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CDK4/6 抑制剂联合姑息性放疗治疗转移性乳腺癌患者的安全性。

Safety of cyclin-dependent kinase4/6 inhibitor combined with palliative radiotherapy in patients with metastatic breast cancer.

机构信息

Department of Radiation Oncology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.

Department of Medicine, Division of Hematology Oncology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.

出版信息

Breast. 2021 Dec;60:163-167. doi: 10.1016/j.breast.2021.10.001. Epub 2021 Oct 9.

Abstract

INTRODUCTION

Cyclin-dependent kinase (CDK)4/6 inhibitor is a first-line therapy for metastatic ER+/HER2-breast cancer. However, there are limited data on safety of combined radiotherapy (RT) and CDK4/6 inhibition.

METHODS

We conducted a retrospective study of women with metastatic breast cancer who received palliative RT within 14 days of CDK4/6 inhibitor use. The primary endpoint was toxicity per Common Terminology Criteria for Adverse Events v5. Secondary endpoints were pain response and local control based on clinical assessment and imaging.

RESULTS

Thirty patients underwent 36 RT courses with palbociclib (n = 34 courses, 94.4%) or abemaciclib (n = 2, 5.6%). RT was delivered before, concurrently or after CDK4/6 inhibitors in 7 (19.4%), 8 (22.2%), and 21 (58.3%) of cases with median 3.5 days from RT to closest CDK4/6 inhibitor administration. Median RT dose was 30Gy (range 8-40.05Gy). Treated sites included brain (n = 5, 11.6%), spine (n = 19, 44.2%), pelvis (n = 9, 20.9%), other bony sites (n = 6, 14.0%) and others (n = 4, 9.3%). No acute grade ≥3 non-hematologic toxicity occurred. No increased hematologic toxicity was attributable to RT with grade 3 hematologic toxicities rates 16.7%, 0%, and 6.7% before, during, and 2 weeks after RT completion. All but one patient (29/30) achieved symptom relief. Local control rates were 94.4%, 91.7% at 6 and 12 months.

CONCLUSIONS

The use of RT within 2 weeks of CDK4/6 inhibitors had low acceptable toxicity and high efficacy, suggesting that it is safe for palliation of metastatic breast cancer.

摘要

介绍

细胞周期蛋白依赖性激酶(CDK)4/6 抑制剂是转移性 ER+/HER2-乳腺癌的一线治疗药物。然而,关于联合放疗(RT)和 CDK4/6 抑制的安全性数据有限。

方法

我们对在使用 CDK4/6 抑制剂后 14 天内接受姑息性 RT 的转移性乳腺癌女性进行了回顾性研究。主要终点是根据通用不良事件术语标准 v5 评估的毒性。次要终点是根据临床评估和影像学评估的疼痛反应和局部控制。

结果

30 例患者接受了 36 次帕博西尼(n=34 次,94.4%)或阿贝西利(n=2 次,5.6%)的 RT。在 7 例(19.4%)、8 例(22.2%)和 21 例(58.3%)中,RT 在 CDK4/6 抑制剂之前、同时或之后进行,从 RT 到最近一次 CDK4/6 抑制剂给药的中位时间为 3.5 天。中位 RT 剂量为 30Gy(范围 8-40.05Gy)。治疗部位包括脑(n=5,11.6%)、脊柱(n=19,44.2%)、骨盆(n=9,20.9%)、其他骨部位(n=6,14.0%)和其他部位(n=4,9.3%)。无急性≥3 级非血液学毒性。无因 RT 导致的血液学毒性增加,RT 前后和完成后 2 周内的 3 级血液学毒性发生率分别为 16.7%、0%和 6.7%。除 1 例患者(29/30)外,所有患者均获得症状缓解。6 个月和 12 个月的局部控制率分别为 94.4%和 91.7%。

结论

在 CDK4/6 抑制剂使用后 2 周内使用 RT 的毒性可接受且疗效高,表明这对转移性乳腺癌的缓解是安全的。

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