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

Abstract

The College does not permit reproduction of any substantial portion of these protocols without its written authorization. The College hereby authorizes use of these protocols by physicians and other health care providers in reporting on surgical specimens, in teaching, and in carrying out medical research for nonprofit purposes. This authorization does not extend to reproduction or other use of any substantial portion of these protocols for commercial purposes without the written consent of the College.The CAP also authorizes physicians and other health care practitioners to make modified versions of the Protocols solely for their individual use in reporting on surgical specimens for individual patients, teaching, and carrying out medical research for non-profit purposes.The CAP further authorizes the following uses by physicians and other health care practitioners, in reporting on surgical specimens for individual patients, in teaching, and in carrying out medical research for non-profit purposes: (1) Dictation from the original or modified protocols for the purposes of creating a text-based patient record on paper, or in a word processing document; (2) Copying from the original or modified protocols into a text-based patient record on paper, or in a word processing document; (3) The use of a computerized system for items (1) and (2), provided that the Protocol data is stored intact as a single text-based document, and is not stored as multiple discrete data fields.Other than uses (1), (2), and (3) above, the CAP does not authorize any use of the Protocols in electronic medical records systems, pathology informatics systems, cancer registry computer systems, computerized databases, mappings between coding works, or any computerized system without a written license from CAP. Applications for such a license should be addressed to the SNOMED Terminology Solutions division of the CAP.Any public dissemination of the original or modified Protocols is prohibited without a written license from the CAP.The College of American Pathologists offers these protocols to assist pathologists in providing clinically useful and relevant information when reporting results of surgical specimen examinations of surgical specimens. The College regards the reporting elements in the "Surgical Pathology Cancer Case Summary" portion of the protocols as essential elements of the pathology report. However, the manner in which these elements are reported is at the discretion of each specific pathologist, taking into account clinician preferences, institutional policies, and individual practice.The College developed these protocols as an educational tool to assist pathologists in the useful reporting of relevant information. It did not issue the protocols for use in litigation, reimbursement, or other contexts. Nevertheless, the College recognizes that the protocols might be used by hospitals, attorneys, payers, and others. Indeed, effective January 1, 2004, the Commission on Cancer of the American College of Surgeons mandated the use of the ...

Magee Equation 3 predicts pathologic response to neoadjuvant systemic chemotherapy in estrogen receptor positive, HER2 negative/equivocal breast tumors

“…It is well established that residual tumor in lymph nodes after neoadjuvant therapy is a poor prognostic indicator. 23 For this reason, various post-therapy prognostic indices, such as 'Residual Cancer Burden' and 'Residual Disease in Breast and Node' models, heavily weigh the amount of residual tumor within lymph nodes. 24,25 Considering patients who failed to achieve pathologic complete response, a higher Magee Equation 3 score showed a higher recurrence rate within both lymph node negative and lymph node positive groups, underscoring that both biology and 'anatomy' are important in determining tumor behavior.…”

“…Oncotype DX (Genomic Health, Redwood City, CA, USA), also known as the 21 gene expression assay, is one such test. 4 It is reported as a numerical recurrence score ranging from 0 to 100 and divided into low-risk (o 18), intermediate risk (18)(19)(20)(21)(22)(23)(24)(25)(26)(27)(28)(29)(30), and high-risk (≥31) categories, and current guidelines, including National Comprehensive Cancer Network (NCCN), recommend its use in women with early stage ER+ disease. Despite the predictive and prognostic information this and other genomic tests provide, they have limitations, including cost of over $4,000 per test, delay in treatment while awaiting results and restricted availability in settings with limited resources.…”

Central pathology review with two-stage quality assurance for pathological response after neoadjuvant chemotherapy in the ARTemis Trial

“…Standardisation of routine reporting in clinical practice for neoadjuvant cases has been addressed recently by an international working group which should make this easier when designing future clinical trials. 11 It is possible that should such standardisation be adopted, a measure of response such as RCB could be calculated locally. Also, although there is some evidence that pathologists are better at assessing chemotherapy response by reading pathology reports than are practicing clinicians 12 this was not borne out by our data.…”

Breast cancer biomarker (ER, PR, HER2) changes in the phenotype after neoadjuvant treatment

“…Между тем именно иммуногистохимический статус лимфатического узла является более важным биологическим индикатором прогноза после проведенной НХТ [2], чем статус опухоли.…”