The Reliability of Assessment of Ki-67 Expression on Core Needle Biopsy and the Surgical Specimens of Invasive Breast Cancer: Comparison of Local Pathologists’ Assessment and Central Review

Mizuno, Yoshio; Natori, Tsuneo; Takeda, Naoko; Yamada, Jun−ichi; Abe, Hiroaki; Inoue, Yuko; Seto, Hiroshi; Sato, Kazuhiko

doi:10.4236/jct.2012.325107

Cited by 3 publications

(4 citation statements)

References 15 publications

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“…Our previous study analyzed 287 primary breast cancer patients who underwent preoperative CNB to compare the concordance rates for assessing Ki-67 status evaluated either by automated or central/local pathology assessment and showed that central review and the use of an automated analyzer can improve the accuracy of Ki-67 assessment. We then confirmed the necessity of a standardized evaluation method for Ki-67 expression in breast cancer to overcome the disadvantages of variable counting methods and measurement sites [23] [24].…”

Section: Discussionsupporting

confidence: 56%

Comparing Oncotype DX Recurrence Score Categories with Immunohistochemically Defined Luminal Subtypes

Mizuno¹,

Fuchikami²,

Takeda³

et al. 2016

JCT

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Background: At the 13th St Gallen International Breast Cancer Conference in 2013, a new definition of luminal Alike and luminal B-like breast cancer was proposed, involving the expression of estrogen receptor (ER), progesterone receptor (PgR), and Ki-67. We examined the rate of concordance between the risk groups using the Oncotype DX recurrence score (RS) and the previous and newly proposed luminal subtypes with the standardized Ki-67 assessment. Method: The relationship between a previously and newly proposed, immunohistochemically defined luminal A and B subtype with the Oncotype DX RS of 41 cases of T1-2 N0-1 M0 (ER positive, HER2 negative) breast cancer was assessed. We first classified the patients into the previously defined luminal A and B subtypes, according to the level of Ki-67 as either "low" (<14%) or "high" (≥14%), as assessed by local pathologists. Next, to consider the necessity for standardizing Ki-67 measurement methods, we reexamined Ki-67 with a central review. By introducing PgR positivity (≥20%), we classified these patients to newly proposed luminal subtypes and compared them with the risk groups stratified by Oncotype DX RS. Results: In the previously proposed luminal subtypes, the concordance rate between luminal A and the low RS category was 76.5% according to local pathologists and 90.1% by central review, whereas the rate between luminal B and the intermediate to high RS category was 46.7% and 45.8%, respectively. In newly proposed luminal subtypes, the concordance rate between luminal A and low RS category was 100% and between the luminal B and intermediate to high RS category was 53.6%. Conclusions: Although this study was based on a retrospective chart review of a small sample size, the newly proposed luminal subtypes including

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Section: Discussionsupporting

confidence: 56%

Comparing Oncotype DX Recurrence Score Categories with Immunohistochemically Defined Luminal Subtypes

Mizuno¹,

Fuchikami²,

Takeda³

et al. 2016

JCT

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“…The core needle biopsy (CNB) procedure is almost as accurate as immunohistochemical analysis of surgical specimens for breast cancer diagnosis and is now widely accepted as the standard diagnostic procedure [17][18][19][20]. However, previous reports have shown variations in Ki-67 expression among pretreatment CNB specimens and post-treatment surgical specimens [21][22][23]. Therefore, it is important to consider potential discrepancies in Ki-67 values between CNB and surgical specimens, even in patients who receive no preoperative treatment, to standardize Ki-67 measurements in preoperative hormone therapy.…”

Section: Introductionmentioning

confidence: 98%

“…Equally in analytical validity, tumor heterogeneity and the lack of standard measuring method by pathologists may affect Ki67 measurement [11]. We had previously reported that these factors might affect the concordance rate for Ki-67 expression between CNB and surgical specimens, and we suggest that standardization of the measurement method by pathologists is most important [21]. However human observers spend considerable time and effort assessing large tissue areas and performing central reviews in general medical facilities which is difficult.…”

Section: Introductionmentioning

confidence: 99%

Standardized Assessment of Ki-67 in Breast Cancer Patients Using Virtual Slides and an Automated Analyzer in Comparison to Central/Local Pathological Assessments

