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
University Hospital Ramón y Cajal, Madrid, Spain.
IOB Madrid, Institute of Oncology, Hospital Beata Maria Ana, Madrid, Spain.
Nat Med. 2025 Jun 4. doi: 10.1038/s41591-025-03734-3.
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 .
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 。
