de Baere Thierry, Guiu Boris, Ronot Maxime, Chevallier Patrick, Sergent Géraldine, Tancredi Illario, Tselikas Lambros, Dioguardi Burgio Marco, Raynaud Lucas, Deschamps Frederic, Verset Gontran
Department of Interventional Radiology, Gustave Roussy Cancer Center, 114 rue Edouard Vaillant, 94805 Villejuif, France.
UFR Médecine Le Kremlin-Bicêtre, Université Paris-Saclay, 94250 Le Kremlin-Bicêtre, France.
Cancers (Basel). 2020 Nov 17;12(11):3405. doi: 10.3390/cancers12113405.
Transarterial chemoembolization with drug-eluting microspheres (DEM-TACE) is recommended for patients with BCLC stage B hepatocellular carcinoma (HCC) and stage 0-A unsuitable for curative treatments. We assessed efficacy and safety along with hepatobiliary toxicities (HBT) of DEM-TACE using a novel microsphere, LifePearl, loaded with anthracyclines.
97 patients diagnosed with HCC were prospectively enrolled and treated using LifePearl loaded with doxorubicin (77%) or idarubicin (23%). Safety and tolerability were assessed using CTCAE, HBT by CT/MRI scans, and tumor response by applying modified Response Evaluation Criteria in Solid Tumors (mRECIST). Follow-up was after 2 years.
Adverse events (AE) were reported in 73.2% of patients, majority being Grade 1-2. Grade ≥ 3 AE reported in 13.4% of patients were mainly related to postembolization syndrome. HBT were observed after 15.5% (29/187) of the DEM-TACEs. Objective response and disease control rates were 81% and 99%, respectively, as the best responses. Survival rates at one and two years were 81% and 66%, respectively, while the median overall survival (OS) was not reached. Median progression free survival was 13.7 months (95% CI: 11.3; 15.6) and median time to TACE untreatable progression was 16.7 months (95% CI: 12.7; not estimable (n.e.)).
DEM-TACE using LifePearl provides a high tumor response rate in HCC patients. HBT rates within or below previously reported results for cTACE and DEM-TACE indicate a good safety profile for LifePearl. The trial was registered in ClinicalTrials.gov National Library of Medicine (ID: NCT03053596).
对于不适合进行根治性治疗的BCLC B期肝细胞癌（HCC）和0 - A期患者，推荐使用载药微球经动脉化疗栓塞术（DEM - TACE）。我们评估了使用载有蒽环类药物的新型微球LifePearl进行DEM - TACE的疗效、安全性以及肝胆毒性（HBT）。
前瞻性纳入97例诊断为HCC的患者，并使用载有阿霉素（77%）或伊达比星（23%）的LifePearl进行治疗。使用CTCAE评估安全性和耐受性，通过CT/MRI扫描评估HBT，并应用实体瘤改良反应评估标准（mRECIST）评估肿瘤反应。随访时间为2年。
73.2%的患者报告了不良事件（AE），大多数为1 - 2级。13.4%的患者报告的≥3级AE主要与栓塞后综合征有关。在15.5%（29/187）的DEM - TACE后观察到HBT。最佳反应时的客观缓解率和疾病控制率分别为81%和99%。一年和两年生存率分别为81%和66%，而中位总生存期（OS）未达到。中位无进展生存期为13.7个月（95%CI：11.3；15.6），至TACE不可治疗进展的中位时间为16.7个月（95%CI：12.7；不可估计（n.e.））。
使用LifePearl的DEM - TACE在HCC患者中提供了较高的肿瘤反应率。HBT发生率在先前报道的cTACE和DEM - TACE结果范围内或以下，表明LifePearl具有良好的安全性。该试验已在ClinicalTrials.gov美国国立医学图书馆注册（ID：NCT03053596）。
