Y90 Radioembolization Significantly Prolongs Time to Progression Compared With Chemoembolization in Patients With Hepatocellular Carcinoma.

Y90 Radioembolization Significantly Prolongs Time to Progression Compared With Chemoembolization in Patients With Hepatocellular Carcinoma.
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DOI:
10.1053/j.gastro.2016.08.029
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发表时间:
2016-12
期刊:
影响因子:
29.4
通讯作者:
Lewandowski RJ
Lewandowski RJ
中科院分区:
医学1区
文献类型:
--
作者:
Salem R;Gordon AC;Mouli S;Hickey R;Kallini J;Gabr A;Mulcahy MF;Baker T;Abecassis M;Miller FH;Yaghmai V;Sato K;Desai K;Thornburg B;Benson AB;Rademaker A;Ganger D;Kulik L;Lewandowski RJ

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传统的经动脉化疗栓塞(cTACE)用于治疗肝细胞癌(HCC)患者。放射栓塞是一种微创手术,将装载有钇-90 (Y90)的微米大小的放射性颗粒植入供应肿瘤的血管。我们进行了一项随机的2期研究,比较cTACE和Y90放射栓塞治疗HCC患者的效果。从2009年10月到2015年10月,我们回顾了所有巴塞罗那临床肝癌(BCLC)分期的HCC患者的资格。其中,179例BCLC A期或B期患者符合我们的入组标准,可以接受cace或Y90治疗。患者被随机分配到接受Y90治疗组(n=24, 50% Child-Pugh A)或cTACE组(n=21, 71% Child-Pugh A)。主要终点是进展时间(TTP),通过意向治疗分析进行评估。次要结局包括安全性、反应率(基于肿瘤大小和坏死标准)和KM生存时间。我们进行了反向概率审查权和竞争风险分析。Y90放射栓塞组患者的中位TTP (bb0 26个月)明显高于cTACE组患者(6.8个月)(P= 0.0012)(风险比=0.122;95% CI, 0.027-0.557; P= 0.007)。考虑移植或死亡的审查加权分析的竞争风险和逆概率证实了这一点。cTACE组出现腹泻的患者比例(21%)明显高于Y90组(0%,P= 0.031)或低白蛋白血症(cTACE组58% vs Y90组4%)(P< 0.001)。两组患者对治疗有反应的比例相似,以坏死为特征(cTACE组为74%,Y90组为87%)(P= 0.433)。cTACE组的中位生存时间为17.7个月(95% CI, 8.3-NC),而Y90组的中位生存时间为18.6个月(95% CI, 7.4-32.5) (P= 0.99)。在一项针对BCLC a期或B期HCC患者的2期研究中,我们发现Y90放射栓塞比cace提供更长的TTP。Y90放射栓塞提供了更好的肿瘤控制,可以减少从移植等待名单中退出。ClinicalTrials.gov没有。NCT00956930
Conventional transarterial chemoembolization (cTACE) is used to treat patients with hepatocellular carcinoma (HCC). Radioembolization is a minimally invasive procedure that involves implantation of radioactive micron-sized particles loaded with yttrium-90 (Y90) inside the blood vessels that supply a tumor. We performed a randomized, phase 2 study to compare the effects of cTACE and Y90 radioembolization in patients with HCC. From October 2009 through October 2015, we reviewed patients with HCC of all Barcelona Clinic Liver Cancer (BCLC) stages for eligibility. Of these, 179 patients with BCLC stages A or B met our enrollment criteria and were candidates for cTACE or Y90 therapy. Patients were randomly assigned to groups that received Y90 therapy (n=24, 50% Child-Pugh A) or cTACE (n=21, 71% Child-Pugh A). The primary outcome was time to progression (TTP), evaluated by intention to treat analysis. Secondary outcomes included safety, rate of response (based on tumor size and necrosis criteria), and KM survival time. We performed inverse probability of censoring weighting and competing risk analyses. Patients in the Y90 radioembolization group had significant longer median TTP (>26 months) than patients in the cTACE group (6.8 months) (P=.0012) (hazard ratio=0.122; 95% CI, 0.027–0.557; P=.007). This was confirmed by competing risk and inverse probability of censoring weighting analyses accounting for transplantation or death. A significantly greater proportion of patients in the cTACE group developed diarrhea (21%) than in the Y90 group (0%; P=.031) or hypoalbuminemia (58% in the cTACE group vs 4% in the Y90 group) (P<.001). Similar proportions of patients in each group had a response to therapy, marked by necrosis (74% in the cTACE group vs 87% in the Y90 group) (P=.433). Median survival time, censored to liver transplantation, was 17.7 months for the cTACE group (95% CI, 8.3–NC) vs 18.6 months for the Y90 group (95% CI, 7.4–32.5) (P=.99). In a phase 2 study of patients with HCC of BCLC stages A or B, we found Y90 radioembolization to provide significantly longer TTP than cTACE. Y90 radioembolization provides better tumor control and could reduce dropout from transplant waitlists. ClinicalTrials.gov no. NCT00956930
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