Hepatocellular carcinoma (HCC) is the most common liver malignant tumor, accounting for 90% of the total. Compared with conservative treatment, transcatheter arterial chemoembolization (TACE) can significantly improve the survival rate of patients. At present, TACE is the most commonly used treatment for unresectable HCC, and doxorubicin is most widely used as a single drug or in combination with other drugs (such as mitomycin C or cisplatin). Unfortunately, only a few clinical studies have compared the application of various chemotherapy drugs in TACE of HCC, so the scheme recommended in TACE guidelines is not supported by high-level evidence.
In the past decade, only two new platinum drugs, LA-12 and bicyclic platinum, have been introduced into clinical practice to obtain better clinical tolerance. Dicyclic platinum is a supramolecular substance, which is made of 1,1-cyclobutanedioic acid ester and carboplatin through four O-H... O hydrogen bonds. This chemical structure makes its chemical structure stable, high water/fat solubility, and good safety, making bicyclic platinum more advantageous than cisplatin and carboplatin. Dicycloplatinum can inhibit the proliferation of cancer cells, increase the production of reactive oxygen species and promote cell apoptosis. Since the approval of bicyclic platinum by the State Administration of Pharmaceutical Products in 2012, its anti-cancer effect and drug tolerance have been fully proved by a series of pre clinical in vitro and in vivo studies and clinical trials.
Recently, a study published in the European Radio magazine evaluated the efficacy and safety of bicycline as a chemotherapy regimen for transcatheter arterial chemoembolization (TACE) in the treatment of hepatocellular carcinoma (HCC), and compared it with other chemotherapy drugs in HCC patients who failed to respond to TACE or relapsed after cure.
In this study, from March 2019 to November 2019, unresectable HCC patients were recruited in 7 centers in China, and each patient was ineffective in TACE treatment or relapsed after surgical resection and ablation. Participants were randomly assigned (1:1:1) to receive TACE and bicycline chemotherapy alone (group A1), bicycline plus epirubicin (group A2) or epirubicin alone (group B). The primary end point was the objective response rate (ORR). Secondary end points included disease control rate (DCR), response time (DOR), progression free survival (PFS), and safety.
The ORR of group A1 (n=22) at 6 months was significantly better than that of group B (p=0.093; 90% confidence interval [CI], 1.03-9.45). DCR of group A1 was significantly higher than that of group B (p=0.045; 90% CI, 1.29-12.88). There was no significant difference in DOR between groups (P=0.271). The median PFS of group A2 (n=25) and group B (n=24) were 6.00 and 3.05 months (p=0.061), respectively. In the safety population, the level 3 or more serious adverse events were similar in each group (p=0.173).
Figure Kaplan Meier estimates of progression free survival in the complete analysis group
This study shows that in patients with unresectable HCC, the safety and tolerability of TACE using bicycline is equivalent to that of epirubicin alone. Compared with epirubicin alone, ORR and DCR of bicyclic platinum were significantly improved.
Source:
Hai-Dong Zhu,Xiao Li,Jian-Song Ji,et al.TACE with dicycloplatin in patients with unresectable hepatocellular carcinoma: a multicenter randomized phase II trial.DOI:10.1007/s00330-022-08848-7
Article link:
https://www.medsci.cn/article/show_article.do?id=12b7e4339494
