Journal of the National Cancer Institute Advance Access published online on January 29, 2008
JNCI Journal of the National Cancer Institute, doi:10.1093/jnci/djm289
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© The Author 2008. Published by Oxford University Press.
Predictive Value of Tumor Ki-67 Expression in Two Randomized Trials of Adjuvant Chemoendocrine Therapy for Node-Negative Breast Cancer
On the behalf of the International Breast Cancer Study Group
Affiliations of the authors: Divisions of Pathology and Laboratory Medicine (GV, MGM, FM) and Medical Oncology (MC, AG), European Institute of Oncology, University of Milan, Milan, Italy; International Breast Cancer Study Group (IBCSG) Statistical Center, Dana-Farber Cancer Institute, Frontier Science and Technology Research Foundation, Harvard School of Public Health, Boston, MA (MMR, KNP, RDG); Department of Pathological Anatomy, University of Bari, Bari, Italy (EM); The Institute of Oncology, Ljubljana, Slovenia (RG); Division of Pathology, Centro di Riferimento Oncologico, Aviano, Italy (TP); Melbourne Pathology, Collingwood, Victoria, Australia (RWB); Department of Pathology, Göteborg/Sahlgrenska University Hospital, Göteborg, Sweden (AK); Division of Anatomical Pathology, Department of Clinical Laboratory Sciences, University of Cape Town, National Health Laboratory Services and Groote Schuur Hospital, Cape Town, South Africa (KP); Kantonspital, St Gallen, Swiss Group for Clinical Cancer Research (SAKK), Bern, Switzerland (CO); Division of Cancer Sciences and Molecular Pathology, Western Infirmary, University of Glasgow, UK (BAG); IBCSG Coordinating Center, Bern, Switzerland (MCG); Oncology Institute of Southern Switzerland, Bellinzona, Switzerland (AG); IBCSG, Bern, Switzerland (ASC); University of Sydney, Australia (ASC)
Correspondence to: Giuseppe Viale, MD, FRCPath, Division of Pathology and Laboratory Medicine, European Institute of Oncology, University of Milan, Via Ripamoniti 435, Milan, Italy (e-mail: giuseppe.viale{at}ieo.it).
Several small studies have reported that having a high percentage of breast tumor cells that express the proliferation antigen Ki-67 (ie, a high Ki-67 labeling index) predicts better response to neoadjuvant chemotherapy. However, the predictive value of a high Ki-67 labeling index for response to adjuvant chemotherapy is unclear. To investigate whether Ki-67 labeling index predicts response to adjuvant chemoendocrine therapy, we assessed Ki-67 expression in tumor tissue from 1924 (70%) of 2732 patients who were enrolled in two randomized International Breast Cancer Study Group trials of adjuvant chemoendocrine therapy vs endocrine therapy alone for node-negative breast cancer. A high Ki-67 labeling index was associated with other factors that predict poor prognosis. Among the 1521 patients with endocrine-responsive tumors, a high Ki-67 labeling index was associated with worse disease-free survival but the Ki-67 labeling index did not predict the relative efficacy of chemoendocrine therapy compared with endocrine therapy alone. Thus, Ki-67 labeling index was an independent prognostic factor but was not predictive of better response to adjuvant chemotherapy in these studies.
| CONTEXT AND CAVEATS Prior knowledge Some studies have suggested that having a high percentage of breast tumor cells that label with an antibody against the proliferation antigen Ki-67 predicts a better response to primary (ie, neoadjuvant) chemotherapy. Study design A retrospective assessment of the predictive value of a high Ki-67 labeling index for response to therapy among women enrolled in two randomized trials of adjuvant chemoendocrine therapy vs endocrine therapy alone for node-negative breast cancer. Contribution A high Ki-67 labeling index did not predict which women would benefit from further treatment with chemotherapy added to endocrine therapy. Limitations Only women with node-negative breast cancer were included in this study. Implications Other biomarkers are needed to define which women with endocrine-responsive node-negative early breast cancer could benefit from the addition of adjuvant chemotherapy to endocrine therapy.
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Manuscript received July 5, 2007; revised November 21, 2007; accepted November 27, 2007.
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J Natl Cancer Inst 2008 100: 159-161.
J Natl Cancer Inst 2008 100: 157.
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