Adjuvant Epirubicin Plus Cyclophosphamide Followed by Taxanes With or Without Carboplatin in Early-Stage Triple-Negative Breast Cancer (RJBC 1501): A Randomized Phase III Trial.

patients_and_methods

In this phase III trial, patients with TNBC with node-positive or node-negative (tumor size ≥1.0 cm) disease who received definitive surgery, were stratified by lymph node status and randomly assigned in a 1:1 ratio to receive four cycles of EC followed by four cycles T with or without carboplatin adjuvant chemotherapy.

在这项III期临床试验中，接受确定性手术的TNBC患者，根据淋巴结状态进行分层，并按1:1的比例随机分配接受四周期EC后序贯四周期T的辅助化疗，有或无卡铂。

The primary end point was disease-free survival (DFS).

主要终点是无病生存期（DFS）。

Secondary end points included distant DFS (DDFS), overall survival(OS), and safety.

次要终点包括远处无病生存期（DDFS）、总生存（OS）和安全性。

This study had 80% power to detect a DFS hazard ratio(HR) of 0.64, with a two-sided type I error of 0.05.

本研究具有80%的把握度检测无病生存期（DFS）风险比（HR）为0.64，双侧第一类错误为0.05。

Results

A total of 786 patients were randomly assigned to receive EC-T (n = 391) or EC-TCb (n = 395) between March 2016 and March 2023.

共有786名患者在2016年3月至2023年3月期间被随机分配接受EC-T（n = 391）或EC-TCb（n = 395）。

With a median follow-up of 4.52 (IQR, 2.83-6.06) years, 62 and 41 events were reported in the EC-T and EC-TCb arm, respectively.

中位随访时间为4.52年（四分位数间距，2.83-6.06年），EC-T和EC-TCb组分别报告了62和41起事件。

Adding carboplatin significantly improved DFS (HR, 0.66; [95% CI, 0.44 to 0.97]; P = .034), DDFS (HR, 0.61 [95% CI, 0.38 to 0.98]; P = .040), and OS (HR, 0.39 [95% CI, 0.16 to 0.94]; P = .029).

添加卡铂显著改善了无病生存期（DFS）（风险比，0.66；[95%置信区间，0.44至0.97]；P = .034）、无远处转移生存期（DDFS）（风险比，0.61 [95%置信区间，0.38至0.98]；P = .040）和总生存期（OS）（风险比，0.39 [95%置信区间，0.16至0.94]；P = .029）。

Grade 3 to 4 adverse events were more frequent among the EC-TCb arm (49.9%) than the EC-T arm (38.7%), primarily driven by higher incidenceof neutropenia (47.0% v 37.8%) and thrombocytopenia (4.5% v 0%).

3级至4级不良事件在EC-TCb组（49.9%）中比EC-T组（38.7%）更为常见，主要由于中性粒细胞减少症（47.0%对比37.8%）和血小板减少症（4.5%对比0%）的发生率更高。

Other grade 3 to 4 toxicities were comparable.

其他3级至4级毒性在两组间是可比的。

Conclusions

Adding carboplatin to adjuvant EC-T chemotherapy significantly improves DFS, DDFS, and OS in patients with early-stage TNBC.

在早期三阴性乳腺癌患者中，将卡铂加入到辅助EC-T化疗中显著提高了无病生存期（DFS）、无远处转移生存期（DDFS）和总生存期（OS）。

Although increased hematologic toxicity was observed, no new safety signals emerged.

尽管观察到血液学毒性增加，但未出现新的安全信号。