Human epidermal growth factor receptor 2 expression in early breast cancer patients: A Swiss cost-effectiveness analysis of different predictive assay strategies

Breast Cancer Research and Treatment

Volumn 124, Issue 2, 2010, Pages 497-507

  Blank, Patricia R ^a,b   Schwenkglenks, Matthias ^a,c   Moch, Holger ^b,d   Szucs, Thomas D ^c  

^a UNIVERSITY OF ZURICH   (Switzerland)

^b Competence Center for Systems Physiology and Metabolic Diseases ^*  (Switzerland)

^c UNIVERSITY OF BASEL   (Switzerland)

^d UNIVERSITY HOSPITAL ZURICH   (Switzerland)

Author keywords

Adjuvant; Breast cancer; Cost effectiveness; Predictive tests; Trastuzumab

Indexed keywords

ANASTROZOLE; EPIDERMAL GROWTH FACTOR RECEPTOR 2; LETROZOLE; TRASTUZUMAB;

ADULT; ARTICLE; BREAST CANCER; CANCER RECURRENCE; CANCER SURVIVAL; COHORT ANALYSIS; COST EFFECTIVENESS ANALYSIS; DISEASE FREE SURVIVAL; DRUG COST; DRUG EFFICACY; FEMALE; FLUORESCENCE IN SITU HYBRIDIZATION; GENE EXPRESSION; GENE IDENTIFICATION; HEALTH CARE COST; HEALTH CARE SYSTEM; HUMAN; IMMUNOHISTOCHEMISTRY; LOADING DRUG DOSE; MAJOR CLINICAL STUDY; METASTASIS; MULTIPLE CYCLE TREATMENT; PRIORITY JOURNAL; PROBABILITY; QUALITY ADJUSTED LIFE YEAR; SWITZERLAND;

ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC AGENTS; BREAST NEOPLASMS; CHEMOTHERAPY, ADJUVANT; COST-BENEFIT ANALYSIS; DRUG COSTS; FEMALE; HEALTH CARE COSTS; HUMANS; IMMUNOHISTOCHEMISTRY; IN SITU HYBRIDIZATION, FLUORESCENCE; MARKOV CHAINS; MASS SCREENING; MODELS, ECONOMIC; NATIONAL HEALTH PROGRAMS; PREDICTIVE VALUE OF TESTS; QUALITY-ADJUSTED LIFE YEARS; RECEPTOR, ERBB-2; SENSITIVITY AND SPECIFICITY; SWITZERLAND; TREATMENT OUTCOME; TUMOR MARKERS, BIOLOGICAL;

EID: 78649332014     PISSN: 01676806     EISSN: 15737217     Source Type: Journal    
DOI: 10.1007/s10549-010-0862-7     Document Type: Article

References (60)

