Lee Yeonhong, Lee Dayae, Seo Inyoung, Chae Heejung, Sim Sung Hoon, Lee Keun Seok, Gwak Hye Sun
College of Pharmacy and Graduate School of Pharmaceutical Sciences, Ewha Womans University, Seoul 03760, Republic of Korea.
Department of Pharmacy, National Cancer Center, Goyang-si 10408, Republic of Korea.
Cancers (Basel). 2023 May 18;15(10):2810. doi: 10.3390/cancers15102810.
This study aimed to determine the risk factors for palbociclib-induced grade 4 or grade 3 neutropenia (NP) requiring dose reduction or delayed treatment in patients with HR+/HER2-metastatic breast cancer in the first 3 cycles (early grade 3/4 NP) and whether the early developing grade 3/4 NP affects progression-free survival.
A retrospective study using electronic medical records was conducted on patients who received palbociclib for metastatic breast cancer between January 2018 and August 2022. The early grade 3/4 NP risk factors were evaluated with univariate and multivariable logistic regression analyses. In addition, the Kaplan-Meier method was used to estimate the median progression-free survival (PFS) to analyze the effect of early grade 3/4 NP on treatment.
Out of the 264 patients included in this study, 173 (65.6%) experienced early grade 3/4 NP. A total of four models were applied for multivariable analysis to identify early grade 3/4 NP-developing factors. Low baseline ANC, WBC, PLT, and BSA were significant risk factors for early grade 3/4 NP; baseline ANC < 3700/mm, WBC < 6.30 × 10/mm, PLT < 230 × 10/mm, and BSA < 1.58 m increased the risk by approximately 4.0-fold, 3.7-4.0-fold, 2.1-fold, and 2.0-fold, respectively. Early grade 3/4 NP did not affect PFS ( = 0.710), although patients with early grade 3/4 NP had more frequent dose reductions or treatment delays.
Based on the results, low baseline ANC, WBC, PLT, and BSA were associated with early grade 3/4 NP. Patients with risk factors require careful monitoring, and this study is expected to help predict NP, which may appear in early treatment.
本研究旨在确定在接受哌柏西利治疗的激素受体阳性/人表皮生长因子受体2阴性转移性乳腺癌患者的前3个周期中，导致需要降低剂量或延迟治疗的4级或3级中性粒细胞减少（NP）的危险因素，以及早期发生的3/4级NP是否会影响无进展生存期。
对2018年1月至2022年8月期间接受哌柏西利治疗转移性乳腺癌的患者进行了一项使用电子病历的回顾性研究。通过单因素和多因素逻辑回归分析评估早期3/4级NP的危险因素。此外，采用Kaplan-Meier方法估计中位无进展生存期（PFS），以分析早期3/4级NP对治疗的影响。
本研究纳入的264例患者中，173例（65.6%）发生了早期3/4级NP。共应用4种模型进行多因素分析，以确定早期3/4级NP的发生因素。低基线中性粒细胞计数（ANC）、白细胞计数（WBC）、血小板计数（PLT）和体表面积（BSA）是早期3/4级NP的显著危险因素；基线ANC<3700/mm³、WBC<6.30×10⁹/mm³、PLT<230×10⁹/mm³和BSA<1.58 m²分别使风险增加约4.0倍、3.7 - 4.0倍、2.1倍和2.0倍。尽管早期3/4级NP的患者更频繁地出现剂量减少或治疗延迟，但早期3/4级NP并未影响PFS（P = 0.710）。
基于研究结果，低基线ANC、WBC、PLT和BSA与早期3/4级NP相关。有危险因素的患者需要仔细监测，本研究有望有助于预测早期治疗中可能出现的NP。
