Application of Neoadjuvant Docetaxel plus Cisplatin in Early-Stage Triple-Negative Breast Cancer (HELEN-001): Results from a Phase II Trial.

IF 10 1区医学 Q1 ONCOLOGY

Clinical Cancer Research Pub Date : 2025-07-01 DOI:10.1158/1078-0432.CCR-25-0289

Dechuang Jiao, Jianghua Qiao, Xianfu Sun, Chengzheng Wang, Zhenduo Lu, Chongjian Zhang, Lianfang Li, Min Yan, Yueqing Feng, Yong Zhou, Miao Deng, Xinlan Liu, Mingde Ma, Haiquan Jia, Qingxin Xia, Geok Hoon Lim, Naohiro Ishii, Armando Orlandi, Fernando Hernanz, Xiuchun Chen, Zhenzhen Liu

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引用次数: 0

Abstract

Purpose: This study investigated the effects of taxane-cisplatin combinations on pathologic complete response (pCR) rates and survival outcomes in triple-negative breast cancer (TNBC).

Patients and methods: The HELEN-001 trial enrolled patients ages 18 to 70 years with stage II-III TNBC, randomly assigning them to receive either docetaxel (75 mg/m2) plus cisplatin (75 mg/m2; TP) or docetaxel (75 mg/m2), doxorubicin (50 mg/m2), and cyclophosphamide (500 mg/m2; TAC). Treatments were administered every 3 weeks for six cycles, with the primary endpoint being pCR (ypT0/isN0) and secondary endpoints being event-free survival (EFS), overall response rate, breast-conserving surgery rate, and toxicity.

Results: From November 2018 to June 2022, 212 Asian female patients were enrolled across six hospitals in China, with 106 patients in each group. The pCR rate was significantly higher for TP (51.9%) than for TAC (35.8%; P = 0.028). After a median follow-up of 40 months, EFS was 86.1% in the TP group and 80.0% in the TAC group (HR, 0.639; P = 0.196). In germline BRCA1/2 mutation carriers, EFS was significantly higher with TP than with TAC (100% vs. 53.8%; P = 0.008). Grade 3 or higher adverse events occurred in 54% of patients in the TP group and 48% in the TAC group.

Conclusions: The TP regimen demonstrated significantly improved pCR rates with a manageable toxicity profile, suggesting the potential benefit of taxane plus platinum regimens in patients with TNBC.

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新辅助多西他赛加顺铂在早期三阴性乳腺癌中的应用（HELEN-001）：一项II期试验的结果

目的：本研究探讨紫杉烷-顺铂联合治疗对三阴性乳腺癌（TNBC）病理完全缓解（pCR）率和生存结局的影响。方法：HELEN-001试验纳入了18-70岁的II-III期TNBC患者，随机分配他们接受多西他赛（75 mg/m²）+顺铂（75 mg/m²）（TP）或多西他赛（75 mg/m²）+阿霉素（50 mg/m²）+环磷酰胺（500 mg/m²）（TAC）治疗。治疗每3周进行一次，共6个周期，主要终点是pCR (ypT0/isN0)，次要终点包括无事件生存期（EFS）、总缓解率（ORR）、保乳手术率和毒性。结果：2018年11月至2022年6月，在中国6家医院招募了212名亚洲女性患者，每组106名患者。TP的pCR率（51.9%）显著高于TAC （35.8%， P=0.028）。中位随访40个月后，TP组EFS为86.1%，TAC组为80.0% (HR= 0.639；P = 0.196)。在种系BRCA1/2突变携带者中，TP组EFS显著高于TAC组（100% vs. 53.8%， P=0.008）。TP组和TAC组分别有54%和48%的患者发生了3级或以上的不良事件。结论：TP方案可显著提高pCR率，且毒性可控，提示紫杉烷加铂方案对TNBC患者有潜在益处。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Clinical Cancer Research 医学-肿瘤学

CiteScore

20.10

自引率

1.70%

发文量

1207

审稿时长

2.1 months

期刊介绍： Clinical Cancer Research is a journal focusing on groundbreaking research in cancer, specifically in the areas where the laboratory and the clinic intersect. Our primary interest lies in clinical trials that investigate novel treatments, accompanied by research on pharmacology, molecular alterations, and biomarkers that can predict response or resistance to these treatments. Furthermore, we prioritize laboratory and animal studies that explore new drugs and targeted agents with the potential to advance to clinical trials. We also encourage research on targetable mechanisms of cancer development, progression, and metastasis.