SCI
2 October 2024
Datopotamab Deruxtecan Versus Docetaxel for Previously Treated Advanced or Metastatic Non–Small Cell Lung Cancer: The Randomized, Open-Label Phase III TROPION-Lung01 Study
(JCO, IF: 42.1)
Ahn M-J, Tanaka K, Paz-Ares L, et al: Datopotamab Deruxtecan Versus Docetaxel for Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer: The Randomized, Open-Label Phase III TROPION-Lung01 Study. J Clin Oncol JCO2401544, 2024
The randomized, open-label, global phase III TROPION-Lung01 study compared the efficacy and safety of datopotamab deruxtecan (Dato-DXd) versus docetaxel in patients with pretreated advanced/metastatic non-small cell lung cancer (NSCLC).
这项随机、开放标签、全球 III 期 TROPION-Lung01研究比较了Datopotamab Deruxtecan (Dato-DXd) vs Docetaxel（多西紫杉醇）用于既往治疗的晚期/转移性非小细胞肺癌(NSCLC)患者的疗效和安全性。
Patients received Dato-DXd 6 mg/kg or docetaxel 75 mg/m2 once every 3 weeks. Dual primary end points were progression-free survival (PFS) and overall survival (OS). Objective response rate, duration of response, and safety were secondary end points.
患者每3周给Dato-DXd 6mg/kg 或多西紫杉醇75mg/m2。双重主要终点是无进展生存期(PFS)和总生存期(OS)。客观反应率、反应持续时间和安全性是次要终点。
In total, 299 and 305 patients were randomly assigned to receive Dato-DXd or docetaxel, respectively. The median PFS was 4.4 months (95% CI, 4.2 to 5.6) with Dato-DXd and 3.7 months (95% CI, 2.9 to 4.2) with docetaxel (hazard ratio [HR], 0.75 [95% CI, 0.62 to 0.91]; P = .004). The median OS was 12.9 months (95% CI, 11.0 to 13.9) and 11.8 months (95% CI, 10.1 to 12.8), respectively (HR, 0.94 [95% CI, 0.78 to 1.14]; P = .530). In the prespecified nonsquamous histology subgroup, the median PFS was 5.5 versus 3.6 months (HR, 0.63 [95% CI, 0.51 to 0.79]) and the median OS was 14.6 versus 12.3 months (HR, 0.84 [95% CI, 0.68 to 1.05]). In the squamous histology subgroup, the median PFS was 2.8 versus 3.9 months (HR, 1.41 [95% CI, 0.95 to 2.08]) and the median OS was 7.6 versus 9.4 months (HR, 1.32 [95% CI, 0.91 to 1.92]). Grade ≥3 treatment-related adverse events occurred in 25.6% and 42.1% of patients, and any-grade adjudicated drug-related interstitial lung disease/pneumonitis occurred in 8.8% and 4.1% of patients, in the Dato-DXd and docetaxel groups, respectively.
共有299名患者和305名患者分别被随机分配接受Dato-DXd 或多西紫杉醇。Dato-DXd 的中位 PFS 为4.4个月(95% CI，4.2-5.6) ，多西紫杉醇为3.7个月(95% CI，2.9-4.2)(风险比[ HR ] ，0.75[95% CI，0.62-0.91] ; P = .004)。中位 OS 分别为12.9个月(95% CI，11.0至13.9)和11.8个月(95% CI，10.1至12.8)(HR，0.94[95% CI，0.78至1.14] ; P = .530)。在预先指定的非鳞状组织学亚组中，中位 PFS 分别为5.5和3.6个月(HR，0.63[95% CI，0.51至0.79]) ，中位 OS 分别为14.6和12.3个月(HR，0.84[95% CI，0.68至1.05])。在鳞状组织学亚组中，中位 PFS 为2.8比3.9个月(HR，1.41[95% CI，0.95-2.08]) ，中位 OS 为7.6比9.4个月(HR，1.32[95% CI，0.91-1.92])。Dato-DXd 组和多西紫杉醇组分别有25.6% 和42.1% 的患者发生≥3级治疗相关不良事件，8.8% 和4.1% 的患者发生任何级别的判定药物相关性间质性肺病/肺炎。
Dato-DXd significantly improved PFS versus docetaxel in patients with advanced/metastatic NSCLC, driven by patients with nonsquamous histology. OS showed a numerical benefit but did not reach statistical significance. No unexpected safety signals were observed.
Dato-DXd相比多西紫杉醇，能显著改善晚期/转移性NSCLC患者的 PFS，其驱动因素为非鳞状细胞组织学。OS 显示了数值上的好处，但没有达到统计学意义。没有观察到意外的安全信号。
喜欢SCI天天读的理由
陪您一起学习SCI医学论文
每天5分钟，让自己的英语牛逼起来
特殊福利让您惊喜连连
W233N01
链接：https://pan.baidu.com/s/1HUkyGKq72D2OonGiELMNuQ?pwd=bnu5
提取码：bnu5
