Pegylated liposomal doxorubicin + cyclophosphamide followed by taxane as adjuvant therapy for early-stage breast cancer: a randomized controlled trial
Lichen Tang, Min He, Cuizhi Geng, Zhimin Fan, Rui Ling, Guangdong Qiao, Li Cai, Ting Luo, Feng Jin, Haibo Wang, Anqin Zhang, Hongwei Zhang, Xiaohua Zeng, Xiaojia Wang, Ming Jiang, Zhonghua Wang, Zhimin Shao
Abstract
BACKGROUND: 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). METHODS: 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. RESULTS: 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). CONCLUSION: 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).