A systematic review of transarterial chemoembolization with irinotecan beads in treatment of colorectal liver metastases

doi:10.3877/cma.j.issn.2095-5782.2017.04.015

Abstract

Abstract:

Objective:

To systematicly evaluate the efficacy and safety of transarterial embolization with drug-eluting beads of irinotecan (DEBIRI) for treatment of unresectable colorectal liver metastasis (CRLM) .

Methods:

A comprehensive search of medical literature identified the studies describing the use of DEBIRI in treatment of CRLM. Data describing adverse events, pharmacokinetics, tumor response, and overall survival were collected.

Results:

Eight observational studies and two randomized controlled trials (RCTs) were reviewed. A total of 578 patients were included in the descriptive analysis of observational studies. Postembolization syndrome was the most common adverse event. Peak plasma levels of irinotecan were observed after 1~2 h of administration. Wide variations in tumor response were observed. The median survival time ranged from 5.4 months to 25 months. In the two RCTs, treatment with DEBIRI was superior to systemic chemotherapy with 5-fluorouracil/leucovorin/irinotecan in terms of overall response rate and progression-free survival.

Conclusions:

For patients with unresectable CRLM, particularly after failure to respond to first-line regimens, DEBIRI represents a novel alternative to systemic chemotherapy alone or other local treatments.

Key words: Colorectal liver metastasis, Irinotecan, Drug-eluting beads

Xinjian Xu, Fei Teng, Hongtao Du. A systematic review of transarterial chemoembolization with irinotecan beads in treatment of colorectal liver metastases[J]. Chinese Journal of Interventional Radiology(Electronic Edition), 2017, 05(04): 273-281.

