ROMA, an algorithm for ovarian cancer

Clinica Chimica Acta - Tập 440 - Trang 143-151 - 2015
Anita Monika Chudecka-Głaz1
1Department of Gynecological Surgery and Gynecological Oncology of Adults and Adolescents, Pomeranian Medical University, Szczecin, Poland

Tài liệu tham khảo

Ferlay, 2013 De Angelis, 2014, Cancer survival in Europe 1999–2007 by country and age: results of EUROCARE−5 a population based study, Lancet Oncol, 15, 23, 10.1016/S1470-2045(13)70546-1 Koshiyana, 2014, Recent concepts of ovarian carcinogenesis: type I and type II, BioMed Res Int, 2014, 934261 Jacobs, 1990, A risk of malignancy index incorporating CA 125, ultrasound and menopausal status for the accurate preoperative diagnosis of ovarian cancer, Br J Obstet Gynecol, 97, 922, 10.1111/j.1471-0528.1990.tb02448.x Macuks, 2011, Comparison of different ovarian cancer detection algorithms, Eur J Gynaecol Oncol, 32, 408 Moore, 2009, A novel multiple marker bioassay utilizing HE4 and CA125 for the prediction of ovarian cancer in patients with a pelvic mass, Gynecol Oncol, 112, 40, 10.1016/j.ygyno.2008.08.031 Moore, 2011, Evaluation of the diagnostic accuracy of the risk of ovarian malignancy algorithm in women with a pelvic mass, Obstet Gynecol, 118, 280, 10.1097/AOG.0b013e318224fce2 Macus, 2012, An ovarian cancer malignancy risk index composed of HE4, CA 125, ultrasonographic score, and menopausal status: use in differentiation of ovarian cancers and benign lesions, Tumor Biol, 33, 1811, 10.1007/s13277-012-0440-1 Kaijser, 2013, A comparison between an ultrasound based prediction model (LR2) and the risk of ovarian malignancy algorithm (ROMA) to assess the risk of malignancy in women with adnexal mass, Gynecol Oncol, 129, 377, 10.1016/j.ygyno.2013.01.018 Ferraro, 2013, Serum human epididymis protein 4 vs carbohydrate antigen CA 125 for ovarian cancer diagnosis, J Clin Pathol, 66, 273, 10.1136/jclinpath-2012-201031 Kaijser, 2014, Are serum HE4 or ROMA scores useful to experienced examiners for improving characterization of adnexal masses after transvaginal ultrasonography?, Ultrasound Obstet Gynecol, 43, 89, 10.1002/uog.12551 Kijser, 2013, Differentiating stage I epithelial ovarian cancer from benign disease in women with adnexal tumor s using biomarkers or the ROMA algorithm, Gynecol Oncol, 130, 398, 10.1016/j.ygyno.2013.04.472 Pitta, 2013, Symptoms, CA 125 and HE4 for the preoperative prediction of ovarian malignancy in Brazilian women with ovarian masses, BMC Cancer, 13, 423, 10.1186/1471-2407-13-423 Escudero, 2011, Comparison of serum human epididymis protein 4 with cancer antigen 125 as tumor marker in patients with malignant and non-malignant disease, Clin Chem, 57, 1534, 10.1373/clinchem.2010.157073 Havrilesky, 2008, Evaluation of biomarker panels for early stage ovarian cancer detection and monitoring for disease recurrence, Gynecol Oncol, 110, 374, 10.1016/j.ygyno.2008.04.041 Yurkovetsky, 2010, Development of a multimarker assay for early detection of ovarian cancer, J Clin Oncol, 28, 2159, 10.1200/JCO.2008.19.2484 Anton, 2012, A comparison of CA125, HE4, risk ovarian malignancy algorithm (ROMA), and risk malignancy index (RMI) for the classification of ovarian masses, Clinics, 67, 437, 10.6061/clinics/2012(05)06 Reade, 2013, Risk and benefits of screening women for ovarian cancer: a systematic review and meta-analysis, Gynecol Oncol, 130, 674, 10.1016/j.ygyno.2013.06.029 Van Gorp, 2012, Subjective assessment by ultrasound is superior