载药微球与常规支气管动脉化疗栓塞术治疗晚期非小细胞肺癌的临床疗效及安全性对比

doi:10.3969/j.issn.1004-583X.2025.03.009

摘要/Abstract

摘要：

目的比较载药微球经支气管动脉化疗栓塞与常规的化疗栓塞术治疗晚期非小细胞肺癌(non-small cell lung cancer,NSCLC)的临床疗效及安全性。方法回顾性分析于2020年1月-2024年3月在华中科技大学同济医学院附属武汉市中心医院住院接受载药微球支气管动脉化疗栓塞(DEB-BACE)或常规的支气管动脉化疗栓塞术(cBACE)治疗的原发性NSCLC患者52例。所有患者既往均经全身化疗、放疗、靶向、免疫等一线治疗后局部进展或不可耐受,根据介入治疗方案的不同分为载药微球组(DEB-BACE组,n=25)与常规组(cBACE组,n=27)。对比两组短期临床疗效、无进展生存时间(progression-free survival, PFS)、总生存期(overall survival,OS)和术后不良反应发生情况。结果两组术前基线资料差异均无统计学意义(P>0.05)。术后1月、3月、6月、12月完全缓解均为0。术后6月两组客观缓解率(44.0% vs 14.8%,χ²= 5.387,P=0.020)和疾病控制率(84.0% vs 55.6%,χ²=4.930,P=0.026)差异均有统计学意义(P<0.05)。DEB-BACE组术后不良反应发生率低于cBACE组,差异有统计学意义(P<0.05),两组均无脊髓损失及异位栓塞等严重不良反应。截至2024年9月,所有患者随访时间为6~34个月,平均随访时间为(13.2±6.6)个月。DEB-BACE组的中位PFS、中位OS均优于cBACE组,差异均有统计学意义(P<0.05)。结论 CalliSpheres载药微球加载吉西他滨经支气管动脉化疗栓塞术比cBACE治疗晚期NSCLC显示出更好的临床疗效,并且术后不良反应率更低,是治疗晚期NSCLC的一种新型安全、有效的方法。

关键词: 癌, 非小细胞肺, 载药微球, 化疗栓塞术, 治疗结果, 安全性

Abstract:

Objective To compare the clinical efficacy and safety of drug-eluting beads bronchial artery chemoembolization (DEB-BACE) versus conventional BACE alone in the treatment of advanced non-small cell lung cancer (NSCLC). Methods A retrospective analysis was conducted in 52 patients with primary NSCLC who were treated with DEB-BACE or conventional BACE alone in Wuhan Central Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology from January 2020 to March 2024. All patients had local progression or intolerability after the first-line treatment, such as systemic chemotherapy, radiotherapy, targeting, and immunization. According to the different interventional treatment regimens, they were divided into the DEB-BACE group (n=25) and conventional BACE group (cBACE group, n=27). The short-term clinical efficacy, progression-free survival (PFS), overall survival (OS), and postoperative adverse events were compared between the two groups. Results There was no significant differences in preoperative baseline data between the two groups (P>0.05). Complete remission was 0 at 1 month, 3 months, 6 months and 12 months postoperatively. There were significant differences in the 6-month objective response rate ( 44.0% vs 14.8%, χ²=5.387, P=0.020) and 6-month disease control rate (84.0% vs 55.6%, χ²=4.930, P=0.026) between the two groups (P<0.05). The incidence of postoperative adverse events in the DEB-BACE group was significantly lower than that of the cBACE group (P<0.05). There were no serious adverse complications, such as spinal cord loss and ectopic embolism in both groups. As of September 2024, all patients were followed up for 6-34 months, with an average follow-up time of (13.2±6.6) months. Compared with the cBACE group, the median PFS and median OS of the DEB-BACE group were significantly better (P<0.05). Conclusion The use of CalliSpheres drug-eluting beads loaded with gemcitabine for BACE demonstrated a superior clinical efficacy compared to cBACE alone in the treatment of advanced NSCLC. It has a lower rate of postoperative adverse events, suggesting a new, safe, and effective treatment option for advanced NSCLC.

Key words: carcinoma, non-small-cell lung, drug-eluting beads, chemoembolization, treatment outcome, safety

中图分类号:

R730.26

黄兴舟, 郑卫华, 张树桐, 陈燕浩. 载药微球与常规支气管动脉化疗栓塞术治疗晚期非小细胞肺癌的临床疗效及安全性对比[J]. 临床荟萃, 2025, 40(3): 243-250.

Huang Xingzhou, Zheng Weihua, Zhang Shutong, Chen Yanhao. Clinical efficacy and safety of drug-eluting beads for bronchial artery chemoembolization versus conventional bronchial artery chemoembolization alone for advanced non-small cell lung cancer[J]. Clinical Focus, 2025, 40(3): 243-250.

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链接本文: https://lchc.magtechjournal.com/CN/10.3969/j.issn.1004-583X.2025.03.009

