Prognostic ability of EndoPredict compared to research-based versions of the PAM50 risk of recurrence (ROR) scores in node-positive, estrogen receptor-positive, and HER2-negative breast cancer. A GEICAM/9906 sub-study

Breast Cancer Research and Treatment

Volumn 156, Issue 1, 2016, Pages 81-89

  Martin, Miguel ^a   Brase, Jan C ^b   Ruiz, Amparo ^e   Prat, Aleix ^f   Kronenwett, Ralf ^b   Calvo, Lourdes ^g   Petry, Christoph ^b   Bernard, Philip S ^h   Ruiz Borrego, Manuel ⁱ   Weber, Karsten E ^b   Rodriguez, César A ^j   Alvarez, Isabel M ^k   Segui, Miguel A ^l   Perou, Charles M ^c,d   Casas, Maribel ^m   Carrasco, Eva ^m   Caballero, Rosalía ^m   Rodriguez Lescure, Alvaro ⁿ  

^a UNIVERSIDAD COMPLUTENSE DE MADRID   (Spain)

^b Sividon Diagnostics GmbH   (Germany)

^c UNIVERSITY OF NORTH CAROLINA   (United States)

^d UNIVERSITY OF NORTH CAROLINA SCHOOL OF MEDICINE   (United States)

^e Valencian Institute of Oncology   (Spain)

^f VALL D HEBRON UNIVERSITY HOSPITAL   (Spain)

^g UNIVERSITY OF A CORUÑA   (Spain)

^h ARUP LABORATORIES   (United States)

ⁱ HOSPITAL UNIVERSITARIO VIRGEN DEL ROCÍO   (Spain)

^j HOSPITAL UNIVERSITARIO DE SALAMANCA   (Spain)

^k HOSPITAL DONOSTIA   (Spain)

^l Parc Taulí Health Corporation   (Spain)

^m Elche University General Hospital ^*  (Spain)

ⁿ Elche University Hospital   (Spain)

more..

Author keywords

Breast cancer; Chemotherapy; EndoPredict; PAM50; Prognosis

Indexed keywords

AROMATASE INHIBITOR; CYCLOPHOSPHAMIDE; EPIDERMAL GROWTH FACTOR RECEPTOR 2; EPIRUBICIN; ESTROGEN RECEPTOR; FLUOROURACIL; PACLITAXEL; TAMOXIFEN; ANTINEOPLASTIC HORMONE AGONISTS AND ANTAGONISTS; ERBB2 PROTEIN, HUMAN;

ADJUVANT THERAPY; ARTICLE; BREAST CANCER; CANCER ADJUVANT THERAPY; CANCER PROGNOSIS; CANCER RECURRENCE; COMPARATIVE STUDY; DIAGNOSTIC TEST ACCURACY STUDY; DISTANT METASTASIS FREE SURVIVAL; ENDOPREDICT SCORE; FEMALE; GENE EXPRESSION; HORMONAL THERAPY; HUMAN; HUMAN TISSUE; LOW RISK PATIENT; LYMPH NODE METASTASIS; MAJOR CLINICAL STUDY; PAM50 ASSAY; PHASE 3 CLINICAL TRIAL (TOPIC); PREDICTION; PRIORITY JOURNAL; PROGNOSTIC ASSESSMENT; RANDOMIZED CONTROLLED TRIAL (TOPIC); RECURRENCE RISK; REVERSE TRANSCRIPTION POLYMERASE CHAIN REACTION; RISK ASSESSMENT; TUMOR VOLUME; ADJUVANT CHEMOTHERAPY; BREAST NEOPLASMS; CLINICAL TRIAL; CONTROLLED STUDY; GENETICS; KAPLAN MEIER METHOD; PATHOLOGY; PHASE 3 CLINICAL TRIAL; PROCEDURES; PROGNOSIS; RANDOMIZED CONTROLLED TRIAL; TREATMENT OUTCOME;

ANTINEOPLASTIC AGENTS, HORMONAL; BREAST NEOPLASMS; CHEMOTHERAPY, ADJUVANT; FEMALE; HUMANS; KAPLAN-MEIER ESTIMATE; PROGNOSIS; RECEPTOR, ERBB-2; RECEPTORS, ESTROGEN; RISK ASSESSMENT; TREATMENT OUTCOME;

EID: 84961189528     PISSN: 01676806     EISSN: 15737217     Source Type: Journal    
DOI: 10.1007/s10549-016-3725-z     Document Type: Article

