Adjuvant CDK Inhibitors for EBC

CE / CME

Integrating Adjuvant CDK4/6 Inhibitors Into Care of Patients With HR-Positive/HER2-Negative Early-Stage Breast Cancer

Physician Assistants/Physician Associates: 0.50 AAPA Category 1 CME credit

Nurses: 0.50 Nursing contact hour

Pharmacists: 0.50 contact hour (0.05 CEUs)

Physicians: maximum of 0.50 AMA PRA Category 1 Credit

Released: May 01, 2024

Expiration: April 30, 2025

Tanya Gupta
Tanya Gupta, MD

Activity

Progress
1 2
Course Completed

References

  1. Garutti M, Griguolo G, Botticelli A, et al. Definition of high-risk early hormone-positive HER2-negative breast cancer: a consensus review. Cancers (Basel). 2022;14:1898.
  2. O'Shaughnessy J, Gradishar W, O’Regan R, et al. Risk of recurrence in patients with HER2+ early-stage breast cancer: literature analysis of patient and disease characteristics. Clin Breast Cancer. 2023;23:350-362.
  3. Orrantia-Borunda E, Anchondo-Nuñez P, Acuña-Aguilar LE, et al. Subtypes of breast cancer. ncbi.nlm.nih.gov/books/NBK583808. Accessed April 24, 2024.
  4. 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;38:3987-3998.
  5. Abemaciclib [prescribing information]. Indianapolis, IN: Lilly; 2017.
  6. Slamon D, Lipatov O, Nowecki Z, et al. Ribociclib plus endocrine therapy in early breast cancer. N Engl J Med. 2024;390:1080-1091.
  7. Cheng L, Swartz MD, Zhao H, et al. Hazard of recurrence among women after primary breast cancer treatment--a 10-year follow-up using data from SEER-Medicare. Cancer Epidemiol Biomarkers Prev. 2012;21:800-809.
  8. Petrelli F, Viale G, Cabiddu M, et al. Prognostic value of different cut-off levels of Ki-67 in breast cancer: a systematic review and meta-analysis of 64,196 patients. Breast Cancer Res Treat. 2015;153:477-491.
  9. Liu Y, Yin W, Yan T, et al. The clinical significance of Ki-67 as a marker of prognostic value and chemosensitivity prediction in hormone-receptor-positive breast cancer: a meta-analysis of the published literature. Curr Med Res Opin. 2013;29:1453-1461.
  10. Otto T, Sicinski P. Cell cycle proteins as promising targets in cancer therapy. Nat Rev Cancer. 2017;17:93-115.
  11. Corona SP, Generali D. Abemaciclib: a CDK4/6 inhibitor for the treatment of HR+/HER2- advanced breast cancer. Drug Des Devel Ther. 2018;12:321-330.
  12. George MA, Qureshi S, Omene C, et al. Clinical and pharmacologic differences of CDK4/6 inhibitors in breast cancer. Front Oncol. 2021;11:693104.
  13. Rastogi P, O'Shaughnessy J, Martin M, et al. Adjuvant abemaciclib plus endocrine therapy for hormone receptor-positive, human epidermal growth factor receptor 2-negative, high-risk early breast cancer: results from a preplanned monarchE overall survival interim analysis, including 5-year efficacy outcomes. J Clin Oncol. 2024;42:987-993.
  14. 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.
  15. National Comprehensive Cancer Network. Clinical practice guidelines in oncology: breast cancer. v.2.2024. nccn.org. Accessed April 24, 2024.
  16. Brown J, Scardo S, Method M, et al. A real-world retrospective study of the use of Ki-67 testing and treatment patterns in patients with HR+, HER2- early breast cancer in the United States. BMC Cancer. 2022;22:502.
  17. Gudlaugsson E, Skaland I, Janssen EA, et al. Comparison of the effect of different techniques for measurement of Ki67 proliferation on reproducibility and prognosis prediction accuracy in breast cancer. Histopathology. 2012;61:1134-1144.
  18. Nielsen TO, Leung SCY, Rimm DL, et al. Assessment of Ki67 in breast cancer: updated recommendations from the International Ki67 in Breast Cancer Working Group. J Natl Cancer Inst. 2021;113:808-819.
  19. Slamon DJ, Fasching PA, Hurvitz S, et al. Rationale and trial design of NATALEE: a phase III trial of adjuvant ribociclib + endocrine therapy versus endocrine therapy alone in patients with HR+/HER2- early breast cancer. Ther Adv Med Oncol. 2023:15:17588359231178125.
