Assessing the potential cost-effectiveness of retesting IHC0, IHC1+, or FISH-negative early stage breast cancer patients for HER2 status

Cancer

Volumn 119, Issue 17, 2013, Pages 3113-3122

  Garrison, Louis P ^a,b   Lalla, Deepa ^c   Brammer, Melissa ^c   Babigumira, Joseph B ^a,b   Wang, Bruce ^a,b   Perez, Edith A ^d  

^a VeriTech Corporation   (United States)

^b UNIVERSITY OF WASHINGTON   (United States)

^c GENENTECH INC   (United States)

^d MAYO CLINIC   (United States)

Author keywords

adjuvant; cost effectiveness; cost utility; early breast cancer; economics; HER2; HER2 testing; Herceptin; pharmacoeconomics; trastuzumab

Indexed keywords

EPIDERMAL GROWTH FACTOR RECEPTOR 2; TRASTUZUMAB;

ARTICLE; BREAST CANCER; CANCER STAGING; COST EFFECTIVENESS ANALYSIS; DIAGNOSTIC TEST ACCURACY STUDY; DRUG COST; FALSE NEGATIVE RESULT; FEMALE; FLUORESCENCE IN SITU HYBRIDIZATION; HUMAN; IMMUNOHISTOCHEMISTRY; MAJOR CLINICAL STUDY; PRIORITY JOURNAL; QUALITY ADJUSTED LIFE YEAR; SENSITIVITY AND SPECIFICITY;

EID: 84882604100     PISSN: 0008543X     EISSN: 10970142     Source Type: Journal    
DOI: 10.1002/cncr.28196     Document Type: Article

References (29)

