Tang Lichen, He Min, Geng Cuizhi, Fan Zhimin, Ling Rui, Qiao Guangdong, Cai Li, Luo Ting, Jin Feng, Wang Haibo, Zhang Anqin, Zhang Hongwei, Zeng Xiaohua, Wang Xiaojia, Jiang Ming, Wang Zhonghua, Shao Zhimin
Department of Breast Surgery, Fudan University Shanghai Cancer Center and Key Laboratory of Breast Cancer in Shanghai, Shanghai, People's Republic of China.
Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, People's Republic of China.
Oncologist. 2025 Jun 4;30(6). doi: 10.1093/oncolo/oyaf101.
Pegylated liposomal doxorubicin (PLD) was shown to have comparable efficacy to doxorubicin, with significantly reduced cardiotoxicity. This study evaluated the cardiotoxicity and efficacy of the PLD-based regimen compared with those of the doxorubicin-based regimen as adjuvant therapy for early-stage breast cancer (BC).
In this open-label, randomized controlled trial, patients with early-stage BC were assigned to receive either 4 cycles of PLD (study group) or doxorubicin (control group) plus cyclophosphamide followed by 4 cycles of docetaxel/paclitaxel. The primary endpoint was cardiotoxicity.
Between November 2017 and September 2019, 247 patients (study group, n = 131; control group, n = 116) were enrolled. Incidence rates of abnormal left ventricular ejection fraction (LVEF, 0 vs. 1.7%) and congestive heart failure (0.0% vs. 0.9%) were similar between the two groups (all P > 0.05). A lower proportion of elevated high-sensitivity cardiac troponin T (3.8% vs. 30.2%, P < 0.001) was observed in the study group. The 5-year disease-free survival (82.7% vs. 83.8%) and overall survival (90.4% vs. 91.6%) rates were comparable (all P > 0.05). Grade 3-4 adverse events in the study group were significantly less than in the control group (43.5% vs. 61.2%, P = 0.005).
The PLD-based regimen for early-stage BC showed significantly lower rates of elevated hs-cTnT and grade 3-4 AEs with comparable efficacy to the doxorubicin-based regimen. (ClinicalTrials.gov Identifier: NCT03949634; IRB Approved: Ethics committee institutional review board of Shanghai Cancer Hospital, Fudan University's (No. 1706173-19-1904B) and other center).
聚乙二醇化脂质体阿霉素（PLD）已被证明与阿霉素疗效相当，且心脏毒性显著降低。本研究评估了以PLD为基础的方案与以阿霉素为基础的方案作为早期乳腺癌（BC）辅助治疗的心脏毒性和疗效。
在这项开放标签、随机对照试验中，早期BC患者被分配接受4个周期的PLD（研究组）或阿霉素（对照组）加环磷酰胺，随后接受4个周期的多西他赛/紫杉醇。主要终点是心脏毒性。
2017年11月至2019年9月期间，共纳入247例患者（研究组，n = 131；对照组，n = 116）。两组间左心室射血分数异常（LVEF，0%对1.7%）和充血性心力衰竭（0.0%对0.9%）的发生率相似（所有P>0.05）。研究组中高敏心肌肌钙蛋白T升高的比例较低（3.8%对30.2%，P<0.001）。5年无病生存率（82.7%对83.8%）和总生存率（90.4%对91.6%）相当（所有P>0.05）。研究组3-4级不良事件明显少于对照组（43.5%对61.2%，P = 0.005）。
早期BC以PLD为基础的方案显示hs-cTnT升高率和3-4级AE明显较低，与以阿霉素为基础的方案疗效相当。（ClinicalTrials.gov标识符：NCT03949634；IRB批准：复旦大学附属上海肿瘤医院伦理委员会机构审查委员会（编号1706173-19-1904B）及其他中心）
