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Yulareb: Transcending the norms of conventional early breast cancer treatment

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In sub-Saharan Africa, ~75% of patients are diagnosed in stages III and IV. The Breast Health Global Initiative stresses that once a patient presents to the healthcare system with signs and/or symptoms, prompt and accurate diagnosis is extremely important.2

Prompt diagnosis starts by taking a medical history and performing a focused physical examination including a clinical breast exam, followed by diagnostic imaging, and tissue sampling with pathologic evaluation – the so-called triple test of BCa diagnosis.2

The ultimate goal of early detection is to reduce BCa mortality. Therefore, prompt diagnosis should be followed by immediate intervention. Ginsburg et al stress that delays in treatment of greater than three months have been associated with more advanced disease and poorer survival.3

According to the European Society for Medical Oncology’s guidelines, treatment of early BCa is complex and the decision to use adjuvant treatment should be based on the predicted sensitivity to particular treatment types, the benefit from their use, and an individual’s risk of recurrence. Adjuvant therapy should be started without undue delays.4

Efficacy and safety in early breast cancer

The efficacy and safety of Yulareb in early BCa was shown in the Abemaciclib Combined With Endocrine Therapy for the Adjuvant Treatment of HR+, HER2-, Node-Positive, High-Risk, Early BCa (monarchE) study (2020). monarchE was an open-label, phase III study, which included patients (n=5637) with HR+, HER2-, high-risk early BCa, who had surgery, radiotherapy and/or adjuvant/neoadjuvant chemotherapy.5

Patients with ≥4 positive nodes, or one to three nodes and tumour size ≥5cm, and/or histologic grade ≥3, were eligible and randomly assigned (1:1) to standard-of-care adjuvant ET, with or without Yulareb (150mg twice daily for two years).5

The primary endpoint was invasive disease-free survival (IDFS), and secondary endpoints included distant relapse-free survival, overall survival, and safety. The team reported that Yulareb plus ET demonstrated superior IDFS versus ET alone, with two-year IDFS rates of 92.2% versus 89.5%, respectively.5

The team concluded that Yulareb, when combined with ET, is the first CDK4/6 inhibitor to demonstrate a significant improvement in IDFS in patients with HR+, HER2- node-positive early BCa at high risk of early recurrence.5

More recently, Johnston et al (2022) reported updated, interim overall survival (OS) as well as IDFS and distant relapse-free survival (DRFS) results from the monarchE cohort.6

At a median follow-up of 42 months, the absolute difference in IDFS between the groups was 6.9% with a 35% reduction in risk of developing an IDFS event; HR of 0.653 (95% Cl: 0.567, 0.753), nominal p<0.0001 in the Yulareb plus ET group.6

The OS data remains immature, but a numerical difference was seen between the two groups, with fewer deaths in the Yulareb plus ET group vs ET alone group (147 vs 168). The most common grade 3-4 adverse events (AEs) were neutropenia (19.6% vs 0.9%), leukopenia (11.4% vs 0.4%), and diarrhoea (7.8% vs 0.2%) in the Yulareb plus ET, and the ET alone groups, respectively.6

Serious AEs occurred in 15.5% of patients in the Yulareb plus ET group, compared to 9.1% in the ET alone group. There were two treatment-related deaths in the Yulareb plus ET group (diarrhoea and pneumonitis), and none in the ET alone group.6

The team concluded that the addition of adjuvant Yulareb to ET reduces the risk of early BCa recurrence. The benefit is sustained beyond the completion of treatment with an absolute increase at four years, further supporting the use of Yulareb in patients with high-risk HR+, HER2- early BCa.6

References

  1. Professional Information. Yulareb®. [Internet]. Available at: https://www.medicalacademic.co.za/wp-content/uploads/sites/2/2023/07/Yulareb_approved_PI_15-June-2023.pdf
  2. Food and Drug Administration. FDA expands early breast cancer indication for abemaciclib with endocrine therapy. 2023. [Internet]. Available at: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-expands-early-breast-cancer-indication-abemaciclib-endocrine-therapy. Accessed 17 July 2023.
  3. Ginsburg O, Yip CH, Brooks A, et al. Breast cancer early detection: A phased approach to implementation. Cancer, 2020.
  4. Curigliano G, Castelo-Branco L, Gennari A, on behalf of the Clinical Practice Guideline author group. ESMO Metastatic Breast Cancer Living Guidelines, v1.1 May 2023. Ann Oncol, 2021.
  5. Johnston SRD, Harbeck N, Hegg R, et al, monarchE Committee Members and Investigators. Abemaciclib Combined With Endocrine Therapy for the Adjuvant Treatment of HR+, HER2-, Node-Positive, High-Risk, Early Breast Cancer (monarchE). J Clin Oncol, 2020.
  6. Johnston SRD, Toi M, O'Shaughnessy J, et al, monarchE Committee Members. Abemaciclib plus endocrine therapy for hormone receptor-positive, HER2-negative, node-positive, high-risk early breast cancer (monarchE): results from a preplanned interim analysis of a randomised, open-label, phase 3 trial. Lancet Oncol, 2023.

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