Ziemlewicz Timothy J, Critchfield Jeffrey J, Mendiratta-Lala Mishal, Wiggermann Philipp, Pech Maciej, Serres-Créixams Xavier, Lubner Meghan, Wah Tze Min, Littler Peter, Davis Clifford R, Narayanan Govindarajan, White Sarah B, Ahmed Osman, Collins Zach S, Parikh Neehar D, Planert Mathis, Thormann Maximilian, Torzilli Guido, Solbiati Luigi A, Cho Clifford S
Department of Radiology, University of Wisconsin School of Medicine and Public Health, Madison, WI USA.
Karmanos Cancer Institute, Wayne State University, Detroit, MI, USA.
Ann Surg. 2025 Apr 9. doi: 10.1097/SLA.0000000000006720.
To evaluate the 1-year clinical outcomes of patients enrolled in the #HOPE4LIVER trial of hepatic histotripsy.
Histotripsy is a novel non-invasive, non-thermal focused ultrasound therapy that liquefies tissue at the focal point of the transducer. Following diagnostic ultrasound targeting, an automated treatment is performed via a robotic arm to treat a user-defined volume of tissue.
Forty-seven patients were enrolled at 14 sites in the United States and Europe. Included patients were ineligible for or had opted out of standard therapies. Tumor control was evaluated via a core laboratory with a primary assessment at each time point and a post hoc assessment performed following completion of each time point to allow for a learning curve of interpreting imaging findings of this novel therapy. Overall survival and freedom from local tumor progression were evaluated via the Kaplan-Meier method.
Nineteen patients with hepatocellular carcinoma and 28 with metastatic disease were enrolled, of whom 89.5% (17/19) and 96.4% (27/28) had multifocal hepatic tumors at the time of treatment. Fifty-two tumors were treated. The 1-year local control rate was 63.4% using the primary assessment method and 90% using the post hoc method. There were six serious adverse device-related effects within 30 days of treatment. Only one non-serious adverse device-related effect was observed after 30 days of treatment. Overall survival at 1-year was 73.3% for patients with HCC and 48.6% for patients with metastatic disease.
Histotripsy results in local control of liver tumors at 1-year that is consistent with current locoregional therapies. The safety profile is favorable, and survival at 1 year is comparable with other therapies for similar disease stages.
评估参与肝脏组织粉碎术#HOPE4LIVER试验患者的1年临床结局。
组织粉碎术是一种新型的非侵入性、非热聚焦超声疗法，可在换能器焦点处使组织液化。在诊断性超声定位后，通过机械臂进行自动治疗，以治疗用户定义的组织体积。
在美国和欧洲的14个地点招募了47名患者。纳入的患者不符合标准治疗或已选择不接受标准治疗。通过核心实验室评估肿瘤控制情况，在每个时间点进行一次主要评估，并在每个时间点完成后进行事后评估，以适应解释这种新型疗法影像学结果的学习曲线。通过Kaplan-Meier方法评估总生存期和无局部肿瘤进展生存期。
纳入了19例肝细胞癌患者和28例转移性疾病患者，其中89.5%（17/19）和96.4%（27/28）在治疗时患有多灶性肝肿瘤。共治疗了52个肿瘤。使用主要评估方法的1年局部控制率为63.4%，使用事后评估方法为90%。治疗后30天内有6例严重的与器械相关的不良事件。治疗30天后仅观察到1例非严重的与器械相关的不良事件。肝细胞癌患者1年总生存率为73.3%，转移性疾病患者为48.6%。
组织粉碎术在1年时可实现肝脏肿瘤的局部控制，与当前的局部区域治疗方法一致。安全性良好，1年生存率与其他针对类似疾病阶段的疗法相当。