References (35)

1. Prat A, Ellis MJ, Perou CM (2012) Practical implications of gene-expression-based assays for breast oncologists. Nat Rev Clin Oncol 9(1):48–57. doi:10.1038/nrclinonc.2011.178
2. Weigelt B, Reis-Filho JS, Swanton C (2012) Genomic analyses to select patients for adjuvant chemotherapy: trials and tribulations. Ann Oncol 23(Suppl 10):x211–x218. doi:10.1093/annonc/mds323
3. Paik S, Tang G, Shak S, Kim C, Baker J, Kim W, Cronin M, Baehner FL, Watson D, Bryant J, Costantino JP, Geyer CE Jr, Wickerham DL, Wolmark N (2006) Gene expression and benefit of chemotherapy in women with node-negative, estrogen receptor-positive breast cancer. J Clin Oncol 24(23):3726–3734. doi:10.1200/jco.2005.04.7985
4. Paik S, Shak S, Tang G, Kim C, Baker J, Cronin M, Baehner FL, Walker MG, Watson D, Park T, Hiller W, Fisher ER, Wickerham DL, Bryant J, Wolmark N (2004) A multigene assay to predict recurrence of tamoxifen-treated, node-negative breast cancer. N Engl J Med 351(27):2817–2826. doi:10.1056/NEJMoa041588
5. van’t Veer LJ, Dai H, van de Vijver MJ, He YD, Hart AA, Mao M, Peterse HL, van der Kooy K, Marton MJ, Witteveen AT, Schreiber GJ, Kerkhoven RM, Roberts C, Linsley PS, Bernards R, Friend SH (2002) Gene expression profiling predicts clinical outcome of breast cancer. Nature 415(6871):530–536. doi:10.1038/415530a
6. van de Vijver MJ, He YD, van’t Veer LJ, Dai H, Hart AA, Voskuil DW, Schreiber GJ, Peterse JL, Roberts C, Marton MJ, Parrish M, Atsma D, Witteveen A, Glas A, Delahaye L, van der Velde T, Bartelink H, Rodenhuis S, Rutgers ET, Friend SH, Bernards R (2002) A gene-expression signature as a predictor of survival in breast cancer. N Engl J Med 347(25):1999–2009. doi:10.1056/NEJMoa021967
7. Buyse M, Loi S, van’t Veer L, Viale G, Delorenzi M, Glas AM, d’Assignies MS, Bergh J, Lidereau R, Ellis P, Harris A, Bogaerts J, Therasse P, Floore A, Amakrane M, Piette F, Rutgers E, Sotiriou C, Cardoso F, Piccart MJ (2006) Validation and clinical utility of a 70-gene prognostic signature for women with node-negative breast cancer. J Natl Cancer Inst 98(17):1183–1192. doi:10.1093/jnci/djj329
8. Albain KS, Barlow WE, Shak S, Hortobagyi GN, Livingston RB, Yeh IT, Ravdin P, Bugarini R, Baehner FL, Davidson NE, Sledge GW, Winer EP, Hudis C, Ingle JN, Perez EA, Pritchard KI, Shepherd L, Gralow JR, Yoshizawa C, Allred DC, Osborne CK, Hayes DF (2010) Prognostic and predictive value of the 21-gene recurrence score assay in postmenopausal women with node-positive, oestrogen-receptor-positive breast cancer on chemotherapy: a retrospective analysis of a randomised trial. Lancet Oncol 11(1):55–65. doi:10.1016/s1470-2045(09)70314-6
9. Cuzick J, Dowsett M, Pineda S, Wale C, Salter J, Quinn E, Zabaglo L, Mallon E, Green AR, Ellis IO, Howell A, Buzdar AU, Forbes JF (2011) Prognostic value of a combined estrogen receptor, progesterone receptor, Ki-67, and human epidermal growth factor receptor 2 immunohistochemical score and comparison with the Genomic Health recurrence score in early breast cancer. J Clin Oncol 29(32):4273–4278. doi:10.1200/jco.2010.31.2835
10. Dowsett M, Cuzick J, Wale C, Forbes J, Mallon EA, Salter J, Quinn E, Dunbier A, Baum M, Buzdar A, Howell A, Bugarini R, Baehner FL, Shak S (2010) Prediction of risk of distant recurrence using the 21-gene recurrence score in node-negative and node-positive postmenopausal patients with breast cancer treated with anastrozole or tamoxifen: a TransATAC study. J Clin Oncol 28(11):1829–1834. doi:10.1200/jco.2009.24.4798
