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## Guidelines for pathological diagnosis |
### Review 1: intrinsic subtype, molecular biological risk classification, and pathological diagnosis |
Pathological substitution of ‘intrinsic subtype’ using the status of the estrogen receptor (ER), progesterone receptor (PgR), HER2 and Ki-67 is prevalent in clinical practice for breast cancer [1]. Definitions vary, but ‘luminal A-like’ is currently usually used for biologically indolent hormone receptor (ER and/or PgR... |
Triple-negative (negative for ER/PgR/HER2) breast cancer (TNBC) can be molecularly classified as basal-like, luminal-AR (androgen receptor), immune-activated, and claudin-low. Pathological classification of TNBC using EGFR, CK5/6, AR, cell-adhesion molecules, and tumor infiltrating lymphocytes (TIL) has been suggested ... |
### Review 2: appropriate pre-analytical methods required for pathological materials |
Formalin-fixed and paraffin-embedded (FFPE) tissue are used for both routine pathological examination and for immunohistochemistry (IHC), in-situ hybridization (ISH), MGEAs, or cancer gene panel examinations. The pre-analytical steps, which are particularly important to assure the quality of the protein, mRNA or DNA, i... |
### Review 3: pathological grading of invasive ductal carcinoma |
There has been a focus on pathological grade, in addition to lymph node status, as a factor that affects clinical outcomes. The usefulness of pathological (histological or nuclear) grade has particularly been emphasized in invasive ductal carcinoma, and pathological grade is an independent prognostic factor. The Nottin... |
### Review 4: lesions for which benign/malignant discrimination is difficult using fine needle aspiration cytology or needle biopsy |
Fine needle aspiration cytology (FNA), core needle biopsy (CNB), and vacuum-assisted biopsy (VAB) are recommended for pathological diagnosis of breast lesions due to lower invasiveness compared with surgical biopsy and high diagnostic accuracy (BQ1). However, differences between FNA/CNB/VAB results and examinations of ... |
The terms ‘flat epithelial atypia (FEA)’, ‘atypical ductal hyperplasia (ADH)’, and ‘atypical lobular hyperplasia (ALH)’ have been used for atypical lesions that do not meet the criteria for carcinoma. The definition of these lesions and the risk of occurrence of breast carcinoma in a person with each lesion is describe... |
FEA, ADH and ALH are originally defined using surgical material. Lesions diagnosed as such in cytology or needle biopsy include both definitive lesions and a wide spectrum of lesions from benign to malignant, causing a lower diagnostic concordance rate [9]. The next step for such lesions should be selected among surgic... |
### Review 5: utility of immunohistochemistry (IHC) for benign/malignant discrimination in intraductal epithelial proliferative lesions |
IHC is increasingly used for pathological diagnosis of intraductal epithelial proliferative lesions to differentiate between a benign and malignant status. Usual ductal hyperplasia (UDH) exhibits a mosaic staining pattern for high molecular weight cytokeratin (HMW-CK) such as CK5/6 or CK14, whereas ADH/low-grade DCIS i... |
### Review 6: confirming the diagnosis of a lesion suspected to be metastatic breast cancer |
IHC may be useful to confirm the diagnosis for a lesion suspected to be metastatic breast cancer. |
IHC using the biomarkers described above is useful for diagnosis of a lesion suspected to be metastatic breast cancer; however, each biomarker can produce atypical results, suggesting the need for comprehensive analyses and panel diagnosis using multiple markers. |
## BQ1: what is recommended first as a diagnostic procedure for a breast lesion: fine needle aspiration cytology (FNAC), core needle biopsy (CNB), or vacuum-assisted biopsy (VAB)? |
### 1. For a non-palpable lesion, CNB or VAB is recommended first due to diagnostic accuracy. |
### 2. For a lesion clinically suspected to be benign, FNAC is recommended first due to cost-effectiveness and relatively high diagnostic accuracy. |
### 3. For a lesion clinically suspected to be malignant, CNB or VAB is recommended first due to diagnostic accuracy and probable abundant pathological information, such as histological type or biomarker presentation. |
FNAC is inexpensive and its diagnostic accuracy is high for a palpable lesion, but low for a non-palpable lesion [17, 18]. |
## BQ2: is pathological examination recommended to evaluate the effect of neoadjuvant therapy? |
### Pathological examination is recommended to evaluate the effect of neoadjuvant therapy and to predict the outcome; however, methods or criteria for examination are not standardized, which may cause discordant results. |
In the General Rules for Clinical and Pathological Recording of Breast Cancer 18th edition, the pathological effect of neoadjuvant therapy for invasive lesions is classified into grade 0 (no response), grade 1a (mild response, less than 1/3), grade 1b (moderate response, 1/3–2/3), grade 2a (high grade changes, 2/3 or m... |
Pathologic complete response (pCR) after neoadjuvant chemotherapy may be a predictor of a favorable outcome in HER2-positive cancer or TNBC [21, 22]; however, the definition of pCR differs among studies. The absence of both an invasive lesion and a nodal metastatic lesion is generally required for a diagnosis of pCR, b... |
In reporting of the pathological effect of neoadjuvant therapy, details should be clearly stated regarding the examined area and the evaluation criteria and results, including the presence or absence of invasive/in-situ/nodal lesions or evidence of tumor disappearance. |
## BQ3: why and how are hormone receptors examined? |
### The hormone receptor status should be examined immunohistochemically to determine the indication for endocrine therapy |
Immunohistochemical examination of ER and PgR is strongly recommended for all primary breast cancers. IHC should be performed using pharmaceutically approved primary antibodies according to each manufacturer’s instruction. Nuclear staining is quantified as a percentage (e.g., J-score) or as a combination of a percentag... |
