Standardization of pathologic evaluation and reporting of postneoadjuvant specimens in clinical trials of breast cancer: recommendations from an international working group

dc.contributor.authorProvenzano, Elena
dc.contributor.authorBossuyt, Veerle
dc.contributor.authorViale, Giuseppe
dc.contributor.authorCameron, David
dc.contributor.authorBadve, Sunil
dc.contributor.authorDenkert, Carsten
dc.contributor.authorMacGrogan, Gaëtan
dc.contributor.authorPenault-Llorca, Frédérique
dc.contributor.authorBoughey, Judy
dc.contributor.authorCurigliano, Giuseppe
dc.contributor.authorDixon, J. Michael
dc.contributor.authorEsserman, Laura
dc.contributor.authorFastner, Gerd
dc.contributor.authorKuehn, Thorsten
dc.contributor.authorPeintinger, Florentia
dc.contributor.authorvon Minckwitz, Gunter
dc.contributor.authorWhite, Julia
dc.contributor.authorYang, Wei
dc.contributor.authorSymmans, W. Fraser
dc.contributor.departmentDepartment of Pathology & Laboratory Medicine, IU School of Medicineen_US
dc.date.accessioned2016-03-24T19:01:30Z
dc.date.available2016-03-24T19:01:30Z
dc.date.issued2015-07
dc.description.abstractNeoadjuvant 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 end point of survival after neoadjuvant therapy. Thus, pathological complete response has become a primary end point 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 after neoadjuvant therapy, and retesting of markers after 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 in breast cancer; other methods can be included per trial protocols and regional preference. Posttreatment 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.en_US
dc.eprint.versionAuthor's manuscripten_US
dc.identifier.citationProvenzano, E., Bossuyt, V., Viale, G., Cameron, D., Badve, S., Denkert, C., … Symmans, W. F. (2015). Standardization of pathologic evaluation and reporting of postneoadjuvant specimens in clinical trials of breast cancer: recommendations from an international working group. Modern Pathology, 28(9), 1185–1201. http://doi.org/10.1038/modpathol.2015.74en_US
dc.identifier.urihttps://hdl.handle.net/1805/9029
dc.language.isoenen_US
dc.publisherNatureen_US
dc.relation.isversionof10.1038/modpathol.2015.74en_US
dc.relation.journalModern Pathologyen_US
dc.rightsPublisher Policyen_US
dc.sourceAuthoren_US
dc.subjectbreast canceren_US
dc.subjectneoadjuvant therapyen_US
dc.subjecthistologic assessmenten_US
dc.titleStandardization of pathologic evaluation and reporting of postneoadjuvant specimens in clinical trials of breast cancer: recommendations from an international working groupen_US
dc.typeArticleen_US
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