Dose-dense paclitaxel plus carboplatin vs. epirubicin and cyclophosphamide with paclitaxel as adjuvant chemotherapy for high-risk triple-negative breast cancer
Dose-dense paclitaxel plus carboplatin vs. epirubicin and cyclophosphamide with paclitaxel as adjuvant chemotherapy for high-risk triple-negative breast cancer
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DOI：
10.21147/j.issn.1000-9604.2020.04.06
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发表时间：
2020-08-01
影响因子：
5.1
通讯作者：
Xu, Binghe
中科院分区：
文献类型：
--
作者：
Li, Qing;Wang, Jiani;Xu, Binghe
目的：这项开放标签、随机研究的目的是比较剂量密集型紫杉醇加卡铂 (PCdd) 与剂量密集型表阿霉素和环磷酰胺联合紫杉醇 (ECdd-P) 作为早期三阴性乳腺癌 (TNBC) 辅助化疗的效果。 方法：我们纳入了接受原发性乳腺癌手术的高复发风险 TNBC 的中国患者。他们被随机分配接受 PCdd [第 1 天紫杉醇 150 mg/m(2) 和卡铂，第 2 天曲线下面积 (AUC)=3] 或 ECdd-P（表阿霉素 80 mg/m(2)，分 2 天，第 1 天环磷酰胺 600 mg/m(2)，共 4 个周期，然后接受紫杉醇 175 mg/m(2)，第 1 天，持续 4 个周期），每 2 周一次，并有粒细胞集落刺激因子 (G-CSF) 支持。主要终点是 3 年无病生存 (DFS)；次要终点是总生存期 (OS) 和安全性。 结果：意向治疗人群包括 143 名患者（PCdd 组 70 名，ECdd-P 组 73 名）。与 ECdd-P 组相比，PCdd 组的 3 年 DFS 显着更高 [93.9% vs. 79.1%；风险比（HR）=0.310； 95%置信区间（95% CI），0.137-0.704；对数秩，P=0.005] 和 OS（98.5% vs. 92.9%；HR=0.142；95% CI，0.060-0.825；对数秩，P=0.028）。 ECdd-P 组的中性粒细胞减少症（3/4 级）比 PCdd 组更严重（47.9% vs. 21.4%，P=0.001）。结论：在改善 3 年 DFS 和 OS 方面，PCdd 作为早期 TNBC 的辅助化疗优于 ECdd-P。 PCdd 还产生较低的血液学毒性。因此，PCdd 可能是复发风险高的早期 TNBC 患者的首选治疗方案。
Objective: The objective of this open-label, randomized study was to compare dose-dense paclitaxel plus carboplatin (PCdd) with dose-dense epirubicin and cyclophosphamide followed by paclitaxel (ECdd-P) as an adjuvant chemotherapy for early triple-negative breast cancer (TNBC).Methods: We included Chinese patients with high recurrence risk TNBC who underwent primary breast cancer surgery. They were randomly assigned to receive PCdd [paclitaxel 150 mg/m(2) on d 1 and carboplatin, the area under the curve, (AUC)=3 on d 2] or ECdd-P (epirubicin 80 mg/m(2) divided in 2 d and cyclophosphamide 600 mg/m(2) on d 1 for 4 cycles followed by paclitaxel 175 mg/m(2) on d 1 for 4 cycles) every 2 weeks with granulocyte colony-stimulating factor (G-CSF) support. The primary endpoint was 3-year disease-free survival (DFS); the secondary endpoints were overall survival (OS) and safety.Results: The intent-to-treat population included 143 patients (70 in the PCdd arm and 73 in the ECdd-P arm). Compared with the ECdd-P arm, the PCdd arm had significantly higher 3-year DFS [93.9% vs. 79.1%; hazard ratio (HR)=0.310; 95% confidence interval (95% CI), 0.137-0.704; log-rank, P=0.005] and OS (98.5% vs. 92.9%; HR=0.142; 95% CI, 0.060-0.825; log-rank, P=0.028). Worse neutropenia (grade 3/4) was found in the ECdd-P than the PCdd arm (47.9% vs. 21.4%, P=0.001).Conclusions: PCdd was superior to ECdd-P as an adjuvant chemotherapy for early TNBC with respect to improving the 3-year DFS and OS. PCdd also yielded lower hematological toxicity. Thus, PCdd might be a preferred regimen for early TNBC patients with a high recurrence risk.