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雷替曲塞联合奥沙利铂经动脉化疗栓塞术治疗不可切除肝细胞癌患者的疗效与安全性

Efficacy And Safety Of Raltitrexed Plus Oxaliplatin-Based Transarterial Chemoembolization In Patients With Unresectable Hepatocellular Carcinoma.

作者信息

Shao Wenbo, Li Caixia, Tang Jun, Song Jinlong, Li Zixiang, Sun Jize, Xu Yili, Zheng Zhaomin, Cao Jingqin, Zhang Lei

机构信息

Department of Surgical Oncology (Interventional Therapy), Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, People's Republic of China.

Department of Interventional Radiology, Qilu Hospital of Shandong University, Jinan, People's Republic of China.

出版信息

Cancer Manag Res. 2019 Nov 19;11:9863-9869. doi: 10.2147/CMAR.S217524. eCollection 2019.

Abstract

OBJECTIVE

To evaluate the efficacy and safety of raltitrexed plus oxaliplatin-based transarterial chemoembolization (TACE) in patients with unresectable hepatocellular carcinoma (HCC).

METHODS

A total of 123 patients with unresectable HCC were recruited into the prospective cohort study. Raltitrexed plus oxaliplatin-based TACE was performed according to the traditional method at monthly intervals and was repeated for up to 4 cycles if no disease progression or intolerable toxicity occurred. The primary efficacy endpoint was overall survival (OS), and the secondary endpoints were progression-free survival (PFS) and tumor response rate. The Cox proportional-hazards regression model was used to assess the independent prognostic factors of OS. Adverse events were also observed.

RESULTS

The median OS time and PFS were 623 days (95% CI: 461, 785) and 338 days (95% CI: 302, 704), respectively. The disease control rate was 95.5% (118/123). The Cox proportional-hazards regression model indicated that age, ECOG performance status and response to TACE as independent prognostic factors of OS. No treatment-related mortality occurred within 30 days of treatment procedure. The most common complications included postembolization syndrome, liver dysfunction and hematological toxicity. Grade 3 pain, transglutaminase abnormality and thrombocytopenia were observed in 16 (13%), 15 (12.2%) and 3 (2.4%) patients, respectively. No grade 4 adverse events were observed.

CONCLUSION

Raltitrexed plus oxaliplatin-based TACE led to high tumor response rate and promising PFS and OS, and was considered safe and tolerable in patients with unresectable HCC.

摘要

目的

评估雷替曲塞联合奥沙利铂经动脉化疗栓塞术(TACE)治疗不可切除肝细胞癌(HCC)患者的疗效和安全性。

方法

共纳入123例不可切除HCC患者进行前瞻性队列研究。按照传统方法每月进行1次雷替曲塞联合奥沙利铂的TACE治疗,若未出现疾病进展或不可耐受的毒性反应,则重复治疗最多4个周期。主要疗效终点为总生存期(OS),次要终点为无进展生存期(PFS)和肿瘤缓解率。采用Cox比例风险回归模型评估OS的独立预后因素。同时观察不良事件。

结果

中位OS时间和PFS分别为623天(95%CI:461,785)和338天(95%CI:302,704)。疾病控制率为95.5%(118/123)。Cox比例风险回归模型表明,年龄、东部肿瘤协作组(ECOG)体能状态和对TACE的反应是OS的独立预后因素。治疗过程30天内未发生与治疗相关的死亡。最常见的并发症包括栓塞后综合征、肝功能障碍和血液学毒性。分别有16例(13%)、15例(12.2%)和3例(2.4%)患者出现3级疼痛、转谷氨酰胺酶异常和血小板减少。未观察到4级不良事件。

结论

雷替曲塞联合奥沙利铂的TACE导致高肿瘤缓解率以及有前景的PFS和OS,且在不可切除HCC患者中被认为是安全且可耐受的。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9be9/6875237/6c2fb58ac824/CMAR-11-9863-g0001.jpg

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