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常规与载药微球化疗栓塞治疗浸润性肝细胞癌:疗效与安全性比较。

Conventional versus drug-eluting beads chemoembolization for infiltrative hepatocellular carcinoma: a comparison of efficacy and safety.

机构信息

Department of Radiology, the Second Xiangya Hospital of Central South University, No.139 Middle Renmin Road, Changsha, 410011, China.

出版信息

BMC Cancer. 2019 Nov 29;19(1):1162. doi: 10.1186/s12885-019-6386-6.

Abstract

BACKGROUND

To compare the efficacy and safety between conventional transarterial chemoembolization (cTACE) and drug-eluting beads TACE (DEB-TACE) in patients with infiltrative hepatocellular carcinoma (iHCC).

METHODS

A total of 89 iHCC patients who were treated with either cTACE (n = 33) or DEB-TACE (n = 56) between April 2013 and September 2017 were included in this retrospective study. Patients with the situations that might have a poor outcome were defined as advanced disease including Child-Pugh class B, bilobar lesions, tumor size greater than 10 cm, ECOG 1-2, tumor burden of 50-70%, and the presence of ascites, arterioportal shunt (APS), and portal venous tumor thrombus (PVTT). The tumor response was measured 1-month and 3-month after the procedure. Progression-free survival (PFS) was calculated. Toxicity was graded by Common Terminology Criteria for Adverse Events v5.0 (CTCAE v5.0). The differences in tumor response, PFS, and toxicity were compared between the DEB-TACE group and cTACE group.

RESULTS

At 1-month and 3-month after the procedure, the objective response rate (ORR) in the overall study population was similar in DEB-TACE group and cTACE group. The disease control rate (DCR), at 1-month after the procedure, was significantly higher in the patients treated with DEB-TACE relative to those treated with cTACE (P = 0.034), while after 3 months, the difference did not differ between two groups. DEB-TACE showed a higher DCR than cTACE in patients with tumor size greater than 10 cm (P = 0.036) or associated with APS (P = 0.030) at 1-month after the procedure, while after 3 months, the difference was only noted in patients with APS (P = 0.036). The median PFS in DEB-TACE group was 96 days, while in cTACE group was 94 days, and there was no difference in PFS between two groups (P = 0.831). In the side effect analysis, abdominal pain (P = 0.034) and fever (P = 0.009) were more frequently present in the cTACE group than DEB-TACE group, but there was no difference in high grade liver toxicity between the two groups.

CONCLUSIONS

Compared to cTACE, DEB-TACE offers slightly better DCR and tolerability for iHCC patients, particularly in patients associated with APS and large tumor size. However, DEB-TACE does not provide higher PFS than cTACE.

摘要

背景

比较常规经动脉化疗栓塞(cTACE)和载药微球化疗栓塞(DEB-TACE)治疗侵袭性肝细胞癌(iHCC)的疗效和安全性。

方法

回顾性分析 2013 年 4 月至 2017 年 9 月期间接受 cTACE(n=33)或 DEB-TACE(n=56)治疗的 89 例 iHCC 患者。预后不良的情况包括 Child-Pugh 分级 B、两叶病变、肿瘤直径大于 10cm、ECOG 1-2、肿瘤负荷 50-70%以及腹水、动静脉分流(APS)和门静脉癌栓(PVTT)。术后 1 个月和 3 个月测量肿瘤反应。计算无进展生存期(PFS)。采用常见不良事件术语标准 5.0(CTCAE v5.0)分级毒性。比较 DEB-TACE 组和 cTACE 组的肿瘤反应、PFS 和毒性差异。

结果

术后 1 个月和 3 个月,DEB-TACE 组和 cTACE 组总体人群的客观缓解率(ORR)相似。术后 1 个月,DEB-TACE 组的疾病控制率(DCR)明显高于 cTACE 组(P=0.034),但 3 个月后两组间差异无统计学意义。DEB-TACE 在肿瘤直径大于 10cm(P=0.036)或伴有 APS(P=0.030)的患者中,术后 1 个月的 DCR 高于 cTACE,而 3 个月后仅在伴有 APS 的患者中存在差异(P=0.036)。DEB-TACE 组中位 PFS 为 96 天,cTACE 组为 94 天,两组 PFS 无差异(P=0.831)。在副作用分析中,cTACE 组腹痛(P=0.034)和发热(P=0.009)的发生率高于 DEB-TACE 组,但两组肝毒性发生率无差异。

结论

与 cTACE 相比,DEB-TACE 为 iHCC 患者提供了稍好的 DCR 和耐受性,特别是对伴有 APS 和大肿瘤体积的患者。然而,DEB-TACE 并不能提供比 cTACE 更高的 PFS。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/93ec/6884873/628e6e7c5197/12885_2019_6386_Fig1_HTML.jpg

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