Observational study of HR+/HER2− metastatic breast cancer patients treated with abemaciclib in Spain in the Named Patient Use Program (AbemusS)

Blanch, S.; Gil-Gil, Miguel; Arumí, Miriam; Aguirre, Elena; Seguí, Miguel Àngel; Atienza, Manuel; Díaz‐Cerezo, Silvia; Molero, A.; Cervera, Jose Manuel; Gavilá, Joaquín

doi:10.1007/s12094-023-03159-9

Cited by 3 publications

(1 citation statement)

References 16 publications

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“…Compared to other real-world studies, the Spanish retrospective analysis reported shorter rwPFS in all treatment lines (19.3 months in the first-line setting, 10.3 months in the second-line setting, and 5.5 months in the third-line setting) [11]. In a US real-world study with shorter median follow-up, rwPFS was not reached; the reported overall 12-month rwPFS probability of the entire cohort was 61.7%, which is similar to our cohort (57%) [12].…”

Section: Discussioncontrasting

confidence: 56%

Abemaciclib for the Treatment of HR+HER2− Metastatic Breast Cancer: An Institutional Experience

Matos,

Cankar,

Režun

et al. 2024

Cancers

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(1) Background: Abemaciclib combined with endocrine therapy is a standard first- or later--line of treatment for HR+/HER2− metastatic breast cancer (MBC). The aim of this retrospective cohort study was to describe the outcomes of patients treated in a real-world setting, with particular focus on elderly patients. (2) Patients and methods: Patients treated with abemaciclib between November 2019 and February 2022 were included in the study. Data were collected from electronic medical records. The primary objective was to determine real-world progression-free survival (rwPFS), and secondary objectives included median overall survival (mOS) and safety. (3) Results: Analysis included 134 patients, with a median follow-up of 42 months. Median age was 62 years, with 29.9% aged 70+ years. A total of 51.5% of patients received abemaciclib in first-line, predominantly with aromatase inhibitor (68.1%). Median rwPFS was 21 in first-line and 20 months in the second-line, with no significant difference between treatment lines (HR 0.96; p = 0.88). Patients treated in the third- or later-line had a significantly shorter rwPFS, at 7 months (HR 1.48, p = 0.003). mOS was not reached in the first-line setting. For second- and third- or later-lines, mOS was 29 and 19 months, respectively. There was no significant difference in mOS between first- or second-line (HR 1.37, p = 0.36). In the 70+ group, median rwPFS was 15 months and mOS was 25 months with no significant difference compared to younger patients (rwPFS HR 1.1; p = 0.65; OS HR 1.4; p = 0.21). Most common adverse events (AEs) were diarrhoea (68.7%), anaemia (64.9%), and increased serum creatinine (63.4%). Grade 3/4 AEs were reported in 21.6% of patients. Dose reductions occurred in 30.6% of patients and were more frequent in patients 70+ (40%) compared to younger patients (28%); the difference was not significant (p = 0.22). At study cut-off, 64.9% of patients discontinued abemaciclib, primarily due to disease progression (73.5%). (4) Conclusions: Our study provides valuable insights into the effectiveness and safety of abemaciclib for the treatment of MBC. We observed comparable outcomes in terms of rwPFS and OS between the first two lines, suggesting consistent effectiveness across treatment lines. In addition, our findings suggest that older age (70+) does not significantly impact the effectiveness and tolerability of abemaciclib, although the careful monitoring and management of AEs are warranted.

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Section: Discussioncontrasting

confidence: 56%

Abemaciclib for the Treatment of HR+HER2− Metastatic Breast Cancer: An Institutional Experience

Matos,

Cankar,

Režun

et al. 2024

Cancers

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Abemaciclib for treating patients with HR+/HER2- metastatic breast cancer: a real-world study in France, Italy and Spain

Blancas,

Grosjean,

Pedersini

et al. 2024

Future Oncology

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Aim: This real-world study aimed to describe patient and clinical characteristics, treatment patterns and outcomes for patients with HR+/HER2- metastatic breast cancer receiving abemaciclib in France, Italy and Spain. Materials & methods: A multicenter chart review was conducted for adult females with HR+/HER2- advanced/metastatic breast cancer who received abemaciclib in routine care. Real-world progression-free survival (rwPFS) was estimated via Kaplan-Meier curves. Results: This study included 151, 173 and 175 patients from France, Italy and Spain, respectively. Abemaciclib was mostly prescribed as first-line therapy concomitantly with hormone therapy. Median rwPFS was >20 months and the 1-year rwPFS rate was >70%. Conclusion: Effectiveness was similar across the three countries and aligns with pivotal studies.

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Efficacy and Safety of Abemaciclib in Combination With Endocrine Therapy for HR+/HER2− Advanced or Metastatic Breast Cancer

Qureshi,

Jamil,

Fatima

et al. 2024

American Journal of Clinical Oncology

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Objectives: Breast cancer, particularly the hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2−) subtype, remains a major global health concern. Abemaciclib, a CDK4/6 inhibitor, has shown promising results in treating advanced cases. This study comprehensively assesses the efficacy and safety of abemaciclib in combination with endocrine therapy for HR+/HER2− advanced or metastatic breast cancer. Methods: Following PRISMA guidelines, a systematic review and meta-analysis was conducted. A thorough literature search was conducted on PubMed, EMBASE, Cochrane Library, and ClinicalTrials.gov til December 2023. Inclusion criteria encompassed randomized controlled trials and retrospective cohort studies reporting on abemaciclib in approved doses, either as monotherapy or in combination. Outcome assessments included progression-free survival (PFS), overall response rate (ORR), side effects/adverse effects (SE/AE), and overall survival (OS). Quality assessment utilized Cochrane’s revised risk of bias tool and Newcastle-Ottawa scale. Results: Pooled results of 22 studies involving 14,010 patients revealed that abemaciclib significantly improved PFS (hazard ratio=0.53; 95% CI: 0.48-0.59; P=0.00; I2=0%), ORR (risk ratio=2.31; 95% CI: 1.93-2.75; P=0.00; I2=0%), and OS (risk ratio=0.76 (95% CI: 0.65-0.87; P=0.001; I2=0%). However, abemaciclib increased the risk of adverse events in the fulvestrant and nonsteroidal aromatase inhibitor (NSAI) combinations, respectively. Conclusions: Abemaciclib, particularly in combination with fulvestrant, emerges as an effective therapeutic option for HR+/HER2− advanced or metastatic breast cancer, improving PFS and OS. The higher toxicity profile warrants cautious use, especially in treatment-naive patients.

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Observational study of HR+/HER2− metastatic breast cancer patients treated with abemaciclib in Spain in the Named Patient Use Program (AbemusS)

Cited by 3 publications

References 16 publications

Abemaciclib for the Treatment of HR+HER2− Metastatic Breast Cancer: An Institutional Experience

Abemaciclib for the Treatment of HR+HER2− Metastatic Breast Cancer: An Institutional Experience

Abemaciclib for treating patients with HR+/HER2- metastatic breast cancer: a real-world study in France, Italy and Spain

Efficacy and Safety of Abemaciclib in Combination With Endocrine Therapy for HR+/HER2− Advanced or Metastatic Breast Cancer

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