Manuscript Section 2:
Title: Standardization of pathologic evaluation and reporting of post-neoadjuvant specimens in clinical trials of breast cancer: Recommendations from an international working groupAuthors:Elena Provenzano, MBBS, PhD, FRCPA, Addenbrooke’s Hospital, Cambridge, United Kingdom, elena.provenzano@addenbrookes.nhs.ukVeerle Bossuyt, MD, Yale University, New Haven, Connecticut, United States, veerle.bossuyt@yale.eduGiuseppe Viale, MD, FRCPath, European Institute of Oncology and University of Milan, Italy, Giuseppe.Viale@ieo.itDavid Cameron, MD, MRCP, University of Edinburgh, United Kingdom, D.Cameron@ed.ac.ukSunil Badve, MBBS, MD, FRCPath, Indiana University Simon Cancer Center, Indianapolis, Indiana, United States, sbadve@iupui.eduCarsten Denkert, MD, Charité Hospital, Berlin, Germany, carsten.denkert@charite.deGa?tan MacGrogan, MD, Institut Bergonié, Bordeaux, France, G.MacGrogan@bordeaux.unicancer.frFrédérique Penault-Llorca, MD, PhD, Centre Jean Perrin and EA 4677 ERTICa Université d'Auvergne, France, Frederique.penault-llorca@cjp.fr Judy Boughey, MD, Mayo Clinic, Rochester, Minnesota, United States, Boughey.Judy@mayo.eduGiuseppe Curigliano, MD, PhD, European Institute of Oncology, Milan, Italy, giuseppe.curigliano@ieo.itJ. Michael Dixon, MBChB, MD, Edinburgh Breast Unit, United Kingdom, mike.dixon@ed.ac.uk Laura Esserman, MD, MBA, University of California, San Francisco, United States, Laura.Esserman@Gerd Fastner, MD, Department of Radiotherapy and Radiation Oncology, Landeskrankenhaus, Paracelsus Medical University, Salzburg, Austria, g.fastner@salk.atThorsten Kuehn, MD, Women’s Clinic at Klinikum Esslingen, Esslingen am Neckar, Germany, kuehn.thorsten@t-online.deFlorentia Peintinger, MD, Medical University of Graz, and University Hospital Salzburg, Breast Center Salzburg, Paracelsus Medical University, Austria, florentia.peintinger@medunigraz.atGunter von Minckwitz, MD, German Breast Group, Neu-Isenburg and University Women's Hospital, Frankfurt, Germany, gunter.vonminckwitz@germanbreastgroup.deJulia White, MD, Ohio State University, Columbus, Ohio, United States Julia.White@osumc.eduWei Yang, MBBS, FRCR, MD Anderson Cancer Center, Houston, Texas, United States, wyang@W. Fraser Symmans, MD, MD Anderson Cancer Center, Houston, Texas, United States, fsymmans@…on behalf of the Residual Disease Characterization Working Group of the Breast International Group-North American Breast Cancer Group (BIG-NABCG) collaborationCorresponding author (page proofs, correspondence, requests for reprints):Dr. Elena ProvenzanoLead Breast HistopathologistBox 235, Addenbrooke’s Hospital, Hills RdCambridge, CB2 0QQ, United KingdomEmail: elena.provenzano@addenbrookes.nhs.uk Telephone: 01223 348177 (Sec); 01223 256154 (Direct line)Fax: 01223 216980Running title: Post-neoadjuvant breast cancer evaluationKey words: breast cancer, neoadjuvant therapy, histologic assessmentAbstractNeoadjuvant systemic therapy is being used increasingly in the treatment of early-stage breast cancer. Response, in the form of pathological complete response, is a validated and evaluable surrogate endpoint of survival after neoadjuvant therapy. Thus, pathological complete response has become a primary endpoint for clinical trials. However, there is a current lack of uniformity in the definition of pathological complete response. A review of standard operating procedures used by 28 major neoadjuvant breast cancer trials and/or 25 sites involved in such trials identified marked variability in specimen handling and histologic reporting. An international working group was convened to develop practical recommendations for the pathologic assessment of residual disease in neoadjuvant clinical trials of breast cancer and information expected from pathology reports. Systematic sampling of areas identified by informed mapping of the specimen and close correlation with radiological findings is preferable to overly exhaustive sampling, and permits taking tissue samples for translational research. Controversial areas are discussed, including measurement of lesion size, reporting of lymphovascular space invasion and the presence of isolated tumor cells in lymph nodes post-neoadjuvant-therapy, and retesting of markers post-treatment. If there has been a pathological complete response, this must be clearly stated, and the presence/ absence of residual ductal carcinoma in situ must be described. When there is residual invasive carcinoma, a comment must be made as to the presence/ absence of chemotherapy effect in the breast and lymph nodes. The Residual Cancer Burden is the preferred method for quantifying residual disease in neoadjuvant clinical trials; other methods can be included per trial protocols and regional preference. Post-treatment tumor staging using the Tumor-Node-Metastasis system should be included. These recommendations for standardized pathological evaluation and reporting of neoadjuvant breast cancer specimens should improve prognostication for individual patients and allow comparison of treatment outcomes within and across clinical trials.INTRODUCTIONNeoadjuvant systemic therapy is being increasingly used in the treatment of early-stage breast cancer. Response, in the form of pathological complete response, is being put forward as an evaluable endpoint for determining the efficacy of new agents in neoadjuvant clinical trials ADDIN EN.CITE <EndNote><Cite><Author>Esserman</Author><Year>2011</Year><RecNum>133</RecNum><record><rec-number>133</rec-number><foreign-keys><key app="EN" db-id="df2swszadvvdrfea9fa5fp53xpt5sa02s9tw">133</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Esserman, L. J.</author><author>Woodcock, J.</author></authors></contributors><auth-address>University of California at San Francisco, 1600 Divisadero St, PO Box 1710, San Francisco, CA 94115, USA. laura.esserman@</auth-address><titles><title>Accelerating identification and regulatory approval of investigational cancer drugs</title><secondary-title>Jama</secondary-title></titles><periodical><full-title>Jama</full-title></periodical><pages>2608-9</pages><volume>306</volume><number>23</number><keywords><keyword>Academic Medical Centers</keyword><keyword>*Antineoplastic Agents</keyword><keyword>Clinical Trials as Topic</keyword><keyword>*Cooperative Behavior</keyword><keyword>Drug Approval/*organization & administration</keyword><keyword>Drug Discovery/*organization & administration</keyword><keyword>Drug Industry</keyword><keyword>Federal Government</keyword><keyword>Humans</keyword><keyword>Interinstitutional Relations</keyword><keyword>Neoplasms/classification/drug therapy</keyword><keyword>Pharmacogenetics</keyword><keyword>Time Factors</keyword><keyword>United States</keyword><keyword>United States Food and Drug Administration</keyword></keywords><dates><year>2011</year><pub-dates><date>Dec 21</date></pub-dates></dates><isbn>1538-3598 (Electronic)
0098-7484 (Linking)</isbn><accession-num>22187281</accession-num><urls><related-urls><url> </url></related-urls></urls><language>eng</language></record></Cite></EndNote>(1) and is an excellent prognostic indicator PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Db3J0YXphcjwvQXV0aG9yPjxZZWFyPjIwMTQ8L1llYXI+
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ADDIN EN.CITE.DATA (3). Therefore, a standard approach to the evaluation of the post-neoadjuvant systemic therapy surgical specimen is essential.Several classification systems have been developed for the assessment of pathologic response to neoadjuvant systemic therapy; these have been reviewed elsewhere PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5BcHBsZTwvQXV0aG9yPjxZZWFyPjIwMDY8L1llYXI+PFJl
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ADDIN EN.CITE.DATA (6, 10, 12-16). However, different staging systems yield different estimates of future risk ADDIN EN.CITE <EndNote><Cite><Author>Corben</Author><Year>2013</Year><RecNum>143</RecNum><record><rec-number>143</rec-number><foreign-keys><key app="EN" db-id="df2swszadvvdrfea9fa5fp53xpt5sa02s9tw">143</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Corben, A. D.</author><author>Abi-Raad, R.</author><author>Popa, I.</author><author>Teo, C. H.</author><author>Macklin, E. A.</author><author>Koerner, F. C.</author><author>Taghian, A. G.</author><author>Brachtel, E. F.</author></authors></contributors><auth-address>From the Departments of Pathology (Drs Corben, Popa, Teo, Koerner, and Brachtel, Radiation Oncology (Drs Abi-Raad and Taghian), and Biostatistics (Dr Macklin), Massachusetts General Hospital and Harvard Medical School, Boston. Dr Corben is now with Memorial Sloan-Kettering Cancer Center, New York, New York. Dr Abi-Raad is now with Yale University, New Haven, Connecticut. Dr Teo is now with Tan Tock Sen Hospital, Singapore.</auth-address><titles><title>Pathologic Response and Long-Term Follow-up in Breast Cancer Patients Treated With Neoadjuvant Chemotherapy: A Comparison Between Classifications and Their Practical Application</title><secondary-title>Arch Pathol Lab Med</secondary-title><alt-title>Archives of pathology & laboratory medicine</alt-title></titles><periodical><full-title>Arch Pathol Lab Med</full-title><abbr-1>Archives of pathology & laboratory medicine</abbr-1></periodical><alt-periodical><full-title>Arch Pathol Lab Med</full-title><abbr-1>Archives of pathology & laboratory medicine</abbr-1></alt-periodical><pages>1074-82</pages><volume>137</volume><number>8</number><dates><year>2013</year><pub-dates><date>Aug</date></pub-dates></dates><isbn>1543-2165 (Electronic)
0003-9985 (Linking)</isbn><accession-num>23899063</accession-num><urls><related-urls><url> </url></related-urls></urls><language>eng</language></record></Cite></EndNote>(17). The Residual Cancer Burden is an online tool for the quantification of residual disease that is simple to apply, reproducible, and has been clinically validated with long-term follow-up data PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TeW1tYW5zPC9BdXRob3I+PFllYXI+MjAwNzwvWWVhcj48
