Ki-67: level of evidence and methodological considerations for its role in the clinical management of breast cancer: analytical and critical review (original) (raw)

2012, Breast Cancer Research and Treatment

Clinicians can use biomarkers to guide therapeutic decisions in estrogen receptor positive (ER?) breast cancer. One such biomarker is cellular proliferation as evaluated by Ki-67. This biomarker has been extensively studied and is easily assayed by histopathologists but it is not currently accepted as a standard. This review focuses on its prognostic and predictive value, and on methodological considerations for its measurement and the cutpoints used for treatment decision. Data describing study design, patients' characteristics, methods used and results were extracted from papers published between January 1990 and July 2010. In addition, the studies were assessed using the REMARK tool. Ki-67 is an independent prognostic factor for disease-free survival (HR 1.05-1.72) in multivariate analyses studies using samples from randomized clinical trials with secondary central analysis of the biomarker. The level of evidence (LOE) was judged to be I-B with the recently revised definition of Simon. However, E. Luporsi (&) INSERM, Centre d'Investigations Cliniques-9501,

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