to the risk of malignancy index (RMI) or the risk of ovarian malignancy algorithm (ROMA) in discriminating benign from malignant adnexal masses, Eur J Cancer, 48, 1649, 10.1016/j.ejca.2011.12.003 Rein, 2011, Potential markers for detection and monitoring of ovarian cancer, J Oncol, 2011, 475983, 10.1155/2011/475983 Bast, 2007, Prevention and early detection of ovarian cancer: mission impossible?, Recent Results Cancer Res, 174, 91, 10.1007/978-3-540-37696-5_9 Bast, 2012, Differential diagnosis of a pelvic mass: improved algorithms and novel biomarkers, Int J Gynecol Cancer, 22, S5, 10.1097/IGC.0b013e318251c97d Leung, 2012, From bench to bedside: discovery of ovarian cancer biomarkers using high-throughput technologies in the past decade, Biomark Med, 6, 613, 10.2217/bmm.12.70 Plebani, 2012, HE4 in gynecological cancers: report of a European investigators and experts, Clin Chem Lab Med, 50, 2127, 10.1515/cclm-2012-0373 Plebani, 2011, ROMA or death: advances in epithelial ovarian cancer diagnosis, Clin Chem Lab Med, 49, 433, 10.1515/CCLM.2011.073 Morgante, 1999, Comparison of two malignancy risk indices based on serum Ca125, ultrasound score and menopausal status in the diagnosis of ovarian masses, Br J Obstet Gynaecol, 106, 524, 10.1111/j.1471-0528.1999.tb08318.x Tinglustad, 1999, The risk of malignancy index to evaluate potential ovarian cancers in local hospitals, Obstet Gynecol, 93, 448, 10.1097/00006250-199903000-00028 Zhang, 2010, The road from discovery to clinical diagnostics: lessons learned from the first FDA-cleared in vitro diagnostic multivariate index assay of proteomic biomarkers, Cancer Epidemiol Biomarkers Prev, 19, 2995, 10.1158/1055-9965.EPI-10-0580 Ware Miller, 2011, Performance of the American Collage of Obstetricians and Gynecologists' ovarian tumor referral guidelines with multivariate index assay, Obstet Gynecol, 117, 1298, 10.1097/AOG.0b013e31821b1d80 Ueland, 2011, Effectiveness of multivariate index assay in the preoperative assessment of ovarian tumors, Obstet Gynecol, 117, 1289, 10.1097/AOG.0b013e31821b5118 Bast, 1981, Reactivity of a monoclonal antibody with human ovarian carcinoma, J Clin Invest, 68, 1331, 10.1172/JCI110380 Bast, 1983, A radioimmunoassay using a monoclonal antibody to monitor the course of epithelial ovarian cancer, N Engl J Med, 309, 169, 10.1056/NEJM198310133091503 Tholander, 1990, Pretreatment serum levels of CA-125, carcinoembryonic antigen, tissue polypeptide antigen, and placental alkaline phosphatase in patients with ovarian carcinoma: influence of histological type, grade of differentiation, and clinical stage of disease, Gynecol Oncol, 39, 26, 10.1016/0090-8258(90)90394-Z Ruibal, 1984, CA 125 seric levels in non-malignant pathologies, Bull Cancer, 71, 145 Niloff, 1984, Elevation of serum CA 25 in carcinomas of fallopian tube, endometrium, and endocervix, Am J Obstet Gynecol, 148, 1057, 10.1016/S0002-9378(84)90444-7 Jacobs, 1989, The CA 125 tumor-associated antigen: a review of the literature, Hum Reprod, 4, 1, 10.1093/oxfordjournals.humrep.a136832 Lutz, 2011, Early diagnosis of ovarian carcinoma: is a solution in sight?, Radiology, 259, 329, 10.1148/radiol.11090563 Duffy, 2005, CA 125 in ovarian cancer: European Group on Tumor Markers guidelines for clinical use, Int J Gynecol Cancer, 15, 679, 10.1111/j.1525-1438.2005.00130.x Bast, 2003, Status of tumor markers in ovarian cancer screening, J Clin Oncol, 21, 200s, 10.1200/JCO.2003.01.068 Rustin, 2011, Definitions