkamp S, Bonsel GJ, Prins MH, van der Meulen JHP, Bossuyt PMM: Empirical evidence of design-related bias in studies of diagnostic tests. JAMA. 1999, 282: 1061-1066. 10.1001/jama.282.11.1061.
Benedet JL, Pecorelli S: Why cancer staging? FIGO 26th Annual Report on the Results of Treatment in Gynecological Cancer. Int J Gynaecol Obstet. 2006, 95 (Suppl 1): S3-
Whiting PF, Rutjes AWS, Westwood ME, Mallett S, Deeks JJ, Reitsma JB, Leeflang MMG, Sterne JAC, Bossuyt PMM: Group tQ-: QUADAS-2: a revised tool for the quality assessment of diagnostic accuracy studies. Ann Intern Med. 2011, 155: 529-536.
Whiting P, Harbord R, Kleijnen J: No role for quality scores in systematic reviews of diagnostic accuracy studies. BMC Med Res Methodol. 2005, 5: 19-10.1186/1471-2288-5-19.
Chappell FM, Raab GM, Wardlaw JM: When are summary ROC curves appropriate for diagnostic meta-analyses?. Stat Med. 2009, 28: 2653-2668. 10.1002/sim.3631.
Rutter CM, Gatsonis CA: A hierarchical regression approach to meta-analysis of diagnostic test accuracy evaluations. Stat Med. 2001, 20: 2865-2884. 10.1002/sim.942.
Reitsma JB, Glas AS, Rutjes AW, Scholten RJ, Bossuyt PM, Zwinderman AH: Bivariate analysis of sensitivity and specificity produces informative summary measures in diagnostic reviews. J Clin Epidemiol. 2005, 58: 982-990. 10.1016/j.jclinepi.2005.02.022.
Higgins JP, Thompson SG, Deeks JJ, Altman DG: Measuring inconsistency in meta-analyses. BMJ. 2003, 327: 557-560. 10.1136/bmj.327.7414.557.
Zamora J, Abraira V, Muriel A, Khan K, Coomarasamy A: Meta-DiSc: a software for meta-analysis of test accuracy data. BMC Med Res Methodol. 2006, 6: 31-10.1186/1471-2288-6-31.
Leeflang MMG, Deeks JJ, Gatsonis C, Bossuyt PMM: Group obotCDTAW: Systematic reviews of diagnostic test accuracy. Ann Intern Med. 2008, 149: 889-897.
Deeks JJ, Macaskill P, Irwig L: The performance of tests of publication bias and other sample size effects in systematic reviews of diagnostic test accuracy was assessed. J Clin Epidemiol. 2005, 58: 882-893. 10.1016/j.jclinepi.2005.01.016.
Dwamena BA: midas: Computational and Graphical Routines for Meta-analytical Integration of Diagnostic Accuracy Studies in Stata. 2007, Division of Nuclear Medicine, Department of Radiology, University of Michigan Medical School, Ann Arbor
Roger M, Harbord PW: metandi: Meta-analysis of diagnostic accuracy using hierarchical logistic regression. Stata J. 2009, 9: 19-
Abdel-Azeez HA, Labib HA, Sharaf SM, Refaie AN: HE4 and mesothelin: novel biomarkers of ovarian carcinoma in patients with pelvic masses. Asian Pac J Cancer Prev. 2010, 11: 111-116.
Kim YM, Whang DH, Park J, Kim SH, Lee SW, Park HA, Ha M, Choi KH: Evaluation of the accuracy of serum human epididymis protein 4 in combination with CA125 for detecting ovarian cancer: a prospective case–control study in a Korean population. Clin Chem Lab Med. 2011, 49: 527-534.
Chang X, Ye X, Dong L, Cheng H, Cheng Y, Zhu L, Liao Q, Zhao Y, Tian L, Fu T, et al: Human epididymis protein 4 (HE4) as a serum tumor biomarker in patients with ovarian carcinoma. Int J Gynecol Cancer. 2011, 21: 852-858. 10.1097/IGC.0b013e31821a3726.
Jacob F, Meier M, Caduff R, Goldstein D, Pochechueva T, Hacker N, Fink D, Heinzelmann-Schwarz V: No benefit from combining HE4 and CA125 as ovarian tumor markers in a clinical setting. Gynecol Oncol. 2011, 121: 487-491. 10.1016/j.ygyno.2011.02.022.
Moore RG, Miller MC, Disilvestro P, Landrum LM, Gajewski W, Ball JJ, Skates SJ: Evaluation of the diagnostic accuracy of the risk of ovarian malignancy algorithm in women with a pelvic mass. Obstet Gynecol. 2011, 118: 280-288. 10.1097/AOG.0b013e318224fce2.
Harbord RM, Deeks JJ, Egger M, Whiting P, Sterne JA: A unification of models for meta-analysis of diagnostic accuracy studies. Biostatistics. 2007, 8: 239-251.
Dinnes J, Deeks J, Kirby J, Roderick P: A methodological review of how heterogeneity has been examined in systematic reviews of diagnostic test accuracy. Health Technol Assess. 2005, 9 (iii): 1-113.
Bolstad N, Oijordsbakken M, Nustad K, Bjerner J: Human epididymis protein 4 reference limits and natural variation in a Nordic reference population. Tumour Biol. 2012, 33: 141-148. 10.1007/s13277-011-0256-4.
Galgano MT, Hampton GM, Frierson HF: Comprehensive analysis of HE4 expression in normal and malignant human tissues. Mod Pathol. 2006, 19: 847-853.
Zhou Y, Yin X, Ying J, Zhang B: Golgi protein 73 versus alpha-fetoprotein as a biomarker for hepatocellular carcinoma: a diagnostic meta- analysis. BMC Cancer. 2012, 12: 17-10.1186/1471-2407-12-17.
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