PROPSEA，对乳腺癌年长患者进行帕博西尼布和利博西尼布的安全评估：一项前瞻性真实世界研究
PROPSEA, safety evaluation of palbociclib and ribociclib in older patients with breast cancer: A prospective real-world TOG study.
发表日期：2023 Sep 06
作者：
Okan Avcı, Yakup İriağaç, Eyyüp Çavdar, Kubilay Karaboyun, Murat Araz, Teoman Şakalar, Ezgi Değerli, Özlem Özdemir, Ali İnal, Birol Ocak, Müslih Ürün, Abdullah Sakin, Seher Yıldız Tacar, Mehmet Zahid Koçak, Hacer Demir, Özden Özer, Eda Tanrıkulu Şimşek, Mustafa Ersoy, Yusuf Karakaş, Rukiye Arıkan, Onur Eşbah, Sercan Ön, Elif Şenocak Taşçı, Nil Molinas Mandel, Sema Türker, Turgut Kaçan, Hasan Çağrı Yıldırım, Özkan Alan, Sinem Akbaş, Gülhan İpek Deniz, Özlem Aydın İsak, Halil Taşkaynatan, Erdoğan Selçuk Şeber
来源：
MEDICINE & SCIENCE IN SPORTS & EXERCISE
摘要：
本研究旨在探讨65岁及以上年龄段的转移性乳腺癌患者中帕博西尼布和瑞博西尼布的毒性和管理情况。在接受帕博西尼布和瑞博西尼布治疗的老年患者中，使用老年人8项评估量表(G8量表)和格罗宁根体衰老指数评估体弱状态。根据基线患者特征，记录和分析剂量调整、药物停用以及其他严重不良事件(SAEs)。共纳入土耳其28个中心的160名患者（帕博西尼布=76，瑞博西尼布=84）。其中43名患者年龄≥75岁。两种药物的首剂调整最常见的原因是中性粒细胞减少症（帕博西尼布97%，瑞博西尼布69%）。瑞博西尼布剂量调整的另外原因包括肝功能检测升高（10%）和肾功能损害（6%）。帕博西尼布停药率为3.9%，瑞博西尼布停药率为6%。使用帕博西尼布的患者中，SAEs发生率为11.8%，瑞博西尼布患者为15.5%。有2级或以上的ECOG疾病状况和年龄超过75岁与剂量减少相关。严重中性粒细胞减少症在非骨转移性疾病患者中更常见，在接受第三线及更高线治疗、同时存在非粒细胞减少的血液副作用（对于瑞博西尼布患者）的患者中更常见。肥胖患者中中性粒细胞减少症较少见。我们的结果表明，在年龄≥75岁和/或ECOG疾病状况≥2的患者中，以降低剂量开始使用帕博西尼布和瑞博西尼布是合理的。版权所有©2023 Elsevier Ltd. 保留所有权利。
In this study, the toxicities and management of palbociclib and ribociclib in older patients (≥65 years) with metastatic breast cancer patients were investigated.Among older patients receiving palbociclib and ribociclib, Geriatric 8 (G8) and Groningen Frailty Index were used to evaluate frailty status. Dose modifications, drug withdrawal and other serious adverse events (SAEs) were recorded and analyzed according to baseline patient characteristics.A total of 160 patients from 28 centers in Turkey were included (palbociclib = 76, ribociclib = 84). Forty-three patients were ≥ 75 years of age. The most common cause of first dose modification was neutropenia for both drugs (97% palbociclib, 69% ribociclib). Liver function tests elevation (10%) and renal function impairment (6%) were also causes for ribociclib dose modification. Drug withdrawal rate was 3.9% for palbociclib and 6% for ribociclib. SAEs were seen in 11.8% of those taking palbociclib and 15.5% of those on riboclib. An ECOG performance status of ≥2 and being older than 75 years were associated with dose reductions. Severe neutropenia was more common in patients with non-bone-only metastatic disease, those receiving treatment third-line therapy or higher, coexistance of non-neutropenic hematological side effects (for ribociclib). Neutropenia was less common among patients with obesity.Our results show that it can be reasonable to start palbociclib and ribociclib at reduced dose in patients aged ≥75 years and/or with an ECOG performance status ≥2.Copyright © 2023 Elsevier Ltd. All rights reserved.