Adjuvant abemaciclib combined with endocrine therapy for high-risk early breast cancer: safety and patient-reported outcomes from the monarchE study
| Autor: | Rugo, H S, O'Shaughnessy, J, Boyle, F, Toi, M, Broom, R, Blancas, I, Gumus, M, Yamashita, T, Im, Y-H, Rastogi, P, Zagouri, F, Song, C, Campone, M, San Antonio, B, Shahir, A, Hulstijn, M, Brown, J, Zimmermann, A, Wei, R, Johnston, S R D, Reinisch, M, Tolaney, S M, monarchE Committee Members |
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| Jazyk: | angličtina |
| Rok vydání: | 2022 |
| Předmět: |
safety
Diarrhea Receptor ErbB-2 HER2 negative Aminopyridines HR positive Breast Neoplasms Hematology abemaciclib monarchE Oncology Antineoplastic Combined Chemotherapy Protocols Quality of Life Humans Benzimidazoles Female Patient Reported Outcome Measures early breast cancer Neoplasm Recurrence Local |
| Popis: | In monarchE, abemaciclib plus endocrine therapy (ET) as adjuvant treatment of hormone receptor-positive, human epidermal growth factor 2-negative, high-risk, early breast cancer (EBC) demonstrated a clinically meaningful improvement in invasive disease-free survival versus ET alone. Detailed safety analyses conducted at a median follow-up of 27 months and key patient-reported outcomes (PROs) are presented. The safety population included all patients who received at least one dose of study treatment (n = 5591). Safety analyses included incidence, management, and outcomes of common and clinically relevant adverse events (AEs). Patient-reported health-related quality of life, ET symptoms, fatigue, and side-effect burden were assessed. The addition of abemaciclib to ET resulted in higher incidence of grade ≥3 AEs (49.7% versus 16.3% with ET alone), predominantly laboratory cytopenias [e.g. neutropenia (19.6%)] without clinical complications. Abemaciclib-treated patients experienced more serious AEs (15.2% versus 8.8%). Discontinuation of abemaciclib and/or ET due to AEs occurred in 18.5% of patients, mainly due to grade 1/2 AEs (66.8%). AEs were managed with comedications (e.g. antidiarrheals), abemaciclib dose holds (61.7%), and/or dose reductions (43.4%). Diarrhea was generally low grade (grade 1/2: 76%); grade 2/3 events were highest in the first month (20.5%), most were short-lived (≤7 days) and did not recur. Venous thromboembolic events (VTEs) were higher with abemaciclib + ET (2.5%) versus ET (0.6%); in the abemaciclib arm, increased VTE risk was observed with tamoxifen versus aromatase inhibitors (4.3% versus 1.8%). PROs were similar between arms, including being 'bothered by side-effects of treatment', except for diarrhea. At ≥3 months, most patients reporting diarrhea reported 'a little bit' or 'somewhat'. In patients with high-risk EBC, adjuvant abemaciclib + ET has an acceptable safety profile and tolerability is supported by PRO findings. Most AEs were reversible and manageable with comedications and/or dose modifications, consistent with the known abemaciclib toxicity profile. |
| Databáze: | OpenAIRE |
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