Analytical validation of a standardized scoring protocol for Ki67: Phase 3 of an international multicenter collaboration

npj Breast Cancer

Volumn 2, Issue 1, 2016, Pages

  Leung, Samuel C Y ^a   Nielsen, Torsten O ^a   Zabaglo, Lila ^b   Arun, Indu ^c   Badve, Sunil S ^d   Bane, Anita L ^e   Bartlett, John M S ^f   Borgquist, Signe ^g   Chang, Martin C ^h   Dodson, Andrew ^b   Enos, Rebecca A ⁱ   Fineberg, Susan ^j   Focke, Cornelia M ^k   Gao, Dongxia ^a   Gown, Allen M ^l   Grabau, Dorthe ^g   Gutierrez, Carolina ^m   Hugh, Judith C ⁿ   Kos, Zuzana ^o   Lænkholm, Anne Vibeke ^p   Lin, Ming Gang ^q   Mastropasqua, Mauro G ^r   Moriya, Takuya ^s   Nofech Mozes, Sharon ^t   Osborne, C Kent ^m   Penault Llorca, Frédérique M ^u   Piper, Tammy ^v   Sakatani, Takashi ^w   Salgado, Roberto ^x   Starczynski, Jane ^y   Viale, Giuseppe ^r   Hayes, Daniel F ^z   McShane, Lisa M ^aa   Dowsett, Mitch ^b   more..

^a UNIVERSITY OF BRITISH COLUMBIA   (Canada)

^b INSTITUTE OF CANCER RESEARCH   (United Kingdom)

^c Tata Medical Centre   (India)

^d INDIANA UNIVERSITY SCHOOL OF MEDICINE   (United States)

^e MCMASTER UNIVERSITY   (Canada)

^f ONTARIO INSTITUTE FOR CANCER RESEARCH   (Canada)

^g LUND UNIVERSITY   (Sweden)

^h MOUNT SINAI HOSPITAL   (Canada)

ⁱ EMMES CORPORATION   (United States)

^j ALBERT EINSTEIN COLLEGE OF MEDICINE   (United States)

^k Department of Pathology   (Germany)

^l PHENOPATH LABORATORIES   (United States)

^m BAYLOR COLLEGE OF MEDICINE   (United States)

ⁿ UNIVERSITY OF ALBERTA   (Canada)

^o UNIVERSITY OF OTTAWA   (Canada)

^p SLAGELSE HOSPITAL   (Denmark)

^q Fred Hutchinson Cancer Research Center   (United States)

^r EUROPEAN INSTITUTE OF ONCOLOGY   (Italy)

^s KAWASAKI MEDICAL SCHOOL   (Japan)

^t SUNNYBROOK RESEARCH INSTITUTE   (Canada)

^u CENTRE JEAN PERRIN   (France)

^v WESTERN GENERAL HOSPITAL   (United Kingdom)

^w NIPPON MEDICAL SCHOOL   (Japan)

^x JULES BORDET INSTITUTE   (Belgium)

^y UNIVERSITY HOSPITALS BIRMINGHAM NHS FOUNDATION TRUST   (United Kingdom)

^z UNIVERSITY OF MICHIGAN COMPREHENSIVE CANCER CENTER   (United States)

^aa NATIONAL CANCER INSTITUTE   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

EID: 85012134592     PISSN: None     EISSN: 23744677     Source Type: Journal    
DOI: 10.1038/npjbcancer.2016.14     Document Type: Article

References (26)

