Yang Fu Ou, Hsu Nicholas C, Moi Sin-Hua, Lu Yin-Che, Hsieh Chia-Ming, Chang King-Jen, Chen Dar-Ren, Tu Chi-Wen, Wang Hwei-Chung, Hou Ming-Feng
Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan.
Graduate Institute of Clinical Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan.
Asia Pac J Clin Oncol. 2018 Jun;14(3):198-203. doi: 10.1111/ajco.12771. Epub 2017 Oct 18.
PEGylated liposomal doxorubicin (PLD) has comparable efficacy and differing toxicity from conventional anthracyclines used to treat advanced breast cancer. This study compared disease-free survival and toxicity between PLD-based and conventional anthracycline-based regimens as adjuvant treatments for early-stage breast cancer.
We analyzed disease-free survival (DFS) rates, and adverse events in 102 women with early-stage (I-IIIa) breast cancer who received adjuvant PLD-based chemotherapy from 2002 to 2008. Each patient was matched for age, stage at diagnosis, HER-2 expression and hormone therapy use to a patient treated with an epirubicin-based regimen. Fisher's exact and Pearson's chi-square tests were used for categorical data analysis. Kaplan-Meier analysis and Cox regression models were used to analyze DFS.
DFS at 5 years was 81.3% for PLD-based regimen and 82.3% for epirubicin-based regimen. This difference was not significant (p = 0.939). Stage IIIa disease was associated with a shorter DFS in univariate analysis (p = 0.048). In multivariate analysis that controlled for adjuvant treatment, age at diagnosis, stage, HER-2 expression, type of surgery and hormone and radiation therapy, stage IIIa disease (P = 0.023) and lack of hormone therapy (P = 0.024) were each independently associated with shorter DFS. Adverse events were evaluated, and with the exception of hand-foot syndrome, more grade 3 and 4 toxicities occurred in patients who received epirubicin-based regimens than in those given PLD-based regimens.
For patients with early-stage breast cancer who received PLD-based adjuvant chemotherapy, 5-year DFS was comparable and toxicity was acceptable, yet different from those of patients who received epirubicin-based regimens.
聚乙二醇化脂质体阿霉素（PLD）与用于治疗晚期乳腺癌的传统蒽环类药物疗效相当，但毒性不同。本研究比较基于PLD的方案和基于传统蒽环类药物的方案作为早期乳腺癌辅助治疗的无病生存期和毒性。
我们分析了2002年至2008年接受基于PLD的辅助化疗的102例早期（I-IIIa期）乳腺癌女性的无病生存期（DFS）率和不良事件。将每位患者的年龄、诊断时的分期、HER-2表达和激素治疗使用情况与接受基于表柔比星方案治疗的患者进行匹配。采用Fisher精确检验和Pearson卡方检验进行分类数据分析。采用Kaplan-Meier分析和Cox回归模型分析DFS。
基于PLD的方案5年DFS为81.3%，基于表柔比星的方案为82.3%。这种差异不显著（p = 0.939）。在单因素分析中，IIIa期疾病与较短的DFS相关（p = 0.048）。在控制辅助治疗、诊断时年龄、分期、HER-2表达、手术类型以及激素和放射治疗的多因素分析中，IIIa期疾病（P = 0.023）和未进行激素治疗（P = 0.024）均与较短的DFS独立相关。对不良事件进行了评估，除手足综合征外，接受基于表柔比星方案的患者出现3级和4级毒性的情况比接受基于PLD方案的患者更多。
对于接受基于PLD的辅助化疗的早期乳腺癌患者，5年DFS相当且毒性可接受，但与接受基于表柔比星方案的患者不同。
