A randomised phase II/III trial of 3-weekly cisplatin-based sequential transarterial chemoembolisation vs embolisation alone for hepatocellular carcinoma.
A randomised phase II/III trial of 3-weekly cisplatin-based sequential transarterial chemoembolisation vs embolisation alone for hepatocellular carcinoma.
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DOI：
10.1038/bjc.2013.85
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发表时间：
2013-04-02
影响因子：
8.8
通讯作者：
Burroughs AK
中科院分区：
文献类型：
--
作者：
Meyer T;Kirkwood A;Roughton M;Beare S;Tsochatzis E;Yu D;Davies N;Williams E;Pereira SP;Hochhauser D;Mayer A;Gillmore R;O'Beirne J;Patch D;Burroughs AK
经动脉化疗栓塞术（TACE）治疗肝细胞癌（HCC）的效果并不上级温和栓塞术（TAE）。我们在未经治疗的HCC患者中进行了一项随机II/III期试验。患者被随机分配至单独使用聚乙烯醇（PVA）颗粒的TAE组或序贯TACE（sTACE）组，其中在PVA栓塞前4-6小时动脉内给予顺铂50 mg。每周重复治疗3次，最多治疗3次。主要终点是总生存期，次要终点是无进展生存期、毒性和反应。II期和III期的目标样本量分别为80和322。在86名患者接受随机化后，试验在II期结束。患者的预后标准匹配良好。57.1%（TAE）和56.8%（TACE）的患者接受了所有三种计划治疗。3/4级毒性发生率分别为63.5%和83.7%（P=0.019）。治疗结束时RECIST缓解（CR+PR）分别为13.2%和32.6%（P=0.04）（mRECIST 47.3%和67.4），中位总生存期和无进展生存期分别为17.3 vs 16.3（P=0.74）个月和7.2 vs 7.5（P=0.59）个月。根据这种新方案进行的经动脉化疗栓塞是可行的，并且与单独TAE相比具有更高的缓解率。TACE相对于TAE的生存获益尚未得到证实。
Transarterial chemoembolisation (TACE) has not been shown to be superior to bland embolisation (TAE) for treatment of hepatocellular carcinoma (HCC). We conducted a randomised phase II/III trial in patients with untreated HCC. Patients were randomised to TAE with polyvinyl alcohol (PVA) particles alone or sequential TACE (sTACE) in which cisplatin 50 mg was administered intrarterially 4–6 h before PVA embolisation. Treatment was repeated 3-weekly for up to three treatments. The primary endpoint was overall survival and secondary endpoints were progression-free survival, toxicity and response. Target sample sizes for phase II and III were 80 and 322. The trial was terminated at phase II after 86 patients had been randomised. Patients were well matched for prognostic criteria. All three planned treatments were given to 57.1% (TAE) and 56.8% (TACE) patients. Grade 3/4 toxicity occurred in 63.5% and 83.7%, respectively (P=0.019). End-of-treatment RECIST response (CR+PR) was 13.2 and 32.6% (P=0.04) (mRECIST 47.3% and 67.4) and median overall survival and progression-free survival was 17.3 vs 16.3 (P=0.74) months and 7.2 vs 7.5 (P=0.59), respectively. Transarterial chemoembolisation according this novel schedule is feasible and associated with a higher response rate than TAE alone. The survival benefit of TACE over TAE remains unproven.
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影响因子：
15.8
作者：
Moher D;Liberati A;Tetzlaff J;Altman DG;PRISMA Group
通讯作者：
PRISMA Group
影响因子：
25.7
作者：
JOHNSON, PJ;KALAYCI, C;WILLIAMS, R
通讯作者：
WILLIAMS, R
影响因子：
13.5
作者：
Lo, CM;Ngan, H;Wong, J
通讯作者：
Wong, J
DOI：
10.1200/jco.2011.37.1021
发表时间：
2011-10-20
期刊：
Journal of clinical oncology : official journal of the American Society of Clinical Oncology
影响因子：
--
作者：
Pawlik TM;Reyes DK;Cosgrove D;Kamel IR;Bhagat N;Geschwind JF
通讯作者：
Geschwind JF
影响因子：
254.7
作者：
Parkin, DM;Bray, F;Pisani, P
通讯作者：
Pisani, P