Department of Experimental and Clinical Biomedical Sciences "M. Serio", University of Florence, Florence, Italy.
Department of Experimental and Clinical Biomedical Sciences "M. Serio", University of Florence, Florence, Italy; Radiation Oncology Unit, Oncology Department, Azienda Ospedaliero Universitaria Careggi, Florence, Italy.
Radiother Oncol. 2022 Dec;177:40-45. doi: 10.1016/j.radonc.2022.10.023. Epub 2022 Oct 28.
Cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) currently represent the standard of care for the initial treatment of patients with metastatic hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) breast cancer. The aim of our study is to evaluate the safety of the use of concomitant radiation therapy (RT) in a consecutive series of HR+/HER2- patients treated in two academic institutions with CDK4/6i in the metastatic setting.
From September 2017 to February 2020, we retrospectively collected and analysed data on a sequential series of patients treated with CDK4/6i, receiving RT or not, at two European institutions. Primary outcome of the study was the association between RT and any adverse events (AEs) ≥ G3. Secondary outcomes were the association between RT and any AEs (any grade), CDK4/6i dose reduction rate, and CDK4/6i treatment discontinuation rate.
We analysed a total of 132 consecutive women; RT was prescribed in 57 (43.2%) patients (70 irradiated lesions). The median age of the series was 52.1 years (range 32.3-78.2). Concomitant RT administration was not significantly related to higher AEs ≥ G3 (p = 0.19) and any grade AEs (p = 1.0); there was no association with RT and CDK4/6i dose reduction (p = 0.49) and discontinuation rates (p = 0.14). At a median follow-up of 18.8 months, the progression-free survival (PFS) rate was 35% and the overall survival (OS) rate was 38.7% in the whole group. The use of concomitant RT did not affect both PFS (p = 0.71) and OS rates (p = 0.55).
Our data are encouraging regarding the safety of this combination, showing that concurrent RT did not increase severe toxicity and did not have an impact on systemic treatment conduction.
细胞周期蛋白依赖性激酶 4/6 抑制剂（CDK4/6i）目前是转移性激素受体阳性/人表皮生长因子受体 2 阴性（HR+/HER2-）乳腺癌初始治疗的标准治疗方法。我们的研究旨在评估在两个学术机构中对接受 CDK4/6i 治疗的 HR+/HER2-患者连续系列中，同时使用放射治疗（RT）的安全性。
从 2017 年 9 月至 2020 年 2 月，我们回顾性地收集并分析了在两个欧洲机构中接受 CDK4/6i 治疗、接受或未接受 RT 的连续系列患者的数据。本研究的主要结果是 RT 与任何不良事件（AE）≥3 级之间的关联。次要结果是 RT 与任何 AE（任何级别）、CDK4/6i 剂量减少率和 CDK4/6i 治疗停药率之间的关联。
我们分析了总共 132 名连续的女性患者；57 名（43.2%）患者接受了 RT（70 个照射病灶）。该系列的中位年龄为 52.1 岁（范围 32.3-78.2）。同时进行 RT 治疗与更高的 AE≥3 级（p=0.19）和任何等级的 AE（p=1.0）之间无显著相关性；与 CDK4/6i 剂量减少（p=0.49）和停药率（p=0.14）也无相关性。在中位随访 18.8 个月时，整个组的无进展生存期（PFS）率为 35%，总生存期（OS）率为 38.7%。同时使用 RT 并未影响 PFS（p=0.71）和 OS 率（p=0.55）。
我们的数据令人鼓舞，表明这种联合治疗是安全的，同时进行 RT 并未增加严重毒性，也没有对全身治疗的进行产生影响。