1. Lei, Y. et al. The prognostic role of Ki-67/MIB-1 in upper urinary-tract urothelial carcinomas: a systematic review and meta-analysis. J. Endourol. 29, 1302–1308 (2015).
2. Desouki, M. M., Chamberlain, B. K. & Li, Z. The role of immunohistochemistry in the evaluation of gynecologic pathology part 2: a comparative study between two academic institutes. Ann. Diagn. Pathol. 19, 296–300 (2015).
3. Luporsi, E. et al. Ki-67: level of evidence and methodological considerations for its role in the clinical management of breast cancer: analytical and critical review. Breast Cancer Res. Treat. 132, 895–915 (2012).
4. de Azambuja, E. et al. Ki-67 as prognostic marker in early breast cancer: a meta-analysis of published studies involving 12,155 patients. Br. J. Cancer 96, 1504–1513 (2007).
5. Denkert, C. et al. Ki67 levels as predictive and prognostic parameters in pre-therapeutic breast cancer core biopsies: a translational investigation in the neoadjuvant GeparTrio trial. Ann. Oncol. 24, 2786–2793 (2013).
6. Inwald, E. C. et al. Ki-67 is a prognostic parameter in breast cancer patients: results of a large population-based cohort of a cancer registry. Breast Cancer Res. Treat. 139, 539–552 (2013).
7. Viale, G. et al. Prognostic and predictive value of centrally reviewed expression of estrogen and progesterone receptors in a randomized trial comparing letrozole and tamoxifen adjuvant therapy for postmenopausal early breast cancer: BIG 1-98. J. Clin. Oncol. 25, 3846–3852 (2007).
8. Viale, G. et al. Predictive value of tumor Ki-67 expression in two randomized trials of adjuvant chemoendocrine therapy for node-negative breast cancer. J. Natl Cancer Inst. 100, 207–212 (2008).
9. Yerushalmi, R., Woods, R., Ravdin, P. M., Hayes, M. M. & Gelmon, K. A. Ki67 in breast cancer: prognostic and predictive potential. Lancet Oncol. 11, 174–183 (2010).
10. Dowsett, M. et al. Assessment of Ki67 in breast cancer: recommendations from the International Ki67 in Breast Cancer working group. J. Natl Cancer Inst. 103, 1656–1664 (2011).
11. Petrelli, F., Viale, G., Cabiddu, M. & Barni, S. Prognostic value of different cut-off levels of Ki-67 in breast cancer: a systematic review and meta-analysis of 64,196 patients. Breast Cancer Res. Treat. 153, 477–491 (2015).
12. Criscitiello, C. et al. High Ki-67 score is indicative of a greater benefit from adjuvant chemotherapy when added to endocrine therapy in luminal B HER2 negative and node-positive breast cancer. Breast 23, 69–75 (2014).
13. Coates, A. S. et al. Tailoring therapies-improving the management of early breast cancer: St Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer. Ann. Oncol. 26, 1533–1546 (2015).
14. Allison, K. H., Kandalaft, P. L., Sitlani, C. M., Dintzis, S. M. & Gown, A. M. Routine pathologic parameters can predict Oncotype DX recurrence scores in subsets of ER positive patients: who does not always need testing? Breast Cancer Res. Treat. 131, 413–424 (2012).
15. Turner, B. M. et al. Use of modified Magee equations and histologic criteria to predict the Oncotype DX recurrence score. Mod. Pathol. 28, 921–931 (2015).
16. Denkert, C. et al. Strategies for developing Ki67 as a useful biomarker in breast cancer. Breast 24 Suppl 2, S67–S72 (2015).
17. Polley, M. Y. et al. An international Ki67 reproducibility study. J. Natl Cancer Inst. 105, 1897–1906 (2013).
18. Polley, M. Y. et al. An international study to increase concordance in Ki67 scoring. Mod. Pathol. 28, 778–786 (2015).
19. Shui, R., Yu, B., Bi, R., Yang, F. & Yang, W. An interobserver reproducibility analysis of Ki67 visual assessment in breast cancer. PLoS ONE 10, e0125131 (2015).
20. Stuart-Harris, R., Caldas, C., Pinder, S. E. & Pharoah, P. Proliferation markers and survival in early breast cancer: a systematic review and meta-analysis of 85 studies in 32,825 patients. Breast 17, 323–334 (2008).
21. Maisonneuve, P. et al. Proposed new clinicopathological surrogate definitions of luminal A and luminal B (HER2-negative) intrinsic breast cancer subtypes. Breast Cancer Res. 16, R65 (2014).
22. Cuzick, J. et al. 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, 4273–4278 (2011).
23. Miglietta, L. et al. A prognostic model based on combining estrogen receptor expression and Ki-67 value after neoadjuvant chemotherapy predicts clinical outcome in locally advanced breast cancer: extension and analysis of a previously reported cohort of patients. Eur. J. Surg. Oncol. 39, 1046–1052 (2013).
24. Zabaglo, L. et al. Comparative validation of the SP6 antibody to Ki67 in breast cancer. J. Clin. Pathol. 63, 800–804 (2010).
25. Landis, J. R. & Koch, G. G. The measurement of observer agreement for categorical data. Biometrics 33, 159–174 (1977).
26. R Core Team. R: A Language And Environment For Statistical Computing (R Foundation for Statistical Computing, Austria, 2015).