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ADDIN EN.CITE.DATA (10, 18, 19). Moreover, novel classification systems are continually being developed, for example those that incorporate biomarkers in addition to traditional histologic prognostic variables, such as the residual proliferative cancer burden, which combines Residual Cancer Burden with post-treatment Ki67 index ADDIN EN.CITE <EndNote><Cite><Author>Sheri</Author><Year>2013</Year><RecNum>164</RecNum><record><rec-number>164</rec-number><foreign-keys><key app="EN" db-id="df2swszadvvdrfea9fa5fp53xpt5sa02s9tw">164</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Sheri, A.</author><author>A'Hern, R.</author><author>Jones, R. L. </author><author>Symmans, W. F. </author><author>Nerurkar, A.</author><author>Hills, M.</author><author>Detre, S.</author><author>Johnston, S. R. D. </author><author>Dowsett, M.</author></authors></contributors><titles><title>Integration of Ki67 with residual cancer burden (RCB) compared to Ki67 or RCB alone to predict long-term term outcome following neoadjuvant chemotherapy [abstract]</title><secondary-title>J Clin Oncol</secondary-title></titles><periodical><full-title>J Clin Oncol</full-title></periodical><pages>Abstract #535</pages><volume>31</volume><number>15_suppl</number><dates><year>2013</year></dates><urls></urls></record></Cite></EndNote>(20). There are also combined clinical and pathological systems that take into account pre-treatment information such as clinical stage as well as post-treatment pathology findings, for example the “clinical-pathologic stage - estrogen/grade” staging system ADDIN EN.CITE <EndNote><Cite><Author>Mittendorf</Author><Year>2011</Year><RecNum>158</RecNum><record><rec-number>158</rec-number><foreign-keys><key app="EN" db-id="df2swszadvvdrfea9fa5fp53xpt5sa02s9tw">158</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Mittendorf, E. A.</author><author>Jeruss, J. S.</author><author>Tucker, S. L.</author><author>Kolli, A.</author><author>Newman, L. A.</author><author>Gonzalez-Angulo, A. M.</author><author>Buchholz, T. A.</author><author>Sahin, A. A.</author><author>Cormier, J. N.</author><author>Buzdar, A. U.</author><author>Hortobagyi, G. N.</author><author>Hunt, K. K.</author></authors></contributors><auth-address>University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA.</auth-address><titles><title>Validation of a novel staging system for disease-specific survival in patients with breast cancer treated with neoadjuvant chemotherapy</title><secondary-title>J Clin Oncol</secondary-title></titles><periodical><full-title>J Clin Oncol</full-title></periodical><pages>1956-62</pages><volume>29</volume><number>15</number><keywords><keyword>Adult</keyword><keyword>Aged</keyword><keyword>Aged, 80 and over</keyword><keyword>*Antineoplastic Agents/therapeutic use</keyword><keyword>Breast Neoplasms/drug therapy/mortality/*pathology</keyword><keyword>Chemotherapy, Adjuvant</keyword><keyword>Disease-Free Survival</keyword><keyword>Female</keyword><keyword>Humans</keyword><keyword>Middle Aged</keyword><keyword>Neoadjuvant Therapy</keyword><keyword>*Neoplasm Staging</keyword><keyword>Prognosis</keyword><keyword>Receptors, Estrogen/metabolism</keyword></keywords><dates><year>2011</year><pub-dates><date>May 20</date></pub-dates></dates><isbn>1527-7755 (Electronic)
0732-183X (Linking)</isbn><accession-num>21482989</accession-num><urls><related-urls><url> </url></related-urls></urls><language>eng</language></record></Cite></EndNote>(21). These approaches also show promise as future means to predict outcome by combining additional clinical or biological information with Residual Cancer Burden or American Joint Committee on Cancer Stage after treatment.National guidelines have been developed for histopathologic assessment of breast cancer specimens in individual countries/regions, including Australasia ADDIN EN.CITE <EndNote><Cite><Author>RCPA</Author><Year>2012</Year><RecNum>37</RecNum><record><rec-number>37</rec-number><foreign-keys><key app="EN" db-id="df2swszadvvdrfea9fa5fp53xpt5sa02s9tw">37</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>RCPA</author></authors></contributors><titles><title>Royal College of Pathologists of Australasia Invasive Breast Cancer Structured Reporting Protocol</title></titles><edition>November 2012, 2nd Edition (Version 2.0)</edition><dates><year>2012</year></dates><isbn>978-1-74187-805-9</isbn><urls></urls></record></Cite></EndNote>(22), Belgium ADDIN EN.CITE <EndNote><Cite><Author>Lambein</Author><Year>2011</Year><RecNum>38</RecNum><record><rec-number>38</rec-number><foreign-keys><key app="EN" db-id="df2swszadvvdrfea9fa5fp53xpt5sa02s9tw">38</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Lambein, K.</author><author>Van de Vijver, K.</author><author>Faverly, D.</author><author>Colpaert, C.</author></authors></contributors><titles><title>Belgian guidelines for laboratory handling and pathology reporting of breast carcinoma after neoadjuvant therapy</title><secondary-title>Belg J Med Oncol</secondary-title></titles><periodical><full-title>Belg J Med Oncol</full-title></periodical><pages>144-153</pages><volume>5</volume><dates><year>2011</year></dates><urls></urls></record></Cite></EndNote>(23), Germany ADDIN EN.CITE <EndNote><Cite ExcludeAuth="1" ExcludeYear="1"><RecNum>149</RecNum><record><rec-number>149</rec-number><foreign-keys><key app="EN" db-id="df2swszadvvdrfea9fa5fp53xpt5sa02s9tw">149</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors></contributors><titles><title>AGO (Arbeitsgemeinschaft Gynaekologische Onkologie Studiengruppe) ;(24), the United Kingdom (now being updated) ADDIN EN.CITE <EndNote><Cite><Author>NHSBSP</Author><Year>2005</Year><RecNum>40</RecNum><record><rec-number>40</rec-number><foreign-keys><key app="EN" db-id="df2swszadvvdrfea9fa5fp53xpt5sa02s9tw">40</key></foreign-keys><ref-type name="Government Document">46</ref-type><contributors><authors><author>NHSBSP</author></authors></contributors><titles><title>Pathology Reporting Of Breast Disease: A Joint Document Incorporating the Third Edition of the NHS Breast Screening Programme’s Guidelines for Pathology Reporting in Breast Cancer Screening and the Second Edition of The Royal College of Pathologists’ Minimum Dataset for Breast Cancer Histopathology. NHSBSP Publication No 58.</title></titles><dates><year>2005</year></dates><publisher>NHS Cancer Screening Programmes jointly with The Royal College of Pathologists</publisher><urls></urls></record></Cite></EndNote>(25), the Netherlands ADDIN EN.CITE <EndNote><Cite ExcludeAuth="1"><Year>2012</Year><RecNum>39</RecNum><record><rec-number>39</rec-number><foreign-keys><key app="EN" db-id="df2swszadvvdrfea9fa5fp53xpt5sa02s9tw">39</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors></contributors><titles><title>Integraal Kankercentrum Nederland. Beoordeling na neoadjuvante chemo- of endocriene therapie ;(26), and the United States ADDIN EN.CITE <EndNote><Cite><Author>CAP</Author><Year>2012</Year><RecNum>36</RecNum><record><rec-number>36</rec-number><foreign-keys><key app="EN" db-id="df2swszadvvdrfea9fa5fp53xpt5sa02s9tw">36</key></foreign-keys><ref-type name="Legal Rule or Regulation">50</ref-type><contributors><authors><author>CAP</author></authors><secondary-authors><author>College of American Pathologists</author></secondary-authors></contributors><titles><title>Protocol for the Examination of Specimens From Patients With Invasive Carcinoma of the Breast</title></titles><pages>;(27). These vary in their approach to evaluating the post-neoadjuvant specimen. Frequently, neoadjuvant systemic therapy will be administered in the setting of a clinical trial. Pathologists must be involved at an early stage in trial development so that specimen handling, reporting, and tissue collection is specified PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5MZXlsYW5kLUpvbmVzPC9BdXRob3I+PFllYXI+MjAwODwv
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ADDIN EN.CITE.DATA (29). In the I-SPY 1 trial, the pathological complete response rate fell by almost 10% among pathologists at 9 centers after they were trained on how to use the Residual Cancer Burden tool (Laura Esserman, personal communication, August 2, 2013). In a French multi-center study which used the Chevallier system PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5DaGV2YWxsaWVyPC9BdXRob3I+PFllYXI+MTk5MzwvWWVh
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ADDIN EN.CITE.DATA (31). Lastly, the definition of pathological complete response has not been uniform, making reporting and interpretation of data challenging PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5LdXJvaTwvQXV0aG9yPjxZZWFyPjIwMDY8L1llYXI+PFJl
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ADDIN EN.CITE.DATA (5, 32). The frequency of use of different definitions of pathological complete response in major neoadjuvant clinical trials is illustrated in Figure 1. These different definitions of pathological complete response can change the apparent survival benefit associated with pathological complete response, depending upon which definition is used. (Figure 2) PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5NYXpvdW5pPC9BdXRob3I+PFllYXI+MjAwNzwvWWVhcj48
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ADDIN EN.CITE.DATA (2, 10, 15, 32, 33). There is general consensus that residual disease in the axillary lymph nodes indicates a worse prognosis, even when there has been a pathological complete response in the breast, and so the definition of pathological complete response should include absence of disease in both the breast and axillary lymph nodes PEVuZE5vdGU+PENpdGUgRXhjbHVkZUF1dGg9IjEiPjxZZWFyPjIwMTQ8L1llYXI+PFJlY051bT4y
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ADDIN EN.CITE.DATA (32, 33). The U.S. Food and Drug Administration -led meta-analysis of 12 neoadjuvant randomized trials with long-term follow-up undertaken by the Collaborative Trials in Neoadjuvant Breast Cancer (CTNeoBC) found similar event-free survival and overall survival in patients without residual invasive carcinoma regardless of the presence/absence of residual DCIS PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Db3J0YXphcjwvQXV0aG9yPjxZZWFyPjIwMTQ8L1llYXI+
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ADDIN EN.CITE.DATA (2).MATERIALS AND METHODSGiven the lack of consensus regarding the pathological assessment of post- neoadjuvant systemic therapy breast cancer specimens in clinical trials, an international working group of pathologists; radiologists; surgeons; medical and radiation oncologists; and gynecologists was convened by the BIG-NABCG collaboration. Members were nominated by BIG-NABCG leadership and the working group co-chairs, as well as by sites responding to the collection of standard operating procedures described below. Members represented an array of disciplines and countries.First, to gauge existing variability in approaches to post- neoadjuvant systemic therapy pathologic assessment, we collected standard operating procedures from neoadjuvant breast cancer trials and from sites participating in such trials. was searched for mainly academic, phase II or III neoadjuvant trials activated since 2005, with a planned recruitment of at least 100 patients. Earlier trials were included if they were one of the trials included in the U.S. Food and Drug Administration meta-analysis noted above, or otherwise were major trials (e.g., above 1 000 patients). Standard operating procedures were requested of 48 trials, both from the leaders of the trials themselves (trial standard operating procedures) and, where leaders responded, the sites involved in those trials (site-specific standard operating procedures). Information from the standard operating procedures was abstracted into categories of “extent of sampling”, “quantification/ size/ grading/ cellularity”, “lymph node evaluation”, “re-testing of markers”, and “other information”. The abstracted information was then compared and contrasted.The working group convened on seven teleconferences (plus three smaller planning calls), exchanged emails, and went through several rounds of comments, resulting in the development of practical recommendations for a minimum, essential set of components that should be included in the pathologic evaluation and reporting of post- neoadjuvant systemic therapy breast cancer specimens. The working group has also written a companion paper intended for a more multi-disciplinary audience, explaining how a standardized approach would benefit the entire medical team and summarizing the more detailed recommendations provided below ADDIN EN.CITE <EndNote><Cite><Author>Bossuyt</Author><Year>2015</Year><RecNum>191</RecNum><record><rec-number>191</rec-number><foreign-keys><key app="EN" db-id="df2swszadvvdrfea9fa5fp53xpt5sa02s9tw">191</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Bossuyt, V. </author><author>Provenzano, E. </author><author>Symmans, W. F. </author><author>Boughey, J. C. </author><author>Coles, C.