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References 30

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作者，发表年份	例数	年龄（岁）	纳入标准	排除标准	早期化疗史	中位生存期	治疗6个月反应率	不良反应事件
Martin 2011	55	60 (34～82)	确诊肝脏转移瘤；患者曾有化疗病史	NS	FOLFOX联合贝伐单抗(n= 17);FOLFOX联合贝伐单抗、FOLFIRI、西妥昔单抗(n =14); ≥3种化疗方案(n=14)	19个月	CR(n=7); PR(n=21); SD(n=19); PD(n=8); DOD(n=5)	总事件数(n=28)；Grade1/2(n=21); Grade≥3(n=7);肝功能异常(n=3)；胆囊炎(n=1)；厌食症(n=1)；心肌梗死致死(n=1)
Aliberti 2011	82	61.8 (46～82)	组织学检查证实肝脏转移瘤；手术史；肝脏肿瘤负荷(25%-50%)	ECOG评分<2；营养损害；肝肾储备功能欠佳；腹水；门静脉血栓	≥2种全身化疗联合PD方案；化疗不敏感	25月(6~34月)；2例患者术后14月及18月接受根治切除治疗	NS	Grade1/2(NS); Grade3疼痛(n=20)
Vogl 2012	77	61 (36～78)	不可切除肝转移瘤；手术禁忌或患者拒绝手术；毒副作用；化疗不敏感	肝外转移；肝脏肿瘤负荷>70%；肝肾储备功能欠佳；门静脉部分/完全血栓形成；呼吸/心脏衰竭	所有患者（奥沙利铂）	22.5月(7~70月)；部分合并残余肿瘤患者接受激光热疗	NS	总事件数(NS)；均为Grade1/2.
Eichler 2012	11	64 (45～85)	1-8个肝内转移瘤；ECOG评分≤1；预期生存期>6月；肝肾储备功能良好	肝外转移；肿瘤/肝脏体积比>30；伊立替康禁忌；活动性细菌、病毒、真菌感染；伴发其他恶性肿瘤	8例患者	NS	PD(n=7); SD(n=2); PR(n=2)	总事件数(n=41)；疼痛(63%)；恶心(22%);呕吐(19.5%)；61%轻度，31%中度。
Martin 2012	10	63 (48～84)	肝内转移瘤数量≥1，直径>1cm；肝脏肿瘤负荷≥80%；肿瘤/肝脏体积比<60%；门脉主干通畅；ECOG评分≤2；预期生存期>3月	根治治疗（切除或射频消融）	无	15.2月(6.5~45.5月)；4例患者接受根治性手术切除	CR(n=8); DOD(n=1); Not assessed(n=1)	总事件数(n=99)；高血压(80%)；腹痛(40%);恶心(40%)；Grade1/2(n= 9); Grade3(n=1)
Fiorentini 2012(RCT)	36	64 (44～77)	组织学检查证实不可切除的肝脏转移瘤；肝脏肿瘤负荷(<0%)	肝外转移；先前肝肿瘤消融病史；栓塞治疗病史；腹水；肝肾储备功能欠佳	≥2种全身化疗方案	NS	NS	总事件数(n=77)；Grade2/3；疼痛(30%);呕吐(25%)；疲乏(20%)；发热(15%)
作者，发表年份	例数	年龄（岁）	纳入标准	排除标准	早期化疗史	中位生存期	治疗6个月反应率	不良反应事件
M. Stutz 2015	27	57 (45～82)	组织学检查证实不可切除的肝脏转移瘤；化疗不敏感；ECOG评分≤2	NS	15例患者曾接受手术治疗（肝叶切除，射频消融或联合治疗）；所有患者对至少1种化疗方案不敏感（1≤n≤5）	5.4月(1.1~22.7月）	NS	总事件数(n=51)；疼痛(16/27，59.3%)；恶心(8/27，30%);呕吐(6/26，22%)；疲乏(9/27，33%)。
Roberto Iezzi 2015	20	65.8 (52～77)	年龄≥18岁；不可切除肝转移瘤；肝脏肿瘤负荷≥80%；肿瘤/肝脏体积比< 60%;化疗不敏感；ECOG评分≤2；肝肾储备功能良好；预期生存期>3月	曾接受卡培他滨化疗方案；伊立替康禁忌；严重外周血管及心脏疾病；严重合并症如恶性高血压，充血性心衰，慢性肾病等；脑转移瘤；妊娠或哺乳期妇女	4例患者接受肝叶/段切除术；所有患者对至少2种化疗方案不敏感	7.3月	PR(n=2); SD(n=10);	总事件数(n=66)；Grade1/2(n=64):恶心/呕吐(n=8)；疲乏(n=8)；疼痛(n=4) Grade3/4(n=2):腹泻(n=1)；心绞痛(n=1)
Robert C 2015(RCT)	40	57	年龄≥18岁；组织学证实肝转移瘤；肝脏肿瘤负荷≥80%；肿瘤/肝脏体积比<60%;所有患者均为初次化疗；ECOG评分≤2	适合根治治疗（如手术或射频消融治疗）	无	NS	CR/PR(n=33); SD(n=3); PD(n=5)	总事件数(n=973)；血液/淋巴系统事件(n=90):心脏事件(n=10)；胃肠道事件(n=206)；肝胆事件(n=13)：感染事件(n=27)；肺事件(n=46)；皮肤事件(n=37);血管事件(n=38)；神经系统事件(75)
?	?	?	?	?	?	?	?	grade3/4(n=144)
Neal Bhutiani 2016	296	63 (32～86)	年龄≥18岁；不可切除肝转移瘤；肝脏肿瘤负荷>50%；化疗不敏感；明确描述化疗方案；ECOG评分≤2	对比剂过敏；难以纠正的凝血功能障碍；严重的外周血管疾病；肝外肿瘤负荷>50%；肿瘤/肝脏体积比>75%;重度肝功能异常；活动性感染	所有患者对至少1种化疗方案不敏感	NS	CR(n=74); PR(n=69); SD(n=76); PD(n=106); DOD(n=29)	总事件数(n=105)；Grade1/2(n=74)疼痛(n=20)；恶心(n =15):呕吐(n=17)；肝功能异常/衰竭(n=9);厌食(n=3)：感染(n=6)；心律失常(n=4)；呼吸衰竭(n=1)
?	?	?	?	?	?	?	?	Grade3/4(n=31)