  20. Hortobagyi G, Stroyakovsky D, Yardley D, et. al. Ribociclib (RIB) + nonsteroidal aromatase inhibitor (NSAI) as adjuvant treatment in patients with HR+/HER2− early breast cancer: final invasive disease–free survival (iDFS) analysis from the NATALEE trial. Presented at: 2023 San Antonio Breast Cancer Symposium; December 5-9, 2023. Abstract GS03-03.
  21. 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;33:616-627.
  22. Fasching PA, Slamon D, Nowecki Z, et al. Health-related quality of life in the phase III NATALEE study of adjuvant ribociclib plus a nonsteroidal aromatase inhibitor (NSAI) vs NSAI alone in patients with HR+/HER2− early breast cancer. Presented at: 2023 European Society for Medical Oncology Virtual Plenary; September 12-15, 2023. Abstract VP3-2023.
  23. Harbeck N, Guarneri V, Seo JH, et al. Long-term patient-reported outcomes from monarchE: abemaciclib plus endocrine therapy for adjuvant HR+, HER2-, node-positive, high-risk, early breast cancer (EBC). Presented at: 2023 European Society for Medical Oncology Breast Cancer Annual Congress; May 11-13, 2023. Abstract 93MO.
  24. Shohdy KS, Lasheen S, Kassem L, et al. Gastrointestinal adverse effects of cyclin-dependent kinase 4 and 6 inhibitors in breast cancer patients: a systematic review and meta-analysis. Ther Adv Drug Saf. 2017;8:337-347.
  25. Sammons S, Moore H, Cushman J, et al. Efficacy, safety and toxicity management of adjuvant abemaciclib in early stage HR+/HER2- high-risk breast cancer. Expert Rev Anticancer Ther. 2022;22:805-814.
  26. Thill M, Schmidt M. Management of adverse events during cyclin-dependent kinase 4/6 (CDK4/6) inhibitor-based treatment in breast cancer. Ther Adv Med Oncol. 2018;10:1758835918793326.
  27. National Library of Medicine. Ribociclib. LiverTox: clinical and research information on drug-induced liver injury. ncbi.nlm.nih.gov/books/NBK548818. Accessed April 24, 2024.
  28. US Food and Drug Administration. Guidance for industry drug-induced liver injury: premarketing clinical evaluation. fda.gov/media/116737/download. Accessed April 24, 2024.
  29. Finnsdottir S, Sverrisdottir A, Björnsson ES. Hepatotoxicity associated with ribociclib among breast cancer patients. Acta Oncol. 2021;60:195-198.
  30. O’Shaughnessy J, Cicin I, Testa L, et al. Impact of dose reductions on efficacy of adjuvant abemaciclib for patients with high-risk early breast cancer (EBC): analyses from the monarchE study. Presented at: 2023 European Society for Medical Oncology Virtual Plenary; September 12-15, 2023. Abstract 274P.
  31. Ribociclib [prescribing information]. East Hanover, NJ: Novartis; 2017.
  32. Greer JA, Amoyal N, Nisotel L, et al. A systematic review of adherence to oral antineoplastic therapies. Oncologist. 2016;21:354-376.
  33. Jacobs JM, Pensak NA, Sporn NJ, et al. Treatment satisfaction and adherence to oral chemotherapy in patients with cancer. J Oncol Pract. 2017;13:e474-e485.
  34. Thomas SA, John T, Criner E, et al. Challenges to oral chemotherapy adherence. US Pharm. 2016;44:HS-9-HS-12.
  35. Vyas A, Descoteaux A, Kogut S, et al. Predictors of adherence to oral anticancer medications: an analysis of 2010-2018 US nationwide claims. J Manag Care Spec Pharm. 2022;28:831-844.
  36. Lambourne T, Minard LV, Deal H, et al. Optimizing patient education of oncology medications: a patient perspective. J Cancer Educ. 2019;34:1024-1030.
  37. Loibl S, André F, Bachelot T, et al. Early breast cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2024;35:159-182.
  38. Kalinsky K, Barlow WE, Gralow JR, et al. 21-gene assay to inform chemotherapy benefit in node-positive breast cancer. N Engl J Med. 2021;385:2336-2347.
  39. Assi HI, Alameh IA, Khoury J, et al. Impact of commercialized genomic tests on adjuvant treatment decisions in early stage breast cancer patients. J Oncol. 2020;2020:9238084.
  40. Geyer CE Jr, Garber JE, Gelber RD, et al. Overall survival in the OlympiA phase III trial of adjuvant olaparib in patients with germline pathogenic variants in BRCA1/2 and high-risk, early breast cancer. Ann Oncol. 2022;33:1250-1268.