</author><author>Curigliano, G. </author><author>Dixon, J. M.</author><author>Esserman, L. </author><author>Fastner, G. </author><author>Kuehn, T. </author><author>Peintinger, F. </author><author>von Minckwitz, G. </author><author>White, J. </author><author>Yang, W. </author><author>Badve, S. </author><author>Denkert, C. </author><author>MacGrogan, G. </author><author>Penault-Llorca, F. </author><author>Viale, G. </author><author>Cameron, D. </author></authors></contributors><titles><title>Recommendations for standardized pathological characterization of residual disease for neoadjuvant clinical trials of breast cancer by the BIG-NABCG collaboration</title><secondary-title>Ann Oncol</secondary-title></titles><periodical><full-title>Ann Oncol</full-title></periodical><volume>in press</volume><dates><year>2015</year></dates><urls></urls></record></Cite></EndNote>(41).RESULTS Standard operating procedures were collected from 28 trials and 25 sites (Supplement #1). Substantial variability of practice was found in all stages of histological evaluation of both breast and nodal neoadjuvant specimens: extent of sampling (ranging from 4 to 40 blocks, depending on presence/absence of a macroscopic identifiable lesion and on tumor size), thickness of primary-tumor sectioning (ranging from 2 to 10 mm), the routine performance of immunohistochemical staining when no tumor was identified on hematoxylin and eosin, how amount of residual tumor was measured and documented, and whether or not a formal system was used to grade response and, if so, which system was used. For small specimens, most sites submitted the entire specimen. Only 6 of 20 sites that discussed retesting of markers in their response noted they retested markers routinely. Of note, several sites emphasized a need for standardization of the pathologic assessment of post-neoadjuvant systemic therapy specimens, within practicable limits. Further details are provided in Supplement #1. RECOMMENDATIONSThe working group’s practical suggestions are detailed below. 1. Pre-treatment assessmentsInitial diagnosis on core biopsy of the breastPercutaneous image-guided core needle biopsy is strongly recommended, and must be adequate for an unequivocal diagnosis of invasive breast carcinoma. Caution must be used if imaging or core needle biopsy findings suggest that a significant portion of the lesion may represent in situ disease, or if there is only a limited amount of invasive carcinoma represented in the core. In these cases, repeat core needle biopsy or surgery for accurate diagnosis, rather than neoadjuvant systemic therapy, may be indicated. Histologic type, tumor grade, estrogen receptor (ER), progesterone receptor (PR), and HER2 status, as well as any other parameters used to select for neoadjuvant systemic therapy (e.g., Ki67, multi-gene assays), should be evaluated on the core needle biopsy. 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ADDIN EN.CITE.DATA (7, 13, 15, 42). Inclusion of an estimate of tumor cellularity in the core needle biopsy is of value if these systems will be used to grade response in the excision specimen.Consideration should be given to dedicated baseline cores for research, either at the time of diagnostic biopsy or as a separate designated biopsy procedure PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Mb2k8L0F1dGhvcj48WWVhcj4yMDExPC9ZZWFyPjxSZWNO
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ADDIN EN.CITE.DATA (43). Research cores should be in addition to those required for diagnosis and should be preserved in order to best meet the research need. Touch preparations or frozen sections can be used to confirm the presence of malignant cells in the dedicated research cores prior to freezing or immersion into a dedicated solution. If using Optimum Cutting Temperature freezing media, one tissue core can be embedded per block. In some cases, formalin-fixed cores can be re-embedded as a research block after reporting. Some trials also require “on-treatment” research core biopsies at subsequent time points (for example, after the first cycle or at mid-course) as well. Evaluation of the axilla before treatmentRoutine axillary ultrasound is recommended to assess the axillary lymph nodes, with fine needle aspiration or core needle biopsy of morphologically abnormal lymph nodes. Thus, sentinel lymph node biopsy prior to neoadjuvant treatment should be limited to cases where the pre-therapeutic lymph node status is required for systemic or local treatment decisions ADDIN EN.CITE <EndNote><Cite><Author>Kuehn</Author><Year>2013</Year><RecNum>130</RecNum><record><rec-number>130</rec-number><foreign-keys><key app="EN" db-id="df2swszadvvdrfea9fa5fp53xpt5sa02s9tw">130</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Kuehn, T.</author><author>Bauerfeind, I.</author><author>Fehm, T.</author><author>Fleige, B.</author><author>Hausschild, M.</author><author>Helms, G.</author><author>Lebeau, A.</author><author>Liedtke, C.</author><author>Minckwitz, Gv</author><author>Nekljudova, V.</author><author>Schmatloch, S.</author><author>Schrenk, P.</author><author>Staebler, A.</author><author>Untch, M.</author></authors></contributors><auth-address>Interdisciplinary Breast Centre, Department of Gynaecology and Obstetrics, Klinikum Esslingen, Esslingen, Germany. Electronic address: t.kuehn@klinikum-esslingen.de.</auth-address><titles><title>Sentinel-lymph-node biopsy in patients with breast cancer before and after neoadjuvant chemotherapy (SENTINA): a prospective, multicentre cohort study</title><secondary-title>Lancet Oncol</secondary-title><alt-title>The lancet oncology</alt-title></titles><periodical><full-title>Lancet Oncol</full-title><abbr-1>The lancet oncology</abbr-1></periodical><alt-periodical><full-title>Lancet Oncol</full-title><abbr-1>The lancet oncology</abbr-1></alt-periodical><pages>609-18</pages><volume>14</volume><number>7</number><dates><year>2013</year><pub-dates><date>Jun</date></pub-dates></dates><isbn>1474-5488 (Electronic)
1470-2045 (Linking)</isbn><accession-num>23683750</accession-num><urls><related-urls><url> </url></related-urls></urls><language>eng</language></record></Cite></EndNote>(44). Pre-treatment sentinel lymph node biopsy precludes assessment of nodal response to neoadjuvant systemic therapy, and invalidates American Joint Committee on Cancer yp Stage and calculation of the Residual Cancer Burden score if an excised sentinel lymph node was originally positive. 2. Evaluation of the surgical specimen post-neoadjuvant systemic therapyA. Clinical information required for pathologic evaluationIt is important that the multi-disciplinary team (e.g., surgeons, radiologists, and pathologists) communicate as a team for patient care; this is covered in detail in the companion multi-disciplinary paper ADDIN EN.CITE <EndNote><Cite><Author>Bossuyt</Author><Year>2015</Year><RecNum>191</RecNum><record><rec-number>191</rec-number><foreign-keys><key app="EN" db-id="df2swszadvvdrfea9fa5fp53xpt5sa02s9tw">191</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Bossuyt, V. </author><author>Provenzano, E. </author><author>Symmans, W. F. </author><author>Boughey, J. C. </author><author>Coles, C.</author><author>Curigliano, G. </author><author>Dixon, J. M.</author><author>Esserman, L. </author><author>Fastner, G. </author><author>Kuehn, T. </author><author>Peintinger, F. </author><author>von Minckwitz, G. </author><author>White, J. </author><author>Yang, W. </author><author>Badve, S. </author><author>Denkert, C. </author><author>MacGrogan, G. </author><author>Penault-Llorca, F. </author><author>Viale, G. </author><author>Cameron, D. </author></authors></contributors><titles><title>Recommendations for standardized pathological characterization of residual disease for neoadjuvant clinical trials of breast cancer by the BIG-NABCG collaboration</title><secondary-title>Ann Oncol</secondary-title></titles><periodical><full-title>Ann Oncol</full-title></periodical><volume>in press</volume><dates><year>2015</year></dates><urls></urls></record></Cite></EndNote>(41). At a bare minimum, the request form must clearly indicate neoadjuvant systemic therapy has been given, along with the location and pre-treatment size of the tumor(s). A suggested template requisition form that can be sent with the specimen is included in Supplement #2.B. Specimen handlingPriorities for evaluation of the surgical specimen are different after neoadjuvant systemic therapy, with emphasis on informed and accurate evaluation of tumor response to treatment. In general, one should apply the principles within national and institutional guidelines for standardization of processing and reporting of breast specimens, such as those noted above. Ideally, specimens should be sliced when fresh to identify the markers of the original tumor bed and to ensure formalin penetration. Residual tumor is usually less well defined and softer than untreated tumor, making it more difficult to detect grossly. Therefore, careful mapping and more extensive sampling is required for histopathologic study. It is strongly recommended that an image of the sliced specimen be recorded (radiograph, photograph, photocopy, or drawing) and then used as a map for the sections taken, so that the histopathologic findings of any residual disease in the breast can be more easily understood. For example, the sections taken can be drawn on a printed image of the sliced specimen and then scanned into the pathology database for viewing at the time of histopathologic study. More precise imaging of the gross specimen and correlation with the histopathologic sections will decrease the number of sections taken from the breast, and increase the efficiency and accuracy of pathologic assessment. This can save time and money while enabling consistent and careful pathologic interpretation. The recommendations below will attempt to supplement existing national guidelines for specific situations encountered in the neoadjuvant setting, however the pathologist should use sound clinical judgment on a case-by-case basis.1. Sampling of small lumpectomy specimens.Many institutional standard operating procedures thinly slice and submit small specimens in their entirety (for example, < 5 cm in greatest diameter in Yale university’s standard operating procedure, < 30g in the Dutch national guideline ADDIN EN.CITE <EndNote><Cite ExcludeAuth="1"><Year>2012</Year><RecNum>39</RecNum><record><rec-number>39</rec-number><foreign-keys><key app="EN" db-id="df2swszadvvdrfea9fa5fp53xpt5sa02s9tw">39</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors></contributors><titles><title>Integraal Kankercentrum Nederland. Beoordeling na neoadjuvante chemo- of endocriene therapie ;(26)) in a manner that allows reconstruction of the specimen at the time of microscopic evaluation through accurate description or with the help of a diagram. Unfortunately, this approach does not allow for tissue collection for research. Clinical judgment should be applied in this setting. If there is obvious gross residual tumor, then a research sample can be taken without compromising accurate histological assessment. In cases where the macroscopic findings are non-specific, or there is clinical doubt about the location of the tumor bed, then consideration should be given to submitting the entire specimen. Research samples may still be taken by thinning the blocks and submitting the trim, or alternatively, small cylinders of tissue can be taken with a punch biopsy tool. 