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阿替利珠单抗联合紫杉醇和贝伐单抗作为晚期三阴性乳腺癌的一线治疗:ATRACTIB 2期试验

Atezolizumab plus paclitaxel and bevacizumab as first-line treatment of advanced triple-negative breast cancer: the ATRACTIB phase 2 trial.

作者信息

Gion María, Blancas Isabel, Cortez-Castedo Patricia, Cortés-Salgado Alfonso, Marmé Frederik, Blanch Salvador, Morales Serafín, Díaz Nieves, Calvo-Plaza Isabel, Recalde Sabela, Martínez-Bueno Alejandro, Ruiz-Borrego Manuel, Llabrés Elisenda, Taberner María Teresa, de Laurentiis Michelino, García-Vicente Silvia, Guerrero José Antonio, Boix Olga, Rodríguez-Morató Jose, Sampayo-Cordero Miguel, Antonarelli Gabriele, Pérez-García José Manuel, Cortés Javier, Llombart-Cussac Antonio

机构信息

University Hospital Ramón y Cajal, Madrid, Spain.

IOB Madrid, Institute of Oncology, Hospital Beata Maria Ana, Madrid, Spain.

出版信息

Nat Med. 2025 Jun 4. doi: 10.1038/s41591-025-03734-3.

Abstract

Triple-negative breast cancer (TNBC) is a highly aggressive subtype of breast cancer with poor prognosis. The current first-line treatment for advanced TNBC (aTNBC) is determined by the expression of programmed cell death-ligand 1 (PD-L1). In the ATRACTIB trial-a multicenter, single-arm, phase 2 study-we evaluated the combination of atezolizumab, paclitaxel and bevacizumab as first-line treatment for patients with aTNBC, independently of PD-L1 status. The primary endpoint was investigator-assessed progression-free survival. One hundred female patients were enrolled, with most evaluable tumors being PD-L1-negative (97.6%). The primary endpoint was met, with a median progression-free survival of 11.0 months (95% confidence interval (CI): 9.0-13.4; P < 0.001). The objective response rate was 63.0% (95% CI: 52.8-72.4) and median overall survival was 27.4 months (95% CI: 23.4-37.4). No treatment-related deaths or new safety signals were observed. This combination demonstrated significant antitumor activity as first-line therapy for aTNBC patients and merits further investigation. ClinicalTrials.gov Identifier: NCT04408118 .

摘要

三阴性乳腺癌(TNBC)是一种侵袭性很强的乳腺癌亚型,预后较差。晚期三阴性乳腺癌(aTNBC)目前的一线治疗方案取决于程序性细胞死亡配体1(PD-L1)的表达情况。在一项多中心、单臂、2期研究——ATRACTIB试验中,我们评估了阿替利珠单抗、紫杉醇和贝伐单抗联合用药作为aTNBC患者一线治疗方案的疗效,该方案不受PD-L1状态的影响。主要终点是研究者评估的无进展生存期。共纳入了100名女性患者,大多数可评估肿瘤为PD-L1阴性(97.6%)。达到了主要终点,中位无进展生存期为11.0个月(95%置信区间(CI):9.0 - 13.4;P < 0.001)。客观缓解率为63.0%(95% CI:52.8 - 72.4),中位总生存期为27.4个月(95% CI:23.4 - 37.4)。未观察到与治疗相关的死亡或新的安全信号。这种联合用药方案作为aTNBC患者的一线治疗方案显示出显著的抗肿瘤活性,值得进一步研究。ClinicalTrials.gov标识符:NCT04408118 。

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