Wang Yanjie, Li Yan, Yan Kun, Shen Lin, Yang Wei, Gong Jifang, Ding Ke
Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), 1Department of Ultrasound.
Department of Gastrointestinal Oncology, Peking University Cancer Hospital & Institute, Beijing 100142, China.
Chin J Cancer Res. 2018 Oct;30(5):553-563. doi: 10.21147/j.issn.1000-9604.2018.05.09.
To explore the safety of ultrasound and microbubbles for enhancing the chemotherapeutic sensitivity of malignant tumors in the digestive system in a clinical trial, as well as its efficacy.
From October 2014 to June 2016, twelve patients volunteered to participate in this study. Eleven patients had hepatic metastases from tumors of the digestive system, and one patient had pancreatic carcinoma. According to the mechanical index (MI) in the ultrasound field, patients were classified into four groups with MIs of 0.4, 0.6, 0.8 and 1.0. Within half an hour after chemotherapy, patients underwent ultrasound scanning with ultrasound microbubbles (SonoVue) to enhance the efficacy of chemotherapy. All adverse reactions were recorded and were classified in 4 grades according to the Common Terminology Criteria for Adverse Events version 4.03 (CTCAE V4.03). Tumor responses were evaluated by the Response Evaluation Criteria in Solid Tumors version 1.1 criteria. All the patients were followed up until progression.
All the adverse reactions recorded were level 1 or level 2. No local pain occurred in any of the patients. Among all the adverse reactions, fever might be related to the treatment with ultrasound combined with microbubbles. Six patients had stable disease (SD), and one patient had a partial response (PR) after the first cycle of treatment. At the end of follow-up, tumor progression was restricted to the original sites, and no new lesions had appeared.
Our preliminary data showed the potential role of a combined treatment with ultrasound and microbubbles in enhancing the chemotherapeutic sensitivity of malignant tumors of the digestive system. This technique is safe when the MI is no greater than 1.0.
在一项临床试验中探讨超声联合微泡增强消化系统恶性肿瘤化疗敏感性的安全性及其疗效。
2014年10月至2016年6月，12例患者自愿参加本研究。11例患者有消化系统肿瘤肝转移，1例患者患有胰腺癌。根据超声场中的机械指数（MI），将患者分为四组，MI分别为0.4、0.6、0.8和1.0。化疗后半小时内，患者接受超声微泡（声诺维）超声扫描以增强化疗效果。记录所有不良反应，并根据不良事件通用术语标准第4.03版（CTCAE V4.03）分为4级。根据实体瘤疗效评价标准第1.1版标准评估肿瘤反应。所有患者均随访至病情进展。
记录的所有不良反应均为1级或2级。所有患者均未出现局部疼痛。在所有不良反应中，发热可能与超声联合微泡治疗有关。6例患者病情稳定（SD），1例患者在第一个治疗周期后出现部分缓解（PR）。随访结束时，肿瘤进展局限于原部位，未出现新病灶。
我们的初步数据显示了超声联合微泡治疗在增强消化系统恶性肿瘤化疗敏感性方面的潜在作用。当MI不大于1.0时，该技术是安全的。