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ADDIN EN.CITE.DATA (43).It is important to document that these small resections have adequately excised the lesion. The tumor bed/clip must be identified. Tumor bed extending to the margins should be documented.2. Sampling of large lumpectomy/ mastectomy specimens (partial submission).Targeted representative sections can be taken from larger specimens, but it is essential to carefully and accurately represent the tumor bed in a manner that can be retrospectively mapped to the gross and/or radiologic findings. This enables more accurate estimation of the extent of residual disease. Correlation with clinical and imaging findings is imperative to ensure the correct area is sampled. Sampling should include grossly visible tumor bed and / or the location of any marker clips, and immediately adjacent tissue to encompass the area suspected of involvement by carcinoma before treatment (Figure 3). This area to be sampled is referred to as the pre-treatment area of involvement in the discussion below. Degree of sampling is then determined by the pre-treatment size in addition to any visible tumor bed or grossly visible residual disease.Ideally, the specimen is sliced to reveal the largest cross-section of the pre-treatment area of involvement. Block(s) representing the full face of the pre-treatment area of involvement should be taken of every 1 cm slice containing pre-treatment area of involvement, or, for very large tumors, five representative blocks of a cross-section of pre-treatment area of involvement per 1-2 cm of pre-treatment size, up to a total maximum of about 25 blocks. In the absence of trial-based evidence as to the degree of sampling required, the committee felt this to be a pragmatic approach which should be sufficient to determine the presence of pathological complete response. The U.S. Food and Drug Administration, in their guidance, have recommended taking “a minimum of one block per cm of pre-treatment tumor size, or at least 10 blocks in total, whichever is greater” (34). The extent of sampling should be guided by good clinical judgment on a case-by-case basis – informed, directed sampling is more important than blindly taking a prescribed number of blocks. For assessment of cellularity of very large tumor beds, 5 representative blocks are sufficient to represent the largest cross-section of residual tumor bed and calculate the Residual Cancer Burden ADDIN EN.CITE <EndNote><Cite ExcludeAuth="1" ExcludeYear="1"><RecNum>32</RecNum><record><rec-number>32</rec-number><foreign-keys><key app="EN" db-id="df2swszadvvdrfea9fa5fp53xpt5sa02s9tw">32</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors></contributors><titles><title>Residual Cancer Burden calculator and associated documents [Guide for Measuring Cancer Cellularity, Examples of Gross & Microscopic Evaluation, Pathology Protocol for Macroscopic and Microscopic Assessment of RCB] Accessed October 30, 2014</title></titles><dates></dates><publisher>MD Anderson Cancer Center, Houston, TX</publisher><urls></urls></record></Cite></EndNote>(45).Precise description must be used to allow reconstruction of the specimen during histologic evaluation for accurate measurements and cellularity estimates. We strongly recommend visual images, such as photographs, specimen radiographs, or sketched diagrams, with annotations to indicate the sites where tissue sections were taken for histopathologic evaluation. If no residual disease is seen on initial sections, or if the distribution of the disease does not correspond to the initial gross impression, then a second pass may be needed to submit further blocks. Additional blocks, including sections documenting margins, should be obtained as with non-neoadjuvant specimens.Laboratories with access to large tissue cassettes are encouraged to utilize this technique as a superior method for mapping the residual tumor bed. Large cassettes enable sampling of a bigger area with fewer blocks, with the entire lesion often captured on a single slide. This simplifies reconstruction of the extent of residual disease, measurement of lesion size, and examination of margins ADDIN EN.CITE <EndNote><Cite><Author>Ibarra</Author><Year>2012</Year><RecNum>42</RecNum><record><rec-number>42</rec-number><foreign-keys><key app="EN" db-id="df2swszadvvdrfea9fa5fp53xpt5sa02s9tw">42</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Ibarra, J. A.</author></authors></contributors><auth-address>Department of Pathology, University of California and Irvine and MemorialCare Breast Center, Orange Coast Memorial Medical Center, 9920 Talbert Avenue, Fountain Valley, CA 92708, USA.</auth-address><titles><title>The Value of Combined Large Format Histopathology Technique to Assess the Surgically Removed Breast Tissue following Neoadjuvant Chemotherapy: A Single Institution Study of 40 Cases</title><secondary-title>Int J Breast Cancer</secondary-title><alt-title>International journal of breast cancer</alt-title></titles><periodical><full-title>Int J Breast Cancer</full-title><abbr-1>International journal of breast cancer</abbr-1></periodical><alt-periodical><full-title>Int J Breast Cancer</full-title><abbr-1>International journal of breast cancer</abbr-1></alt-periodical><pages>361707</pages><volume>2012</volume><dates><year>2012</year></dates><isbn>2090-3189 (Electronic)</isbn><accession-num>23119168</accession-num><urls><related-urls><url> </url></related-urls></urls><language>eng</language></record></Cite></EndNote>(46).In cases where the above cutoffs would not result in submission of the entire tumor bed, remaining tissue can be sampled for research. Areas with grossly visible tumor can easily be sampled. Cases where the above cutoffs result in submission of the entire tumor bed can be sampled for research as described in Section 2.B.1 above. If only formalin fixed paraffin-embedded tissue is needed, additional blocks can be submitted from a second pass for research from areas that had residual tumor on microscopy.3. Multiple lesions in lumpectomy or mastectomySame as Section 2 above for each lesion, plus blocks of tissue in between the lesions to ensure that they are truly separate and to evaluate the presence of other intervening disease, such as DCIS.C. Microscopic reportingPrognostic and predictive factors traditionally evaluated in surgical specimens following primary surgery are all relevant in the neoadjuvant systemic therapy setting. Although some familiar prognostic information may be altered by treatment (e.g., tumor grade and histological type) or may be less reliable (lymph node and margin status), much can be gained from the opportunity to evaluate response to treatment. Histologic tumor type and gradeThe method for determination of histologic tumor type and tumor grade is identical to non-neoadjuvant specimens, although it is not clear whether these add prognostic information to the pre-treatment results. Tumors with a typical appearance of no special type before treatment may have a lobular growth pattern following neoadjuvant chemotherapy ADDIN EN.CITE <EndNote><Cite><Author>Carder</Author><Year>1999</Year><RecNum>137</RecNum><record><rec-number>137</rec-number><foreign-keys><key app="EN" db-id="df2swszadvvdrfea9fa5fp53xpt5sa02s9tw">137</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Carder, P.</author></authors></contributors><titles><title>Typing breast cancer following primary chemotherapy</title><secondary-title>Histopathology</secondary-title><alt-title>Histopathology</alt-title></titles><periodical><full-title>Histopathology</full-title><abbr-1>Histopathology</abbr-1></periodical><alt-periodical><full-title>Histopathology</full-title><abbr-1>Histopathology</abbr-1></alt-periodical><pages>584-5</pages><volume>35</volume><number>6</number><keywords><keyword>Antineoplastic Combined Chemotherapy Protocols/therapeutic use</keyword><keyword>Breast Neoplasms/*classification/*drug therapy/pathology</keyword><keyword>Carcinoma, Lobular/*classification/*drug therapy/pathology</keyword><keyword>Chemotherapy, Adjuvant</keyword><keyword>Female</keyword><keyword>Humans</keyword><keyword>Middle Aged</keyword></keywords><dates><year>1999</year><pub-dates><date>Dec</date></pub-dates></dates><isbn>0309-0167 (Print)
0309-0167 (Linking)</isbn><accession-num>10583584</accession-num><urls><related-urls><url> </url></related-urls></urls><language>eng</language></record></Cite></EndNote>(47). Treatment can cause nuclear hyperchromasia and pleomorphism; however, the findings should be compared to the pre-treatment biopsy before assuming they are treatment-related. The mitotic rate may be reduced by treatment; this finding is associated with a better prognosis (disease-free survival and overall survival) PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5QZW5hdWx0LUxsb3JjYTwvQXV0aG9yPjxZZWFyPjIwMDg8
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ADDIN EN.CITE.DATA (49). Clonal heterogeneity within the tumor may be reflected by variable response to therapy, and by areas with different morphology and grade. A comment regarding the presence of such heterogeneity should be made in the report, and is important when choosing blocks for post-neoadjuvant systemic therapy hormone receptor and HER2 assessment.If multiple, morphologically distinct tumors are present, which are clearly separated by adipose tissue, then they should be reported as separate lesions. However, it should be noted that the largest residual primary tumor is used for determination of both Residual Cancer Burden and yp-Stage. Note that yp-T stage is defined by the largest contiguous focus of invasive cancer, whereas Residual Cancer Burden uses the two dimensions of the largest residual area of residual invasive cancer (that does not need to be contiguous) in the tumor bed. Size and extentTumor size/extent is often more difficult to assess after neoadjuvant systemic therapy. There are two main patterns of tumor response following neoadjuvant systemic therapy – concentric shrinking and the scatter pattern (Figure 3). Measurement of lesion size in this latter scenario may be difficult. Our suggested approach is described in Table 1.CellularityIn addition to its effect on tumor size, neoadjuvant systemic therapy often has a profound effect on tumor cellularity. Tumor size may not decrease, but overall cellularity may be markedly reduced (Figure 3), making residual tumor cellularity an important way to assess response PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5SYWphbjwvQXV0aG9yPjxZZWFyPjIwMDQ8L1llYXI+PFJl
