Quan Xianghua, Li Jing, Sun Jialin, Xing Xiaomin, Liu Donghua, Ji Hongyan, Guo Qie
Department of Clinical Pharmacy, The Affiliated Hospital of Qingdao University, Qingdao, Shandong, China.
Front Oncol. 2025 May 22;15:1564681. doi: 10.3389/fonc.2025.1564681. eCollection 2025.
Doxorubicin (DOX) is a primary treatment for breast cancer (BC), but its widespread use is hindered by cardiotoxicity. Pegylated liposomal doxorubicin (PLD) has been developed to enhance the efficacy of DOX and mitigate its cardiotoxic effects. However, PLD is associated with adverse reactions (ADRs) such as hand-foot syndrome (HFS) and oral mucositis (OM), which have garnered significant attention. Although not life-threatening, HFS and OM can cause severe discomfort and functional impairment. Severe cases may necessitate a reduced PLD dose or even delay or interrupt chemotherapy, ultimately leading to decreased medication compliance. Here, we conduct an analysis of the risk factors associated with HFS and OM during the PLD chemotherapy regimen, thus providing early warning indicators for the potential occurrence of these adverse reactions in BC patients.
In this study, a total of 395 BC patients receiving PLD chemotherapy were enrolled. Follow-up observations towards the baseline and clinical characteristics in these patients were exhibited. The evaluation of HFS and OM in these patients was also performed based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Analysis of factors influencing simultaneous incidence of HFS and OM was executed using the univariate analysis and multivariate logistic regression analysis.
Dose intensity, history of cholelithiasis, ALT, AST, and Hb were identified as related risk factors for HFS. Dose intensity and reductions in white blood cell (WBC) counts were associated with the risk of OM. Furthermore, increased dose intensity, decreased WBC counts, and a history of cholelithiasis emerged as independent risk factors for the concurrent occurrence of HFS and OM.
This study investigated the various risk factors related to HFS, OM, and their combination in BC patients undergoing PLD chemotherapy, offering insights for the prevention and treatment of BC and other cancers.
阿霉素（DOX）是乳腺癌（BC）的主要治疗药物，但其广泛应用受到心脏毒性的阻碍。聚乙二醇化脂质体阿霉素（PLD）已被开发出来，以提高DOX的疗效并减轻其心脏毒性作用。然而，PLD与诸如手足综合征（HFS）和口腔黏膜炎（OM）等不良反应相关，这些不良反应已引起了广泛关注。尽管HFS和OM不会危及生命，但它们会导致严重不适和功能障碍。严重病例可能需要降低PLD剂量，甚至延迟或中断化疗，最终导致药物依从性下降。在此，我们对PLD化疗方案期间与HFS和OM相关的危险因素进行分析，从而为BC患者中这些不良反应的潜在发生提供早期预警指标。
在本研究中，共纳入了395例接受PLD化疗的BC患者。展示了对这些患者的基线和临床特征的随访观察。还根据不良事件通用术语标准（CTCAE）第5.0版对这些患者的HFS和OM进行了评估。使用单因素分析和多因素逻辑回归分析对影响HFS和OM同时发生的因素进行分析。
剂量强度、胆石症病史、谷丙转氨酶（ALT）、谷草转氨酶（AST）和血红蛋白（Hb）被确定为HFS的相关危险因素。剂量强度和白细胞（WBC）计数降低与OM风险相关。此外，剂量强度增加、WBC计数降低和胆石症病史是HFS和OM同时发生的独立危险因素。
本研究调查了接受PLD化疗的BC患者中与HFS、OM及其合并症相关的各种危险因素，为BC和其他癌症的预防和治疗提供了见解。