1. DJ Slamon W Godolphin LA Jones JA Holt SG Wong DE Keith WJ Levin SG Stuart J Udove A Ullrich, et al. 1989 Studies of the HER-2/neu proto-oncogene in human breast and ovarian cancer Science (NY) 244 4905 707 712 1:STN:280:DyaL1M3kt1Wntg%3D%3D
2. B Breuer S Smith A Thor S Edgerton MP Osborne R Minick HS Cody III E Nowak A Cortese RM Simmons, et al. 1998 ErbB-2 protein in sera and tumors of breast cancer patients Breast Cancer Res Treat 49 3 261 270 1:CAS:528: DyaK1cXmvVSrurg%3D 10.1023/A:1006033214721 9776510 (Pubitemid 28416792)
3. KL Jones AU Buzdar 2009 Evolving novel anti-HER2 strategies Lancet Oncol 10 12 1179 1187 1:CAS:528:DC%2BD1MXhsV2lurrJ 10.1016/S1470-2045(09)70315-8 19959074
4. MA Owens BC Horten MM Da Silva 2004 HER2 amplification ratios by fluorescence in situ hybridization and correlation with immunohistochemistry in a cohort of 6556 breast cancer tissues Clin Breast Cancer 5 1 63 69 1:CAS:528:DC%2BD2cXltFygsbc%3D 10.3816/CBC.2004.n.011 15140287
5. A Goldhirsch JH Glick RD Gelber AS Coates B Thurlimann HJ Senn 2005 Meeting highlights: international expert consensus on the primary therapy of early breast cancer 2005 Ann Oncol 16 10 1569 1583 1:STN:280: DC%2BD2MvpvFKhsA%3D%3D 10.1093/annonc/mdi326 16148022 (Pubitemid 41511089)
6. JS Winston J Ramanaryanan E Levine 2004 HER-2/neu evaluation in breast cancer are we there yet? Am J Clin Pathol 121 Suppl S33 S49 15298149
7. DJ Slamon B Leyland-Jones S Shak H Fuchs V Paton A Bajamonde T Fleming W Eiermann J Wolter M Pegram, et al. 2001 Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2 N Engl J Med 344 11 783 792 1:CAS:528:DC%2BD3MXisVGktrc%3D 10.1056/ NEJM200103153441101 11248153 (Pubitemid 32222155)
8. MA Cobleigh CL Vogel D Tripathy NJ Robert S Scholl L Fehrenbacher JM Wolter V Paton S Shak G Lieberman, et al. 1999 Multinational study of the efficacy and safety of humanized anti-HER2 monoclonal antibody in women who have HER2-overexpressing metastatic breast cancer that has progressed after chemotherapy for metastatic disease J Clin Oncol 17 9 2639 2648 1:CAS:528:DyaK1MXmtlWrurk%3D 10561337
9. CL Vogel MA Cobleigh D Tripathy JC Gutheil LN Harris L Fehrenbacher DJ Slamon M Murphy WF Novotny M Burchmore, et al. 2002 Efficacy and safety of trastuzumab as a single agent in first-line treatment of HER2-overexpressing metastatic breast cancer J Clin Oncol 20 3 719 726 1:CAS:528: DC%2BD38XhsVGmt7o%3D 10.1200/JCO.20.3.719 11821453 (Pubitemid 34111379)
10. M Marty F Cognetti D Maraninchi R Snyder L Mauriac M Tubiana-Hulin S Chan D Grimes A Anton A Lluch, et al. 2005 Randomized phase II trial of the efficacy and safety of trastuzumab combined with docetaxel in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer administered as first-line treatment: the M77001 study group J Clin Oncol 23 19 4265 4274 1:CAS:528:DC%2BD2MXms12gs70%3D 10.1200/JCO.2005.04.173 15911866 (Pubitemid 46207001)
11. H Joensuu PL Kellokumpu-Lehtinen P Bono T Alanko V Kataja R Asola T Utriainen R Kokko A Hemminki M Tarkkanen, et al. 2006 Adjuvant docetaxel or vinorelbine with or without trastuzumab for breast cancer N Engl J Med 354 8 809 820 1:CAS:528:DC%2BD28Xhsl2gsrY%3D 10.1056/NEJMoa053028 16495393 (Pubitemid 43290919)
12. MJ Piccart-Gebhart M Procter B Leyland-Jones A Goldhirsch M Untch I Smith L Gianni J Baselga R Bell C Jackisch, et al. 2005 Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer N Engl J Med 353 16 1659 1672 1:CAS:528:DC%2BD2MXhtFansr3L 10.1056/NEJMoa052306 16236737 (Pubitemid 41464705)
