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Prognostic and predictive value of centrally reviewed Ki-67 labeling index in postmenopausal women with endocrine-responsive breast cancer : results from Breast International Group Trial 1-98 comparing adjuvant tamoxifen with letrozole

Viale, Giuseppe and Giobbie-Hurder, Anita and Regan, Meredith M. and Coates, Alan S. and Mastropasqua, Mauro G. and Dell'Orto, Patrizia and Maiorano, Eugenio and MacGrogan, Gaëtan and Braye, Stephen G. and Ohlschlegel, Christian and Neven, Patrick and Orosz, Zsolt and Olszewski, Wojciech P. and Knox, Fiona and Thürlimann, Beat and Price, Karen N. and Castiglione-Gertsch, Monica and Gelber, Richard D. and Gusterson, Barry A. and Goldhirsch, Aron. (2008) Prognostic and predictive value of centrally reviewed Ki-67 labeling index in postmenopausal women with endocrine-responsive breast cancer : results from Breast International Group Trial 1-98 comparing adjuvant tamoxifen with letrozole. Journal of clinical oncology, Vol. 26. pp. 5569-5575.

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Official URL: http://edoc.unibas.ch/dok/A6002961

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Abstract

PURPOSE: To evaluate the prognostic and predictive value of Ki-67 labeling index (LI) in a trial comparing letrozole (Let) with tamoxifen (Tam) as adjuvant therapy in postmenopausal women with early breast cancer. PATIENTS AND METHODS: Breast International Group (BIG) trial 1-98 randomly assigned 8,010 patients to four treatment arms comparing Let and Tam with sequences of each agent. Of 4,922 patients randomly assigned to receive 5 years of monotherapy with either agent, 2,685 had primary tumor material available for central pathology assessment of Ki-67 LI by immunohistochemistry and had tumors confirmed to express estrogen receptors after central review. The prognostic and predictive value of centrally measured Ki-67 LI on disease-free survival (DFS) were assessed among these patients using proportional hazards modeling, with Ki-67 LI values dichotomized at the median value of 11%. RESULTS: Higher values of Ki-67 LI were associated with adverse prognostic factors and with worse DFS (hazard ratio [HR; high:low] = 1.8; 95% CI, 1.4 to 2.3). The magnitude of the treatment benefit for Let versus Tam was greater among patients with high tumor Ki-67 LI (HR [Let:Tam] = 0.53; 95% CI, 0.39 to 0.72) than among patients with low tumor Ki-67 LI (HR [Let:Tam] = 0.81; 95% CI, 0.57 to 1.15; interaction P = .09). CONCLUSION: Ki-67 LI is confirmed as a prognostic factor in this study. High Ki-67 LI levels may identify a patient group that particularly benefits from initial Let adjuvant therapy.
Faculties and Departments:03 Faculty of Medicine > Bereich Medizinische Fächer (Klinik) > Onkologie
03 Faculty of Medicine > Departement Klinische Forschung > Bereich Medizinische Fächer (Klinik) > Onkologie
UniBasel Contributors:Thürlimann, Beat
Item Type:Article, refereed
Article Subtype:Research Article
Bibsysno:Link to catalogue
Publisher:American Society of Clinical Oncology
ISSN:0732-183X
Note:Publication type according to Uni Basel Research Database: Journal article
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Last Modified:08 Nov 2012 16:23
Deposited On:08 Nov 2012 16:20

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