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期刊来源：Nat Med

原文链接：https://doi.org/10.1038/s41591-024-03021-7

摘要内容如下：

与曲妥珠单抗emtansine（T-DM1）相比，曲妥珠单抗deruxtecan（T-DXD）在Destiny-Breast03（中位随访时间为28个月）中的疗效显著提高。我们报告了最新的疗效和安全性分析，包括Destiny-Breast03的次要和探索性疗效终点（中位随访时间为41个月）。既往接受紫杉烷和曲妥珠单抗治疗的晚期HER2阳性转移性乳腺癌患者随机接受T-DXD（5.4mg/kg（261例患者））或T-DM1（3.6mg/kg（263例患者））治疗。主要终点是通过盲法独立中心审查的无进展生存期（PFS），先前已有报道。关键的次要终点是总生存期（OS）。其他次要终点包括客观缓解率、缓解持续时间和PFS（均由研究者评估）以及安全性。在数据截止日2023年11月20日，研究者评估的中位PFS分别为29.0和7.2个月（风险比（HR）为0.30；95%可信区间（CI），0.24-0.38），36个月无进展生存率分别为45.7%和12.4%，中位OS分别为52.6和42.7个月（HR，0.73；95%CI，0.56-0.94），分别为T-DXD和T-DM1。治疗中出现的不良事件与之前的分析一致。未发生新的≥3级间质性肺病或肺炎（所有级别的发生率分别为16.7%（T-DXD）和3.4%（T-DM1））。随着随访时间的延长，T-DXD继续表现出优于T-DM1的疗效，且安全性可控。ClinicalTrials.gov注册：NCT03529110。

英文原文如下：

Abstracts

Trastuzumab deruxtecan (T-DXd) demonstrated significantly improved efficacy over trastuzumab emtansine (T-DM1) in DESTINY-Breast03 (median follow-up, 28 months). We report updated efficacy and safety analyses, including secondary and exploratory efficacy endpoints (median follow-up, 41 months) of DESTINY-Breast03. Patients with advanced HER2-positive metastatic breast cancer previously treated with taxane and trastuzumab were randomized to T-DXd (5.4 mg per kg (261 patients)) or T-DM1 (3.6 mg per kg (263 patients)). The primary endpoint was progression-free survival (PFS) by blinded independent central review and was previously reported. The key secondary endpoint was overall survival (OS). Other secondary endpoints included objective response rate, duration of response and PFS (all by investigator assessment) and safety. At data cutoff, 20 November 2023, median PFS by investigator assessment was 29.0 versus 7.2 months (hazard ratio (HR), 0.30; 95% confidence interval (CI), 0.24-0.38), the 36-month PFS rate was 45.7% versus 12.4% and median OS was 52.6 versus 42.7 months (HR, 0.73; 95% CI, 0.56-0.94) with T-DXd versus T-DM1, respectively. Treatment-emergent adverse events were consistent with the previous analyses. No new instances of grade ≥3 interstitial lung disease or pneumonitis occurred (all grade rate, 16.7% (T-DXd) versus 3.4% (T-DM1)). With longer follow-up, T-DXd continued to demonstrate superior efficacy over T-DM1 with a manageable safety profile. ClinicalTrials.gov registration: NCT03529110 .

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