Улогата на трансартериска хемоемболизација со партикли со можност за збогатување со цитостатик во третман на хепатоцелуларен карцином

Abstract

Introduction: Hepatocellular carcinoma (HCC) is one of the most common types of cancers, with an annual incidence of 850.000 new cases worldwide. Majority of HCC patients are diagnosed at intermediate or advanced clinical stages, which excludes them from potentially curative treatment options, such as: resection, liver transplantation or local ablative techniques. According to Barcelona Clinic Liver Cancer Classification System (BCLC), transarterial chemoembolization (TACE) represents the standard treatment option for patients with intermediate stage HCC, with Child-Pugh class A or B liver cirrhosis and good clinical presentation, ECOG 0-1. Several different types of embolisation techniques are available for these patients like: “Bland” embolization (TAE), conventional chemoembolisation (c-TACE) and drug-eluting microspheres chemoembolisation (DEM-TACE). Current literature in terms of better outcomes with one chemoembolisation techniques or the other are limited. Aim of the study: Primary aim of this study is to compare the 12- and 24-months overall survival rates between intermediate stage unresectable HCC patients who are threated with c-TACE or DEM-TACE, respectively. Secondary endpoints are comparison of intensity and duration of postembolisation syndrome (PES) between the two methods and evaluation of the severe adverse events (SAE). Study design: Prospective, randomized, single-center study which includes 60 patients with intermediate stage HCC according to the BCLC classification, threated with c-TACE or DEM-TACE. Material and methods: This clinical trial is conducted at the Department for Diagnostic and interventional Radiology, City General Hospital “8th September”, Skopje. Patients were randomized one-to-one for c-TACE or DEM-TACE, respectively. Patients follow-up was performed at least 24-months after finishing the treatment or until their death. All subjects were patients with diagnosis of HCC in intermediate stage, and decision for transarterial chemoembolisation was made on a multidisciplinary tumor board meeting. Preprocedural radiological imaging investigations with multiphasic MDCT or MRI of the liver were performed as well as post-treatment studies for investigating the results of the chemoembolization. Control imaging studies were usually performed at intervals of 3-4 weeks after TACE, and if any radiological signs of incomplete treatment, residual tumor or new lesions were detected another session of TACE was immediately scheduled until complete response was achieved. Results: In this study are presented the results obtained with statistical analysis of 60 patients with intermediate stage HCC. Patients were threated with two different TACe techniques, 28 (46.7%) with c-TACE, and 32 (53.3%) with DEM-TACE. Most of the patients are ate the age >71y. (41.7%), with significantly more male gender (68.3%). Majority of the enrolled patients received two sessions of TACE, in both arms. Average tumor diameter was 5.3cm in the c-TACE, and 5.0cm in the DEM-TACE group. Mean in-hospital stay was 3 days for patients treated with c-TACE, and 2 days in the DEM-TACE group. The overall 12- and 24-months survival rates were 89.8% and 70.7%, respectively. Median survival for all patients was 21.1 months. Overall 12- and 24- months survival rates after c-TACE were 85.7% and 63.6%, while 90.2% and 75.8% after DEM-TACE, without any statistically significant difference detected (p=0.18). Significant difference regarding 12- and 24-months survival was detected between patients with Child-Pugh A class versus those with Child-Pugh B class of liver cirrhosis before TACE (p=0.001). Postprocedural pain was detected in 28 (46.7%) of patients, 16 (57.1%) of which were in the c-TACE group and 12 (37.5%) in the DEM-TACE group. This difference was not significant (p=0.13). Elevated body temperature as a part of the post-embolisation syndrome after TACE was detected in 36 (60%) of individuals, significantly more often in the c-TACE group with values of p=0.001. Conclusions: Both, c-TACE and DEM-TACE are equally safe and effective techniques in the treatment of intermediate stage HCC with excellent rates of 12- and 24-months survival rates in selected candidates. No significant difference was detected with regards to the adverse events after both methods. Post-embolisation syndrome is slightly more severe after c-TACE, mainly because of the postprocedural elevated body temperature. The preference on one TACE technique over the other remains to be a personal choice of the operator himself, the particular center for interventional radiology and of course the local needs and economic situation.