Real-World Outcomes of CDK4/6 Inhibitors Treatment in Metastatic Breast Cancer in Romania

Abstract

The introduction in clinical practice of selective cyclin-dependent kinase (CDK) 4/6 inhibitors improves the outcome of patients with hormone receptor (HR)-positive human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer (mBC). In Romania, the three available CDK 4/6 inhibitors (Palbociclib, Ribociclib and Ademaciclib) have been approved by the National Agency for Medicines (ANM) in 2019, 2020 and 2021. We conducted a retrospective study from 2019 to 2022 on 107 patients with metastatic breast cancer HR+ that have been treated with CDK 4/6 inhibitors in addition to hormone therapy in the Oncology Department of Colțea Clinical Hospital in Bucharest. The purpose of this study is to calculate the median progression-free survival (PFS) and to compare it with the median PFS from other randomized clinical trials. A key difference from other studies is that our study evaluated both patients with non-visceral mBC and patients with visceral mBC, as these two groups often have different outcomes. A total of 79.4% were postmenopausal patients and 20.6% were premenopausal; 42,1% had different stages at the beginning of disease and 57.9% presented newly metastatic disease. Median PFS was 17 months, unlike randomized clinical trials which reported a median PFS of 25.3 months. The combination of CDK 4/6 inhibitors with endocrine therapy is the golden standard treatment in HR-positive, HER2-negative metastatic breast cancer, bringing a prolongation of survival for these patients. Our results show no major differences compared to randomized clinical trials, despite the smaller patient group. In order to have a picture of the efficacy of the treatment as close as possible to the real-world data, we believe that it would be very useful to have a collaboration between several oncology departments in different institutions to carry out a multi-center study on large groups of patients.

The Impact on Survival of Neoadjuvant Treatment Interruptions in Locally Advanced Rectal Cancer Patients

“…Patient compliance and personalized assessment of acute toxicities contribute to achieving the goal of uninterrupted treatment [ 74 ]. The role of psychological and nutritional support teams that can predict and manage potentially disruptive problems early on is all the more important in the era of intensified non-surgical cancer treatments.…”

Prediction of Subclinical and Clinical Multiple Organ Failure Dysfunction in Breast Cancer Patients—A Review Using AI Tools

“…Clusters: articles that are close to each other on the dendrogram are more similar to each other, while articles that are farther apart are less similar. The clusters formed in the dendrogram indicate groups of articles with similar characteristics or attributes (References are arranged in a descending order from top to bottom: [ 1 , 2 , 5 , 6 , 9 , 10 , 11 , 12 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 49 , 50 , 51 , 53 , 54 , 55 , 56 , 58 , 60 , 61 , 63 , 64 , 65 , 66 , 67 , 68 , 69 , 70 , …”

“…Recent large clinical studies have turned their attention to adjuvant therapies to limit the metastasis process, but their effect on how they restrain the tumor from disseminating is still unclear [ 3 ]. Despite these results, the actual treatment aims at molecular targets like HER2/neu [ 4 ] and CDK4/6 inhibitors [ 5 ]. However, these key components in molecular aberrations in cancerous cells have yet to be proven as a significant factor in the process of dissemination [ 6 ].…”

Assessing the Impact of Organ Failure and Metastases on Quality of Life in Breast Cancer Patients: A Prospective Study Based on Utilizing EORTC QLQ-C30 and EORTC QLQ-BR45 Questionnaires in Romania

“…QoL can be influenced, on the one hand, by the direct involvement of malignancy and, on the other hand, by secondary therapies such as mastectomy, systemic therapies, radiotherapy, and hormonal therapy [16,17]. While novel therapies such as hormonal therapy, immunotherapy, and molecular-targeted therapy have improved the survival rate, approaches to enhance the QoL have not been developed accordingly [11,18,19]. Therefore, we consider that this particular group of patients should benefit from research not only on disease-free survival (DFS), overall survival (OS), and progression-free survival (PFS) but on QoL as well.…”