for response and progression in ovarian cancer clinical trials incoroporatingg RECIST 1.1 and CA 125 agreed by the Gynecologic Cancer Intergroup (GCIG), Int J Gynecol Cancer, 21, 419, 10.1097/IGC.0b013e3182070f17 Yedema, 1992, Use of serum tumor markers in the differentia diagnosis between ovarian and colorectal carcinomas, Tumor Biol, 13, 18, 10.1159/000217748 Sorensen, 2011, Combination of cancer antigen CA125 and carcinoembryonic antigen can improve ovarian cancer diagnosis, Dan Med Bull, 58, A4331 Makar, 1992, Prognostic value of pre- and postoperative serum CA 125 levels in ovarian cancer: new aspects and multivariate analysis, Obstet Gynecol, 79, 1002 Parker, 1994, Serum albumin and CA 125 are powerful predictors of survival in epithelial ovarian cancer, Br J Obstet Gynaecol, 101, 888, 10.1111/j.1471-0528.1994.tb13550.x Bandiera, 2011, Serum human epididymis protein 4 and risk for ovarian malignancy algorithm as new diagnostic and prognostic tools for epithelial ovarian management, Cancer Epidemiol Biomarkers Prev, 20, 2496, 10.1158/1055-9965.EPI-11-0635 Ławicki, 2013, The plasma concentration of VEGF, HE4 and CA 125 as new biomarkers panel in different stages and subtypes of epithelial ovarian tumors, J Ovarian Res, 6, 45, 10.1186/1757-2215-6-45 Hellström, 2003, The HE4 (WFDC2) protein is a biomarker for ovarian carcinoma, Cancer Res, 63, 3695 Hellstrom, 2011, Two novel biomarkers, mesothelin and HE4, for diagnosis of ovarian carcinoma, Exp Opin Med Diagn, 5, 227, 10.1517/17530059.2011.559459 Drapkin, 2005, Human epididymis protein 4 (HE4) is a secreted glycoprotein that is overexpressed by serous and endometrioid ovarian carcinomas, Cancer Res, 65, 2162, 10.1158/0008-5472.CAN-04-3924 Kadija, 2012, The utility of human epididymal protein 4, cancer antigen 125, and risk form malignancy algorithm in ovarian cancer and endometriosis, Int J Gynecol Cancer, 22, 238, 10.1097/IGC.0b013e318234f852 Langmár, 2011, HE4- a novel promising serum marker in the diagnosis of ovarian carcinoma, Eur J Gynaecol Oncol, 32, 605 Kirchoff, 1991, A major human epididymis — specific cDNA encodes a protein with sequence homology to extracellular proteinase inhibitors, Biol Reprod, 45, 350, 10.1095/biolreprod45.2.350 Kirchoff, 1998, Molecular characterization of epididymal proteins, Rev Reprod, 3, 86, 10.1530/ror.0.0030086 Lu, 2012, Human epididymis protein 4 (HE4) plays a key role in ovarian cancer cell adhesion and motility, Biochem Biophys Res Commun, 419, 274, 10.1016/j.bbrc.2012.02.008 Zou, 2011, Effect of human epididymis protein 4 gene silencing on the malignant phenotype in ovarian cancer, Chin Med J, 124, 3133 Bingle, 2006, WFDC2 (HE4): a potential role in the innate immunity of the oral cavity and respiratory tract and the development of adenocarcinomas of the lung, Respir Res, 10.1186/1465-9921-7-61 Bingle, 2002, The putative ovarian tumor marker gene HE4 (WFDC2), is expressed in normal tissues and undergoes complex alternative splicing to yield multiple protein isoforms, Oncogene, 21, 2768, 10.1038/sj.onc.1205363 Galgano, 2006, Comprehensive analysis of HE4 expression in normal and malignant human tissues, Mod Pathol, 19, 847, 10.1038/modpathol.3800612 Wang, 1999, Monitoring gene expression profile changes in ovarian carcinomas using cDNA microarray, Gene, 229, 101, 10.1016/S0378-1119(99)00035-9 Schummer, 1999, Comparative hybridization of an array of 21500 ovarian cDNAs for the discovery of genes overexpressed