曲妥珠单抗德鲁司替康治疗her2低转移性乳腺癌:随机3期DESTINY-Breast04试验的长期生存分析

IF 50 1区 医学 Q1 BIOCHEMISTRY & MOLECULAR BIOLOGY
Shanu Modi, William Jacot, Hiroji Iwata, Yeon Hee Park, Maria Vidal Losada, Wei Li, Junji Tsurutani, Naoto T Ueno, Khalil Zaman, Aleix Prat, Konstantinos Papazisis, Hope S Rugo, Toshinari Yamashita, Nadia Harbeck, Seock-Ah Im, Michelino De Laurentiis, Jean-Yves Pierga, Xiaojia Wang, Andrea Gombos, Eriko Tokunaga, Cecilia Orbegoso Aguilar, Lotus Yung, Feng Xiao, Yingkai Cheng, David Cameron
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引用次数: 0

摘要

在DESTINY-Breast04 (NCT03734029)中,与医生选择的化疗(TPC)治疗相比,曲妥珠单抗德鲁西替康(T-DXd)显著提高了人表皮生长因子受体2-低(her2 -低)(免疫组织化学(IHC) 1+或IHC 2+/原位杂交阴性)转移性乳腺癌患者的总生存期(OS)和无进展生存期。中位随访32.0个月后,T-DXd患者的中位OS为22.9个月,TPC患者的中位OS为16.8个月(风险比0.69;95%可信区间0.55-0.86)。对于激素受体阳性队列,T-DXd和TPC的中位生存期分别为23.9和17.6个月(风险比0.69;95%可信区间0.55-0.87)。在激素受体阴性、雌激素受体IHC 1%-10%和雌激素受体IHC 10%的探索性分析中,中位OS也倾向于T-DXd。T-DXd的总体安全性是可以接受的,并且通常是可控的。结果证实T-DXd是her2低转移性乳腺癌患者化疗后的标准治疗。ClinicalTrials.gov识别码:NCT03734029。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Trastuzumab deruxtecan in HER2-low metastatic breast cancer: long-term survival analysis of the randomized, phase 3 DESTINY-Breast04 trial.

In DESTINY-Breast04 ( NCT03734029 ), trastuzumab deruxtecan (T-DXd) significantly improved overall survival (OS) and progression-free survival compared with treatment of physician's choice of chemotherapy (TPC) for patients with human epidermal growth factor receptor 2-low (HER2-low) (immunohistochemistry (IHC) 1+ or IHC 2+/in situ hybridization-negative) metastatic breast cancer. After an extended median follow-up of 32.0 months, median OS in the overall cohort was 22.9 months for T-DXd and 16.8 months for TPC (hazard ratio 0.69; 95% confidence interval 0.55-0.86). For the hormone receptor-positive cohort, median OS was 23.9 and 17.6 months for T-DXd and TPC, respectively (hazard ratio 0.69; 95% confidence interval 0.55-0.87). Median OS also favored T-DXd in exploratory analyses of hormone receptor-negative, estrogen receptor IHC 1%-10% and estrogen receptor IHC >10% cohorts. The overall safety profile of T-DXd was acceptable and generally manageable. Results confirm T-DXd as standard of care after prior chemotherapy in patients with HER2-low metastatic breast cancer. ClinicalTrials.gov identifier: NCT03734029 .

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来源期刊
Nature Medicine
Nature Medicine 医学-生化与分子生物学
CiteScore
100.90
自引率
0.70%
发文量
525
审稿时长
1 months
期刊介绍: Nature Medicine is a monthly journal publishing original peer-reviewed research in all areas of medicine. The publication focuses on originality, timeliness, interdisciplinary interest, and the impact on improving human health. In addition to research articles, Nature Medicine also publishes commissioned content such as News, Reviews, and Perspectives. This content aims to provide context for the latest advances in translational and clinical research, reaching a wide audience of M.D. and Ph.D. readers. All editorial decisions for the journal are made by a team of full-time professional editors. Nature Medicine consider all types of clinical research, including: -Case-reports and small case series -Clinical trials, whether phase 1, 2, 3 or 4 -Observational studies -Meta-analyses -Biomarker studies -Public and global health studies Nature Medicine is also committed to facilitating communication between translational and clinical researchers. As such, we consider “hybrid” studies with preclinical and translational findings reported alongside data from clinical studies.
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