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ADDIN EN.CITE.DATA (7, 13, 15, 42). If a formal classification system for grading of response is used, this should be noted in the report. Since tumor cellularity is often heterogeneous, the pre-treatment core biopsy may not be representative of the entire tumor. Similarly, changes in tumor cellularity induced by neoadjuvant systemic therapy can be heterogeneous and therefore extensive sampling may be needed to accurately assess cellularity. The descriptions of these scoring systems do not explicitly state how to deal with this heterogeneity, and it can be tempting only to assess the most cellular areas of the tumor. The Residual Cancer Burden system does not require pre-treatment cellularity, but proposes standardized sampling of the specimen with assessment of the average cellularity across the largest two-dimensional area of residual tumor bed. For Residual Cancer Burden, the tumor bed area is defined by the two largest dimensions of gross tumor bed defined by macroscopic examination with or without accompanying specimen radiography, but can be later revised after those corresponding slides have been reviewed under the microscope. Hence the importance of accurate block description and advisability of an illustrative map to determine how the slides map to the gross tumor bed (described above). The online cellularity standard provided on the Residual Cancer Burden website ADDIN EN.CITE <EndNote><Cite ExcludeAuth="1" ExcludeYear="1"><RecNum>32</RecNum><record><rec-number>32</rec-number><foreign-keys><key app="EN" db-id="df2swszadvvdrfea9fa5fp53xpt5sa02s9tw">32</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors></contributors><titles><title>Residual Cancer Burden calculator and associated documents [Guide for Measuring Cancer Cellularity, Examples of Gross & Microscopic Evaluation, Pathology Protocol for Macroscopic and Microscopic Assessment of RCB] Accessed October 30, 2014</title></titles><dates></dates><publisher>MD Anderson Cancer Center, Houston, TX</publisher><urls></urls></record></Cite></EndNote>(45) and the images in the publication for the Miller-Payne score are useful aids for pathologists in estimating cellularity PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5PZ3N0b248L0F1dGhvcj48WWVhcj4yMDAzPC9ZZWFyPjxS
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ADDIN EN.CITE.DATA (15). The presence or absence of residual DCIS, and the percentage of residual tumor present as in situ disease, should also be documented as per the Residual Cancer Burden.We advocate submitting the largest cross-section of the residual tumor bed with the relevant sections noted in the pathology report.Lymphovascular invasionThe presence or absence of lymphovascular invasion should be documented (Figure 4). There is insufficient data on the independent prognostic significance of lymphovascular invasion in neoadjuvant specimens. See Table 1 for suggested approaches to assessing and reporting lymphovascular invasion.MarginsIn cases with variable response leading to multiple, small foci of residual disease in a subtle tumor bed, carcinoma may extend beyond an apparently negative margin. Tumor bed extending to the margins, and which margin is involved, should be documented (Figure 5).D. Evaluation of the axilla after treatmentSeveral studies have shown that post-treatment nodal status is an important determinant of disease-free survival and overall survival, regardless of response within the breast PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Sb3V6aWVyPC9BdXRob3I+PFllYXI+MjAwMjwvWWVhcj48
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ADDIN EN.CITE.DATA (32, 35-40). Currently, lymph node staging in patients who have received neoadjuvant systemic therapy is usually performed by either sentinel lymph node biopsy or axillary lymph node dissection. The accuracy of sentinel lymph node biopsy for staging post-neoadjuvant systemic therapy is still under investigation, especially in patients with clinically positive nodes pre-treatment PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5LdWVobjwvQXV0aG9yPjxZZWFyPjIwMTM8L1llYXI+PFJl
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ADDIN EN.CITE.DATA (44, 51). This is reflected in the use of the phrase “sampled regional lymph nodes” by the U.S. Food and Drug Administration in its proposed definition of pathological complete response ADDIN EN.CITE <EndNote><Cite ExcludeAuth="1"><Year>2014</Year><RecNum>29</RecNum><record><rec-number>29</rec-number><foreign-keys><key app="EN" db-id="df2swszadvvdrfea9fa5fp53xpt5sa02s9tw">29</key></foreign-keys><ref-type name="Government Document">46</ref-type><contributors></contributors><titles><title>U.S. Food and Drug Administration. Guidance for Industry: Pathological Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint to Support Accelerated Approval. October 2014. </title></titles><pages>. Accessed October 30, 2014</pages><dates><year>2014</year></dates><urls></urls></record></Cite></EndNote>(34).The procedure for evaluating sentinel lymph nodes and axillary lymph nodes should be the same as for non-neoadjuvant specimens. All surgically removed lymph nodes should be sectioned at 2mm intervals and entirely submitted for histologic evaluation. Some special considerations apply, however. Some studies have indicated a lower number of lymph nodes identified at axillary lymph node dissection after neoadjuvant systemic therapy, whilst others have found no significant difference following careful pathological evaluation PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5CZWxhbmdlcjwvQXV0aG9yPjxZZWFyPjIwMDg8L1llYXI+
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ADDIN EN.CITE.DATA (52-54). Pathologists evaluating axillary lymph node dissection tissue should subject any tissue that may represent lymph node for microscopic evaluation.The size of the largest metastatic deposit should be measured microscopically and the presence or absence of any extranodal extension documented. Post-neoadjuvant systemic therapy tumor cells are often present as scattered single cells within an area of reactive stromal changes or lymphoid tissue. When measuring the size of the metastasis in this context, the size of the area that is even partly involved by metastatic tumor should be measured, not just the size of the largest tumor cluster. Clearly separate smaller foci in a node are not included in the maximum size measurement. Since micrometastases and isolated tumor cells found post-neoadjuvant systemic therapy are predictors of worse survival, specimens with nodal micrometastases or isolated tumor cells should not be designated as pathological complete response PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5LbGF1YmVyLURlTW9yZTwvQXV0aG9yPjxZZWFyPjIwMDY8
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ADDIN EN.CITE.DATA (40, 55). Our suggested approach to assessing isolated tumor cells in this context is provided in Table 1. The presence of treatment effect in the lymph nodes in the form of fibrosis (Figure 6), mucin pools, or large aggregates of foamy histiocytes, identifies a subset of patients with an outcome intermediate between that of completely node-negative and node-positive post-neoadjuvant systemic therapy PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5OZXdtYW48L0F1dGhvcj48WWVhcj4yMDAzPC9ZZWFyPjxS
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ADDIN EN.CITE.DATA (56). However, small fibrous scars in lymph nodes can also be seen in patients without treatment, and in patients who have had a previous biopsy it can be impossible to reliably distinguish biopsy site changes from regressed metastasis ADDIN EN.CITE <EndNote><Cite><Author>Donnelly</Author><Year>2001</Year><RecNum>61</RecNum><record><rec-number>61</rec-number><foreign-keys><key app="EN" db-id="df2swszadvvdrfea9fa5fp53xpt5sa02s9tw">61</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Donnelly, J.</author><author>Parham, D. M.</author><author>Hickish, T.</author><author>Chan, H. Y.</author><author>Skene, A. I.</author></authors></contributors><auth-address>Royal Bournemouth Hospital Breast Unit, Bournemouth, UK. jill.donnelly@</auth-address><titles><title>Axillary lymph node scarring and the association with tumour response following neoadjuvant chemoendocrine therapy for breast cancer</title><secondary-title>Breast</secondary-title><alt-title>Breast (Edinburgh, Scotland)</alt-title></titles><periodical><full-title>Breast</full-title><abbr-1>Breast (Edinburgh, Scotland)</abbr-1></periodical><alt-periodical><full-title>Breast</full-title><abbr-1>Breast (Edinburgh, Scotland)</abbr-1></alt-periodical><pages>61-6</pages><volume>10</volume><number>1</number><dates><year>2001</year><pub-dates><date>Feb</date></pub-dates></dates><isbn>0960-9776 (Print)
0960-9776 (Linking)</isbn><accession-num>14965563</accession-num><urls><related-urls><url> </url></related-urls></urls><language>eng</language></record></Cite></EndNote>(57). Previously involved nodes may also look completely normal after treatment. The latter scenario can cause concern when there was histologically-proven metastasis pre-treatment, but evidence of a positive node cannot be found in the final surgical specimen. In this setting, the specimen (including axillary tail, if a mastectomy) should be carefully re-examined to ensure all nodes have been retrieved, and the patient re-examined, before assuming there has been complete response. Clipping the involved node pre-treatment can also be of value in determining nodal response.In some centers, sentinel lymph nodes are assessed by molecular assays (e.g., one-step nucleic acid amplification) without any morphological evaluation. This does not allow assessment of response in the node; moreover, one-step nucleic acid amplification is usually not calibrated to detect isolated tumor cells PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5GZWxkbWFuPC9BdXRob3I+PFllYXI+MjAxMTwvWWVhcj48