https://lchc.magtechjournal.com/CN/Y2025/V40/I3/243

图/表 6

参考文献 31

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项目	DEB-BACE组(n=25)	cBACE组(n=27)	t/χ²值	P值
年龄(岁)	67.6±8.6	67.3±6.7	0.125	0.901
性别[例(%)]
男女	16(64.0) 9(36.0)	18(66.7) 9(33.3)	0.410	0.840
吸烟史[例(%)]
是否	17(68.0) 8(32.0)	14(51.9) 13(48.1)	1.406	0.236
基础疾病[例(%)]
高血压	13(52.0)	9(33.3)	1.853	0.173
2型糖尿病	7(28.0)	4(14.8)	1.353	0.245
慢性阻塞性肺疾病	8(32.0)	7(25.9)	0.233	0.629
ECOG评分[例(%)]
0~1分 2分	19(76.0) 6(24.0)	22(81.5) 5(18.5)	0.234	0.629
肿瘤直径(mm)	51.9±20.6	49.7±19.9	0.381	0.705
病理类型[例(%)]
腺癌鳞癌	19(76.0) 6(24.0)	18(66.7) 9(33.3)	0.551	0.458
肿瘤分期[例(%)]
Ⅲ期 Ⅳ期	6(24.0) 19(76.0)	10(37.0) 17(63.0)	1.036	0.309
肿瘤位置[例(%)]
中央型周围型	14(56.0) 11(44.0)	12(44.4) 15(55.6)	0.693	0.405
并发症[例(%)]
咯血	8(32.0)	10(37.0)	0.146	0.703
胸腔积液	5(20.0)	9(33.3)	1.173	0.279
阻塞性肺炎或肺不张	24(96.0)	25(92.6)	0.000	1.000
干预次数[例(%)]
1~2次 ≥3次	16(64.0) 9(36.0)	21(77.8) 6(22.2)	1.201	0.273

项目	DEB-BACE组(n=25)	cBACE组(n=27)	t/χ²值	P值
年龄(岁)	67.6±8.6	67.3±6.7	0.125	0.901
性别[例(%)]
男女	16(64.0) 9(36.0)	18(66.7) 9(33.3)	0.410	0.840
吸烟史[例(%)]
是否	17(68.0) 8(32.0)	14(51.9) 13(48.1)	1.406	0.236
基础疾病[例(%)]
高血压	13(52.0)	9(33.3)	1.853	0.173
2型糖尿病	7(28.0)	4(14.8)	1.353	0.245
慢性阻塞性肺疾病	8(32.0)	7(25.9)	0.233	0.629
ECOG评分[例(%)]
0~1分 2分	19(76.0) 6(24.0)	22(81.5) 5(18.5)	0.234	0.629
肿瘤直径(mm)	51.9±20.6	49.7±19.9	0.381	0.705
病理类型[例(%)]
腺癌鳞癌	19(76.0) 6(24.0)	18(66.7) 9(33.3)	0.551	0.458
肿瘤分期[例(%)]
Ⅲ期 Ⅳ期	6(24.0) 19(76.0)	10(37.0) 17(63.0)	1.036	0.309
肿瘤位置[例(%)]
中央型周围型	14(56.0) 11(44.0)	12(44.4) 15(55.6)	0.693	0.405
并发症[例(%)]
咯血	8(32.0)	10(37.0)	0.146	0.703
胸腔积液	5(20.0)	9(33.3)	1.173	0.279
阻塞性肺炎或肺不张	24(96.0)	25(92.6)	0.000	1.000
干预次数[例(%)]
1~2次 ≥3次	16(64.0) 9(36.0)	21(77.8) 6(22.2)	1.201	0.273

组别	例数		术后1月												术后3月
组别	例数		CR		PR [例(%)]		SD [例(%)]		PD [例(%)]		ORR (%)		DCR (%)		CR	PR [例(%)]	SD [例(%)]	PD [例(%)]	ORR (%)	DCR (%)
DEB-BACE组	25		0		13(52.0)		12(48.0)		0		52.0		100.0		0	13(52.0)	11(44.0)	1(4.0)	52.0	96.0
cBACE组	27		0		9(33.3)		16(59.3)		2(7.4)		33.3		92.6		0	8(29.6)	15(55.6)	4(14.8)	29.6	85.2
组别		术后6月												术后12月
组别		CR		PR [例(%)]		SD [例(%)]		PD [例(%)]		ORR (%)		DCR (%)		CR		PR [例(%)]	SD [例(%)]	PD [例(%)]	ORR (%)	DCR (%)
DEB-BACE组		0		11(44.0)		10(40.0)		4(16.0)		44.0		84.0		0		4(16.0)	2(8.0)	19(76.0)	16.0	24.0
cBACE组		0		4(14.8)		11(40.7)		12(44.4)		14.8		55.6		0		2(7.4)	1(3.7)	24(88.9)	7.4	11.1

组别	例数		术后1月												术后3月
组别	例数		CR		PR [例(%)]		SD [例(%)]		PD [例(%)]		ORR (%)		DCR (%)		CR	PR [例(%)]	SD [例(%)]	PD [例(%)]	ORR (%)	DCR (%)
DEB-BACE组	25		0		13(52.0)		12(48.0)		0		52.0		100.0		0	13(52.0)	11(44.0)	1(4.0)	52.0	96.0
cBACE组	27		0		9(33.3)		16(59.3)		2(7.4)		33.3		92.6		0	8(29.6)	15(55.6)	4(14.8)	29.6	85.2
组别		术后6月												术后12月
组别		CR		PR [例(%)]		SD [例(%)]		PD [例(%)]		ORR (%)		DCR (%)		CR		PR [例(%)]	SD [例(%)]	PD [例(%)]	ORR (%)	DCR (%)
DEB-BACE组		0		11(44.0)		10(40.0)		4(16.0)		44.0		84.0		0		4(16.0)	2(8.0)	19(76.0)	16.0	24.0
cBACE组		0		4(14.8)		11(40.7)		12(44.4)		14.8		55.6		0		2(7.4)	1(3.7)	24(88.9)	7.4	11.1

组别	例数	发热	恶心呕吐	胸痛或胸闷	骨髓抑制	总计
DEB-BACE组	25	1(4.0)	4(16.0)	3(12.0)	0	8(32.0)
cBACE组	27	3(11.1)	5(18.5)	6(22.2)	3(11.1)	17(63.0)
χ²值						4.985
P值						0.026