Hepatic artery infusion chemotherapy using mFOLFOX versus transarterial chemoembolization for massive unresectable hepatocellular carcinoma: a prospective non-randomized study.
Hepatic artery infusion chemotherapy using mFOLFOX versus transarterial chemoembolization for massive unresectable hepatocellular carcinoma: a prospective non-randomized study.
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使用 mFOLFOX 的肝动脉灌注化疗与经动脉化疗栓塞治疗大块不可切除的肝细胞癌：前瞻性非随机研究
DOI：
10.1186/s40880-017-0251-2
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发表时间：
2017-10-23
影响因子：
--
通讯作者：
Shi M
中科院分区：
文献类型：
--
作者：
He MK;Le Y;Li QJ;Yu ZS;Li SH;Wei W;Guo RP;Shi M
经动脉化疗栓塞（TACE）被推荐为巴塞罗那临床肝癌（BCLC）A-B期不可切除肝细胞癌（HCC）的标准治疗。然而，TACE治疗大肝癌（≥ 10 cm）的疗效仍不理想，肝动脉灌注化疗（HAIC）可能是较好的一线治疗方法。因此，我们比较了HAIC与改良FOLFOX（mFOLFOX）方案和TACE在大面积不可切除HCC患者中的安全性和有效性。一项前瞻性、非随机、II期研究在大面积不可切除的HCC患者中进行。该方案涉及HAIC联合mFOLFOX方案（奥沙利铂，85 mg/m2动脉内输注;亚叶酸，400 mg/m2动脉内输注;氟尿嘧啶，400 mg/m2推注和2400 mg/m2持续输注），每3周一次，以及TACE联合50 mg表阿霉素、50 mg洛铂、6 mg丝裂霉素、阿托碘油和聚乙烯醇颗粒。评估肿瘤缓解、至进展时间（TTP）和安全性。本研究共招募了79例患者：HAIC组38例，TACE组41例。HAIC组的部分缓解率和疾病控制率高于TACE组（52.6% vs. 9.8%，P < 0.001; 83.8% vs. 52.5%，P = 0.004）。HAIC和TACE组的中位TTP分别为5.87和3.6个月（危险比[HR] = 2.35，95%置信区间[CI] = 1.16-4.76，P = 0.015）。HAIC组中接受切除术的患者多于TACE组（10 vs. 3，P = 0.033）。HAIC组3-4级不良事件（AE）和严重不良事件（SAE）的比例低于TACE组（3-4级AE：13 vs. 27，P = 0.007; SAE：6 vs. 15，P = 0.044）。TACE组中因不可耐受的治疗相关不良事件或撤回知情同意而提前终止研究治疗的患者多于HAIC组（10 vs. 2，P = 0. 026）。HAIC联合mFOLFOX的治疗反应明显优于TACE，严重毒性也较TACE低。HAIC可能是一个可行的和有前途的一线治疗大规模不可切除的肝癌患者。
Transarterial chemoembolization (TACE) is recommended as the standard care for unresectable hepatocellular carcinoma (HCC) at Barcelona Clinic Liver Cancer (BCLC) stage A–B. However, the efficacy of TACE on large (≥ 10 cm) stage A–B HCC is far from satisfactory, and it is proposed that hepatic artery infusion chemotherapy (HAIC) might be a better first-line treatment of this disease. Hence, we compared the safety and efficacy of HAIC with the modified FOLFOX (mFOLFOX) regimen and those of TACE in patients with massive unresectable HCC. A prospective, non-randomized, phase II study was conducted on patients with massive unresectable HCC. The protocol involved HAIC with the mFOLFOX regimen (oxaliplatin, 85 mg/m2 intra-arterial infusion; leucovorin, 400 mg/m2 intra-arterial infusion; and fluorouracil, 400 mg/m2 bolus infusion and 2400 mg/m2 continuous infusion) every 3 weeks and TACE with 50 mg of epirubicin, 50 mg of lobaplatin, 6 mg of mitomycin, and lipiodol and polyvinyl alcohol particles. The tumor responses, time-to-progression (TTP), and safety were assessed. A total of 79 patients were recruited for this study: 38 in the HAIC group and 41 in the TACE group. The HAIC group exhibited higher partial response and disease control rates than did the TACE group (52.6% vs. 9.8%, P < 0.001; 83.8% vs. 52.5%, P = 0.004). The median TTPs for the HAIC and TACE groups were 5.87 and 3.6 months (hazard radio [HR] = 2.35, 95% confidence interval [CI] = 1.16–4.76, P = 0.015). More patients in the HAIC group than in the TACE group underwent resection (10 vs. 3, P = 0.033). The proportions of grade 3–4 adverse events (AE) and serious adverse events (SAE) were lower in the HAIC group than in the TACE group (grade 3–4 AEs: 13 vs. 27, P = 0.007; SAEs: 6 vs. 15, P = 0.044). More patients in the TACE group than in the HAIC group had the study treatment terminated early due to intolerable treatment-related adverse events or the withdrawal of consent (10 vs. 2, P = 0.026). HAIC with mFOLFOX yielded significantly better treatment responses and less serious toxicity than did TACE. HAIC might represent a feasible and promising first-line treatment for patients with massive unresectable HCC.
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DOI：
10.3350/kjhep.2010.16.4.355
发表时间：
2010-12
期刊：
The Korean journal of hepatology
影响因子：
--
作者：
Kim HY;Kim JD;Bae SH;Park JY;Han KH;Woo HY;Choi JY;Yoon SK;Jang BK;Hwang JS;Kim SG;Kim YS;Seo YS;Yim HJ;Um SH;Korean Liver Cancer Study Group
通讯作者：
Korean Liver Cancer Study Group
影响因子：
13.8
作者：
Lin, Chen-Chun;Hung, Chien-Fu;Lin, Shi-Ming
通讯作者：
Lin, Shi-Ming
影响因子：
45.3
作者：
Kemeny, NE;Niedzwiecki, D;Mayer, RJ
通讯作者：
Mayer, RJ
DOI：
10.1097/coc.0b013e31819d8668
发表时间：
2010-02-10
影响因子：
2.6
作者：
Rathore, Ritesh;Safran, Howard;Kennedy, Teresa
通讯作者：
Kennedy, Teresa
影响因子：
3.7
作者：
Tsai WL;Lai KH;Liang HL;Hsu PI;Chan HH;Chen WC;Yu HC;Tsay FW;Wang HM;Tsai HC;Cheng JS
通讯作者：
Cheng JS