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  • 张锡武,陈莹,黄娟,谢青,段克修,詹世林,王伟中.CalliSpheres®载药微球化学栓塞治疗中早期肝细胞癌患者的疗效、安全性及预后因素分析[J].第二军医大学学报,2019,40(4):399-407    [点击复制]
  • ZHANG Xi-wu,CHEN Ying,HUANG Juan,XIE Qing,DUAN Ke-xiu,ZHAN Shi-lin,WANG Wei-zhong.Efficacy, safety and prognostic factors of CalliSpheres® drug-eluting bead-transarterial chemoembolization in patients with early and middle stage hepatocellular carcinoma[J].Acad J Sec Mil Med Univ,2019,40(4):399-407   [点击复制]
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CalliSpheres®载药微球化学栓塞治疗中早期肝细胞癌患者的疗效、安全性及预后因素分析
张锡武1,陈莹1,黄娟1,谢青1,段克修1,詹世林2,王伟中1*
0
(1. 解放军南部战区总医院介入室, 广州 510010;
2. 解放军南部战区总医院肝胆外科, 广州 510010
*通信作者)
摘要:
目的 评估载药微球经动脉化学栓塞术(DEB-TACE)治疗中早期肝细胞癌(HCC)患者的疗效、安全性及预后因素。方法 本研究为前瞻性队列研究,连续纳入接受DEB-TACE治疗的中早期HCC患者26例。记录患者的围手术期不良事件,根据改良实体瘤疗效评价标准(mRECIST)评估患者治疗后影像学检查结果。随访至2017年12月20日,记录患者无进展生存期(PFS)和总生存期(OS),采用多变量logistic回归模型和Cox比例风险回归模型分析影响疗效和预后的因素。结果 26例患者共接受了32次DEB-TACE。记录到31次治疗的不良事件发生情况,围手术期发生疼痛频次为15次(48.4%),包括轻度疼痛10次(32.3%)、中度疼痛5次(16.1%);发生发热频次为10次(32.3%);发生胃肠道反应频次为5次(16.1%)。DEB-TACE治疗后3个月内,患者总缓解率(ORR)为65.4%(17/26),疾病控制率(DCR)为84.6%(22/26)。治疗前肿瘤最大直径<50 mm的患者ORR高于肿瘤最大直径≥50 mm的患者[92.3%(12/13)vs 38.5%(5/13),P=0.013)],巴塞罗那分期A期的患者ORR高于B期患者[81.3%(13/16)vs 40.0%(4/10),P=0.031]。随访2.9~20.0个月(中位随访时间7.2个月),患者的中位PFS为11.9个月(95% CI:5.0~18.9个月),中位OS为14.6个月(95% CI:9.9~19.2个月)。多变量logistic回归模型分析结果显示肿瘤最大直径≥50 mm是患者ORR较差的独立预测因素(P=0.036),Cox比例风险回归模型分析显示无临床病理特征能够独立预测患者的PFS和OS。结论 DEB-TACE治疗对于中早期HCC患者具有良好的疗效及安全性,肿瘤最大直径≥50 mm可作为评估患者临床应答的独立预测因素。
关键词:  载药微球经动脉化学栓塞术  肝肿瘤  肝细胞癌  治疗结果  安全性  预后
DOI:10.16781/j.0258-879x.2019.04.0399
投稿时间:2018-11-12修订日期:2019-01-15
基金项目:
Efficacy, safety and prognostic factors of CalliSpheres® drug-eluting bead-transarterial chemoembolization in patients with early and middle stage hepatocellular carcinoma
ZHANG Xi-wu1,CHEN Ying1,HUANG Juan1,XIE Qing1,DUAN Ke-xiu1,ZHAN Shi-lin2,WANG Wei-zhong1*
(1. Intervention Section, General Hospital of Southern Theater Command of PLA, Guangzhou 510010, Guangdong, China;
2. Department of Hepatobiliary Surgery, General Hospital of Southern Theater Command of PLA, Guangzhou 510010, Guangdong, China
*Corresponding author)
Abstract:
Objective To explore the efficacy, safety and prognostic factors of drug-eluting bead-transarterial chemoembolization (DEB-TACE) in treatment of the patients with early and middle stage hepatocellular carcinoma (HCC). Methods Twenty-six early and middle stage HCC patients receiving DEB-TACE treatment were enrolled in this prospective cohort study. Modified response evaluation criteria in solid tumors (mRECIST) was used to evaluate the efficacy of DEB-TACE treatment. The deadline for follow-up was Dec. 20, 2017, and the progression free survival (PFS) and overall survival (OS) were recorded. Multivariate logistic regression model and Cox proportional regression model were used to analyze the factors affecting the efficacy and prognosis. Results A total of 32 DEB-TACE treatment were performed in 26 patients. Treatment-related adverse events were recorded in 31 DEB-TACE treatments. Perioperative pain frequency was 15 times (48.4%), including mild pain 10 times (32.3%) and moderate pain 5 times (16.1%); and fever frequency was 10 times (32.3%) and gastrointestinal reaction was 5 times (16.1%). Within 3 months of DEB-TACE treatment, the overall response rate (ORR) was 65.4% (17/26), and disease control rate (DCR) was 84.6% (22/26). Compared with the patients with maximum diameter of tumors ≥ 50 mm, the patients with maximum diameter of tumors<50 mm had a significantly higher ORR (92.3%[12/13] vs 38.5%[5/13], P=0.013). Compared with the patients with Barcelona stage B, the patients with Barcelona stage A had a significantly higher ORR (81.3%[13/16] vs 40.0%[4/10], P=0.031). The follow-up ranged from 2.9 to 20.0 months (median 7.2 months), median PFS was 11.9 months (95% CI 5.0-18.9 months), and median OS was 14.6 months (95% CI 9.9-19.2 months). Multivariate logistic regression revealed that tumor maximum diameter ≥ 50 mm was an independent predictor of poor ORR (P=0.036). Cox proportional regression model analysis showed that no clinicopathological characteristics were independent predictors of PFS or OS. Conclusion DEB-TACE treatment is an effective and safe method for early and middle stage HCC patients, and maximum diameter of tumor ≥ 50 mm can be used as an independent prognostic biomarker.
Key words:  drug-eluting bead-transarterial chemoembolization  liver neoplasms  hepatocellular carcinoma  outcomes  safety  prognosis