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期刊来源：Nat Med

原文链接：https://doi.org/10.1038/s41591-023-02677-x

摘要内容如下：

免疫检查点阻断联合化疗一线治疗晚期三阴性乳腺癌（TNBC）的结果喜忧参半。TORCHLIGHT是一项随机、双盲的3期临床试验，旨在评估一线托利帕利单抗和白蛋白结合型紫杉醇（NAB-P）的疗效和安全性（n=353；实验组）与安慰剂和NAB-P（n=178；对照组）用于治疗患有转移性或复发性TNBC的妇女。主要终点是PD-L1阳性和意向治疗人群中通过盲法独立中心评价评估的无进展生存期（PFS）。次要终点包括总生存率和安全性。总体而言，Toripalimab组和安慰剂组分别有200名和100名患者患有PD-L1阳性TNBC。在预先指定的中期分析中，在PD-L1阳性人群的实验组中，通过盲法独立中心审查评估的PFS改善具有统计学意义（中位PFS 8.4个月对5.6个月；风险比（HR）=0.65，95%可信区间（CI）0.470-0.906，P=0.0102）。中位总生存期分别为32.8个月和19.5个月（HR=0.62，95%CI 0.414-0.914，P=0.0148）。在实验组和对照组中，治疗中出现的不良事件（AE）（99.2%对98.9%）、≥3级治疗中出现的不良事件（56.4%对54.3%）和致命性不良事件（0.6%对3.4%）的发生率相似。在NAB-P中加入Toripalimab可显著改善患有转移性或复发性TNBC的PD-L1阳性患者的PFS，且安全性可接受。

英文原文如下：

Abstracts

The combination of immune-checkpoint blockade with chemotherapy for the first-line treatment of advanced triple-negative breast cancer (TNBC) has generated mixed results. TORCHLIGHT is a randomized, double-blinded phase 3 trial evaluating the efficacy and safety of first-line toripalimab and nab-paclitaxel (nab-P) (n = 353; experimental arm) versus placebo and nab-P (n = 178; control arm) for the treatment of women with metastatic or recurrent TNBC. The primary end point was progression-free survival (PFS) assessed by a blinded independent central review in the PD-L1-positive and intention-to-treat populations. The secondary end points included overall survival and safety. Overall, 200 and 100 patients, in the toripalimab and placebo arm respectively had PD-L1-positive TNBC. At the prespecified interim analysis, a statistically significant improvement in PFS assessed by a blinded independent central review was demonstrated in the experimental arm in the PD-L1-positive population (median PFS 8.4 versus 5.6 months; hazard ratio (HR) = 0.65, 95% confidence interval (CI) 0.470-0.906, P = 0.0102). The median overall survival was 32.8 versus 19.5 months (HR = 0.62, 95% CI 0.414-0.914, P = 0.0148). Similar incidences of treatment-emergent adverse events (AEs) (99.2% versus 98.9%), grade ≥3 treatment-emergent AEs (56.4% versus 54.3%) and fatal AEs (0.6% versus 3.4%) occurred in the experimental and control arms. The addition of toripalimab to nab-P provided a significant improvement in PFS for PD-L1-positive patients with metastatic or recurrent TNBC with an acceptable safety profile.

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