载药微球动脉化疗栓塞术治疗中国肝细胞肝癌患者的疗效、安全性及预后因素的研究。
An investigation of efficacy, safety, and prognostic factors of drug-eluting beads-transarterial chemoembolization operation with CalliSpheres Microspheres in treating Chinese hepatocellular carcinoma patients.
机构信息
Department of Radiology, The First Affiliated Hospital, Zhejiang University, Hangzhou, China.
Department of Radiology, Shengzhou People's Hospital, Shengzhou, China.
出版信息
J Clin Lab Anal. 2019 Oct;33(8):e22975. doi: 10.1002/jcla.22975. Epub 2019 Jul 22.
BACKGROUND
We aimed to investigate treatment response, survival profiles, safety profiles, and predictive factors of drug-eluting beads-transarterial chemoembolization (DEB-TACE) with CalliSpheres Microspheres (CSM) in treating Chinese hepatocellular carcinoma (HCC) patients.
METHODS
A total of 66 HCC patients about to receive DEB-TACE with CSM therapy were consecutively enrolled in this prospective cohort study. Treatment response was recorded. Besides, progression-free survival (PFS) and overall survival (OS) were also recorded. All adverse events including pain, nausea, vomiting, fever, and liver function damage were recorded during hospitalization.
RESULTS
37.9% of patients achieved complete response (CR) and 81.8% of patients achieved an objective response rate (ORR). For survival, mean PFS and OS were 13.7 (11.7-15.8) months and 18.8 (95% CI: 16.3-21.2) months, respectively. Multivariate logistic regression analysis revealed that a number of nodules ≥2 was an independent factor for worse CR; moreover, multivariate Cox's regression analysis disclosed that largest sample size ≥5 cm was an independent factor for shorter PFS, and Child-Pugh B and BCLC stage B/C were independent predictive factors for unfavorable OS. As to AEs, numbers of patients suffered liver function damage, pain, nausea, vomiting, and fever were 29 (43.9%), 27 (40.9%), 22 (33.3%), 13 (19.7%), and 37 (56.1%), respectively.
CONCLUSION
Drug-eluting beads-transarterial chemoembolization with CSM is an effective and tolerated treatment for Chinese HCC patients, and number of nodules ≥2, largest nodule size ≥5 cm, Child-Pugh stage B, and BCLC stage B/C correlates with unfavorable prognosis.
背景
本研究旨在探讨 CalliSpheres 微球载药栓塞剂（CSM）行载药微球动脉化疗栓塞术（DEB-TACE）治疗中国肝细胞癌（HCC）患者的疗效、生存状况、安全性及预测因素。
方法
本前瞻性队列研究连续纳入 66 例行 DEB-TACE 治疗的 HCC 患者。记录治疗反应，无进展生存期（PFS）和总生存期（OS）。所有不良反应（包括疼痛、恶心、呕吐、发热和肝功能损害）均在住院期间记录。
结果
37.9%的患者达到完全缓解（CR），81.8%的患者达到客观缓解率（ORR）。中位 PFS 和 OS 分别为 13.7（11.7-15.8）个月和 18.8（95%CI：16.3-21.2）个月。多因素逻辑回归分析显示，结节数≥2 是影响 CR 的独立因素；此外，多因素 Cox 回归分析显示，最大样本大小≥5 cm 是影响 PFS 的独立因素，而 Child-Pugh B 级和 BCLC 分期 B/C 是影响 OS 的独立预测因素。AE 方面，有 29 例（43.9%）患者发生肝功能损害，27 例（40.9%）患者发生疼痛，22 例（33.3%）患者发生恶心，13 例（19.7%）患者发生呕吐，37 例（56.1%）患者发生发热。
结论
CSM 载药微球动脉化疗栓塞术是一种有效且可耐受的治疗中国 HCC 患者的方法，结节数≥2、最大结节大小≥5 cm、Child-Pugh 分级 B 和 BCLC 分期 B/C 与不良预后相关。
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