Third Department of Breast Surgery, Tianjin Medical University Cancer Institute and Hospital; National Clinical Research Center for Cancer; Key Laboratory of Cancer Prevention and Therapy; Clinical Research Center for Cancer, Tianjin, 300060, China.
Department of Breast Surgery, Beijing Chaoyang Hospital, Capital Medical University, Beijing, 100020, China.
BMC Cancer. 2021 Dec 6;21(1):1301. doi: 10.1186/s12885-021-09050-6.
Pegylated liposomal doxorubicin (PLD) is an improved formulation of doxorubicin with comparable effectiveness but significantly lower cardiotoxicity than conventional anthracycline. This study aimed to evaluate the real-world effectiveness and safety of PLD versus epirubicin as neoadjuvant or adjuvant treatment for breast cancer.
Clinical data of invasive breast cancer patients who received neoadjuvant or adjuvant chemotherapy with PLD or epirubicin were retrospectively collected. Propensity score matching (PSM) was performed to reduce the risk of selection bias. The molecular typing of these patients included Luminal A, Luminal B, HER2-positive, and basal-like/triple-negative. The primary outcome was pathological complete response (pCR) rate for neoadjuvant chemotherapy and 3-year disease-free survival (DFS) rate for adjuvant chemotherapy. Noninferiority was suggested if the lower limit of the 95% CI for the 3-year DFS rate difference was greater than - 10%. The secondary outcome was adverse reactions.
A total of 1213 patients were included (neoadjuvant, n = 274; adjuvant, n = 939). pCR (ypT0/Tis ypN0) rates of patients who received neoadjuvant chemotherapy were 11.6% for the PLD group and 7.0% for the epirubicin group, but the difference was not statistically significant (P = 0.4578). The 3-year DFS rate of patients who received adjuvant chemotherapy was 94.9% [95%CI, 91.1-98.6%] for the PLD group and 95.4% [95%CI, 93.0-97.9%] for the epirubicin group (P = 0.5684). Rate difference between the two groups and its 95% CI was - 0.55 [- 5.02, 3.92]. The lower limit of the 95% CI was - 5.0% > - 10.0%, suggesting that PLD is not be inferior to epirubicin in adjuvant chemotherapy for breast cancer. The incidences of myelosuppression, decreased appetite, alopecia, gastrointestinal reactions, and cardiotoxicity were lower in the PLD group than in the epirubicin group, while the incidence of nausea was higher in the PLD group.
In the neoadjuvant and adjuvant treatment of breast cancer, effectiveness is similar but toxicities are different between the PLD-containing regimen and epirubicin-containing regimen. Therefore, further study is warranted to explore PLD-based neoadjuvant and adjuvant chemotherapy for breast cancer.
脂质体多柔比星（PLD）是一种改良的多柔比星制剂，其疗效相当，但心脏毒性明显低于传统蒽环类药物。本研究旨在评估 PLD 与表柔比星作为乳腺癌新辅助或辅助治疗的真实世界疗效和安全性。
回顾性收集接受 PLD 或表柔比星新辅助或辅助化疗的浸润性乳腺癌患者的临床资料。采用倾向评分匹配（PSM）降低选择偏倚的风险。这些患者的分子分型包括 Luminal A、Luminal B、HER2 阳性和基底样/三阴性。主要结局为新辅助化疗的病理完全缓解（pCR）率和辅助化疗的 3 年无病生存率（DFS）率。如果 3 年 DFS 率差异的 95%CI 下限大于-10%，则提示非劣效性。次要结局为不良反应。
共纳入 1213 例患者（新辅助组 n=274，辅助组 n=939）。新辅助化疗患者的 pCR（ypT0/Tis ypN0）率分别为 PLD 组 11.6%和表柔比星组 7.0%，但差异无统计学意义（P=0.4578）。辅助化疗患者的 3 年 DFS 率分别为 PLD 组 94.9%[95%CI，91.1-98.6%]和表柔比星组 95.4%[95%CI，93.0-97.9%]（P=0.5684）。两组之间的差异率及其 95%CI 为-0.55[-5.02，3.92]。95%CI 的下限为-5.0%>-10.0%，提示 PLD 在乳腺癌辅助化疗中并不劣于表柔比星。PLD 组的骨髓抑制、食欲下降、脱发、胃肠道反应和心脏毒性发生率低于表柔比星组，而恶心发生率高于表柔比星组。
在乳腺癌的新辅助和辅助治疗中，PLD 方案与表柔比星方案的疗效相似，但毒性不同。因此，有必要进一步研究 PLD 为基础的新辅助和辅助化疗治疗乳腺癌。