11. Albanell J, Gonzalez A, Ruiz-Borrego M, Alba E, Garcia-Saenz JA, Corominas JM, Burgues O, Furio V, Rojo A, Palacios J, Bermejo B, Martinez-Garcia M, Limon ML, Munoz AS, Martin M, Tusquets I, Rojo F, Colomer R, Faull I, Lluch A (2012) Prospective transGEICAM study of the impact of the 21-gene Recurrence Score assay and traditional clinicopathological factors on adjuvant clinical decision making in women with estrogen receptor-positive (ER+) node-negative breast cancer. Ann Oncol 23(3):625–631. doi:10.1093/annonc/mdr278
12. Geffen DB, Abu-Ghanem S, Sion-Vardy N, Braunstein R, Tokar M, Ariad S, Delgado B, Bayme M, Koretz M (2011) The impact of the 21-gene recurrence score assay on decision making about adjuvant chemotherapy in early-stage estrogen-receptor-positive breast cancer in an oncology practice with a unified treatment policy. Ann Oncol 22(11):2381–2386. doi:10.1093/annonc/mdq769
13. Lo SS, Mumby PB, Norton J, Rychlik K, Smerage J, Kash J, Chew HK, Gaynor ER, Hayes DF, Epstein A, Albain KS (2010) Prospective multicenter study of the impact of the 21-gene recurrence score assay on medical oncologist and patient adjuvant breast cancer treatment selection. J Clin Oncol 28(10):1671–1676. doi:10.1200/jco.2008.20.2119
14. Dubsky P, Brase JC, Jakesz R, Rudas M, Singer CF, Greil R, Dietze O, Luisser I, Klug E, Sedivy R, Bachner M, Mayr D, Schmidt M, Gehrmann MC, Petry C, Weber KE, Fisch K, Kronenwett R, Gnant M, Filipits M (2013) The EndoPredict score provides prognostic information on late distant metastases in ER+/HER2− breast cancer patients. Br J Cancer 109(12):2959–2964. doi:10.1038/bjc.2013.671
15. Sestak I, Dowsett M, Zabaglo L, Lopez-Knowles E, Ferree S, Cowens JW, Cuzick J (2013) Factors predicting late recurrence for estrogen receptor-positive breast cancer. J Natl Cancer Inst 105(19):1504–1511. doi:10.1093/jnci/djt244
16. Kronenwett R, Bohmann K, Prinzler J, Sinn BV, Haufe F, Roth C, Averdick M, Ropers T, Windbergs C, Brase JC, Weber KE, Fisch K, Muller BM, Schmidt M, Filipits M, Dubsky P, Petry C, Dietel M, Denkert C (2012) Decentral gene expression analysis: analytical validation of the Endopredict genomic multianalyte breast cancer prognosis test. BMC Cancer 12:456. doi:10.1186/1471-2407-12-456
17. Denkert C, Kronenwett R, Schlake W, Bohmann K, Penzel R, Weber KE, Hofler H, Lehmann U, Schirmacher P, Specht K, Rudas M, Kreipe HH, Schraml P, Schlake G, Bago-Horvath Z, Tiecke F, Varga Z, Moch H, Schmidt M, Prinzler J, Kerjaschki D, Sinn BV, Muller BM, Filipits M, Petry C, Dietel M (2012) Decentral gene expression analysis for ER+/HER2− breast cancer: results of a proficiency testing program for the EndoPredict assay. Virchows Archiv 460(3):251–259. doi:10.1007/s00428-012-1204-4
18. Filipits M, Rudas M, Jakesz R, Dubsky P, Fitzal F, Singer CF, Dietze O, Greil R, Jelen A, Sevelda P, Freibauer C, Muller V, Janicke F, Schmidt M, Kolbl H, Rody A, Kaufmann M, Schroth W, Brauch H, Schwab M, Fritz P, Weber KE, Feder IS, Hennig G, Kronenwett R, Gehrmann M, Gnant M (2011) A new molecular predictor of distant recurrence in ER-positive, HER2-negative breast cancer adds independent information to conventional clinical risk factors. Clin Cancer Res 17(18):6012–6020. doi:10.1158/1078-0432.ccr-11-0926
