Ki-67: level of evidence and methodological considerations for its role in the clinical management of breast cancer: analytical and critical review
Year: 2011
Type: review
Abstract: 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 cut-points 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, standardization of the techniques and scoring methods are needed for the integration of this biomarker in everyday practice. Ki-67 was not found to be predictive for long-term follow-up after chemotherapy. Nevertheless, high KI-67 was found to be associated with immediate pathological complete response in the neoadjuvant setting, with an LOE of II-B. The REMARK score improved over time (with a range of 6-13/20 vs. 10-18/20, before and after 2005, respectively). KI-67 could be considered as a prognostic biomarker for therapeutic decision. It is assessed with a simple assay that could be standardized. However, international guidelines are needed for routine clinical use.
Authors: Elisabeth Luporsi, Fabrice André, Frédérique Spyratos, Pierre-Marie Martin, Jocelyne Jacquemier, Frédérique Penault-Llorca, Nicole Tubiana-Mathieu, Brigitte Sigal-Zafrani, Laurent Arnould, Anne Gompel, Caroline Egele, Bruno Poulet, Krishna B. Clough, Hubert Crouet, Alain Fourquet, Jean-Pierre Lefranc, Carole Mathelin, Nicolas Rouyer, Daniel Serin, Marc Spielmann, Margaret Haugh, Marie-Pierre Chenard, Etienne Brain, Patricia de Cremoux, Jean-Pierre Bellocq
Institutions: Inserm, Centre Hospitalier Régional et Universitaire de Nancy, Institut Gustave Roussy, Hôpital René Huguenin, Institut Curie, Assistance Publique Hôpitaux de Marseille, Institut Paoli-Calmettes, Université Clermont Auvergne, Centre Jean Perrin, Centre Hospitalier Universitaire de Limoges, Hôpital Universitaire Dupuytren, Centre Georges François Leclerc, Assistance Publique – Hôpitaux de Paris, Université Paris Descartes, Hôpitaux Universitaires de Strasbourg, Hôpital d'Hautepierre, Centre François Baclesse, Pitié-Salpêtrière Hospital, Institut Sainte Catherine, Hôpital Saint-Louis
Language: English
Subfield: Cancer Research
Domain: Life Sciences
Open Access status: hybrid
Estimated APC paid: $4,190
OpenAlex ID: W2168197820