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ADDIN EN.CITE.DATA (58). Therefore we do not recommend the use of these techniques in the neoadjuvant setting.Pathologic complete response Our group agrees with the following core principle of the definition of pathological complete response as proposed by the U.S. Food and Drug Administration: “Pathological complete response is defined as the absence of residual invasive cancer on…. evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy” ADDIN EN.CITE <EndNote><Cite ExcludeAuth="1"><Year>2014</Year><RecNum>29</RecNum><record><rec-number>29</rec-number><foreign-keys><key app="EN" db-id="df2swszadvvdrfea9fa5fp53xpt5sa02s9tw">29</key></foreign-keys><ref-type name="Government Document">46</ref-type><contributors></contributors><titles><title>U.S. Food and Drug Administration. Guidance for Industry: Pathological Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint to Support Accelerated Approval. October 2014. </title></titles><pages>. Accessed October 30, 2014</pages><dates><year>2014</year></dates><urls></urls></record></Cite></EndNote>(34). However, we advocate that the presence of invasive tumor cells is considered residual disease regardless of method of detection – i.e., hematoxylin and eosin or immunohistochemistry – although the latter is not routinely recommended. The alternative definition, requiring absence of both DCIS and invasive carcinoma in the breast, can also be used. The definition of pathological complete response chosen should be agreed between pathologists and clinicians within individual institutions, and clearly stated in the report. If the patient is enrolled in a clinical trial, the definition of pathological complete response prescribed by the trial standard operating procedure should be included as part of the report with an explanatory note. Regardless of which definition is used, the presence/ absence and extent of residual DCIS should be reported as detailed in our recommended template (Table 2).Microscopically, the tumor bed may be identified as a focal area of loose, oedematous reactive stroma with a variable inflammatory cell infiltrate that may include collections of lipid or haemosiderin laden macrophages, lymphocytes, and plasma cells. Background breast lobules often appear hyalinised and atrophic with a perilobular lymphocytic infiltrate.We would like to stress the following. Accurate, reproducible documentation of pathological complete response requires adequate sampling of the correct area of the breast. Overly exhaustive sampling and histologic evaluation of the entire tumor bed are not generally required and are far less valuable than intelligent mapping of the correct locations within the specimen. Therefore, correlation of clinical and imaging information and markers of the tumor site with gross pathology of the specimen are indispensible.Retesting of markers in the post-neoadjuvant therapy specimenReassessment of hormone receptor and HER2 status in residual cancer after neoadjuvant systemic therapy is variable between individual centers, with no consensus regarding if and when retesting of markers is advisable. The clinical utility of reassessing marker status in the surgical specimen may depend on the results from the core biopsies taken prior to neoadjuvant systemic therapy. If retesting is performed, it may be done on either the residual primary tumor or residual nodal disease if the latter contains a better representation of residual tumor cells. Our recommendations are provided in Table 3.Finally, in some centers, assessment of Ki67 labeling index is performed before and after neoadjuvant systemic therapy. Post-treatment Ki67 index has been shown to correlate with long-term outcome after both neoadjuvant endocrine PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5FbGxpczwvQXV0aG9yPjxZZWFyPjIwMDg8L1llYXI+PFJl
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ADDIN EN.CITE.DATA (62-64). Proliferation is commonly reduced by neoadjuvant systemic therapy, so, in addition to Ki67, results of multi-gene assays that include proliferation genes may also change if assessed before and after treatment ADDIN EN.CITE <EndNote><Cite><Author>Earl</Author><Year>2013</Year><RecNum>182</RecNum><record><rec-number>182</rec-number><foreign-keys><key app="EN" db-id="df2swszadvvdrfea9fa5fp53xpt5sa02s9tw">182</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Earl, H. M.</author><author>Chin, S. </author><author>Dunning, M. </author><author>Iddawela, M. </author><author>Rueda, O. </author><author>Russell, R. </author><author>Jones, L. </author><author>Vallier, A.L. </author><author>Hughes-Davies, L. </author><author>Abraham, J. </author><author>Chan, S. </author><author>Skene, A. </author><author>Benstead, K. </author><author>Gallagher, C. J. </author><author>Murray, N. </author><author>Ritchie, D. </author><author>Dunn, J. A. </author><author>Hiller, L. </author><author>Provenzano, E. </author><author>Caldas, C. </author></authors></contributors><titles><title>Neo-tAnGo science: A translational study of PAM 50 sub-typing in sequential fresh tissue samples during neoadjuvant chemotherapy [abstract #1015]</title><secondary-title>Journal of Clinical Oncology</secondary-title></titles><periodical><full-title>Journal of Clinical Oncology</full-title></periodical><volume>31</volume><number>15_suppl (May 20 Supplment)</number><dates><year>2013</year></dates><urls><related-urls><url>;(65). G.. Minimum data set to be reported by pathologistsA suggested summary template for reporting neoadjuvant systemic therapy specimens is presented in Table 2, with minimum data set items highlighted. The U.S. National Cancer Institute’s Breast Oncology Local Disease (BOLD) Task Force has also recommended standardized data elements for collection in preoperative breast cancer clinical trials ADDIN EN.CITE <EndNote><Cite ExcludeAuth="1" ExcludeYear="1"><RecNum>187</RecNum><record><rec-number>187</rec-number><foreign-keys><key app="EN" db-id="df2swszadvvdrfea9fa5fp53xpt5sa02s9tw">187</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors></contributors><titles><title>National Cancer Institute. Breast Cancer Steering Committee. Investigator Resources. NCI BOLD Task Force CDEs. Accessed October 30, 2014.</title></titles><dates></dates><urls></urls></record></Cite></EndNote>(66).ConclusionPost-neoadjuvant systemic therapy histopathological changes are complex, and careful systematic review of the specimen is required for accurate diagnosis and follow-up treatment. For pathological complete response to be used as an indicator of response to novel therapies, it is essential to have a standardized way in which residual disease is measured and reported. We designed the recommendations specifically for the clinical trial setting, however they can be optionally incorporated into routine practice because, in our opinion, standardization is most effective when uniformly applied. Hopefully, such standardization will improve our knowledge and ability to compare outcomes, promote the submission of specimens for translational research, and facilitate the more timely introduction of new agents.The recommendation of this committee is that pathologic reports of residual disease after neoadjuvant chemotherapy and/or targeted therapy in clinical trials should include the following information:Pathologic Complete Response or Residual Disease. This should separately describe whether there was residual invasive cancer in the breast, in situ cancer in the breast, and the pathologic status of the regional lymph nodes.Residual Cancer Burden as the preferred method for more detailed quantification of residual disease. The report should provide the final residual tumor dimensions, cellularity of cancer in the final tumor bed area and the proportion of in situ component within that cancer, and the number of positive nodes and the size of the largest metastasis, as well as the Residual Cancer Burden score and class. ypTN Stage. The report should separately report the ypT and ypN Stages and the pathologist should use the most current edition of the American Joint Committee on Cancer / Union for International Cancer Control Staging definitions when evaluating tumor size after neoadjuvant chemotherapy.Supplementary information is available at Modern Pathology’s website.Supplement #1: MS Word document. This file describes our collection and review of standard operating procedures for the histologic assessment of post-neoadjuvant breast cancer specimens that we collected from various institutions/trials.Supplement #2: MS Word document. This file is a suggested template for a requisition form that can be provided with the specimen when it is sent to the pathologist.Disclosure/Conflict of Interest:Dr. Symmans filed Residual Cancer Burden as intellectual property (Nuvera Biosciences), patenting the Residual Cancer Burden equation. (The Residual Cancer Burden equation is freely available on the worldwide web.) Dr. Symmans reports current stock in Nuvera Biosciences and past stock in Amgen. Dr. MacGrogan reports grants and personal fees from Roche, and personal fees from Sanofi Aventis, outside the submitted work.Acknowledgments:We would like to thank the BIG-NABCG leadership:Dr. Nancy E. Davidson, MD, of the University of Pittsburgh Cancer Institute and UPMC Cancer Center, Pittsburgh, Pennsylvania; NABCG Co-Chair of the BIG-NABCG collaborationDr. Martine Piccart, MD, PhD, of Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium; BIG Co-Chair of the BIG-NABCG collaborationDr. Larry Norton, MD, of the Memorial Sloan-Kettering Cancer Center, New York, New YorkWe also wish to thank the following for providing their input: Dr. Helena Earl of the University of Cambridge Department of Oncology, United Kingdom; Dr. Keith Amos of University of North Carolina, Chapel Hill; Dr Véronique Becette of Institut Curie / H?pital René Huguenin, France; Dr. Wojciech Biernat of the Medical University of Gdansk, Poland; Dr. Hervé Bonnefoi of Institut Bergonié, France; Dr. Aman Buzdar of MD Anderson Cancer Center, Texas; Dr. Vicente Peg Cámara of Vall d'Hebron University Hospital, Barcelona, Spain; Dr. Paul Cane and Dr. Sarah Pinder of Guy’s St. Thomas’ Hospital, London; Dr. Lesley Carson of Aberdeen Royal Infirmary, Foresterhill, NHS Grampian, Aberdeen, United Kingdom; Dr. Diana Dickson-Witmer of Christiana Care, Delaware; Dr. Gyungyub Gong of Asan Medical Center, University of Ulsan College of Medicine, Korea; Dr. Jimmy Green of Pathology Sciences Medical Group, Norfolk, Virginia; Dr. Chih-Yi Hsu and Ling-Ming Tseng of Taipei Veterans General Hospital, Taipei, Taiwan; Dr. Judith Kroep of Leiden University Medical Center, Netherlands; Dr. A. Marilyn Leitch and Dr. Venetia Sarode of UT Southwestern Medical Center, Texas; Dr. Paul Kelly Marcom of Duke University, North Carolina; Dr. Paolo Nuciforo of Vall d'Hebron Institute of Oncology, Barcelona, Spain; Dr. Soonmyung Paik of the Yonsei University College of Medicine, Seoul, Korea, and the National Surgical Adjuvant Breast and Bowel Project; Dr. David Peston of Charing Cross Hospital, London; Dr. Jean-Yves Pierga of Institut Curie, France;Dr. Roberto Salgado of Institut Jules Bordet, Belgium; Dr. Miguel Quintela-Fandino of Centro Nacional de Investigaciones Oncológicas, Spain; Dr. William Sikov of Women and Infants Hospital, Breast Health Center, Rhode Island; SPANISH BREAST CANCER RESEARCH GROUP; Dr. Jeremy Thomas of Western General Hospital, NHS Lothian, Edinburgh; Dr. Gary Unzeitig of Laredo Breast Care, Texas; Dr. Jelle Wesseling of Netherlands Cancer Institute; andDr. Marc Wilt of Centre Paul Strauss, Strasbourg, FranceWe would like to thank Rebecca Enos of the Emmes Corporation for information gathering and for coordination and administrative support of the BIG-NABCG Residual Disease Characterization Working Group. 