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Risk Assessment and Ki-67 Testing in HR-Positive/HER2-Negative EBC for Adjuvant Abemaciclib
  • CME
  • CE

Yara Abdou, MD
Released: May 12, 2022
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  1. Wolff AC, Hammond MEH, Allison KH, et al. Human epidermal growth factor receptor 2 testing in breast cancer: American Society of Clinical Oncology/College of American Pathologists clinical practice guideline focused update. J Clin Oncol. 2018;36:2105-2122.
  2. National Comprehensive Cancer Network. Clinical practice guidelines in oncology: breast cancer. v.2.2022. nccn.org. Accessed May 4, 2022.
  3. Allison KH, Hammond MEH, Dowsett M, et al. Estrogen and progesterone receptor testing in breast cancer: ASCO/CAP guideline update. J Clin Oncol. 2020;38:1346-1366.
  4. Viale G, Giobbie-Hurder A, Regan MM, et al. Prognostic and predictive value of centrally reviewed Ki-67 labeling index in postmenopausal women with endocrine-responsive breast cancer: Results from Breast International Group Trial 1-98 comparing adjuvant tamoxifen with letrozole. J Clin Oncol. 2008;26:5569-75.
  5. Fasching PA, Gass P, Häberle L, et al. Prognostic effect of Ki-67 in common clinical subgroups of patients with HER2-negative, hormone receptor-positive early breast cancer. Breast Cancer Res Treat. 2019;175:617-625.
  6. Nielsen TO, Leung SCY, Rimm DL, et al. Assessment of Ki-67 in breast cancer: Updated recommendations from the International Ki-67 in Breast Cancer Working Group. J Natl Cancer Inst. 2021;113:808-819.
  7. Dowsett M, Nielsen TO, Ahern R, et al. Assessment of Ki-67 in breast cancer: Recommendations from the International Ki-67 in Breast Cancer Working Group. J Natl Cancer Inst 2011;103:1656-1664.
  8. Johnston SRD, Harbeck N, Hegg, R, et al. Abemaciclib combined with endocrine therapy for the adjuvant treatment of HR+, HER2-, node-positive, high-risk, early breast cancer (monarchE). J Clin Oncol. 2020;38:3987-3997.
  9. Nielson G, Gu Y, Weaver A, et al. Development of a novel clinical trial immunohistochemistry (IHC) assay using Ki-67, clone MIB-1, monoclonal antibody for Dako Omnis. Presented at the 2020 Congress of the ESP and XXXIII International Congress of the IAP. Abstract PS-01-045.
  10. US Food and Drug Administration. Ki-67 IHC MIB-1 pharmDx (Dako Omnis) - P210026. fda.gov/medical-devices/recently-approved-devices/ki-67-ihc-mib-1-pharmdx-dako-omnis-p210026. Accessed May 4, 2022.
  11. Gluz O, Nitz UA, Christgen M, et al. West German Study Group phase III planB trial: First prospective outcome data for the 21-gene recurrence score assay and concordance of prognostic markers by central and local pathology assessment. J Clin Oncol. 2016;34:2341-2348.
  12. Shah M, Nunes MR, Stearns V, et al. CDK4/6 inhibitors: Game changers in the management of hormone receptor–positive advanced breast cancer? Oncology (Williston Park). 2018;32:216-222.
  13. Mayer EM, Dueck AC, Martin M, et al. Palbociclib with adjuvant endocrine therapy in early breast cancer (PALLAS): Interim analysis of a multicenter, open-label, randomized, phase 3 study. Lancet Oncol. 2021;22:212-222.
  14. Loibl SL, Marmé F, Martin M, et al. Palbociclib for residual high-risk invasive HR-positive and HER2-negative early breast cancer—The PENELOPE-B trial. J Clin Oncol. 2021;39:1518-1530.
  15. Harbeck N, Rastogi P, Martin M, et al. Adjuvant abemaciclib combined with endocrine therapy for high-risk early breast cancer: Updated efficacy and Ki-67 analysis from the monarchE study. Ann Oncol. 2021;32:1571-1581.
  16. Slamon DJ, Fasching PA, Patel, R, et al. NATALEE: Phase III study of ribociclib (RIBO) + endocrine therapy (ET) as adjuvant treatment in hormone receptor–positive (HR+), human epidermal growth factor receptor 2–negative (HER2–) early breast cancer (EBC). Presented at: ASCO Annual Meeting 2019; May 31 - June 4, 2019. Abstract TPS597.
  17. O’Shaughnessy J, Rastogi P, Harbeck N, et al. Adjuvant abemaciclib combined with endocrine therapy (ET): Updated results from monarchE. ESMO Virtual Plenary Abstracts. 2021;32:1646-1649. Abstract VP8-2021.
  18. O’Shaughnessy JA, Johnston S, Harbeck N, et al. Primary outcome analysis of invasive disease-free survival for monarchE: Abemaciclib combined with adjuvant endocrine therapy for high-risk early breast cancer. Presented at: 2020 San Antonio Breast Cancer Symposium; December 8-11, 2020. Abstract GS1-01.
  19. Harbeck N, Rastogi P, Shahir A, et al. Letter to the Editor for adjuvant abemaciclib combined with endocrine therapy for high-risk early breast cancer: Updated efficacy and Ki-67 analysis from the monarchE study. Ann Oncol. 2022;33:227-228.
  20. Rugo HS, O'Shaughnessy J, Boyle F, et al. Adjuvant abemaciclib combined with endocrine therapy for high-risk early breast cancer: Safety and patient-reported outcomes from the monarchE study. Ann Oncol. 2022;Epub ahead of print.
  21. Toi, M, Harbeck N, Puig JM, et al. Characterization of venous thromboembolic events (VTE), elevated aminotransferases (EAT), and interstitial lung disease (ILD) in monarchE. Presented at: ESMO Breast Cancer Virtual Congress; May 5-8, 2021. Abstract 440.
  22. US Food and Drug Administration. FDA approves abemaciclib with endocrine therapy for early breast cancer. fda.gov/drugs/resources-information-approved-drugs/fda-approves-abemaciclib-endocrine-therapy-early-breast-cancer. Accessed May 4, 2022.
  23. Giordano SH, Freedman RA, Somerfield MR; et al. Abemaciclib with endocrine therapy in the treatment of high-risk early breast cancer: ASCO optimal adjuvant chemotherapy and targeted therapy guideline rapid recommendation update. J Clin Oncol. 2022;40:307-309.
  24. Abemaciclib [prescribing information]. Indianapolis, IN: Lilly USA LLC; 2021.
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