经动脉化疗栓塞联合索拉非尼与索拉非尼单药治疗巴塞罗那临床肝癌分期 B/C 期患者的安全性和有效性。
The safety and efficacy of transarterial chemoembolization combined with sorafenib and sorafenib mono-therapy in patients with BCLC stage B/C hepatocellular carcinoma.
机构信息
Department of Hepatobiliary Surgery, Affiliated Tumor Hospital of Guangxi Medical University, He Di Rd #71, Nanning, 530021, People's Republic of China.
Guangxi Liver Cancer Diagnosis and Treatment Engineering and Technology Research Center, Nanning, China.
出版信息
BMC Cancer. 2017 Sep 12;17(1):645. doi: 10.1186/s12885-017-3545-5.
BACKGROUND
Sorafenib and transarterial chemoembolization (TACE) are recommended therapies for advanced hepatocellular carcinoma (HCC), but their combined efficacy remains unclear.
METHODS
Between August 2004 and November 2014, 104 patients with BCLC stage B/C HCC were enrolled at the Affiliated Tumor Hospital of Guangxi Medical University, China. Forty-eight patients were treated with sorafenib alone (sorafenib group) and 56 with TACE plus sorafenib (TACE + sorafenib group). Baseline demographic/clinical data were collected. The primary outcomes were median overall survival (OS) and progression-free survival (PFS). Secondary outcomes were overall response rate (ORR) and sorafenib-related adverse events (AEs). Baseline characteristics associated with disease prognosis were identified using multivariate Cox hazards regression.
RESULTS
The mean age of the 104 patients (94 males; 90.38%) was 49.02 ± 12.29 years. Of the baseline data, only albumin level (P = 0.028) and Child-Pugh class (P = 0.017) differed significantly between groups. Median OS did not differ significantly between the sorafenib and TACE + sorafenib groups (18.0 vs. 22.0 months, P = 0.223). Median PFS was significantly shorter in the sorafenib group than that in the TACE + sorafenib group (6.0 vs. 8.0 months, P = 0.004). Six months after treatments, the ORRs were similar between the sorafenib and TACE + sorafenib groups (12.50% vs. 18.75%, P = 0.425). The rates of grade III-IV adverse events in sorafenib and TACE + sorafenib groups were 29.2% vs. 23.2%, respectively. TACE plus sorafenib treatment (HR = 0.498, 95% CI = 0.278-0.892), no vascular invasion (HR = 0.354, 95% CI = 0.183-0.685) and Child-Pugh class A (HR = 0.308, 95% CI = 0.141-0.674) were significantly associated with better OS, while a larger tumor number was predictive of poorer OS (HR = 1.286, 95% CI = 1.031-1.604). TACE plus sorafenib treatment (HR = 0.461, 95% CI = 0.273-0.780) and no vascular invasion (HR = 0.557, 95% CI = 0.314-0.988) were significantly associated with better PFS.
CONCLUSIONS
Compared with sorafenib alone, combining TACE with sorafenib might prolong survival and delay disease progression in patients with advanced HCC.
背景
索拉非尼和经动脉化疗栓塞（TACE）是晚期肝细胞癌（HCC）的推荐治疗方法，但它们联合治疗的疗效尚不清楚。
方法
2004 年 8 月至 2014 年 11 月，104 例 BCLC 分期 B/C 期 HCC 患者入组广西医科大学附属肿瘤医院。48 例患者接受索拉非尼单药治疗（索拉非尼组），56 例患者接受 TACE 联合索拉非尼治疗（TACE+索拉非尼组）。收集基线人口统计学/临床数据。主要终点为中位总生存期（OS）和无进展生存期（PFS）。次要终点为总缓解率（ORR）和索拉非尼相关不良事件（AE）。使用多变量 Cox 风险回归确定与疾病预后相关的基线特征。
结果
104 例患者（94 例男性；90.38%）的平均年龄为 49.02±12.29 岁。在基线数据中，只有白蛋白水平（P=0.028）和 Child-Pugh 分级（P=0.017）在两组间有显著差异。索拉非尼组和 TACE+索拉非尼组的中位 OS 无显著差异（18.0 与 22.0 个月，P=0.223）。索拉非尼组中位 PFS 明显短于 TACE+索拉非尼组（6.0 与 8.0 个月，P=0.004）。治疗 6 个月后，索拉非尼组和 TACE+索拉非尼组的 ORR 相似（12.50%与 18.75%，P=0.425）。索拉非尼组和 TACE+索拉非尼组 3/4 级不良事件发生率分别为 29.2%和 23.2%。TACE 联合索拉非尼治疗（HR=0.498，95%CI=0.278-0.892）、无血管侵犯（HR=0.354，95%CI=0.183-0.685）和 Child-Pugh 分级 A（HR=0.308，95%CI=0.141-0.674）与 OS 显著相关，而肿瘤数量较多与 OS 较差相关（HR=1.286，95%CI=1.031-1.604）。TACE 联合索拉非尼治疗（HR=0.461，95%CI=0.273-0.780）和无血管侵犯（HR=0.557，95%CI=0.314-0.988）与 PFS 显著相关。
结论
与单独使用索拉非尼相比，TACE 联合索拉非尼可能延长晚期 HCC 患者的生存时间并延缓疾病进展。
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