13. EH Romond EA Perez J Bryant VJ Suman CE Geyer Jr NE Davidson E Tan-Chiu S Martino S Paik PA Kaufman, et al. 2005 Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer N Engl J Med 353 16 1673 1684 1:CAS:528:DC%2BD2MXhtFansr3F 10.1056/NEJMoa052122 16236738 (Pubitemid 41464706)
14. I Smith M Procter RD Gelber S Guillaume A Feyereislova M Dowsett A Goldhirsch M Untch G Mariani J Baselga, et al. 2007 2-year follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer: a randomised controlled trial Lancet 369 9555 29 36 1:CAS:528: DC%2BD2sXit12itg%3D%3D 10.1016/S0140-6736(07)60028-2 17208639 (Pubitemid 46039831)
15. M Kroese RL Zimmern SE Pinder 2007 HER2 status in breast cancer-an example of pharmacogenetic testing J R Soc Med 100 7 326 329 10.1258/jrsm.100.7.326 17606754 (Pubitemid 47104950)
16. G Sauter J Lee JM Bartlett DJ Slamon MF Press 2009 Guidelines for human epidermal growth factor receptor 2 testing: biologic and methodologic considerations J Clin Oncol 27 8 1323 1333 1:CAS:528:DC%2BD1MXktFKhsbs%3D 10.1200/JCO.2007.14.8197 19204209
17. N Dendukuri K Khetani M McIsaac J Brophy 2007 Testing for HER2-positive breast cancer: a systematic review and cost-effectiveness analysis CMAJ 176 10 1429 1434 17485695 (Pubitemid 46762020)
18. AM Gown 2008 Current issues in ER and HER2 testing by IHC in breast cancer Mod Pathol 21 2 S8 S15 1:CAS:528:DC%2BD1cXltFehsr8%3D 10.1038/modpathol.2008.34 18437174 (Pubitemid 351592775)
19. AC Wolff ME Hammond JN Schwartz KL Hagerty DC Allred RJ Cote M Dowsett PL Fitzgibbons WM Hanna A Langer, et al. 2007 American Society of Clinical Oncology/College of American Pathologists guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer J Clin Oncol 25 1 118 145 1:CAS:528:DC%2BD2sXht1ejs7Y%3D 10.1200/JCO.2006.09.2775 17159189 (Pubitemid 350003059)
20. G Demonty C Bernard-Marty F Puglisi I Mancini M Piccart 2007 Progress and new standards of care in the management of HER-2 positive breast cancer Eur J Cancer 43 3 497 509 10.1016/j.ejca.2006.10.020 17223541 (Pubitemid 46177593)
21. TD Szucs KJ Dedes 2008 Balancing costs and benefits in cancer therapy and prevention Ann Oncol 19 Suppl 7 vii313 vii319 10.1093/annonc/mdn475 18790974
22. MF Drummond AR Mason 2007 European perspective on the costs and cost-effectiveness of cancer therapies J Clin Oncol 25 2 191 195 10.1200/JCO.2006.07.8956 17210939 (Pubitemid 350003033)
23. LP Garrison Jr D Lubeck D Lalla V Paton A Dueck EA Perez 2007 Cost-effectiveness analysis of trastuzumab in the adjuvant setting for treatment of HER2-positive breast cancer Cancer 110 3 489 498 1:CAS:528: DC%2BD2sXpt1yqurc%3D 10.1002/cncr.22806 17592827 (Pubitemid 47106136)
24. NL Liberato M Marchetti G Barosi 2007 Cost effectiveness of adjuvant trastuzumab in human epidermal growth factor receptor 2-positive breast cancer J Clin Oncol 25 6 625 633 10.1200/JCO.2006.06.4220 17308267 (Pubitemid 350002916)
25. KJ Dedes TD Szucs P Imesch A Fedier MK Fehr D Fink 2007 Cost-effectiveness of trastuzumab in the adjuvant treatment of early breast cancer: a model-based analysis of the HERA and FinHer trial Ann Oncol 18 9 1493 1499 1:STN:280:DC%2BD2srhtFaqtg%3D%3D 10.1093/annonc/mdm185 17761705 (Pubitemid 47365481)
26. EB Elkin MC Weinstein EP Winer KM Kuntz SJ Schnitt JC Weeks 2004 HER-2 testing and trastuzumab therapy for metastatic breast cancer: a cost-effectiveness analysis J Clin Oncol 22 5 854 863 10.1200/JCO.2004.04.158 14990641 (Pubitemid 41103597)
27. M Lidgren B Jonsson C Rehnberg N Willking J Bergh 2008 Cost-effectiveness of HER2 testing and 1-year adjuvant trastuzumab therapy for early breast cancer Ann Oncol 19 3 487 495 1:STN:280:DC%2BD1c7ksVeisg%3D%3D 10.1093/annonc/mdm488 18065409 (Pubitemid 351325669)