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Figure 1: Use of different definitions1 of pathological complete response in major neoadjuvant breast cancer clinical trials.Trials included in graphic above: 1st bar: GeparDuo, GeparTrio, GeparQuattro, GeparQuinto, GeparSixto, GeparSepto, NEOCENT 2nd bar: ABCSG 32, ACOSOG-Z1031, ACOSOG-Z1071, ARTemis, CHERLOB, CNIO-BR-01 2010, I-SPY 2, MDACC 2012-0167, neo-tAnG0, neo-TN (used Neoadjuvant Response Index), NEO-ZOTAC, NOAH, REMAGUS 02, S0800, TECHNO 3rd bar: ACOSOG-Z1041, AGO1 , CALGB-40601, CALGB-40603, ECTO, GEICAM/2006-14, Neo-ALTTO, Neo-Sphere, NSABP-B-18, NSABP-B-27, NSABP-B-40, NSABP-B-41, S0012 4th bar: EORTC-109941 Definition used in the primary endpoint or, where pathological complete response was not the primary endpoint, in the secondary endpoint.Figure 2: Survival curves for different definitions of pathological complete responseReprinted with permission. ? 2012 American Society of Clinical Oncology.? All rights reserved. von Minckwitz G et al. Definition and impact of pathologic complete response on prognosis after neoadjuvant chemotherapy in various intrinsic breast cancer subtypes. J Clin Oncol 2012 May 20; 30: 1796-804.CReprinted from The Lancet, Vol 384, Cortazar et al., Pathological complete response and long-term clinical benefit in breast cancer: the CTNeoBC pooled analysis, Pages 164-172, ? 2014, with permission from Elsevier.DCReprinted with permission. ? 2007 American Society of Clinical Oncology.? All rights reserved. Mazouni C et al. Residual ductal carcinoma in situ in patients with complete eradication of invasive breast cancer after neoadjuvant chemotherapy does not adversely affect patient outcome. J Clin Oncol 2007 Jul 1; 25: 2650-5.FEReprinted from Breast (Edinburgh, Scotland), 12, Ogston KN, Miller ID, Payne S, et al., A new histological grading system to assess response of breast cancers to primary chemotherapy: prognostic significance and survival. Pages 320-7. Copyright 2003, with permission from Elsevier. EReprinted with permission. ? 2007 American Society of Clinical Oncology.? All rights reserved. Symmans WF, Peintinger F, Hatzis C, et al. Measurement of residual breast cancer burden to predict survival after neoadjuvant chemotherapy. J Clin Oncol 2007;25:4414-22 . Graphs showing impact of different definitions of pathological complete response on survival. A. Data from the German Breast Group and AGO-B trials pooled analysis showing reduced disease-free survival for patients with ypTisypN0 versus ypT0ypN0. Patients who had residual nodal disease despite absence of invasive cancer in the breast (ypT0/isypN+) had the poorest disease-free survival PEVuZE5vdGU+PENpdGU+PEF1dGhvcj52b24gTWluY2t3aXR6PC9BdXRob3I+PFllYXI+MjAxMjwv
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ADDIN EN.CITE.DATA (32). B. Results from the same study showing no significant difference in overall survival between ypT0ypN0 and ypTisypN0. The ypT0/isypN+ has a significantly worse overall survival compared with ypT0/isypN0. C. In the CTNeoBC pooled analysis, ypT0 pN0 and ypT0/is ypN0 were more strongly associated with improved event-free survival and overall survival than ypT0/is alone. Moreover, ypT0 ypN0 and ypT0/is ypN0 were similar in their associations to event-free survival and overall survival. D. MD Anderson study showing 5- and 10-year overall survival (left) and disease-free survival (right) rates were identical for the patients with pathological complete response versus pathological complete response + DCIS PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5NYXpvdW5pPC9BdXRob3I+PFllYXI+MjAwNzwvWWVhcj48
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ADDIN EN.CITE.DATA (10).Figure 3: Problems related to sampling for histologic evaluationGross residual tumor may or may not be present after neoadjuvant therapy (Top left). Even when the tumor bed is entirely submitted, histologic evaluation has limits (Top center). The blue and black slides represent different levels obtained from the same block. The blue slides show a complete response. The black slides show minimal residual microscopic disease. Partial response shows various patterns and the decrease in cellularity is often heterogeneous (Right). In these cases, random sampling of tumor can lead to very different estimates of tumor cellularity (Bottom center). Random sampling with the blue blocks would conclude a complete response. Random sampling with the black blocks would document residual disease. Often, the microscopic tumor extends beyond a grossly visible tumor bed (Bottom left). The largest cross-section of tumor bed is sampled for an estimate of tumor cellularity.Figure 4: Extensive lymphovascular space invasion post-chemotherapy. In this case, an invasive tumor focus was not identified despite extensive sampling. The axillary nodes were positive for residual metastatic carcinoma.Courtesy of Elena ProvenzanoFigure 5: Tumor bed present at the resection marginCourtesy of Frédérique Penault-LlorcaFigure 6: Lymph node showing zonal areas of fibrosis post-chemotherapy indicative of metastasis with response to therapy Courtesy of Elena ProvenzanoA. Low-power image of lymph node showing zonal fibrosis indicating site of metastasis. B. On higher magnification of a different node, residual islands of tumor cells are present in a setting of reactive fibrosis with haemosiderin-laden macrophages, consistent with chemotherapy effect.Table 1: Controversial scenarios in reporting breast cancer post-neoadjuvant systemic therapyScenarioCurrent evidence/ guidelinesSuggested approachResidual tumor present as scattered foci(common)Tumor size often more difficult to assess after neoadjuvant treatment. Residual carcinoma may be present as multiple, small foci scattered over a (ill-defined) tumor bed.There are two main options as to how size is measured in this setting:Residual tumor bed size in two dimensions (used to calculate the Residual Cancer Burden score): The extent of the area involved by all islands of residual invasive tumor cells and intervening stroma. This does not include tumor bed beyond the area containing residual invasive tumor cells.Tumor size according to American Joint Committee on Cancer: If the residual tumor consists of microscopic nests in a fibrotic stroma, ypT should be based on the largest contiguous area of invasive carcinoma, with an indication that multiple foci are present (“m”).If there is a single lesion present on pre-treatment imaging, then regard residual disease as a single tumor, especially if tumor cells are present within a reactive stromal background consistent with a solitary tumor bed. (Opinion)When there are scattered islands of tumor cells, measurement (B) as described by American Joint Committee on Cancer 7th edition ADDIN EN.CITE <EndNote><Cite><Author>Edge</Author><Year>2009</Year><RecNum>47</RecNum><record><rec-number>47</rec-number><foreign-keys><key app="EN" db-id="df2swszadvvdrfea9fa5fp53xpt5sa02s9tw">47</key></foreign-keys><ref-type name="Edited Book">28</ref-type><contributors><authors><author>Edge, S. B. </author><author>Byrd, D. R. </author><author>Compton, C. C. </author><author>Fritz, A. G. </author><author>Greene, F. L. </author><author>Trotti, A. </author></authors></contributors><titles><title>American Joint Committee on Cancer (AJCC) Cancer Staging Manual, 7th edition</title></titles><dates><year>2009</year></dates><publisher>New York, NY: Springer-Verlag</publisher><urls></urls></record></Cite></EndNote>(67) may result in significant underestimation of tumor extent. There is also currently no data on the relationship of measurement (B) to outcome. (Opinion)Lesion size including the cell clusters and intervening fibrous tissue (A), which is congruent with the earlier, 6th edition of American Joint Committee on Cancer ADDIN EN.CITE <EndNote><Cite><Author>Greene</Author><Year>2002</Year><RecNum>161</RecNum><record><rec-number>161</rec-number><foreign-keys><key app="EN" db-id="df2swszadvvdrfea9fa5fp53xpt5sa02s9tw">161</key></foreign-keys><ref-type name="Edited Book">28</ref-type><contributors><authors><author>Greene, F. L.</author><author>Page, D. L.</author><author>Fleming, I. D.</author><author>Fritz, A.</author><author>Balch, C. M.</author><author>Haller, D. G.</author><author>Morrow, M. 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ADDIN EN.CITE.DATA (69) and may be more relevant, for example for comparison with radiology. (Limited Evidence)In our opinion, the combination of residual tumor cellularity and measurement (A) is the better indicator of response. (Opinion) When required to report American Joint Committee on Cancer 7th edition stage, both measurements (A) and (B) should be given in the pathology report, with an explanation of how the final size and stage designation was made. (Published Guideline)If there are multiple tumors present on pre-treatment imaging or tumor foci are separated by normal breast tissue, then regard as multiple lesions and measure independently as distinct tumor foci. Dimensions from the largest tumor deposit should be used for ypTNM staging. (Published Guideline)Presence of lymphovascular invasion in the absence of an identifiable residual invasive tumor mass(rare)There is insufficient data on the independent prognostic significance of the presence of lymphovascular invasion or extensive lymphovascular invasion in neoadjuvant specimens.One small study found that such intra-lymphatic tumor carries adverse prognostic significance, even in the absence of residual stromal invasion ADDIN EN.CITE <EndNote><Cite><Author>Rabban</Author><Year>2009</Year><RecNum>54</RecNum><record><rec-number>54</rec-number><foreign-keys><key app="EN" db-id="df2swszadvvdrfea9fa5fp53xpt5sa02s9tw">54</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Rabban, J. T.</author><author>Glidden, D.</author><author>Kwan, M. L.</author><author>Chen, Y. Y.</author></authors></contributors><auth-address>Department of Pathology, University of California San Francisco, San Francisco, CA 94143, USA. joseph.rabban@ucsf.edu</auth-address><titles><title>Pure and predominantly pure intralymphatic breast carcinoma after neoadjuvant chemotherapy: an unusual and adverse pattern of residual disease</title><secondary-title>Am J Surg Pathol</secondary-title><alt-title>The American journal of surgical pathology</alt-title></titles><periodical><full-title>Am J Surg Pathol</full-title><abbr-1>The American journal of surgical pathology</abbr-1></periodical><alt-periodical><full-title>Am J Surg Pathol</full-title><abbr-1>The American journal of surgical pathology</abbr-1></alt-periodical><pages>256-63</pages><volume>33</volume><number>2</number><keywords><keyword>Adult</keyword><keyword>Antineoplastic Agents/therapeutic use</keyword><keyword>Breast Neoplasms/*drug therapy/metabolism/*pathology</keyword><keyword>Female</keyword><keyword>Humans</keyword><keyword>Immunohistochemistry</keyword><keyword>Lymphatic Metastasis/*pathology</keyword><keyword>Middle Aged</keyword><keyword>*Neoadjuvant Therapy</keyword><keyword>Neoplasm Staging</keyword><keyword>Neoplasm, Residual/metabolism/*pathology</keyword></keywords><dates><year>2009</year><pub-dates><date>Feb</date></pub-dates></dates><isbn>1532-0979 (Electronic)
