Dowling Gavin P, Daly Gordon R, Keelan Stephen, Boland Fiona, Toomey Sinead, Hill Arnold D K, Hennessy Bryan T
Department of Molecular Medicine, Medical Oncology Lab, Royal College of Surgeons in Ireland (RCSI) University of Medicine and Health Sciences, Dublin, Ireland; Department of Surgery, RCSI University of Medicine and Health Sciences, Dublin, Ireland; Department of Surgery, Bons Secours Hospital, Dublin, Ireland.
Department of Surgery, RCSI University of Medicine and Health Sciences, Dublin, Ireland.
Clin Breast Cancer. 2023 Dec;23(8):847-855.e2. doi: 10.1016/j.clbc.2023.09.005. Epub 2023 Sep 11.
Trastuzumab deruxtecan (T-DXd) is a novel antibody-drug-conjugate (ADC), primarily used in the treatment of HER2-positive breast cancer. This study aimed to conduct a systematic review to evaluate the efficacy and safety of T-DXd in treating breast cancer, based on clinical trials. A systematic search of the literature was conducted to identify clinical trials investigating the efficacy and safety of T-DXd in breast cancer. Clinical trials of any phase were included. Outcome measures were any adverse events and survival. Meta-analysis was conducted where possible. Pooled prevalence for each adverse event of any grade and grade 3 or greater were estimated. Progression-free survival (PFS), overall survival (OS) and objective response rates (ORRs) were also reported to evaluate the efficacy of T-DXd in breast cancer. A total of 1593 patients from 6 clinical trials were included. Common adverse events of any grade were nausea, anemia, neutropenia, vomiting, fatigue, constipation and diarrhea, occurring in greater than 30% of cases. In terms of adverse events of grade 3 or more, only anemia and neutropenia occurred at a relatively high rate. Median PFS ranged from 11.1 to 22.1 months. There was evidence of a benefit of T-DXd compared to controls in terms of both PFS (OR: 0.38; 95% CI: 0.32, 0.45) and OS (OR: 0.61; 95% CI: 0.48, 0.78). ORRs ranged from 37% to 79.9%. The present systematic review shows evidence that T-DXd is a safe and effective agent in the treatment of breast cancer based on currently available data. The most common adverse events affected the blood, lymphatic and gastrointestinal systems. Interstitial lung disease (ILD) is a notable and potentially serious adverse event.
曲妥珠单抗德瓦鲁单抗（T-DXd）是一种新型抗体药物偶联物（ADC），主要用于治疗HER2阳性乳腺癌。本研究旨在基于临床试验进行系统评价，以评估T-DXd治疗乳腺癌的疗效和安全性。对文献进行系统检索，以确定研究T-DXd治疗乳腺癌疗效和安全性的临床试验。纳入任何阶段的临床试验。观察指标为任何不良事件和生存率。尽可能进行荟萃分析。估计了每个不良事件的任何级别以及3级或更高级别不良事件的合并患病率。还报告了无进展生存期（PFS）、总生存期（OS）和客观缓解率（ORR），以评估T-DXd治疗乳腺癌的疗效。共纳入6项临床试验的1593例患者。任何级别的常见不良事件包括恶心、贫血、中性粒细胞减少、呕吐、疲劳、便秘和腹泻，发生率超过30%。在3级或更高级别的不良事件方面，只有贫血和中性粒细胞减少的发生率相对较高。中位PFS为11.1至22.1个月。有证据表明，与对照组相比，T-DXd在PFS（OR：0.38；95%CI：0.32，0.45）和OS（OR：0.61；95%CI：0.48，0.78）方面均有获益。ORR为37%至79.9%。目前的系统评价表明，根据现有数据，T-DXd是治疗乳腺癌的一种安全有效的药物。最常见的不良事件影响血液、淋巴和胃肠道系统。间质性肺疾病（ILD）是一种值得注意的潜在严重不良事件。