28. M Lidgren N Wilking B Jonsson C Rehnberg 2008 Cost-effectiveness of HER2 testing and trastuzumab therapy for metastatic breast cancer Acta Oncol (Stockholm) 47 6 1018 1028 1:CAS:528:DC%2BD1cXhtVOrur%2FL 10.1080/ 02841860801901618
29. DG Hicks S Kulkarni 2008 HER2+ breast cancer: review of biologic relevance and optimal use of diagnostic tools Am J Clin Pathol 129 2 263 273 10.1309/99AE032R9FM8WND1 18208807 (Pubitemid 352029317)
30. MF Press G Sauter L Bernstein IE Villalobos M Mirlacher JY Zhou R Wardeh YT Li R Guzman Y Ma, et al. 2005 Diagnostic evaluation of HER-2 as a molecular target: an assessment of accuracy and reproducibility of laboratory testing in large, prospective, randomized clinical trials Clin Cancer Res 11 18 6598 6607 1:CAS:528:DC%2BD2MXhtVShsb%2FF 10.1158/1078-0432.CCR-05-0636 16166438 (Pubitemid 41339000)
31. Schink T (2007) Diagnostic procedure to detect and assess resectability of pancreatic carcinomas: comparison and clinical decision analysis (Diagnostische Verfahren zur Detektion und Resektabilitaetsbeurteilung beim Pankreaskarzinom: Vergleich und klinische Entscheidungsanalyse). Charité Medical University Berlin, Munich
32. SE Singletary C Allred P Ashley LW Bassett D Berry KI Bland PI Borgen GM Clark SB Edge DF Hayes, et al. 2003 Staging system for breast cancer: revisions for the 6th edition of the AJCC Cancer Staging Manual Surg Clin N Am 83 4 803 819 10.1016/S0039-6109(03)00034-3 12875597
33. Fleming ID, Cooper J, Henson DE et al (1998) AJCC cancer staging manual, 5th edn. Lippincott-Raven, Philadelphia
34. EE Harris WT Hwang F Seyednejad LJ Solin 2003 Prognosis after regional lymph node recurrence in patients with stage I-II breast carcinoma treated with breast conservation therapy Cancer 98 10 2144 2151 10.1002/cncr.11767 14601083 (Pubitemid 37392417)
35. J Shen KK Hunt NQ Mirza TA Buchholz GV Babiera HM Kuerer I Bedrosian MI Ross FC Ames BW Feig, et al. 2005 Predictors of systemic recurrence and disease-specific survival after ipsilateral breast tumor recurrence Cancer 104 3 479 490 10.1002/cncr.21224 15968686 (Pubitemid 41022803)
36. AD Seidman D Berry C Cirrincione L Harris H Muss PK Marcom G Gipson H Burstein D Lake CL Shapiro, et al. 2008 Randomized phase III trial of weekly compared with every-3-weeks paclitaxel for metastatic breast cancer, with trastuzumab for all HER-2 overexpressors and random assignment to trastuzumab or not in HER-2 nonoverexpressors: final results of Cancer and Leukemia Group B protocol 9840 J Clin Oncol 26 10 1642 1649 1:CAS:528:DC%2BD1cXltlWhsr0%3D 10.1200/JCO.2007.11.6699 18375893
37. M Clarke R Collins S Darby C Davies P Elphinstone E Evans J Godwin R Gray C Hicks S James, et al. 2005 Effects of radiotherapy and of differences in the extent of surgery for early breast cancer on local recurrence and 15-year survival: an overview of the randomised trials Lancet 366 9503 2087 2106 1:STN:280:DC%2BD2MnnsVSitA%3D%3D 16360786
38. Swiss Federal Statistic Office-Life Tables 2006. http://www.bfs.admin.ch/ bfs/portal/de/index/themen/14/02/04.html
39. M Lidgren N Wilking B Jonsson C Rehnberg 2007 Health related quality of life in different states of breast cancer Qual Life Res 16 6 1073 1081 10.1007/s11136-007-9202-8 17468943 (Pubitemid 47174889)
40. AGO (2006) Recommendation for gynaecologic oncological aftercare. In. Zurich: consortium of gynaecological oncology of the Swiss Society of Gynaecology and Obstetrics (SGGG)
41. J Fodor T Major C Polgar Z Orosz Z Sulyok M Kasler 2008 Prognosis of patients with local recurrence after mastectomy or conservative surgery for early-stage invasive breast cancer Breast (Edinburgh, Scotland) 17 3 302 308 1:STN:280:DC%2BD1czkvVSksA%3D%3D
