Nature Medicine ( IF 58.7 ) Pub Date : 2025-06-04 , DOI: 10.1038/s41591-025-03734-3
María Gion, Isabel Blancas, Patricia Cortez-Castedo, Alfonso Cortés-Salgado, Frederik Marmé, Salvador Blanch, Serafín Morales, Nieves Díaz, Isabel Calvo-Plaza, Sabela Recalde, Alejandro Martínez-Bueno, Manuel Ruiz-Borrego, Elisenda Llabrés, María Teresa Taberner, Michelino de Laurentiis, Silvia García-Vicente, José Antonio Guerrero, Olga Boix, Jose Rodríguez-Morató, Miguel Sampayo-Cordero, Gabriele Antonarelli, José Manuel Pérez-García, Javier Cortés, Antonio Llombart-Cussac
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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.
中文翻译:

Atezolizumab 联合紫杉醇和贝伐珠单抗作为晚期三阴性乳腺癌的一线治疗:ATRACTIB 2 期试验
三阴性乳腺癌 (TNBC) 是一种预后不良的高侵袭性乳腺癌亚型。目前晚期 TNBC (aTNBC) 的一线治疗由程序性细胞死亡配体 1 (PD-L1) 的表达决定。在 ATRACTIB 试验(一项多中心、单臂、2 期研究)中,我们评估了阿替利珠单抗、紫杉醇和贝伐珠单抗联合治疗作为 aTNBC 患者的一线治疗,与 PD-L1 状态无关。主要终点是研究者评估的无进展生存期。纳入 100 例女性患者,其中大多数可评估的肿瘤为 PD-L1 阴性 (97.6%)。达到主要终点,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性信号。这种组合作为 aTNBC 患者的一线治疗显示出显着的抗肿瘤活性,值得进一步研究。ClinicalTrials.gov 标识符:NCT04408118。