دورية أكاديمية
أعرض في EDS

Ki67 assessment protocol as an integral biomarker for avoiding radiotherapy in the LUMINA breast cancer trial.

التفاصيل البيبلوغرافية
العنوان: Ki67 assessment protocol as an integral biomarker for avoiding radiotherapy in the LUMINA breast cancer trial.
المؤلفون: Nielsen TO; Department of Pathology and Laboratory Medicine, University of British Columbia, Vancouver, BC, Canada., Leung SCY; Department of Pathology and Laboratory Medicine, University of British Columbia, Vancouver, BC, Canada., Riaz N; Department of Pathology and Laboratory Medicine, University of British Columbia, Vancouver, BC, Canada., Mulligan AM; University Health Network, Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, Ontario, Canada., Kos Z; Department of Pathology and Laboratory Medicine, University of British Columbia, Vancouver, BC, Canada., Bane A; University Health Network, Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, Ontario, Canada., Whelan TJ; Department of Oncology, McMaster University, Hamilton, Ontario, Canada.
المصدر: Histopathology [Histopathology] 2023 Dec; Vol. 83 (6), pp. 903-911. Date of Electronic Publication: 2023 Aug 23.
نوع المنشور: Journal Article
اللغة: English
بيانات الدورية: Publisher: Blackwell Scientific Publications Country of Publication: England NLM ID: 7704136 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1365-2559 (Electronic) Linking ISSN: 03090167 NLM ISO Abbreviation: Histopathology Subsets: MEDLINE
أسماء مطبوعة: Original Publication: Oxford, Blackwell Scientific Publications.
مواضيع طبية MeSH: Breast Neoplasms*/diagnosis, Female ; Humans ; Ki-67 Antigen ; Immunohistochemistry
مستخلص: Aims: The LUMINA trial demonstrated a very low local recurrence rate in women ≥55 years with low-risk luminal A breast cancer (defined as grade I-II, T1N0, hormone receptor positive, HER2 negative and Ki67 index ≤13.25%) treated with breast-conserving surgery and endocrine therapy (but no other systemic therapy), supporting the safe omission of radiation in these women. Here we describe the protocol for Ki67 assessment, the companion diagnostic used to guide omission of adjuvant radiotherapy.
Methods: Ki67 immunohistochemistry was performed on full-face sections at one of three regional labs. Pathologists trained in the International Ki67 in Breast Cancer Working Group (IKWG) method demarcated tumour areas on scanned slides and scored 100 nuclei from each of at least five randomly selected 1-mm fields. For cases with high Ki67 heterogeneity, further virtual cores were selected and scored in order to confidently assign a case as luminal A (≤13.25%) or B (>13.25%). Interlaboratory variability was assessed through an annual quality assurance programme during the study period.
Results: From the quality assurance programme, the mean Ki67 index across all cases/labs was 13%. The observed intraclass correlation coefficient (ICC) and kappa statistics were ≥0.9 and ≥0.7, respectively, indicating a substantial level of agreement. Median scoring time was 4 min per case. The IKWG-recommended scoring method, performed directly from slides, requiring up to four scored fields, is concordant with the LUMINA scoring method (ICC ≥ 0.9).
Conclusion: Ki67 is a practical, reproducible, and inexpensive biomarker that can identify low-risk luminal A breast cancers as potential candidates for radiation de-escalation.
Clinical Trial Registration: ClinicalTrials.gov number, NCT01791829.
(© 2023 The Authors. Histopathology published by John Wiley & Sons Ltd.)
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معلومات مُعتمدة: Canadian Breast Cancer Foundation; Canadian Cancer Society
فهرسة مساهمة: Keywords: Ki67; LUMINA; biomarker; breast cancer; clinical trial; immunohistochemistry; radiotherapy
سلسلة جزيئية: ClinicalTrials.gov NCT01791829
المشرفين على المادة: 0 (Ki-67 Antigen)
تواريخ الأحداث: Date Created: 20230823 Date Completed: 20231107 Latest Revision: 20231107
رمز التحديث: 20231107
DOI: 10.1111/his.15032
PMID: 37609778
قاعدة البيانات: MEDLINE
الوصف
تدمد:1365-2559
DOI:10.1111/his.15032