Details

Autor(en) / Beteiligte

• VIALE, Giuseppe
• GIOBBIE-HURDER, Anita
• NEVEN, Patrick
• OROSZ, Zsolt
• OLSZEWSKI, Wojciech P
• KNOX, Fiona
• THÜRLIMANN, Beat
• PRICE, Karen N
• CASTIGLIONE-GERTSCH, Monica
• GELBER, Richard D
• GUSTERSON, Barry A
• GOLDHIRSCH, Aron
• REGAN, Meredith M
• COATES, Alan S
• MASTROPASQUA, Mauro G
• DELL'ORTO, Patrizia
• MAIORANO, Eugenio
• MACGROGAN, Gaëtan
• BRAYE, Stephen G
• OHISCHLEGEL, Christian

Titel

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

Ist Teil von

• Journal of clinical oncology, 2008-12, Vol.26 (34), p.5569-5575

Ort / Verlag

Alexandria, VA: American Society of Clinical Oncology

Erscheinungsjahr

2008

Quelle

MEDLINE

Beschreibungen/Notizen

• 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. 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%. 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). 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.