Miron Andreea-Iuliana, Anghel Alexandra-Valentina, Barnonschi Andrei-Alexandru, Mitre Ruxandra, Liscu Horia-Dan, Găinariu Estera, Pătru Raluca, Coniac Simona
Department of Oncological Radiotherapy and Medical Imaging, "Carol Davila" University of Medicine and Pharmacy, 020021 Bucharest, Romania.
Department of Medical Oncology, Colțea Clinical Hospital, 030167 Bucharest, Romania.
Diagnostics (Basel). 2023 Jun 1;13(11):1938. doi: 10.3390/diagnostics13111938.
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.
选择性细胞周期蛋白依赖性激酶（CDK）4/6抑制剂在临床实践中的引入改善了激素受体（HR）阳性、人表皮生长因子受体2（HER2）阴性转移性乳腺癌（mBC）患者的预后。在罗马尼亚，三种可用的CDK 4/6抑制剂（哌柏西利、瑞博西尼和阿贝西利）已于2019年、2020年和2021年获得国家药品管理局（ANM）的批准。我们对2019年至2022年期间在布加勒斯特科尔泰亚临床医院肿瘤科接受激素治疗并同时接受CDK 4/6抑制剂治疗的107例HR +转移性乳腺癌患者进行了一项回顾性研究。本研究的目的是计算中位无进展生存期（PFS），并将其与其他随机临床试验的中位PFS进行比较。与其他研究的一个关键区别在于，我们的研究评估了非内脏型mBC患者和内脏型mBC患者，因为这两组患者的预后通常不同。共有79.4%为绝经后患者，20.6%为绝经前患者；42.1%在疾病初发时处于不同阶段，57.9%为新诊断的转移性疾病。中位PFS为17个月，与报告中位PFS为25.3个月的随机临床试验不同。CDK 4/6抑制剂与内分泌治疗联合是HR阳性、HER2阴性转移性乳腺癌的金标准治疗方法，可延长这些患者的生存期。我们的结果显示，尽管患者组较小，但与随机临床试验相比没有重大差异。为了尽可能获得与真实世界数据接近的治疗疗效情况，我们认为不同机构的多个肿瘤科之间开展合作，对大量患者进行多中心研究将非常有用。
