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

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Journal of Cancer Therapy 2014年第2期5卷 141-146页

作者： Yoshio Mizuno Hiromi Fuchikami tsuneo natori Naoko Takeda Yuko Inoue Junichi Yamada Hiroaki Abe Hiroshi Seto Kazuhiko Sato Clinical Testing Business Testing Division SRL Inc. Tokyo Japan Department of Breast Oncology Tokyo-West Tokushukai Hospital Tokyo Japan Department of Clinical Pathology Tokyo-West Tokushukai Hospital Tokyo Japan Inoue Ladies Clinic Tokyo Japan Seto Hospital Tokorozawa Japan

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.

关键词： Ki-67 Core Needle Biopsy Concordance Rate Virtual Slides Automated Analyzer Standardized Assessment

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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

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Journal of Cancer Therapy 2012年第5期3卷 841-845页

作者： Yoshio Mizuno tsuneo natori Naoko Takeda Junichi Yamada Hiroaki Abe Yuko Inoue Hiroshi Seto Kazuhiko Sato Clinical Testing Business Testing Division Special Reference Laboratories Inc. Tokyo Japan Department of Breast Oncology Tokyo-West Tokushukai Hospital Tokyo Japan Department of Clinical Pathology Tokyo-West Tokushukai Hospital Tokyo Japan Inoue Ladies Clinic Tokyo Japan Seto Hospital Saitama Japan

Purpose: The aim of this study was to assess the reliability of Ki-67 expression on core needle biopsy (CNB) and the surgical specimens of invasive breast cancer. We examined the concordance rate of Ki-67 expressions, hormone receptors, and human epidermal growth factor receptor 2 (HER2) status from a CNB with from a surgery in invasive breast cancer. Methods: A retrospective study was conducted on a clinical database of patients who underwent surgery for early breast cancer. Of these, 193 patients who underwent CNB before the surgery were enrolled. A cut-off value of 20% was used for Ki-67-positive criteria. Expression of estrogen receptor (ER), progesterone receptor (PgR), and HER2 were examined and compared with that of Ki-67. To evaluate discordance between the pathologists’ earlier assessments, we re-examined Ki-67 expression among the Ki-67 discordant group in a central laboratory. Results: The concordance rate for Ki-67 expression between the two specimen types was 77.7%, which was significantly lower than that for ER, PgR, and HER2 expression (95.9%, 88.1%, and 91.6%, respectively). The concordance rate for re-examined Ki-67 expression among the Ki-67 discordant group improved to 93.8% and was not significantly different from that for the other receptors. Conclusion: The concordance rate for Ki-67 expression between biopsy and surgical specimens was significantly lower than that for ER, PgR, and HER2 expressions, but re-examination of Ki-67 expression in a central laboratory revealed no significant difference among the receptors, suggesting the need for standard pathological assessment of Ki-67 expression for clinical use as a predictive marker of breast cancer.

关键词： Ki-67 CNB Concordance Rate Standard Assessment

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