Journal of Cancer Research and Therapeutics

ORIGINAL ARTICLE
Year
: 2019  |  Volume : 15  |  Issue : 4  |  Page : 773--783

Thermosensitive liposomal doxorubicin plus radiofrequency ablation increased tumor destruction and improved survival in patients with medium and large hepatocellular carcinoma: A randomized, double-blinded, dummy-controlled clinical trial in a single center


Wei Yang1, Jung-Chieh Lee1, Min-Hua Chen1, Zhong-Yi Zhang1, Xiu-Mei Bai1, Shan-Shan Yin1, Kun Cao2, Song Wang1, Wei Wu1, Kun Yan1 
1 Department of Ultrasound, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital and Institute, Beijing, China
2 Department of Radiology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital and Institute, Beijing, China

Correspondence Address:
Min-Hua Chen
Department of Ultrasound, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital and Institute, Beijing 100142
China

Background: Lyso-thermosensitive liposomal doxorubicin (LTLD, ThermoDox) consists of doxorubicin encapsulated contained within a heat-sensitive liposome. Aims and Objectives: We sought to evaluate whether the use of combined radiofrequency ablation (RFA) and LTLD would result in larger coagulation volume and longer overall survival (OS) compared with the use of RFA alone in patients with 3–7 cm unresectable hepatocellular carcinoma (HCC). Materials and Methods: Between 2010 and 2012, 22 HCC patients were randomly assigned to one of two treatments in our center: (1) ultrasound-guided percutaneous RFA plus intravenous (IV) infusion of LTLD (combination, n = 11) or (2) RFA plus IV dummy (RFA, n = 11). Four patients withdrew from the study, and the remaining 18 patients entered the final analysis. There were 14 male and 4 female patients with an average age of 61.1 ± 9.3 years (range: 40–73 years). The average tumor size was 4.2 ± 1.0 cm (range: 3.1–6.1 cm). One-month enhanced computed tomography was used to evaluate the ablation efficacy and coagulation volume after RFA. Regular follow-up after RFA was performed to assess toxicity, local response rates, and OS rates. Results: A major complication (empyema) occurred in one case in the combination group. Combination treatment region did not induce any additional toxicity beyond doxorubicin. The primary ablation success rate was 93.3% (14/15 tumors) in the combination group and 77.8% (7/9 tumors) in the RFA group (P = 0.308). The difference in coagulation volume between pre- and post-RFA in the combination group was significantly larger than that of the RFA group (105.7 ± 73.8 cm 3 vs. 37.3 ± 8.5 cm 3, P = 0.013). The follow-up period ranged from 11 to 80 months (average: 49.1 ± 24.8 months). The local progression rate was 6.7% (1/15 tumors) in the combination group and 22.2% (2/9 tumors) in the RFA group. The mean OS for the combination group was 68.5 ± 7.2 months, which was significantly greater compared with the RFA group (46.0 ± 10.6 months, P = 0.045). Conclusions: RFA with heat target delivery chemotherapy facilitated better tumor coagulation necrosis without additional toxicity. This combined treatment may improve the clinical efficacy of RFA or free doxorubicin and prolong survival in patients with medium to large HCC.


How to cite this article:
Yang W, Lee JC, Chen MH, Zhang ZY, Bai XM, Yin SS, Cao K, Wang S, Wu W, Yan K. Thermosensitive liposomal doxorubicin plus radiofrequency ablation increased tumor destruction and improved survival in patients with medium and large hepatocellular carcinoma: A randomized, double-blinded, dummy-controlled clinical trial in a single center.J Can Res Ther 2019;15:773-783


How to cite this URL:
Yang W, Lee JC, Chen MH, Zhang ZY, Bai XM, Yin SS, Cao K, Wang S, Wu W, Yan K. Thermosensitive liposomal doxorubicin plus radiofrequency ablation increased tumor destruction and improved survival in patients with medium and large hepatocellular carcinoma: A randomized, double-blinded, dummy-controlled clinical trial in a single center. J Can Res Ther [serial online] 2019 [cited 2020 Apr 7 ];15:773-783
Available from: http://www.cancerjournal.net/article.asp?issn=0973-1482;year=2019;volume=15;issue=4;spage=773;epage=783;aulast=Yang;type=0