作者，发表年份	例数	年龄（岁）	纳入标准	排除标准	早期化疗史	中位生存期	治疗6个月反应率	不良反应事件
Martin 2011	55	60 (34～82)	确诊肝脏转移瘤；患者曾有化疗病史	NS	FOLFOX联合贝伐单抗(n= 17);FOLFOX联合贝伐单抗、FOLFIRI、西妥昔单抗(n =14); ≥3种化疗方案(n=14)	19个月	CR(n=7); PR(n=21); SD(n=19); PD(n=8); DOD(n=5)	总事件数(n=28)；Grade1/2(n=21); Grade≥3(n=7);肝功能异常(n=3)；胆囊炎(n=1)；厌食症(n=1)；心肌梗死致死(n=1)
Aliberti 2011	82	61.8 (46～82)	组织学检查证实肝脏转移瘤；手术史；肝脏肿瘤负荷(25%-50%)	ECOG评分<2；营养损害；肝肾储备功能欠佳；腹水；门静脉血栓	≥2种全身化疗联合PD方案；化疗不敏感	25月(6~34月)；2例患者术后14月及18月接受根治切除治疗	NS	Grade1/2(NS); Grade3疼痛(n=20)
Vogl 2012	77	61 (36～78)	不可切除肝转移瘤；手术禁忌或患者拒绝手术；毒副作用；化疗不敏感	肝外转移；肝脏肿瘤负荷>70%；肝肾储备功能欠佳；门静脉部分/完全血栓形成；呼吸/心脏衰竭	所有患者（奥沙利铂）	22.5月(7~70月)；部分合并残余肿瘤患者接受激光热疗	NS	总事件数(NS)；均为Grade1/2.
Eichler 2012	11	64 (45～85)	1-8个肝内转移瘤；ECOG评分≤1；预期生存期>6月；肝肾储备功能良好	肝外转移；肿瘤/肝脏体积比>30；伊立替康禁忌；活动性细菌、病毒、真菌感染；伴发其他恶性肿瘤	8例患者	NS	PD(n=7); SD(n=2); PR(n=2)	总事件数(n=41)；疼痛(63%)；恶心(22%);呕吐(19.5%)；61%轻度，31%中度。
Martin 2012	10	63 (48～84)	肝内转移瘤数量≥1，直径>1cm；肝脏肿瘤负荷≥80%；肿瘤/肝脏体积比<60%；门脉主干通畅；ECOG评分≤2；预期生存期>3月	根治治疗（切除或射频消融）	无	15.2月(6.5~45.5月)；4例患者接受根治性手术切除	CR(n=8); DOD(n=1); Not assessed(n=1)	总事件数(n=99)；高血压(80%)；腹痛(40%);恶心(40%)；Grade1/2(n= 9); Grade3(n=1)
Fiorentini 2012(RCT)	36	64 (44～77)	组织学检查证实不可切除的肝脏转移瘤；肝脏肿瘤负荷(<0%)	肝外转移；先前肝肿瘤消融病史；栓塞治疗病史；腹水；肝肾储备功能欠佳	≥2种全身化疗方案	NS	NS	总事件数(n=77)；Grade2/3；疼痛(30%);呕吐(25%)；疲乏(20%)；发热(15%)
作者，发表年份	例数	年龄（岁）	纳入标准	排除标准	早期化疗史	中位生存期	治疗6个月反应率	不良反应事件
M. Stutz 2015	27	57 (45～82)	组织学检查证实不可切除的肝脏转移瘤；化疗不敏感；ECOG评分≤2	NS	15例患者曾接受手术治疗（肝叶切除，射频消融或联合治疗）；所有患者对至少1种化疗方案不敏感（1≤n≤5）	5.4月(1.1~22.7月）	NS	总事件数(n=51)；疼痛(16/27，59.3%)；恶心(8/27，30%);呕吐(6/26，22%)；疲乏(9/27，33%)。
Roberto Iezzi 2015	20	65.8 (52～77)	年龄≥18岁；不可切除肝转移瘤；肝脏肿瘤负荷≥80%；肿瘤/肝脏体积比< 60%;化疗不敏感；ECOG评分≤2；肝肾储备功能良好；预期生存期>3月	曾接受卡培他滨化疗方案；伊立替康禁忌；严重外周血管及心脏疾病；严重合并症如恶性高血压，充血性心衰，慢性肾病等；脑转移瘤；妊娠或哺乳期妇女	4例患者接受肝叶/段切除术；所有患者对至少2种化疗方案不敏感	7.3月	PR(n=2); SD(n=10);	总事件数(n=66)；Grade1/2(n=64):恶心/呕吐(n=8)；疲乏(n=8)；疼痛(n=4) Grade3/4(n=2):腹泻(n=1)；心绞痛(n=1)
Robert C 2015(RCT)	40	57	年龄≥18岁；组织学证实肝转移瘤；肝脏肿瘤负荷≥80%；肿瘤/肝脏体积比<60%;所有患者均为初次化疗；ECOG评分≤2	适合根治治疗（如手术或射频消融治疗）	无	NS	CR/PR(n=33); SD(n=3); PD(n=5)	总事件数(n=973)；血液/淋巴系统事件(n=90):心脏事件(n=10)；胃肠道事件(n=206)；肝胆事件(n=13)：感染事件(n=27)；肺事件(n=46)；皮肤事件(n=37);血管事件(n=38)；神经系统事件(75)
?	?	?	?	?	?	?	?	grade3/4(n=144)
Neal Bhutiani 2016	296	63 (32～86)	年龄≥18岁；不可切除肝转移瘤；肝脏肿瘤负荷>50%；化疗不敏感；明确描述化疗方案；ECOG评分≤2	对比剂过敏；难以纠正的凝血功能障碍；严重的外周血管疾病；肝外肿瘤负荷>50%；肿瘤/肝脏体积比>75%;重度肝功能异常；活动性感染	所有患者对至少1种化疗方案不敏感	NS	CR(n=74); PR(n=69); SD(n=76); PD(n=106); DOD(n=29)	总事件数(n=105)；Grade1/2(n=74)疼痛(n=20)；恶心(n =15):呕吐(n=17)；肝功能异常/衰竭(n=9);厌食(n=3)：感染(n=6)；心律失常(n=4)；呼吸衰竭(n=1)
?	?	?	?	?	?	?	?	Grade3/4(n=31)

