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学科主题临床医学
Phase III HEAT Study Adding Lyso-Thermosensitive Liposomal Doxorubicin to Radiofrequency Ablation in Patients with Unresectable Hepatocellular Carcinoma Lesions
Tak, Won Young1; Lin, Shi-Ming2; Wang, Yijun3; Zheng, Jiasheng4; Vecchione, Aldo5; Park, Soo Young1; Chen, Min Hua6; Wong, Stephen7; Xu, Ruocai8; Peng, Cheng-Yuan9; Chiou, Yi-You10; Huang, Guan-Tarn11; Cai, Jianqiang12; Abdullah, Basri Johan Jeet13; Lee, June Sung14; Lee, Jae Young15; Choi, Jong-Young16; Gopez-Cervantes, Julieta17; Shermans, Morris18; Finn, Richard S.19; Omata, Masao20; O′ Neal, Michael21; Makris, Lukas22; Borys, Nicholas23; Poon, Ronnie24; Lencioni, Riccardo25
通讯作者Tak, Won Young(1)
刊名CLINICAL CANCER RESEARCH
2018
DOI10.1158/1078-0432.CCR-16-2433
24期:1页:73-83
收录类别SCI
文章类型Article
WOS标题词Science & Technology
类目[WOS]Oncology
研究领域[WOS]Oncology
关键词[WOS]THERMAL ABLATION ; LIVER-TUMORS ; HYPERTHERMIA ; CANCER ; ANTHRACYCLINES ; MALIGNANCIES ; ENHANCEMENT ; ADRIAMYCIN ; RECURRENCE ; MODEL
英文摘要

Purpose: Lyso-thermosensitive liposomal doxorubicin (LTLD) consists of doxorubicin contained within a heat-sensitive liposome. When heated to >= 40 degrees C, LTLD locally releases a high concentration of doxorubicin. We aimed to determine whether adding LTLD improves the efficacy of radiofrequency ablation (RFA) for hepatocellular carcinoma (HCC) lesions with a maximum diameter (dmax) of 3 to 7 cm.

Experimental Design: The HEAT Study was a randomized, double-blind, dummy-controlled trial of RFA +/- LTLD. The 701 enrolled patients had to have <= 4 unresectable HCC lesions, at least one of which had a dmax of 3 to 7 cm. The primary endpoint was progression-free survival (PFS) and a key secondary endpoint was overall survival (OS). Post hoc subset analyses investigated whether RFA duration was associated with efficacy.

Results: The primary endpoint was not met; in intention-totreat analysis, the PFS HR of RFA thorn LTLD versus RFA alone was 0.96 [95% confidence interval (CI), 0.79-1.18; P = 0.71], and the OS HR ratio was 0.95 (95% CI, 0.76-1.20; P = 0.67). Among 285 patients with a solitary HCC lesion who received >= 45 minutes RFA dwell time, theOSHRwas 0.63 (95% CI, 0.41-0.96; P < 0.05) in favor of combination therapy. RFA thorn LTLD had reversible myelosuppression similar to free doxorubicin.

Conclusions: Adding LTLD to RFA was safe but did not increase PFS or OS in the overall study population. However, consistent with LTLD′s heat-based mechanism of action, subgroup analysis suggested that RFA thorn LTLD efficacy is improved when RFA dwell time for a solitary lesion >= 45 minutes. (C) 2017 AACR.

语种英语
WOS记录号WOS:000437730900009
通讯作者邮箱wytak@knu.ac.kr
第一作者单位Kyungpook Natl Univ, Sch Med, Dept Internal Med, Div Gastroenterol & Hepatol, Daegu, South Korea
通讯作者单位Kyungpook Natl Univ, Sch Med, Dept Internal Med, Div Gastroenterol & Hepatol, Daegu, South Korea
ISSN1078-0432
引用统计
文献类型期刊论文
条目标识符http://ir.bjmu.edu.cn/handle/400002259/142597
专题北京大学临床肿瘤学院_超声科
作者单位1.Chang Gung Mem Hosp Linkou, Taoyuan, Taiwan;
2.Third Cent Hosp Tianjin, Tianjin, Peoples R China;
3.Kyungpook Natl Univ, Sch Med, Dept Internal Med, Div Gastroenterol & Hepatol, Daegu, South Korea;
4.Capital Med Univ, Beijing Youan Hosp, Beijing, Peoples R China;
5.Natl Canc Inst Naples, Naples, Italy;
6.Peking Univ, Canc Hosp, Dept Ultrasound, Beijing, Peoples R China;
7.Chinese Gen Hosp, Manila, Philippines;
8.Hunan Canc Hosp, Dept Hepatobiliary & Pancreat Internal Med, Changsha, Hunan, Peoples R China;
9.China Med Univ Hosp, Taichung, Taiwan;
10.Taipei Vet Gen Hosp, Taipei, Taiwan;
11.Natl Taiwan Univ Hosp, Taipei, Taiwan;
12.Chinese Acad Med Sci, Canc Inst, Beijing, Peoples R China;
13.Univ Malaya, Med Ctr, Kuala Lumpur, Malaysia;
14.Inje Univ, Ilsan Paik Hosp, Goyang, South Korea;
15.Seoul Natl Univ Hosp, Seoul, South Korea;
16.Catholic Univ Korea, Seoul, South Korea;
17.St Lukes Med Ctr, Quezon City, Philippines;
18.Toronto Gen Hosp, Toronto, ON, Canada;
19.UCLA, Dept Med, Geffen Sch Med, Los Angeles, CA 90024 USA;
20.Yamanashi Prefectural Cent Hosp, Kofu, Yamanashi, Japan;
21.BioClin Inc, Princeton, NJ USA;
22.Stathmi, New Hope, PA USA;
23.Cels Corp, Lawrenceville, NJ USA;
24.Univ Hong Kong, Queen Mary Hosp, Hong Kong, Hong Kong, Peoples R China;
25.Univ Miami, Miller Sch Med, Sect Vasc & Intervent Radiol, Sylvester Comprehens Canc Ctr, Miami, FL 33136 USA
推荐引用方式
GB/T 7714
Tak, Won Young,Lin, Shi-Ming,Wang, Yijun,et al. Phase III HEAT Study Adding Lyso-Thermosensitive Liposomal Doxorubicin to Radiofrequency Ablation in Patients with Unresectable Hepatocellular Carcinoma Lesions[J]. CLINICAL CANCER RESEARCH,2018,24(1):73-83.
APA Tak, Won Young.,Lin, Shi-Ming.,Wang, Yijun.,Zheng, Jiasheng.,Vecchione, Aldo.,...&Lencioni, Riccardo.(2018).Phase III HEAT Study Adding Lyso-Thermosensitive Liposomal Doxorubicin to Radiofrequency Ablation in Patients with Unresectable Hepatocellular Carcinoma Lesions.CLINICAL CANCER RESEARCH,24(1),73-83.
MLA Tak, Won Young,et al."Phase III HEAT Study Adding Lyso-Thermosensitive Liposomal Doxorubicin to Radiofrequency Ablation in Patients with Unresectable Hepatocellular Carcinoma Lesions".CLINICAL CANCER RESEARCH 24.1(2018):73-83.
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