关于Trastuzumab Deruxtecan (T-DXd)相关不良事件的监测和管理的临床指南:亚太地区多学科小组的见解。
Clinical Guidance on the Monitoring and Management of Trastuzumab Deruxtecan (T-DXd)-Related Adverse Events: Insights from an Asia-Pacific Multidisciplinary Panel.
发表日期:2023 Aug 08
作者:
Joanne Wing Yan Chiu, Soo Chin Lee, James Chung-Man Ho, Yeon Hee Park, Ta-Chung Chao, Sung-Bae Kim, Elgene Lim, Ching-Hung Lin, Sherene Loi, Su Ying Low, Lynette Li San Teo, Winnie Yeo, Rebecca Dent
来源:
DRUG SAFETY
摘要:
三嘉唑酮二杆菌素(T-DXd) - 靶向人表皮生长因子受体2(HER2)的抗体药物结合物可改善HER2阳性和HER2低表达的转移性乳腺癌患者的结果。由于实际和文化考虑以及健康护理基础设施的差异,监测和管理与T-DXd相关的不良事件(AE)的指南成为一项新兴的未满足需求。因此,来自亚太地区的13名专家,包括肿瘤学家、肺科医生和放射科医生,聚集在一起,利用DESTINY-Breast试验的最新证据、我们自己的临床试验经验和地区卫生保健的考虑,提供了T-DXd相关的AE监测和管理的建议。尽管在DESTINY-Breast03研究中,亚洲人群(不包括日本人)与整体人群的亚组分析未发现主要差异,但我们认为积极监测和管理对于最大化T-DXd的益处至关重要。由于间质性肺疾病(ILD)/肺炎是一种严重的AE,患者应定期接受计算机断层扫描,但频率可能要考虑ILD/pneumonitis发作的中位时间和可及性。三嘉唑酮二杆菌素似乎是一种高呕吐方案,应考虑使用5-HT3受体拮抗剂和地塞米松(联合或不联合神经激肽1受体拮抗剂)进行预防。医疗保健专业人士应警惕疲劳的可治疗原因,并鼓励患者使用支持团体和进行低强度运动。为了增加治疗接受度,在开始使用T-DXd之前,应让患者意识到脱发的风险。进一步讨论了与T-DXd相关的AE的详细监测和管理建议。 ©2023. 作者。
Trastuzumab deruxtecan (T-DXd)-an antibody-drug conjugate targeting the human epidermal growth factor receptor 2 (HER2)-improved outcomes of patients with HER2-positive and HER2-low metastatic breast cancer. Guidance on monitoring and managing T-DXd-related adverse events (AEs) is an emerging unmet need as translating clinical trial experience into real-world practice may be difficult due to practical and cultural considerations and differences in health care infrastructure. Thus, 13 experts including oncologists, pulmonologists and a radiologist from the Asia-Pacific region gathered to provide recommendations for T-DXd-related AE monitoring and management by using the latest evidence from the DESTINY-Breast trials, our own clinical trial experience and loco-regional health care considerations. While subgroup analysis of Asian (excluding Japanese) versus overall population in the DESTINY-Breast03 uncovered no major differences in the AE profile, we concluded that proactive monitoring and management are essential in maximising the benefits with T-DXd. As interstitial lung disease (ILD)/pneumonitis is a serious AE, patients should undergo regular computed tomography scans, but the frequency may have to account for the median time of ILD/pneumonitis onset and access. Trastuzumab deruxtecan appears to be a highly emetic regimen, and prophylaxis with serotonin receptor antagonists and dexamethasone (with or without neurokinin-1 receptor antagonist) should be considered. Health care professionals should be vigilant for treatable causes of fatigue, and patients should be encouraged to use support groups and practice low-intensity exercises. To increase treatment acceptance, patients should be made aware of alopecia risk prior to starting T-DXd. Detailed monitoring and management recommendations for T-DXd-related AEs are discussed further.© 2023. The Author(s).