Cai Ze-Lin, Yang Hui-Ting, Huang Ting, Yu Zhuo-Ran, Ren Ning, Su Jing-Yang, Lin Xian-Lei, Zhou He-Ran
Hangzhou TCM Hospital of Zhejiang Chinese Medical University (Hangzhou Hospital of Traditional Chinese Medicine) Hangzhou 310007, Zhejiang, China.
Department of Oncology, Hangzhou TCM Hospital Affiliated to Zhejiang Chinese Medical University Hangzhou 310007, Zhejiang, China.
Am J Cancer Res. 2023 Aug 15;13(8):3266-3274. eCollection 2023.
Trastuzumab deruxtecan (T-DXd, DS-8201) is a targeted antibody-drug conjugate that specifically targets human epidermal growth factor receptor 2 (HER2). In 2019, it was approved by the US Food and Drug Administration for the treatment of HER2-positive breast cancer. However, ongoing research is exploring its potential efficacy in other solid tumors, such as non-small-cell lung cancer and colorectal cancer, as well as in tumors with low HER2 levels. It is important to examine the safety and effectiveness of trastuzumab deruxtecan in these various types of solid tumors, as some studies have raised concerns about potential serious adverse events associated with its use. In this meta-analysis, we conducted a comprehensive search of PubMed, EMBASE, Cochrane Library, and Web of Science to identify randomized controlled trials (RCTs) that evaluated the efficacy and safety of trastuzumab deruxtecan in solid tumors. We used RevMan 5.4 software to perform a meta-analysis, calculating odds ratios (OR), risk ratios (RR), and weighted mean differences (WMD) with 95% confidence intervals (CIs). After an exhaustive search, we identified three articles that met our inclusion criteria, which included a total of 1268 patients. The results of the meta-analysis showed that the treatment group had significantly higher overall survival (WMD=5.12, 95% CI (2.79, 7.44), P<0.0001), progression-free survival (WMD=3.45, 95% CI (0.8, 6.1), P=0.01), overall response rate (OR=6.49, 95% CI (4.90, 8.58), P<0.00001), and disease control rate (OR=4.68, 95% CI (2.78, 7.89), P<0.00001), TRAEs (RR=6.93, 95% CI (2.06, 23.25), P=0.002). However, there was no significant difference in TRAEs≥3 (RR=1.08, 95% CI (0.75, 1.56), P=0.68) between the trials. Based on the available evidence, trastuzumab deruxtecan appears to be an effective and safe treatment option for HER2-positive solid tumors. Although the number of studies included in this analysis is limited, ongoing trials are being conducted, further evaluating its potential in various solid tumors. The results of these trials will enhance our understanding of trastuzumab deruxtecan and potentially expand its applications, bringing hope to more patients with solid tumors.
曲妥珠单抗德曲妥珠单抗（T-DXd，DS-8201）是一种靶向抗体药物偶联物，可特异性靶向人表皮生长因子受体2（HER2）。2019年，它被美国食品药品监督管理局批准用于治疗HER2阳性乳腺癌。然而，正在进行的研究正在探索其在其他实体瘤中的潜在疗效，如非小细胞肺癌和结直肠癌，以及HER2水平较低的肿瘤。研究曲妥珠单抗德曲妥珠单抗在这些不同类型实体瘤中的安全性和有效性很重要，因为一些研究对其使用可能相关的潜在严重不良事件提出了担忧。在这项荟萃分析中，我们对PubMed、EMBASE、Cochrane图书馆和科学网进行了全面检索，以确定评估曲妥珠单抗德曲妥珠单抗在实体瘤中疗效和安全性的随机对照试验（RCT）。我们使用RevMan 5.4软件进行荟萃分析，计算比值比（OR）、风险比（RR）和加权平均差（WMD）以及95%置信区间（CI）。经过详尽检索，我们确定了3篇符合纳入标准的文章，共纳入1268例患者。荟萃分析结果显示，治疗组的总生存期显著更长（WMD=5.12，95%CI（2.79，7.44），P<0.0001）、无进展生存期（WMD=3.45，95%CI（0.8，6.1），P=0.01）、总缓解率（OR=6.49，95%CI（4.90，8.58），P<0.00001）和疾病控制率（OR=4.68，95%CI（2.78，7.89），P<0.00001），治疗相关不良事件（TRAE）（RR=6.93，95%CI（2.06，23.25），P=0.002）。然而，各试验之间≥3级TRAE无显著差异（RR=1.08，95%CI（0.75，1.56），P=0.68）。基于现有证据，曲妥珠单抗德曲妥珠单抗似乎是HER2阳性实体瘤的一种有效且安全的治疗选择。尽管本分析纳入的研究数量有限，但正在进行更多试验，进一步评估其在各种实体瘤中的潜力。这些试验的结果将加深我们对曲妥珠单抗德曲妥珠单抗的理解，并可能扩大其应用范围，为更多实体瘤患者带来希望。
