PMID- 33788029 OWN - NLM STAT- MEDLINE DCOM- 20220303 LR - 20220303 IS - 1432-2218 (Electronic) IS - 0930-2794 (Linking) VI - 36 IP - 3 DP - 2022 Mar TI - High-intensity focused ultrasound alone or combined with transcatheter arterial chemoembolization for the treatment of hepatocellular carcinoma with unsuitable indications for hepatectomy and radiofrequency ablation: a phase II clinical trial. PG - 1857-1867 LID - 10.1007/s00464-021-08465-3 [doi] AB - OBJECTIVES: This study aims to evaluate the efficacy and safety of high-intensity focused ultrasound (HIFU) alone or combined with transcatheter arterial chemoembolization (TACE) for patients with hepatocellular carcinoma (HCC) but were contraindicated for hepatectomy and radiofrequency ablation (RFA). METHODS: Patients between 20 and 80 years of age with 1-3 foci of HCC were selected. Included patients have had primary or recurrent liver lesions with no evidence of extra-hepatic metastasis prior to the study. Patients were treated with ultrasound-guided HIFU alone or HIFU combined with TACE (treated with TACE once within 4 weeks prior to receiving HIFU). RESULTS: Thirty-seven patients were enrolled, for a total of 45 lesions. The 2-year local control (LC) rate was 73.0% and the median LC time was 22 months. The 2-year progression-free survival (PFS) was 29.7% and the median PFS time was 9 months. Finally, the 2-year overall survival (OS) was 70.3%, and the median OS time was 24 months. The most common adverse events (AEs) were elevated liver enzymes, followed by fatigue, and pain, no grade 4 AEs or death occurred. Multivariate analysis showed that age, Child-Pugh class, and the number of tumors were independent prognostic factors for PFS and that the AFP levels and the number of tumors were significantly correlated with the OS. CONCLUSIONS: This study indicates that the HIFU/HIFU combined with TACE treatment is safe, and is capable of achieving both a good LC rate and a considerably good prognosis. The procedure should be considered for patients who were deemed unsuitable for other local treatments. CI - (c) 2021. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature. FAU - Gu, Lihu AU - Gu L AD - Department of General Surgery, HwaMei Hospital, University of Chinese Academy of Sciences, Ningbo, Zhejiang, China. AD - Key Laboratory of Diagnosis and Treatment of Digestive System Tumors of Zhejiang Province, Ningbo, Zhejiang, China. AD - Ningbo Institute of Life and Health Industry, University of Chinese Academy of Sciences, Ningbo, Zhejiang, China. FAU - Shen, Zefeng AU - Shen Z AD - Department of General Surgery, Zhejiang University School of Medicine Sir Run Run Shaw Hospital, Hangzhou, Zhejiang, China. FAU - Ji, Linling AU - Ji L AD - Ningbo Yinzhou No. 2 Hospital, Ningbo, Zhejiang, China. FAU - Ng, Derry Minyao AU - Ng DM AD - Medical College of Ningbo University, Ningbo, Zhejiang, China. FAU - Du, Nannan AU - Du N AD - The Second Clinical Medical College, Zhejiang Chinese Medical University, Hangzhou, Zhejiang, China. FAU - He, Ning AU - He N AD - Department of Tumor HIFU Therapy, HwaMei Hospital,, University of Chinese Academy of Sciences, Northwest Street 41, Haishu District, Ningbo, 315010, Zhejiang, China. FAU - Fan, Xiaoxiang AU - Fan X AD - Department of Interventional Therapy, HwaMei Hospital, University of Chinese Academy of Sciences, Ningbo, Zhejiang, China. FAU - Yan, Kun AU - Yan K AD - Department of Medical Image, HwaMei Hospital, University of Chinese Academy of Sciences, Ningbo, Zhejiang, China. FAU - Zheng, Zhi AU - Zheng Z AD - Department of Tumor HIFU Therapy, HwaMei Hospital,, University of Chinese Academy of Sciences, Northwest Street 41, Haishu District, Ningbo, 315010, Zhejiang, China. FAU - Chen, Bo AU - Chen B AD - Department of Medical Image, HwaMei Hospital, University of Chinese Academy of Sciences, Ningbo, Zhejiang, China. FAU - Ma, Li AU - Ma L AD - Department of Liver Disease, HwaMei Hospital, University of Chinese Academy of Sciences, Ningbo, Zhejiang, China. FAU - Qiu, Guangping AU - Qiu G AD - Department of Interventional Therapy, HwaMei Hospital, University of Chinese Academy of Sciences, Ningbo, Zhejiang, China. FAU - Chen, Ping AU - Chen P AD - Department of General Surgery, HwaMei Hospital, University of Chinese Academy of Sciences, Ningbo, Zhejiang, China. FAU - Zheng, Jianjun AU - Zheng J AD - Department of Medical Image, HwaMei Hospital, University of Chinese Academy of Sciences, Ningbo, Zhejiang, China. FAU - Yang, Tong AU - Yang T AD - Department of Tumor HIFU Therapy, HwaMei Hospital,, University of Chinese Academy of Sciences, Northwest Street 41, Haishu District, Ningbo, 315010, Zhejiang, China. tongyang2020@163.com. LA - eng PT - Clinical Trial, Phase II PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20210331 PL - Germany TA - Surg Endosc JT - Surgical endoscopy JID - 8806653 SB - IM MH - *Carcinoma, Hepatocellular/surgery MH - *Catheter Ablation/methods MH - *Chemoembolization, Therapeutic/methods MH - Combined Modality Therapy MH - Hepatectomy MH - Humans MH - *Liver Neoplasms/surgery MH - *Radiofrequency Ablation/methods MH - Treatment Outcome OTO - NOTNLM OT - Hepatocellular carcinoma OT - High-intensity focused ultrasound OT - Prognostic factors OT - Survival OT - Transcatheter arterial chemoembolization EDAT- 2021/04/01 06:00 MHDA- 2022/03/04 06:00 CRDT- 2021/03/31 13:26 PHST- 2020/09/11 00:00 [received] PHST- 2021/03/18 00:00 [accepted] PHST- 2021/04/01 06:00 [pubmed] PHST- 2022/03/04 06:00 [medline] PHST- 2021/03/31 13:26 [entrez] AID - 10.1007/s00464-021-08465-3 [pii] AID - 10.1007/s00464-021-08465-3 [doi] PST - ppublish SO - Surg Endosc. 2022 Mar;36(3):1857-1867. doi: 10.1007/s00464-021-08465-3. Epub 2021 Mar 31.