title: Recommendations for standardized pathological characterization of residual disease for neoadjuvant clinical trials of breast cancer by the BIG-NABCG collaboration.
abstract: Neoadjuvant systemic therapy (NAST) provides the unique opportunity to assess response to treatment after months rather than years of follow-up. However, significant variability exists in methods of pathologic assessment of response to NAST, and thus its interpretation for subsequent clinical decisions. Our international multidisciplinary working group was convened by the Breast International Group-North American Breast Cancer Group (BIG-NABCG) collaboration and tasked to recommend practical methods for standardized evaluation of the post-NAST surgical breast cancer specimen for clinical trials that promote accurate and reliable designation of pathologic complete response (pCR) and meaningful characterization of residual disease. Recommendations include multidisciplinary communication; clinical marking of the tumor site (clips); and radiologic, photographic, or pictorial imaging of the sliced specimen, to map the tissue sections and reconcile macroscopic and microscopic findings. The information required to define pCR (ypT0/is ypN0 or ypT0 yp N0), residual ypT and ypN stage using the current AJCC/UICC system, and the Residual Cancer Burden system were recommended for quantification of residual disease in clinical trials.
authors.affiliation: Department of Pathology, Yale University, New Haven, USA veerle.bossuyt@yale.edu.
authors.forename: V
authors.initials: V
authors.lastname: Bossuyt
authors.affiliation: Department of Oncology, University of Cambridge, Addenbrooke's Hospital, Cambridge, UK.
authors.forename: E
authors.initials: E
authors.lastname: Provenzano
authors.affiliation: Department of Pathology, The University of Texas M.D. Anderson Cancer Center, Houston.
authors.forename: W F
authors.initials: WF
authors.lastname: Symmans
authors.affiliation: Division of Subspecialty General Surgery, Mayo Clinic, Rochester, USA.
authors.forename: J C
authors.initials: JC
authors.lastname: Boughey
authors.affiliation: Oncology Centre, Cambridge University Hospitals National Health Services Foundation Trust, Cambridge, UK.
authors.forename: C
authors.initials: C
authors.lastname: Coles
authors.affiliation: Division of Early Drug Development for Innovative Therapies, European Institute of Oncology, Milan, Italy.
authors.forename: G
authors.initials: G
authors.lastname: Curigliano
authors.affiliation: Edinburgh Breast Unit, Western General Hospital, Edinburgh, UK.
authors.forename: J M
authors.initials: JM
authors.lastname: Dixon
authors.affiliation: Carol Franc Buck Breast Care Center, University of California, San Francisco, USA.
authors.forename: L J
authors.initials: LJ
authors.lastname: Esserman
authors.affiliation: Department of Radiotherapy and Radiation Oncology, Landeskrankenhaus, Paracelsus Medical University, Salzburg, Austria.
authors.forename: G
authors.initials: G
authors.lastname: Fastner
authors.affiliation: Department of Gynecology and Obstetrics, Interdisciplinary Breast Center, Klinikum Esslingen, Essligen, Germany.
authors.forename: T
authors.initials: T
authors.lastname: Kuehn
authors.affiliation: Institute of Pathology, Medical University of Graz, Graz Breast Center Salzburg, Paracelsus Medical University, University Hospital Salzburg, Salzburg, Austria.
authors.forename: F
authors.initials: F
authors.lastname: Peintinger
authors.affiliation: German Breast Group, Neu-Isenburg, and University Women's Hospital, Frankfurt, Germany.
authors.forename: G
authors.initials: G
authors.lastname: von Minckwitz
authors.affiliation: Department of Radiation Oncology, Ohio State University Comprehensive Cancer Center, Columbus.
authors.forename: J
authors.initials: J
authors.lastname: White
authors.affiliation: Department of Diagnostic Radiology, The University of Texas M.D. Anderson Cancer Center, Houston.
authors.forename: W
authors.initials: W
authors.lastname: Yang
authors.affiliation: Department of Pathology and Laboratory Medicine, Indiana University School of Medicine, Indianapolis, USA.
authors.forename: S
authors.initials: S
authors.lastname: Badve
authors.affiliation: Institute of Pathology, Charité Hospital, Campus Mitte, Berlin, Germany.
authors.forename: C
authors.initials: C
authors.lastname: Denkert
authors.affiliation: Department of Biopathology, Institut Bergonié, Bordeaux.
authors.forename: G
authors.initials: G
authors.lastname: MacGrogan
authors.affiliation: Centre Jean Perrin, Clermont-Ferrand, and Université d'Auvergne, France.
authors.forename: F
authors.initials: F
authors.lastname: Penault-Llorca
authors.affiliation: Department of Pathology, European Institute of Oncology and University of Milan, Milan, Italy.
authors.forename: G
authors.initials: G
authors.lastname: Viale
authors.affiliation: Edinburgh Cancer Research UK Centre, The University of Edinburgh, Edinburgh, UK.
authors.forename: D
authors.initials: D
authors.lastname: Cameron
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy / Q000473:pathology*; D017024:Chemotherapy, Adjuvant; D002986:Clinical Trials as Topic / Q000592:standards*; D005260:Female; D006801:Humans; D020360:Neoadjuvant Therapy / Q000592:standards*; D009367:Neoplasm Staging; D018365:Neoplasm, Residual / Q000188:drug therapy / Q000473:pathology*; D017410:Practice Guidelines as Topic; D011379:Prognosis
keywords: breast cancer; neoadjuvant systemic therapy; pathologic assessment; pathologic complete response; residual disease; response evaluation