42. S Chia B Norris C Speers M Cheang B Gilks AM Gown D Huntsman IA Olivotto TO Nielsen K Gelmon 2008 Human epidermal growth factor receptor 2 overexpression as a prognostic factor in a large tissue microarray series of node-negative breast cancers J Clin Oncol 26 35 5697 5704 1:CAS:528:DC%2BD1MXotFemsw%3D%3D 10.1200/JCO.2007.15.8659 19001334
43. M Nadji C Gomez-Fernandez P Ganjei-Azar AR Morales 2005 Immunohistochemistry of estrogen and progesterone receptors reconsidered: experience with 5,993 breast cancers Am J Clin Pathol 123 1 21 27 10.1309/4WV79N2GHJ3X1841 15762276
44. Tarmed Switzerland. http://www.tarmed.ch/
45. The hospitals of Switzerland-Tariffs and Prices. http://www.hplus.ch/de/ tarife-preise/tarmed/
46. BFS (2005) Swiss Federal Statistic Office-Medical statistics of hospitals. In: Erwin Wueest
47. Swiss Agency for Therapeutic Products. http://www.swissmedic.ch/
48. CJ Clopper ES Pearson 1934 The use of confidence or fiducial limits illustrated in the case of the binomial Biometrika 26 404 413 10.1093/biomet/26.4.404
49. AH Briggs R Goeree G Blackhouse BJ O'Brien 2002 Probabilistic analysis of cost-effectiveness models: choosing between treatment strategies for gastroesophageal reflux disease Med Decis Making 22 4 290 308 12150595
50. Drummond MF, Stoddart GL, Torrance GW, O'Brien BJ, Stoddart GL (2005) Methods for the economic evaluation of health care programmes, 3rd edn. Oxford University Press, Oxford, pp 131-135
51. Swiss Association of Cancer Registries, Statistics, Prevalence. http://www.asrt.ch/asrt/newstat/extracted-from-globocan2002.pdf
52. Sari E, Guler G, Hayran M, Gullu I, Altundag K, Ozisik Y (2010) Comparative study of the immunohistochemical detection of hormone receptor status and HER-2 expression in primary and paired recurrent/metastatic lesions of patients with breast cancer. Med Oncol. doi: 10.1007/s12032-010-9418-2
53. HB Neuman M Morrogh M Gonen KJ Van Zee M Morrow TA King 2010 Stage IV breast cancer in the era of targeted therapy: does surgery of the primary tumor matter? Cancer 116 5 1226 1233 10.1002/cncr.24873 20101736
54. EE Lower E Glass R Blau S Harman 2009 HER-2/neu expression in primary and metastatic breast cancer Breast Cancer Res Treat 113 2 301 306 1:CAS:528:DC%2BD1MXhsVKntA%3D%3D 10.1007/s10549-008-9931-6 18273700
55. A Santinelli E Pisa D Stramazzotti G Fabris 2008 HER-2 status discrepancy between primary breast cancer and metastatic sites. Impact on target therapy Int J Cancer 122 5 999 1004 1:CAS:528:DC%2BD1cXhslGhtb0%3D 10.1002/ijc.23051 17973263 (Pubitemid 351213996)
56. S Dawood E Resetkova AM Gonzalez-Angulo 2008 Trastuzumab administration associated with change in HER2 status Clinical Breast Cancer 8 4 366 369 10.3816/CBC.2008.n.044 18757266
57. T Fehm W Jager S Kraemer C Sohn G Solomayer-Meyberg EF Solomayer R Kurek D Wallwiener G Gebauer 2004 Changes of serum HER2 status during clinical course of metastatic breast cancer patients Anticancer Res 24 6 4205 4210 1:CAS:528:DC%2BD2MXitFyltLc%3D 15739264
58. RD Cebul JC Hershey SV Williams 1982 Using multiple tests: series and parallel approaches Clin Lab Med 2 4 871 890 1:STN:280:DyaL3s7jtVemtQ%3D%3D 7160153
59. EE Harris WT Hwang EA Lee KA Cengel MD Feldman A Demichele G Kao LJ Solin 2006 The impact of HER-2 status on local recurrence in women with stage I-II breast cancer treated with breast-conserving therapy Breast J 12 5 431 436 10.1111/j.1075-122X.2006.00297.x 16958961 (Pubitemid 44337435)
60. BFS (2007) Medical statistics of hospitals In: Edited by office SFS: Erwin Wueest