19. Dubsky P, Filipits M, Jakesz R, Rudas M, Singer CF, Greil R, Dietze O, Luisser I, Klug E, Sedivy R, Bachner M, Mayr D, Schmidt M, Gehrmann MC, Petry C, Weber KE, Kronenwett R, Brase JC, Gnant M (2013) EndoPredict improves the prognostic classification derived from common clinical guidelines in ER-positive, HER2-negative early breast cancer. Ann Oncol 24(3):640–647. doi:10.1093/annonc/mds334
20. Parker JS, Mullins M, Cheang MC, Leung S, Voduc D, Vickery T, Davies S, Fauron C, He X, Hu Z, Quackenbush JF, Stijleman IJ, Palazzo J, Marron JS, Nobel AB, Mardis E, Nielsen TO, Ellis MJ, Perou CM, Bernard PS (2009) Supervised risk predictor of breast cancer based on intrinsic subtypes. J Clin Oncol 27(8):1160–1167. doi:10.1200/jco.2008.18.1370
21. Nielsen TO, Parker JS, Leung S, Voduc D, Ebbert M, Vickery T, Davies SR, Snider J, Stijleman IJ, Reed J, Cheang MC, Mardis ER, Perou CM, Bernard PS, Ellis MJ (2010) A comparison of PAM50 intrinsic subtyping with immunohistochemistry and clinical prognostic factors in tamoxifen-treated estrogen receptor-positive breast cancer. Clin Cancer Res 16(21):5222–5232. doi:10.1158/1078-0432.ccr-10-1282
22. Martin M, Prat A, Rodriguez-Lescure A, Caballero R, Ebbert MT, Munarriz B, Ruiz-Borrego M, Bastien RR, Crespo C, Davis C, Rodriguez CA, Lopez-Vega JM, Furio V, Garcia AM, Casas M, Ellis MJ, Berry DA, Pitcher BN, Harris L, Ruiz A, Winer E, Hudis C, Stijleman IJ, Tuck DP, Carrasco E, Perou CM, Bernard PS (2013) PAM50 proliferation score as a predictor of weekly paclitaxel benefit in breast cancer. Breast Cancer Res Treat 138(2):457–466. doi:10.1007/s10549-013-2416-2
23. Bastien RR, Rodriguez-Lescure A, Ebbert MT, Prat A, Munarriz B, Rowe L, Miller P, Ruiz-Borrego M, Anderson D, Lyons B, Alvarez I, Dowell T, Wall D, Segui MA, Barley L, Boucher KM, Alba E, Pappas L, Davis CA, Aranda I, Fauron C, Stijleman IJ, Palacios J, Anton A, Carrasco E, Caballero R, Ellis MJ, Nielsen TO, Perou CM, Astill M, Bernard PS, Martin M (2012) PAM50 breast cancer subtyping by RT-qPCR and concordance with standard clinical molecular markers. BMC Med Genomics 5:44. doi:10.1186/1755-8794-5-44
24. Prat A, Cheang MC, Martin M, Parker JS, Carrasco E, Caballero R, Tyldesley S, Gelmon K, Bernard PS, Nielsen TO, Perou CM (2013) Prognostic significance of progesterone receptor-positive tumor cells within immunohistochemically defined luminal A breast cancer. J Clin Oncol 31(2):203–209. doi:10.1200/jco.2012.43.4134
25. Martin M, Brase JC, Calvo L, Krappmann K, Ruiz-Borrego M, Fisch K, Ruiz A, Weber KE, Munarriz B, Petry C, Rodriguez CA, Kronenwett R, Crespo C, Alba E, Carrasco E, Casas M, Caballero R, Rodriguez-Lescure A (2014) Clinical validation of the EndoPredict test in node-positive, chemotherapy-treated ER+/HER2− breast cancer patients: results from the GEICAM 9906 trial. Breast Cancer Res 16(2):R38. doi:10.1186/bcr3642
26. Martin M, Rodriguez-Lescure A, Ruiz A, Alba E, Calvo L, Ruiz-Borrego M, Munarriz B, Rodriguez CA, Crespo C, de Alava E, Lopez Garcia-Asenjo JA, Guitian MD, Almenar S, Gonzalez-Palacios JF, Vera F, Palacios J, Ramos M, Gracia Marco JM, Lluch A, Alvarez I, Segui MA, Mayordomo JI, Anton A, Baena JM, Plazaola A, Modolell A, Pelegri A, Mel JR, Aranda E, Adrover E, Alvarez JV, Garcia Puche JL, Sanchez-Rovira P, Gonzalez S, Lopez-Vega JM, Investigators GS (2008) Randomized phase 3 trial of fluorouracil, epirubicin, and cyclophosphamide alone or followed by Paclitaxel for early breast cancer. J Natl Cancer Inst 100(11):805–814. doi:10.1093/jnci/djn151