0147-5185 (Linking)</isbn><accession-num>18936689</accession-num><urls><related-urls><url> </url></related-urls></urls><language>eng</language></record></Cite></EndNote>(70). However, most of the patients also had residual disease in the lymph nodes and multivariate analysis was not possible.Residual lymphovascular invasion should NOT be classed as pathological complete response – make a statement in the pathology report that residual tumor is present in the form of intravascular disease. (Opinion)Ensure tumor bed has been accurately localized and adequately sampled to exclude residual invasive disease. (Opinion)Ensure truly lymphovascular invasion, not DCIS or retraction artifact. This may be difficult; immunohistochemistry may be helpful. (Opinion)Measurement is optional. If a limited area is involved, a measurement in mm can be given. Alternatively, lymphovascular invasion can be quantified as focal or extensive with “extensive” defined as one or more foci in more than one block PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Db2xsZW9uaTwvQXV0aG9yPjxZZWFyPjIwMDc8L1llYXI+
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ADDIN EN.CITE.DATA (71). (Opinion)Whilst it was agreed residual lymphovascular invasion should not be regarded as pathological complete response, in the absence of adequate data the working group felt it was not appropriate to give definite reporting recommendations. (Opinion)Presence of Isolated Tumor Cells in lymph nodes(common)American Joint Committee on Cancer TNM recommends isolated tumor cell’s post-chemotherapy be called node negative (ypN0itc) but not regarded as pathological complete response ADDIN EN.CITE <EndNote><Cite><Author>Edge</Author><Year>2009</Year><RecNum>47</RecNum><record><rec-number>47</rec-number><foreign-keys><key app="EN" db-id="df2swszadvvdrfea9fa5fp53xpt5sa02s9tw">47</key></foreign-keys><ref-type name="Edited Book">28</ref-type><contributors><authors><author>Edge, S. B. </author><author>Byrd, D. R. </author><author>Compton, C. C. </author><author>Fritz, A. G. </author><author>Greene, F. L. </author><author>Trotti, A. </author></authors></contributors><titles><title>American Joint Committee on Cancer (AJCC) Cancer Staging Manual, 7th edition</title></titles><dates><year>2009</year></dates><publisher>New York, NY: Springer-Verlag</publisher><urls></urls></record></Cite></EndNote>(67).World Health Organization recommends isolated tumor cell’s post-chemotherapy be called node positive ADDIN EN.CITE <EndNote><Cite><Author>Lakhani</Author><Year>2012</Year><RecNum>106</RecNum><record><rec-number>106</rec-number><foreign-keys><key app="EN" db-id="df2swszadvvdrfea9fa5fp53xpt5sa02s9tw">106</key></foreign-keys><ref-type name="Book">6</ref-type><contributors><authors><author>Lakhani, S.R.</author><author>Ellis. I.O.</author><author>Schnitt, S.J.</author><author>Tan, P.H.</author><author>van de Vijver, M.J.</author></authors></contributors><titles><title>WHO Classification of Tumours of the Breast, Fourth Edition</title></titles><dates><year>2012</year></dates><urls></urls></record></Cite></EndNote>(72).Findings include:Disease-free survival and overall survival worsened with increasing number of nodes and deposit size. Size of largest metastasis was strongest predictor of overall survival in multivariate analysis. Micrometastatic disease < 2mm, including isolated tumor cells, was predictive of worse outcome PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5LbGF1YmVyLURlTW9yZTwvQXV0aG9yPjxZZWFyPjIwMDY8
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ADDIN EN.CITE.DATA (40).No difference in relapse-free survival and overall survival between groups when size of the largest residual metastatic deposit was classified as ≤0.1cm, 0.1-1 cm, and ≥1 cm in patients with proven axillary nodal disease before neoadjuvant chemotherapy ADDIN EN.CITE <EndNote><Cite><Author>Hennessy</Author><Year>2005</Year><RecNum>58</RecNum><record><rec-number>58</rec-number><foreign-keys><key app="EN" db-id="df2swszadvvdrfea9fa5fp53xpt5sa02s9tw">58</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Hennessy, B. T.</author><author>Hortobagyi, G. N.</author><author>Rouzier, R.</author><author>Kuerer, H.</author><author>Sneige, N.</author><author>Buzdar, A. U.</author><author>Kau, S. W.</author><author>Fornage, B.</author><author>Sahin, A.</author><author>Broglio, K.</author><author>Singletary, S. E.</author><author>Valero, V.</author></authors></contributors><auth-address>Department of Breast Medical Oncology, The University of Texas M.D. Anderson Cancer Center, Houston, TX 77030, USA. bhennessy@</auth-address><titles><title>Outcome after pathologic complete eradication of cytologically proven breast cancer axillary node metastases following primary chemotherapy</title><secondary-title>J Clin Oncol</secondary-title></titles><periodical><full-title>J Clin Oncol</full-title></periodical><pages>9304-11</pages><volume>23</volume><number>36</number><keywords><keyword>Adult</keyword><keyword>Aged</keyword><keyword>Axilla</keyword><keyword>Breast Neoplasms/*drug therapy/*pathology</keyword><keyword>Clinical Trials as Topic</keyword><keyword>Disease-Free Survival</keyword><keyword>Female</keyword><keyword>Humans</keyword><keyword>*Lymphatic Metastasis</keyword><keyword>Middle Aged</keyword><keyword>Neoplasm Staging</keyword><keyword>Prognosis</keyword><keyword>Retrospective Studies</keyword><keyword>Treatment Outcome</keyword></keywords><dates><year>2005</year><pub-dates><date>Dec 20</date></pub-dates></dates><isbn>0732-183X (Print)
0732-183X (Linking)</isbn><accession-num>16361629</accession-num><urls><related-urls><url> </url></related-urls></urls><language>eng</language></record></Cite></EndNote>(39).No change in prognosis with occult metastases identified by immunohistochemical staining for cytokeratins PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Mb3lhPC9BdXRob3I+PFllYXI+MjAwOTwvWWVhcj48UmVj
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ADDIN EN.CITE.DATA (73).Any residual disease in the lymph node, including micrometastases and isolated tumor cells, should NOT be classified as pathological complete response. (Limited Evidence)If no associated fibrosis, treat as in adjuvant setting and call node negative. (Opinion)If associated fibrosis present, the likelihood is this represents previous micro- or macrometastasis with response. A comment should be included regarding the presence of chemotherapy effect, and the size of the entire area, including tumor cells and intervening stroma, should be measured, rather than the size of the largest cell cluster. (Limited Evidence)Additional levels and / or immunohistochemistry are not routinely required. However, immunohistochemistry may be useful if suspicious cells are identified on hematoxylin and eosin, and levels can be used to clarify the size of a deposit if isolated tumor cells/ micrometastasis are present on the initial section. (Limited Evidence)Limited Evidence = consensus opinion of committee based on limited evidence; Opinion = consensus opinion of committee in the absence of reliable evidence.Table 2: Suggested template for reporting breast cancer specimens post-neoadjuvant systemic therapy in clinical trials (Italicized items = Suggested minimum data set specific to post-neoadjuvant specimens, IN ADDITION to minimum required for other types of specimens)Pre-treatmentPre-treatment core biopsy findings (where available)Histological tumor typePre-treatment histological grade(Pre-treatment cellularity)Presence of DCISHormone receptor and HER2 status(Ki67, multi-gene assays)Type of neoadjuvant treatment : chemotherapy, hormone therapy, radiotherapy, chemo+radiotherapyType of procedureBreast - (Wide local excision +/- localization, mastectomy, other)Lymph nodes – (Sentinel Lymph Nodes, axillary dissection, other lymph nodes e.g. internal mammary)Laterality – (left, right, not specified)MACROSCOPYResidual macroscopic tumor identified– yes/ noIf residual macroscopic tumor:Site of tumor – (Upper Outer, Lower Outer, Upper Inner, Lower Inner, central)Unifocal versus multi-focal If multi-focal, number of fociSize of macroscopic lesion(s) - _ x _ x _ mmIf no residual macroscopic tumor:Area of fibrosis present – yes/ noSite of fibrosisSize of fibrosis - _ x _ x _ mmRadiological marker identified – yes / no/ not presentMICROSCOPYSize/ extent of residual tumor - _ mmLargest cross section of residual tumor bed (entire area involved) … x… mm represented in cassettes (….)Post-treatment histological gradeResidual cellularity…….%DCIS – present/ absentTotal lesion size including DCIS - _ x _ mmPercentage of residual cellularity that is CIS__%Lymphovascular space invasion – present/ absent/ indeterminate/ extensiveIn the absence of residual tumor, is the previous tumor site identified (clip site/ area of fibrosis) – yes/noMargin statusInvasive carcinoma – present / absent; distance to closest marginDCIS – present / absent; distance to closest marginTumor bed – present/ absentLymph node statusNumber of Sentinel/ axillary Lymph NodesNumber of Sentinel/ axillary Lymph Nodes with metastasesSize of largest metastasisEvidence of treatment response in the metastases – present/ absentNumber of Lymph Nodes with evidence of treatment response (fibrosis or histiocytic infiltrate) but no tumor cellsPresence (extent) of extracapsular extensionFINAL CLASSIFICATION OF CHEMOTHERAPY RESPONSEGrade of response and classification system usedIf no formal grading system used, minimum comment regarding response as below:Breast:pathologic Complete ResponseResidual invasive carcinoma, no definite responseResidual invasive carcinoma with probable or definite response to chemotherapy* If there is more than one tumor with variable response between lesions, then the poorest level of response should be taken as the overall classification.Lymph nodes:Metastasis present, no responseMetastasis present, evidence of responseNo residual metastasis but evidence of previous metastasis with responseNo metastasis or fibrosis (true negative)ypTN stageRepeat marker testing:ER/ PR/ HER2 if initial biopsy was negative or equivocal(Ki67)List of abbreviations: CIS: carcinoma in situ component DCIS: Ductal carcinoma in situ; Table 3: Retesting of hormone receptors and HER2 post-neoadjuvant therapyRecommendationClinical settingCommentsRoutine reassessment not currently recommendedPositive ER/ PR/ HER2 result on pre-treatment core biopsyNo change in marker expression in the majority of patients PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5DaGVuPC9BdXRob3I+PFllYXI+MjAxMjwvWWVhcj48UmVj
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ADDIN EN.CITE.DATA (77, 81).Retesting may give a positive result in a small percentage of patients.Positive result would indicate eligibility for targeted therapy.If HER2 status reassessed and found to be discordant, retesting should be performed with both immunohistochemistry and in situ hybridization.DCIS: ductal carcinoma in situ; ER: estrogen receptor; PR: progesterone receptor. 1 Pre-treatment core biopsy should be adequate for unequivocal diagnosis of invasive carcinoma and assessment of key prognostic and predictive markers as this forms the only tumor sample if there is a complete pathological response. If this is not the case, repeat core biopsy should be performed or primary surgery considered. ................
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