A common language in neoadjuvant breast cancer clinical trials: proposals for standard definitions and endpoints - 29/05/12

Doi : 10.1016/S1470-2045(11)70378-3

Debora Fumagalli, MD ^a, Philippe L Bedard, MD ^b, Zeina Nahleh, MD ^c, Stefan Michiels, PhD ^a, Christos Sotiriou, MD ^a, Sherene Loi, MD ^a, Joseph A Sparano, ProfMD ^d, Matthew Ellis, ProfMD ^e, Nola Hylton, ProfPhD ^f, Jo Anne Zujewski, MD ^g, Clifford Hudis, ProfMD ^h, Laura Esserman, ProfMD ⁱ, Martine Piccart, ProfMD ^j,^⁎
on behalf of the BIG-NABCG collaboration
^a Breast Cancer Translational Research Laboratory, Faculty of Medicine, Université Libre de Bruxelles, Institut Jules Bordet, Brussels, Belgium
^b Division of Medical Oncology and Hematology, Princess Margaret Hospital, Department of Medicine, University of Toronto, Toronto, ON, Canada
^c Division of Hematology-Oncology, Department of Internal Medicine TTUHSC-Paul L Foster School of Medicine, El Paso, TX, USA
^d Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY, USA
^e Siteman Cancer Center, Washington University in St Louis, St Louis, MO, USA
^f Department of Radiology and Biomedical Imaging, University of California San Francisco, San Francisco, CA, USA
^g National Cancer Institute, Cancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis, Bethesda, MD, USA
^h Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY, USA
ⁱ Department of Surgery and Radiology, University of California San Francisco, San Francisco, CA, USA
^j Breast International Group, Institut Jules Bordet, Brussels, Belgium

^*Correspondence to: Prof Martine Piccart, Breast International Group, Institut Jules Bordet, Boulevard de Waterloo 121, 1000 Brussels, Belgium

Summary

The neoadjuvant setting provides a unique opportunity to study the effect of systemic treatments on breast cancer biology and to identify clinically useful prognostic and predictive biomarkers. Discrepancies and inconsistencies in the use of definitions and endpoint assessments in this setting confound the analysis and interpretation of results across clinical trials and hinder research progress. This Review represents a joint effort of the Breast International Group and the National Cancer Institute-sponsored North American Breast Cancer Group to provide clinicians and researchers with a series of standardised definitions and endpoints that could be implemented in future neoadjuvant clinical trials. Definitions of the setting of interest and of survival endpoints are recommended, together with proposals for standard assessment of the response to treatment, use of functional and molecular imaging endpoints, and characterisation and selection of the population to treat. We expect that implementation of these recommendations will improve the conduct, reporting, and effectiveness of clinical trials and fully exploit the clinical and scientific potential of the neoadjuvant setting in breast cancer.

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