1. Siegel R, Naishadham D, Jemal A,. Cancer statistics, 2013. CA Cancer J Clin. 2013; 63: 11-30.
2. Paik S, Hazan R, Fisher ER, et al. Pathologic findings from the National Surgical Adjuvant Breast and Bowel Project: prognostic significance of erbB-2 protein overexpression in primary breast cancer. J Clin Oncol. 1990; 8: 103-112.
3. Slamon DJ, Clark GM, Wong SG, Levin WJ, Ullrich A, McGuire WL,. Human breast cancer: correlation of relapse and survival with amplification of the HER-2/neu oncogene. Science. 1987; 235: 177-182.
4. Perez EA, Baweja M,. HER2-positive breast cancer: current treatment strategies. Cancer Invest. 2008; 26: 545-552.
5. Romond EH, Perez EA, Bryant J, et al. Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer. N Engl J Med. 2005; 353: 1673-1684.
6. Perez EA, Romond EH, Suman VJ, et al. Four-year follow-up of trastuzumab plus adjuvant chemotherapy for operable human epidermal growth factor receptor 2-positive breast cancer: joint analysis of data from NCCTG N9831 and NSABP B-31. J Clin Oncol. 2011; 29: 3366-3373.
7. Sauter G, Lee J, Bartlett JM, Slamon DJ, Press MF,. Guidelines for human epidermal growth factor receptor 2 testing: biologic and methodologic considerations. J Clin Oncol. 2009; 27: 1323-1333.
8. Perez EA, Roche PC, Jenkins RB, et al. HER2 testing in patients with breast cancer: poor correlation between weak positivity by immunohistochemistry and gene amplification by fluorescence in situ hybridization. Mayo Clin Proc. 2002; 77: 148-154.
9. Ross JS, Slodkowska EA, Symmans WF, Pusztai L, Ravdin PM, Hortobagyi GN,. The HER-2 receptor and breast cancer: ten years of targeted anti-HER-2 therapy and personalized medicine. Oncologist. 2009; 14: 320-368.
10. Wolff AC, Hammond ME, Schwartz JN, et al. American Society of Clinical Oncology/College of American Pathologists guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer. Arch Pathol Lab Med 2007; 131: 18-43.
11. Wolff AC, Hammond ME, Schwartz JN, et al. 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. 2007; 25: 118-145.
12. Grimm EE, Schmidt RA, Swanson PE, Dintzis SM, Allison KH,. Achieving 95% cross-methodological concordance in HER2 testing: causes and implications of discordant cases. Am J Clin Pathol. 2010; 134: 284-292.
13. Cuadros M, Villegas R,. Systematic review of HER2 breast cancer testing. Appl Immunohistochem Mol Morphol 2009; 17: 1-7.
14. Paik S, Kim C, Wolmark N,. HER2 status and benefit from adjuvant trastuzumab in breast cancer. N Engl J Med. 2008; 358: 1409-1411.
15. Dendukuri N, Khetani K, McIsaac M, Brophy J,. Testing for HER2-positive breast cancer: a systematic review and cost-effectiveness analysis. CMAJ. 2007; 176: 1429-1434.
16. Mayo Clinic. Mayo Medical Laboratories Reimbursement. Available at: http://www.mayomedicallaboratories.com/test-catalog/Fees+and+Coding/81504. Accessed May 25, 2012.
17. Garrison LP Jr, Lubeck D, Lalla D, Paton V, Dueck A, Perez EA,. Cost-effectiveness analysis of trastuzumab in the adjuvant setting for treatment of HER2-positive breast cancer. Cancer. 2007; 110: 489-498.
18. Centers for Medicare & Medicaid Services. Medicare part B drug average sales price. Available at: https://www.Cms.Gov/ mcrpartbdrugavgsalesprice/01a19-2010aspfiles.Asp. Accessed September 24, 2010.
19. Jemal A, Siegel R, Xu J, Ward E,. Cancer statistics, 2010. CA Cancer J Clin. 2010; 60: 277-300.
20. Briggs AH,. Handling uncertainty in cost-effectiveness models. Pharmacoeconomics. 2000; 17: 479-500.
21. Chambers JD, Neumann PJ, Buxton MJ,. Does Medicare have an implicit cost-effectiveness threshold? Med Decis Making. 2010; 30: E14-E27.
22. Guzauskas GF, Boudreau DM, Villa KF, Levine SR, Veenstra DL,. The cost-effectiveness of primary stroke centers for acute stroke care. Stroke. 2012; 43: 1617-1623.
23. Perez EA, Press MF, Dueck AC, et al. Immunohistochemistry and fluorescence in situ hybridization assessment of HER2 in clinical trials of adjuvant therapy for breast cancer (NCCTG N9831, BCIRG 006, and BCIRG 005). Breast Cancer Res Treat. 2013; 138: 99-108
24. Perez EA, Dueck AC, McCullough AE, et al. Predictability of adjuvant trastuzumab benefit in N9831 patients using the ASCO/CAP HER2-positivity criteria. J Natl Cancer Inst. 2012; 104: 159-162.
25. Vogel CL, Bloom K, Burris H, et al. Discordance between central and local laboratory HER2 testing from a large HER2-negative population in VIRGO, a metastatic breast cancer registry. Cancer Res. 2011; 71 (24 suppl): P1-07-02.
26. Dowsett M, Procter M, McCaskill-Stevens W, et al. Disease-free survival according to degree of HER2 amplification for patients treated with adjuvant chemotherapy with or without 1 year of trastuzumab: the HERA Trial. J Clin Oncol. 2009; 27: 2962-2969.
27. Ross JS,. Saving lives with accurate HER2 testing. Am J Clin Pathol. 2010; 134: 183-184.
28. Chien AJ, Rugo HS,. The cardiac safety of trastuzumab in the treatment of breast cancer. Expert Opin Drug Saf. 2010; 9: 335-346.
29. Blank PR, Schwenkglenks M, Moch H, Szucs TD,. Human epidermal growth factor receptor 2 expression in early breast cancer patients: a Swiss cost-effectiveness analysis of different predictive assay strategies. Breast Cancer Res Treat. 2010; 124: 497-507.