Center of Interventional Radiology & Vascular Surgery, Department of Radiology, Zhongda Hospital, Medical School, Southeast University, 87 Dingjiaqiao Road, Nanjing, 210009, China.
Department of Interventional Therapy, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.
Eur Radiol. 2022 Nov;32(11):7335-7343. doi: 10.1007/s00330-022-08848-7. Epub 2022 Jul 1.
To investigate the efficacy and safety of dicycloplatin as chemotherapeutic regimen in transcatheter arterial chemoembolization (TACE) for hepatocellular carcinoma (HCC).
In this randomized, open-label, phase II trial, patients with unresectable HCC who were TACE treatment-naïve or experienced recurrence after surgical resection or ablation were enrolled at 7 centers in China from March 2019 to November 2019. Participants were randomly assigned (1:1:1) to receive TACE with chemotherapeutic regimen of dicycloplatin alone (group A1), dicycloplatin plus epirubicin (group A2), or epirubicin alone (group B). The primary endpoint was objective response rate (ORR). The secondary endpoints included disease control rate (DCR), duration of response (DOR), progression-free survival (PFS), and safety.
The ORR at 6 months in group A1 (n = 22) was significantly better than that in group B (p = 0.093; 90% confidence interval [CI], 1.03-9.45). The DCR in group A1 was significantly higher than that in group B (p = 0.045; 90% CI, 1.29-12.88). There was no significant difference in DOR among the groups (p = 0.271). The median PFS were 6.00 and 3.05 months in groups A2 (n = 25) and B (n = 24), respectively (p = 0.061). Grade 3 or worse adverse events were similar among groups in the safety population (p = 0.173).
TACE with dicycloplatin was comparably safe and well tolerable as epirubicin alone in patients with unresectable HCC. Compared with epirubicin alone, significant improvement in ORR and DCR when dicycloplatin was applied, as well as prolonged PFS when dicycloplatin plus epirubicin was applied, was generated.
• To our knowledge, this is the first multicenter randomized trial to assess the efficacy and safety of TACE with dicycloplatin in patients with unresectable HCC. • This phase II trial showed that TACE with dicycloplatin alone or plus epirubicin was comparably safe and well tolerable as epirubicin alone. • Significant improvements in ORR, DCR when dicycloplatin was applied, and prolonged PFS when dicycloplatin plus epirubicin was applied were recorded compared with epirubicin alone.
探讨顺铂对比表柔比星在经导管动脉化疗栓塞术（TACE）治疗肝细胞癌（HCC）中的疗效和安全性。
本研究为随机、开放标签、二期临床试验，共纳入了 2019 年 3 月至 2019 年 11 月中国 7 家中心的 TACE 初治或手术切除或消融后复发的不可切除 HCC 患者。参与者被随机分配（1:1:1）接受单纯顺铂（A1 组）、顺铂联合表柔比星（A2 组）或表柔比星（B 组）的 TACE 治疗。主要终点为客观缓解率（ORR）。次要终点包括疾病控制率（DCR）、缓解持续时间（DOR）、无进展生存期（PFS）和安全性。
A1 组（n = 22）6 个月时的 ORR 明显优于 B 组（p = 0.093；90%置信区间[CI]，1.03-9.45）。A1 组的 DCR 明显高于 B 组（p = 0.045；90%CI，1.29-12.88）。三组的 DOR 无显著差异（p = 0.271）。A2 组（n = 25）和 B 组（n = 24）的中位 PFS 分别为 6.00 和 3.05 个月（p = 0.061）。在安全性人群中，各组的 3 级或更高级别的不良事件发生率相似（p = 0.173）。
在不可切除 HCC 患者中，与表柔比星单药治疗相比，顺铂联合 TACE 治疗同样安全且耐受良好。与表柔比星单药治疗相比，应用顺铂可显著提高 ORR 和 DCR，应用顺铂联合表柔比星可延长 PFS。
据我们所知，这是第一项评估顺铂在不可切除 HCC 患者中应用于 TACE 的疗效和安全性的多中心随机试验。
这项二期试验表明，单纯顺铂或顺铂联合表柔比星的 TACE 治疗与表柔比星单药治疗同样安全且耐受良好。
与表柔比星单药治疗相比，应用顺铂可显著提高 ORR、DCR，应用顺铂联合表柔比星可延长 PFS。