## BQ4: why and how is HER2 examined? |
### To determine the indication for anti-HER2 therapy, the HER2 status should be examined by immunohistochemistry (IHC) or in situ hybridization (ISH) |
HER2 status is a predictor for anti-HER2 therapy and clinical outcome, and should be examined for the invasive component of breast cancer. In Japan, IHC is usually performed first and results in a score of 0, 1 + , 2 + , or 3 + , where 0/1 + is HER2-negative, 3 + is HER2-positive, and 2 + is equivocal for HER2. In 2 + ... |
## BQ5: How should the surgical margin be determined pathologically in partial mastectomy? |
### 1. The pathological method to determine the surgical margin of partially removed breast material is not standardized. The pathological report should include the absence or presence of tumors, the method used for examination, and the details of the nearest tumor to the margin (type of tumor element, amount, etc.). |
### 2. Intraoperative margin examination may not lead to an accurate diagnosis. |
The following details of the nearest tumor to the margin should be reported: shortest distance from the margin, type of tumor element (invasive/in-situ, histology, grade, presence/absence of comedo necrosis), and amount [26, 27]. The pathological accuracy of intraoperative margin examination is high enough to be recomm... |
## BQ6: how should a sentinel lymph node be examined pathologically? |
### 1. A sentinel lymph node should be examined pathologically using hematoxylin–eosin sections. One-step nucleic acid amplification (OSNA) can substitute for the usual pathological examination. |
### 2. Routine immunohistochemical examination is not recommended for pathological diagnosis of a sentinel lymph node. |
A metastatic lesion can be classified into isolated tumor cells (ITC, ≤ 0.2 mm in diameter or ≤ 200 tumor cells), micrometastasis (≤ 2 mm), and macrometastasis (> 2 mm) based on the largest dimension of the metastatic lesion. To detect macrometastasis, examination of slices at every 2-mm interval is required. Nodes wit... |
Health insurance can be used for OSNA, as a molecular examination of metastasis in sentinel lymph nodes [28]. OSNA can reduce the workload of pathologists and technicians. Metastasis that is only detected immunohistochemically has less clinical importance [29]. |
## BQ7: is evaluation of nuclear grade or comedo necrosis recommended for DCIS? |
### Nuclear grading of tumor cells or evaluation of comedo necrosis has become increasingly important for selection of cases to be treated with partial mastectomy without radiation or to be followed up without treatment; however, the evaluation methods are not standardized and the interobserver consistency rate is not ... |
The pathological grade of DCIS affects the clinical outcome [30]. There are several nuclear grading systems that to date are not standardized. The Van Nuys classification incorporates the presence or absence of comedo necrosis, as well as the nuclear grade. [8, 31]. An incorrect understanding of the definition of comed... |
## BQ8: is examination of the hormone receptor or HER2 status recommended for needle biopsy material? |
### 1. Examination of the hormone receptor or HER2 status in needle biopsy specimens is required to determine the neoadjuvant treatment strategy. |
### 2. Examination of the hormone receptor or HER2 status in needle biopsy specimens is not necessarily required for cases for which neoadjuvant therapy is not planned. |
In the examination of hormone receptors and HER2, needle biopsy specimens can be substituted for surgical specimens. For cases without neoadjuvant treatment, hormone receptors can be reexamined in needle biopsy specimens if they are negative in surgical specimens. For cases with neoadjuvant treatment, the status of hor... |
## FRQ1: which kind of invasive breast cancer should be examined for Ki-67? How should Ki-67 be estimated? |
### 1. Ki-67 is useful to predict the clinical outcome of ER-positive/HER2-negative breast cancer, but not for selection of medication; thus, treatment should not be determined using Ki-67 alone. |
### 2. The method for evaluation of Ki-67 has not been standardized. |
Detection of Ki-67 nuclear staining is considered to be positive staining regardless of the intensity. Distribution of the Ki-67 labeling index (LI) differs among subtypes. Setting a cut-off value is difficult, but indexes of < 5% and ≥ 30% are largely accepted as low and high cut-offs, respectively. A Ki-67 labeling i... |
## FRQ2: is examination of hormone receptors or HER2 recommended for DCIS? |
### 1. Hormone receptors may be examined in DCIS if adjuvant endocrine therapy is being considered. |
### 2. To date, there is no evidence to recommend HER2 examination in DCIS. |
Neither hormone receptor nor HER2 status in DCIS predict ipsilateral breast tumor recurrence with invasion after breast conserving therapy. If adjuvant endocrine therapy is being considered to reduce DCIS recurrence in the conserved breast or events in the contralateral breast, hormone receptors may be examined in DCIS... |
## FRQ3: is examination of cell block material from metastatic breast cancer recommended to determine the treatment strategy? |
### For a distant metastasis, a cell block from aspiration material or body cavity fluid is likely to be available for biomarker examination using IHC or ISH; however, health insurance is currently not applicable for biomarker examination using a cell block from metastatic breast cancer. |
A FFPE cell block can be used for IHC or ISH, and the results of ER/PgR/HER2 in a cell block sample are comparable with those from a corresponding tissue sample [34]. A cell block sample can also be used to confirm breast origin by IHC using GATA3, GCDFP-15, or mammoglobin [35]. |
## FRQ4: is evaluation of tumor infiltrating lymphocytes (TIL) useful in invasive ductal carcinoma? |
### A TIL-high status is a favorable prognostic factor for some breast cancers and may also be a predictive marker for neoadjuvant chemotherapy. TIL evaluation is now being standardized; however, diagnostic reproducibility should be verified. Thus, TIL may be evaluated, but this is currently not necessary. |
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