in ovarian carcinomas, Gene, 238, 375, 10.1016/S0378-1119(99)00342-X Hough, 2000, Large-scale serial analysis of gene expression reveals genes differentially expressed in ovarian cancer, Cancer Res, 60, 6281 Perou, 2000, Molecular portraits of human breast tumors, Nature, 406, 747, 10.1038/35021093 Ross, 2000, Systematic variation in gene expression patterns in human cancer cell lines, Nat Genet, 24, 227, 10.1038/73432 Bolstad, 2008, Human epididymis protein 4 reference limits and natural variations in a Nordic reference population, Tumor Biol, 44, 251 Montagnana, 2011, 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, 49, 521, 10.1515/CCLM.2011.075 Moore, 2010, Comparison of a novel multiple marker assay vs the Risk of Malignancy Index for the prediction of epithelial ovarian cancer in patients with a pelvic mass, Am J Obstet Gynecol, 203, e1, 10.1016/j.ajog.2010.03.043 Moore, 2012, Serum HE4 levels are less frequently elevated than CA 125 in women with benign gynecological disorders, Am J Obstet Gynecol, 206, 351.e1, 10.1016/j.ajog.2011.12.029 Wu, 2012, Diagnostic value of serum human epididymis protein 4 (HE4) in ovarian carcinoma, Int J Gynecol Cancer, 22, 1106, 10.1097/IGC.0b013e318263efa2 Wang, 2014, Diagnostic accuracy of serum HE4, CA 125 and ROMA in patients with ovarian cancer: a meta analysis, Tumor Biol, 35, 6127, 10.1007/s13277-014-1811-6 Lin, 2012, Diagnostic value of human epididymis protein 4 compared with mesothelin for ovarian cancer: a systematic review and meta-analysis, Asian Pac J Cancer Prev, 13, 5427, 10.7314/APJCP.2012.13.11.5427 Lin, 2012, Human epididymis protein 4 for differential diagnosis between benign gynaecologic disease and ovarian cancer: a systematic review and meta-analysis, Eur J Obstet Gynecol Reprod Biol, 167, 81, 10.1016/j.ejogrb.2012.10.036 Hellstrom, 2008, SMRP and HE4 as biomarkers for ovarian carcinoma when used alone and in combination with CA 125 and/or each other, Adv Exp Med Biol, 622, 15, 10.1007/978-0-387-68969-2_2 Holomb, 2011, Human epididymis protein 4 offers superior specificity in the differentiation of benign and malignant adnexal masses in premenopausal women, Am J Obstet Gynecol, 205 Hallamaa, 2012, Serum HE4 concentration is not dependent on menstrual cycle or hormonal treatment among endometriosis patients and healthy premenopausal women, Gynecol Oncol, 125, 667, 10.1016/j.ygyno.2012.03.011 Anastasi, 2013, The use of HE4, CA 125 and CA 72–4 biomarkers for differential diagnosis between ovarian endometrioma and epithelial ovarian cancer, J Ovarian Res, 6, 44, 10.1186/1757-2215-6-44 Zheng, 2012, Serum HE4 as a useful biomarker in discriminating ovarian cancer from benign disease, Int J Gynecol Cancer, 22, 1000, 10.1097/IGC.0b013e318249bee7 Huhinten, 2009, Serum HE4 concentration differentiates malignant tumours from ovarian endometriotic cysts, Br J Cancer, 100, 1315, 10.1038/sj.bjc.6605011 Xu, 2013, Prognostic significance of several biomarkers in epithelial ovarian cancer: a meta analysis of published studies, J Cancer Res Clin Oncol, 139, 1257, 10.1007/s00432-013-1435-z Steffensen, 2012, The prognostic and predictive value of combined HE4 and CA125 in ovarian cancer patients, Int J Gynecol Cancer, 22, 1474, 10.1097/IGC.0b013e3182681cfd Kong, 2012, Serum HE4 level is an independent prognostic factor in epithelial ovarian cancer, Ann Surg Oncol, 19, 1707, 10.1245/s10434-011-1943-5 Chen, 2014, HE4 as a serum biomarker for ROMA prediction and