27. Muller BM, Kronenwett R, Hennig G, Euting H, Weber K, Bohmann K, Weichert W, Altmann G, Roth C, Winzer KJ, Kristiansen G, Petry C, Dietel M, Denkert C (2011) Quantitative determination of estrogen receptor, progesterone receptor, and HER2 mRNA in formalin-fixed paraffin-embedded tissue—a new option for predictive biomarker assessment in breast cancer. Diagn Mol Pathol B 20(1):1–10. doi:10.1097/PDM.0b013e3181e3630c
28. Fan C, Prat A, Parker JS, Liu Y, Carey LA, Troester MA, Perou CM (2011) Building prognostic models for breast cancer patients using clinical variables and hundreds of gene expression signatures. BMC Med Genomics 4:3. doi:10.1186/1755-8794-4-3
29. Evaluation of Genomic Applications in Practice and Prevention (EGAPP) Working Group (2009) Recommendations from the EGAPP Working Group: can tumor gene expression profiling improve outcomes in patients with breast cancer? Genet Med 11(1):66–73. doi:10.1097/GIM.0b013e3181928f56
30. Fan C, Oh DS, Wessels L, Weigelt B, Nuyten DS, Nobel AB, van’t Veer LJ, Perou CM (2006) Concordance among gene-expression-based predictors for breast cancer. N Engl J Med 355(6):560–569. doi:10.1056/NEJMoa052933
31. Haibe-Kains B, Desmedt C, Piette F, Buyse M, Cardoso F, Van’t Veer L, Piccart M, Bontempi G, Sotiriou C (2008) Comparison of prognostic gene expression signatures for breast cancer. BMC Genom 9:394. doi:10.1186/1471-2164-9-394
32. Dowsett M, Sestak I, Lopez-Knowles E, Sidhu K, Dunbier AK, Cowens JW, Ferree S, Storhoff J, Schaper C, Cuzick J (2013) Comparison of PAM50 risk of recurrence score with oncotype DX and IHC4 for predicting risk of distant recurrence after endocrine therapy. J Clin Oncol 31(22):2783–2790. doi:10.1200/jco.2012.46.1558
33. Cheang MC, Voduc KD, Tu D, Jiang S, Leung S, Chia SK, Shepherd LE, Levine MN, Pritchard KI, Davies S, Stijleman IJ, Davis C, Ebbert MT, Parker JS, Ellis MJ, Bernard PS, Perou CM, Nielsen TO (2012) Responsiveness of intrinsic subtypes to adjuvant anthracycline substitution in the NCIC.CTG MA.5 randomized trial. Clin Cancer Res 18(8):2402–2412. doi:10.1158/1078-0432.ccr-11-2956
34. Chia SK, Bramwell VH, Tu D, Shepherd LE, Jiang S, Vickery T, Mardis E, Leung S, Ung K, Pritchard KI, Parker JS, Bernard PS, Perou CM, Ellis MJ, Nielsen TO (2012) A 50-gene intrinsic subtype classifier for prognosis and prediction of benefit from adjuvant tamoxifen. Clin Cancer Res 18(16):4465–4472. doi:10.1158/1078-0432.ccr-12-0286
35. Gnant M, Filipits M, Greil R, Stoeger H, Rudas M, Bago-Horvath Z, Mlineritsch B, Kwasny W, Knauer M, Singer C, Jakesz R, Dubsky P, Fitzal F, Bartsch R, Steger G, Balic M, Ressler S, Cowens JW, Storhoff J, Ferree S, Schaper C, Liu S, Fesl C, Nielsen TO (2014) Predicting distant recurrence in receptor-positive breast cancer patients with limited clinicopathological risk: using the PAM50 risk of recurrence score in 1478 postmenopausal patients of the ABCSG-8 trial treated with adjuvant endocrine therapy alone. Ann Oncol 25(2):339–345. doi:10.1093/annonc/mdt494