Zheng J, Shao G, Luo J
Department of Interventional Radiology, Zhejiang Cancer Hospital, No. 38 Guangji Road, Banshanqiao, Hangzhou, 310022, China,
Clin Transl Oncol. 2014 Nov;16(11):1012-7. doi: 10.1007/s12094-014-1189-3. Epub 2014 Jun 4.
To retrospectively analyze the efficacy and safety of transcatheter arterial chemoembolization (TACE) in combination with sorafenib for the treatment of patients with intermediate-advanced hepatocellular carcinoma (HCC) and assess the prognostic impact of baseline characteristics.
Patients with intermediate-advanced HCC received TACE combined with sorafenib in this Phase 2 clinical trial. The primary outcome was median time to disease progression (mTTP). Secondary outcomes were median overall survival (mOS), the disease benefit rate and the sorafenib-related adverse events (AEs). Baseline characteristics' impacts on prognosis were analyzed by univariate COX proportional hazards regression model.
From June 2008 to June 2013, 75 patients were enrolled. At the end of the study, 54 patients were dead or lost to follow-up and 21 patients survived. This combination therapy resulted in a mTTP of 7.09 months (95 % CI, 1.5-45 months) and a mOS of 11.44 months (95 % CI, 1.5-45 months). The disease benefit rate was 88 %. Child-Pugh score (P = 0.000), Eastern Cooperative Oncology Group performance status (P = 0.001), Barcelona Clinic Liver Cancer stage (P = 0.000), sorafenib treatment regimen (P = 0.001), presence of extrahepatic metastasis (P = 0.002), and type of tumor (P = 0.027) were significantly correlated with OS. Multivariate analysis revealed Child-Pugh score (P = 0.001) and BCLC stage (P = 0.002) as significant independent prognostic predictors for OS. AEs were HFSR (18.7 %), gastrointestinal reactions (13.3 %), liver dysfunction (6.7 %), myelosuppression (5.3 %), fatigue (4 %), and hypertension (1.3 %).
TACE in combination with sorafenib might have acceptable safety and efficiency in the treatment of intermediate-advanced HCC.
回顾性分析经动脉化疗栓塞术(TACE)联合索拉非尼治疗中晚期肝细胞癌(HCC)患者的疗效和安全性,并评估基线特征对预后的影响。
在这项2期临床试验中,中晚期HCC患者接受了TACE联合索拉非尼治疗。主要结局是疾病进展的中位时间(mTTP)。次要结局是中位总生存期(mOS)、疾病获益率和索拉非尼相关不良事件(AE)。通过单因素COX比例风险回归模型分析基线特征对预后的影响。
2008年6月至2013年6月,共纳入75例患者。研究结束时,54例患者死亡或失访,21例患者存活。这种联合治疗导致mTTP为7.09个月(95%CI,1.5 - 45个月),mOS为11.44个月(95%CI,1.5 - 45个月)。疾病获益率为88%。Child-Pugh评分(P = 0.000)、东部肿瘤协作组体能状态(P = 0.001)、巴塞罗那临床肝癌分期(P = 0.000)、索拉非尼治疗方案(P = 0.001)、肝外转移的存在(P = 0.002)和肿瘤类型(P = 0.027)与OS显著相关。多因素分析显示Child-Pugh评分(P = 0.001)和BCLC分期(P = 0.002)是OS的显著独立预后预测因素。不良事件包括手足皮肤反应(18.7%)、胃肠道反应(13.3%)、肝功能障碍(6.7%)、骨髓抑制(5.3%)、疲劳(4%)和高血压(1.3%)。
TACE联合索拉非尼治疗中晚期HCC可能具有可接受的安全性和有效性。