prognosis of epithelial ovarian cancer, Asian Pac J Cancer Prev, 15, 101, 10.7314/APJCP.2014.15.1.101 Hynninen, 2011, Serum HE4 profile during primary chemotherapy of epithelial ovarian cancer, Int J Gynecol Cancer, 21, 1573, 10.1097/IGC.0b013e3182225509 Braicu, 2013, Preoperative HE4 expression in plasma predicts surgical outcome in primary ovarian cancer patients. Results from the OVCAD study, Gynecol Oncol, 128, 245, 10.1016/j.ygyno.2012.11.023 Chudecka-Głaz, 2012, Human epididymal protein 4 (HE4) is a novel biomarker and promising prognostic factor in ovarian cancer patients, Eur J Gynaecol Oncol, 33, 382 Chudecka-Głaz, 2014, Serum HE4, CA125, YKL-10, bcl-2, cathepsin-l and prediction optimal debulking surgery, response to chemotherapy in ovarian cancer, J Ovarian Res, 7, 62, 10.1186/1757-2215-7-62 Angioli, 2013, Can the preoperative HE4 level predict optimal cytoreduction in patients with advanced ovarian carcinoma?, Gynecol Oncol, 128, 579, 10.1016/j.ygyno.2012.11.040 Anastasi, 2010, HE4: a potential early biomarker for the recurrence of ovarian cancer, Tumor Biol, 31, 113, 10.1007/s13277-009-0015-y Plotti, 2012, Does HE4 have a role as biomarker in the recurrence of ovarian cancer, Tumor Biol, 33, 2117, 10.1007/s13277-012-0471-7 Geurts, 2011, Considering early detection of relapsed ovarian cancer : a review of the literature, Int J Gynecol Cancer, 21, 837, 10.1097/IGC.0b013e31821bb88c Park, 2011, Diagnostic performance of HE4 and CA125 for the detection of ovarian cancer from patients with various gynecologic and non-gynecologic diseases, Clin Biochem, 44, 884, 10.1016/j.clinbiochem.2011.04.011 Kim, 2011, Evaluation of accuracy of serum human epididymis protein 4 in combination with CA 125 for detecting ovarian cancer : a prospective case control study in Korean population, Clin Chem Lab Med, 49, 527, 10.1515/CCLM.2011.085 Azzam, 2013, Evaluation of HE4 as an extra biomarker to CA 125 to improve detection of ovarian carcinoma: is it time for step forward, Arch Gynecol Obstet, 288, 167, 10.1007/s00404-013-2722-2 Andersen, 2010, Use of a symptom index, CA 125 and HE4 to predict ovarian cancer, Gynecol Oncol, 116, 378, 10.1016/j.ygyno.2009.10.087 Yip, 2011, Comprehensiveserum profiling for the discovery of epithelial ovarian cancer biomarkers, PLos ONE, 6, e29533, 10.1371/journal.pone.0029533 Li, 2013, HE4 (WFDC2) promotes tumour growth in endometrial cancer cell lines, Int J Mol Sci, 14, 6026, 10.3390/ijms14036026 Moore, 2008, The use of multiple novel tumor biomarkers for the detection of ovarian carcinoma in patients with a pelvic mass, Gynecol Oncol, 108, 402, 10.1016/j.ygyno.2007.10.017 Su, 2013, Detection and monitoring of ovarian cancer, Clin Chim Acta, 415, 341, 10.1016/j.cca.2012.10.058 ROMA™ (HE4EIA + ARCHITECT CA125II™) Prod. No. 404-10US. Instructions for use. 2011–09. 2011, Elecsys® HE4 and CA 125 II and their use in the risk assessment of epithelial ovarian cancer by ROMA (Risk of Ovarian Malignancy) 2014 HE4 EIA Prod. No. 404–10. Instructions for use. 2014–04. Chan, 2013, The use of HE4 in the prediction of ovarian cancer in Asian women with pelvic mass, Gynecol Oncol, 128, 239, 10.1016/j.ygyno.2012.09.034 Ortiz-Munoz, 2014, HE4, CA 125 and ROMA algorithm for differential diagnosis between benign gynaecological diseases and ovarian cancer, Tumor Biol, 35, 7249, 10.1007/s13277-014-1945-6 Lenhardt, 2011, The diagnostic accuracy of two epididymis protein 4 (HE4) testing system in combination