作者，发表年份	治疗方案	微球类型	微球直径（μm）	伊立替康浓度(mg/ml)	平均总剂量(mg)	每次栓塞治疗平均剂量(mg)	每例患者平均（中位）栓塞次数
Martin 2011	16例(16/55)患者DEBIRI联合卡培他滨或灌注5-FU	DC	100-300, 300-500，500-700	25	185	100	1.8(2)
Aliberti 2011	DEBIRI单药治疗	DC	100-300, 300-500	50	352	156	2.3(2.2)
Vogl	DEBIRI单药治疗；每四周接受一次	SM	NS	NS	NS	150 mg/m² BSA	3.2
2012	DEBIRI（≥3次）	?	?	?	?	?	?
Eichler 2012	每三周接受一次DEBIRI（≤4次）	DC	100-300,300-500	50	293	73	4(4)
Martin	0/14天标准化疗方案(FOLFOX)，7/	DC	100-300	50	280	100	2.8(2.5)
2012	21天接受DEBIRI	?	?	?	?	?	?
Fiorentini 2012(RCT)	DEBIRI单药治疗；1月后剂量加倍	DC	100-300	50	400	200	2(2)
M. Stutz 2015	DEBIRI单药治疗	DC	100-300	50	138	106	1.3
Roberto Iezzi 2015	DEBIRI联合卡培他滨	DC	<150	50	270	100	2.7(3)
Robert C 2015(RCT)	0/14天标准化疗方案(FOLFOX)，7/ 21天接受DEBIR	DC	100-300	50	290	100	2.9(4)
Neal Bhutiani 2016	DEBIRI单药治疗	DC	75-150,100-300，300-500, 500-700	50	230	100	2.3