Mizuno¹,

Fuchikami²,

Natori³

et al. 2014

JCT

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Purpose: To standardize the methods to measure Ki-67, there is an interest in automating the assessment of Ki-67. Therefore, we reviewed the possibility of introducing an automated analyzer to standardize the Ki-67 evaluation method. Methods: We retrospectively reviewed a clinical database of patients who underwent surgery for early breast cancer at Tokyo-West Tokushukai Hospital. Among them, those who underwent preoperative core needle biopsy (CNB) were enrolled. The concordance rates of estrogen receptor (ER), progesterone receptor (PgR), human epidermal growth factor receptor 2 (HER2), and Ki-67 by local pathologists were reviewed (valuations made by local pathologists), and nonmatching cases (from August 2008 to October 2011) were reassessed both by central review and using an automated analyzer with virtual slides. The results were compared with the evaluations made by local pathologists, and we reexamined the concordance rate by using central review and the automated analyzer. Results: The concordance rate of Ki-67 evaluations made by local pathologists in the preoperative CNB and surgical specimens was 78.7% in 287 cases pathologically assessed from October 2008 to March 2013. This rate was significantly lower (p < 0.01) than that of ER (95.6%), PgR (88.5%), and HER2 (91.6%). Reassessment of the 37 cases of nonmatching Ki-67 values from 2008 to October 2011 using central review and an automated analyzer resulted in clear improvement in matching of 22 (92.1%) and 24 (93.1%) of 37 cases, respectively. Conclusion: The concordance rate of Ki-67 in preoperative CNB and surgical specimens was lower than that of other biological markers; however, they were nearly equal by reassessment using central review and an automated analyzer.

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“…However, the concordance rates of Ki-67 levels between core needle biopsy and postsurgical specimens have not been much investigated. Moreover, a few studies have reported that the concordance rates of Ki-67 between the two types of samples were lower than those for ER, PR, or HER2 expression [ 9 , 10 , 20 , 21 ]. However, the International Ki-67 in Breast Cancer Working Group commented on the type of biopsy and stated that both core and whole sections were suitable, although some data suggested that scores from whole sections might be higher than those from core biopsies [ 7 ].…”

Section: Discussionmentioning

confidence: 99%

Risk Factors Associated with Discordant Ki-67 Levels between Preoperative Biopsy and Postoperative Surgical Specimens in Breast Cancers

et al. 2016

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PurposeThe Ki-67 labelling index is significant for the management of breast cancer. However, the concordance of Ki-67 expression between preoperative biopsy and postoperative surgical specimens has not been well evaluated. This study aimed to find the correlation in Ki-67 expression between biopsy and surgical specimens and to determine the clinicopathological risk factors associated with discordant values.Patients and MethodsKi-67 levels were immunohistochemically measured using paired biopsy and surgical specimens in 310 breast cancer patients between 2008 and 2013. ΔKi-67 was calculated by postoperative Ki-67 minus preoperative levels. The outliers of ΔKi-67 were defined as [lower quartile of ΔKi-67–1.5 × interquartile range (IQR)] or (upper quartile + 1.5 × IQR) and were evaluated according to clinicopathological parameters by logistic regression analysis.ResultsThe median preoperative and postoperative Ki-67 levels were 10 (IQR, 15) and 10 (IQR, 25), respectively. Correlation of Ki-67 levels between the two specimens indicated a moderately positive relationship (coefficient = 0.676). Of 310 patients, 44 (14.2%) showed outliers of ΔKi-67 (range, ≤-20 or ≥28). A significant association with poor prognostic factors was found among these patients. Multivariate analysis determined that significant risk factors for outliers of ΔKi-67 were tumor size >1 cm, negative progesterone receptor (PR) expression, grade III cancer, and age ≤35 years. Among 171 patients with luminal human epidermal growth factor receptor 2-negative tumors, breast cancer subtype according to preoperative or postoperative Ki-67 levels discordantly changed in 46 (26.9%) patients and a significant proportion of patients with discordant cases had ≥1 risk factor.ConclusionKi-67 expression showed a substantial concordance between biopsy and surgical specimens. Extremely discordant Ki-67 levels may be associated with aggressive tumor biology. In patients with luminal subtype disease, clinical application of Ki-67 values should be cautious considering types of specimens and clinicopathological risk factors.

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The Reliability of Assessment of Ki-67 Expression on Core Needle Biopsy and the Surgical Specimens of Invasive Breast Cancer: Comparison of Local Pathologists’ Assessment and Central Review

Cited by 3 publications

References 15 publications

Comparing Oncotype DX Recurrence Score Categories with Immunohistochemically Defined Luminal Subtypes

Comparing Oncotype DX Recurrence Score Categories with Immunohistochemically Defined Luminal Subtypes

Standardized Assessment of Ki-67 in Breast Cancer Patients Using Virtual Slides and an Automated Analyzer in Comparison to Central/Local Pathological Assessments

Risk Factors Associated with Discordant Ki-67 Levels between Preoperative Biopsy and Postoperative Surgical Specimens in Breast Cancers

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