with CA 125 in the differential diagnosis of ovarian masses, Clin Chem Lab Med, 49, 2081 Kalapotharakos, 2012, High preoperative blood levels of HE4 predicts poor prognosis in patients with ovarian cancer, J Ovarian Res, 5, 20, 10.1186/1757-2215-5-20 Ruggieri, 2011, HE4 and epithelial ovarian cancer: comparison and clinical evaluation of two immunoassays and a combination algorithm, Clin Chim Acta, 412, 1447, 10.1016/j.cca.2011.04.028 Yang, 2013, The reference intervals for HE4, CA 125, and ROMA in healthy female with electrochemiluminescence immunoassay, Clin Biochem, 46, 1705, 10.1016/j.clinbiochem.2013.08.019 Van Gorp, 2011, HE4 and CA 125 as diagnostic test in ovarian cancer: prospective validation of the risk of ovarian malignancy algorithm, Br J Cancer, 104, 863, 10.1038/sj.bjc.6606092 Fritz-Rdzanek, 2012, HE4 protein and SMRP: potential novel biomarkers in ovarian cancer detection, Oncol Lett, 4, 385, 10.3892/ol.2012.757 Kobayashi, 2012, Biomarkers for screening, diagnosis and monitoring ovarian cancer, Cancer Epidemiol Biomarkers Prev, 21, 1902, 10.1158/1055-9965.EPI-12-0646 Kaijser, 2013, Improving strategies for diagnosisng ovarian cancer: a summary of the international ovarian tumor analysis (IOTA) studies, Ultrasound Obstet Gynecol, 41, 9, 10.1002/uog.12323 Hakansson, 2012, DANISH PELVIC MASS OVARIAN CANCER STUDY. Risk of malignancy index used as diagnostic tool in a tertiary centre for patients with pelvic mass, Acta Obstet Gynecol Scand, 91, 496, 10.1111/j.1600-0412.2012.01359.x Jacob, 2011, No benefit from combining HE4 and CA 125 as ovarian tumor markers in a clinical setting, Gynecol Oncol, 121, 487, 10.1016/j.ygyno.2011.02.022 Partheen, 2011, Evaluation of ovarian cancer biomarkers HE4 and CA-125 in women presenting with a suspicious cystic ovarian mass, J Gynecol Oncol, 22, 244, 10.3802/jgo.2011.22.4.244 Molina, 2011, Her novel tumor marker for ovarian cancer: comparison with CA 125 and ROMA algorithm in patients with gynaecological diseases, Tumor Biol, 32, 1087, 10.1007/s13277-011-0204-3 Sandri, 2013, Comparison of HE4, CA125 and ROMA algorithm in women with a pelvic mass: correlation with pathological outcome, Gynecol Oncol, 128, 233, 10.1016/j.ygyno.2012.11.026 Karlsen, 2012, Evaluation of HE4, CA 125, risk of malignancy algorithm (ROMA) and risk of malignancy index (RMI) as diagnostic tools of epithelial ovarian cancer patients with pelvic mass, Gynecol Oncol, 127, 379, 10.1016/j.ygyno.2012.07.106 Van Calster, 2012, Triaging women with ovarian masses for surgery: observational diagnostic study to compare RCOG guidelines with an International Ovarian Tumour Analysis (IOTA) group protocol, BJOG, 119, 662, 10.1111/j.1471-0528.2012.03297.x Novotny, 2012, HE4 and ROMA index in Czech postmenopausal women, Anticancer Res, 32, 4137 Ledermann, 2012, Newly diagnosed and relapsed epithelial ovarian carcinoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow up, Ann Oncol, 24, vi24 Rustin, 2009, A randomized trial in ovarian cancer (OC) of early treatment of relapse based on CA125 level alone versus delayed treatment based on conventional clinical indicators (MRC OV05/EORTC 55955 trials), J Clin Oncol, 27, 1, 10.1200/jco.2009.27.18_suppl.1 Granato, 2012, Role of HE4, CA 72.4 and CA 125 in monitorin ovarian cancer, Tumor Biol, 33, 1335, 10.1007/s13277-012-0381-8 Anastasi, 2010, HE4: a new potential early biomarker for the recurrence of ovarian cancer, Tumor Biol, 31, 113, 10.1007/s13277-009-0015-y