CDK4/6抑制剂在高原与低海拔地区激素受体阳性、人表皮生长因子受体2阴性(HR+/HER2-)晚期乳腺癌(ABC)患者中的疗效和安全性特征:一项多中心回顾性研究

{"_":"Efficacy and safety profiles of CDK4/6 inhibitor in patients with hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced breast cancer (ABC) from the high-altitude low-altitude regions: a multi-center retrospective study.","i":["versus"]}

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摘要(中文译文)

CDK4/6抑制剂(CDK4/6i)是HR+/HER2-晚期乳腺癌(ABC)的标准治疗。本研究评估了来自高海拔和低海拔地区的HR+/HER2- ABC患者从一线(1L)到三线(3L)接受CDK4/6i治疗的疗效和安全性特征。研究从中国四家癌症中心纳入接受CDK4/6i治疗的HR+/HER2- ABC患者。共350例患者符合研究条件,其中低海拔组268例,高海拔组82例。在一线治疗中,低海拔组的客观缓解率(ORR,23.7% 对 5.3%,P=0.01)、临床获益率(CBR,88.1% 对 57.9%,P<0.0001)和中位无进展生存期(PFS,42.1个月 对 15.2个月,P=0.001)均优于高海拔组。在二线治疗中,低海拔组的CBR更高(87.5% 对 48.0%,P=5.3E-4)。ORR(20.8% 对 4.0%,P=0.08)和PFS(15.8个月 对 8.2个月,P=0.11)差异无统计学意义。在三线治疗中,PFS(5.2个月 对 5.8个月,P=0.45)、ORR(16.5% 对 21.1%,P=0.74)和CBR(47.1% 对 47.4%,P=1)均未观察到显著差异。高海拔组贫血(43.9% 对 28.3%,P=0.01)、≥3级贫血(9.8% 对 1.9%,P=3.10E-03)、≥3级血小板减少(9.8% 对 1.9%,P=3.10E-03)、≥3级ALT(6.1% 对 0.4%,P=3.10E-03)和AST(7.3% 对 1.9%,P=0.02)功能异常的发生率更高。高海拔地区HR+/HER2- ABC患者接受CDK4/6i治疗的生存结局较差,耐受性存在个体化差异,这可能为中国HR+/HER2- ABC患者的科学研究和CDK4/6i管理提供参考。

Abstract

CDK4/6 inhibitors (CDK4/6i) represent the standard treatment for HR+/HER2- ABC. The study assessed the efficacy and safety profiles of CDK4/6i from first-line (1 L) to third-line (3 L) in patients with HR+/HER2- ABC from high-altitude low-altitude regions. HR+/HER2- ABC patients who received CDK4/6i were enrolled from four cancer centers in China. A total of 350 patients were eligible for the study, involving 268 from the low-altitude group and 82 from the high-altitude group. In the 1 L, objective response rate (ORR, 23.7% 5.3%, = 0.01), clinical benefit rate (CBR, 88.1% 57.9%, < 0.0001), and median progression-free survival (PFS, 42.1 months 15.2 months, = 0.001) in the low-altitude group were superior to those in the high-altitude group. In the second-line treatment, CBR in the low-altitude group was higher (87.5% 48.0%, = 5.3E-4). The ORR (20.8% 4.0%, = 0.08) and PFS (15.8 months 8.2 months, = 0.11) were not significantly different. In the 3 L settings, no significance was observed in PFS (5.2 months 5.8 months, = 0.45), ORR (16.5% 21.1%, = 0.74), and CBR (47.1% 47.4%, = 1). The incidence of anemia (43.9% 28.3%, = 0.01), ≥grade 3 anemia (9.8% 1.9%, = 3.10E-03), ≥grade 3 thrombocytopenia (9.8% 1.9%, = 3.10E-03), ≥grade 3 ALT (6.1% 0.4%, = 3.10E-03) and AST (7.3% 1.9%, = 0.02) dysfunction occurred more frequently in the high-altitude group. Patients with HR+/HER2- ABC in the high-altitude region experienced inferior survival outcomes and individualized tolerability to CDK4/6i, which may inform scientific research and the management of CDK4/6i in Chinese patients with HR+/HER2- ABC.

如何引用

AMA

Yujing Tan, Yinyin Ye, Weihong Zhao, Hangfang Jiang, Jiani Wang, Jiuda Zhao, et al. {"_":"Efficacy and safety profiles of CDK4/6 inhibitor in patients with hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced breast cancer (ABC) from the high-altitude low-altitude regions: a multi-center retrospective study.","i":["versus"]}. Cancer biology & therapy. 2026; doi:10.1080/15384047.2026.2683159.

APA

Yujing Tan, Yinyin Ye, Weihong Zhao, Hangfang Jiang, Jiani Wang, Jiuda Zhao, et al (2026). {"_":"Efficacy and safety profiles of CDK4/6 inhibitor in patients with hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced breast cancer (ABC) from the high-altitude low-altitude regions: a multi-center retrospective study.","i":["versus"]}. Cancer biology & therapy. https://doi.org/10.1080/15384047.2026.2683159

GB/T 7714

Yujing Tan, Yinyin Ye, Weihong Zhao, Hangfang Jiang, Jiani Wang, Jiuda Zhao, et al. {"_":"Efficacy and safety profiles of CDK4/6 inhibitor in patients with hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced breast cancer (ABC) from the high-altitude low-altitude regions: a multi-center retrospective study.","i":["versus"]}[J]. Cancer biology & therapy, 2026 doi:10.1080/15384047.2026.2683159.

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