作者，发表年份	治疗方案	微球类型	微球直径（μm）	伊立替康浓度(mg/ml)	平均总剂量(mg)	每次栓塞治疗平均剂量(mg)	每例患者平均（中位）栓塞次数
Martin 2011	16例(16/55)患者DEBIRI联合卡培他滨或灌注5-FU	DC	100-300, 300-500，500-700	25	185	100	1.8(2)
Aliberti 2011	DEBIRI单药治疗	DC	100-300, 300-500	50	352	156	2.3(2.2)
Vogl	DEBIRI单药治疗；每四周接受一次	SM	NS	NS	NS	150 mg/m² BSA	3.2
2012	DEBIRI（≥3次）	?	?	?	?	?	?
Eichler 2012	每三周接受一次DEBIRI（≤4次）	DC	100-300,300-500	50	293	73	4(4)
Martin	0/14天标准化疗方案(FOLFOX)，7/	DC	100-300	50	280	100	2.8(2.5)
2012	21天接受DEBIRI	?	?	?	?	?	?
Fiorentini 2012(RCT)	DEBIRI单药治疗；1月后剂量加倍	DC	100-300	50	400	200	2(2)
M. Stutz 2015	DEBIRI单药治疗	DC	100-300	50	138	106	1.3
Roberto Iezzi 2015	DEBIRI联合卡培他滨	DC	<150	50	270	100	2.7(3)
Robert C 2015(RCT)	0/14天标准化疗方案(FOLFOX)，7/ 21天接受DEBIR	DC	100-300	50	290	100	2.9(4)
Neal Bhutiani 2016	DEBIRI单药治疗	DC	75-150,100-300，300-500, 500-700	50	230	100	2.3

作者，发表年份	首次造影	栓塞靶区选择	栓塞终点
Martin 2011	股动脉穿刺肝动脉造影确定肝动脉起点	肝叶动脉水平栓塞	NS
Aliberti 2011	选择性动脉插管造影评估肝动脉血供及肠系膜动脉造影排除附属肝动脉；导管头端超过胃十二指肠动脉开口水平	肝叶/段动脉水平栓塞	5分钟内缓慢推注微球，栓塞终点NS
Vogl 2012	选择性动脉插管造影评估肝动脉血供；导管头超过胃十二指肠动脉开口水平	段/亚段水平栓塞	血管造影见血流停滞时停止载药微球栓塞
Eichler 2012	诊断性造影评估肝动脉血供及门脉通畅性	超选择性插管，避开胆囊动脉至病灶近端	出现血流停滞时停止载药微球栓塞，未使用其他栓塞物质
Martin 2012	股动脉穿刺肝动脉造影确定肝动脉起点	肝叶动脉水平栓塞	NS
Fiorentini 2012(RCT)	NS	超选择性至肿瘤滋养血管栓塞	NS
M. Stutz 2015	股动脉穿刺肝动脉造影确定肝动脉起点	肝叶/段动脉水平栓塞	造影见血流停滞时停止载药微球栓塞
Roberto Iezzi 2015	诊断性造影评估肝动脉血供及门脉通畅性	肝叶动脉水平栓塞	造影见血流停滞时停止载药微球栓塞
Robert C 2015(RCT)	股动脉穿刺肝动脉造影确定肝动脉起点	肝叶动脉水平栓塞	NS
Neal Bhutiani 2016	股动脉穿刺肝动脉造影确定肝动脉起点	肝叶动脉水平栓塞	NS

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