Kolligs Frank T, Bilbao Jose I, Jakobs Tobias, Iñarrairaegui Mercedes, Nagel Jutta M, Rodriguez Macarena, Haug Alexander, D'Avola Delia, op den Winkel Mark, Martinez-Cuesta Antonio, Trumm Christoph, Benito Alberto, Tatsch Klaus, Zech Christoph J, Hoffmann Ralf-Thorsten, Sangro Bruno
Department of Internal Medicine II, University of Munich, Munich, Germany.
Interventional Radiology, Clinica Universidad de Navarra and Instituto de Investigaciones Sanitarias de Navarra (IDISNA), Pamplona, Spain.
Liver Int. 2015 Jun;35(6):1715-21. doi: 10.1111/liv.12750. Epub 2015 Jan 17.
BACKGROUND & AIMS: To compare selective internal radiation therapy (SIRT) with transarterial chemoembolization (TACE), the standard-of-care for intermediate-stage unresectable, hepatocellular carcinoma (HCC), as first-line treatment.
SIRTACE was an open-label multicenter randomized-controlled pilot study, which prospectively compared primarily safety and health-related quality of life (HRQoL) changes following TACE and SIRT. Patients with unresectable HCC, Child-Pugh ≤B7, ECOG performance status ≤2 and ≤5 liver lesions (≤20 cm total maximum diameter) without extrahepatic spread were randomized to receive either TACE (at 6-weekly intervals until tumour enhancement was not observed on MRI or disease progression) or single-session SIRT (yttrium-90 resin microspheres).
Twenty-eight patients with BCLC stage A (32.1%), B (46.4%) or C (21.4%) received either a mean of 3.4 (median 2) TACE interventions (N = 15) or single SIRT (N = 13). Both treatments were well tolerated. Despite SIRT patients having significantly worse physical functioning at baseline, at week-12, neither treatment had a significantly different impact on HRQoL as measured by Functional Assessment of Cancer Therapy-Hepatobiliary total or its subscales. Both TACE and SIRT were effective for the local control of liver tumours. Best overall response-rate (RECIST 1.0) of target lesions were 13.3% and 30.8%, disease control rates were 73.3% and 76.9% for TACE and SIRT, respectively. Two patients in each group were down-staged for liver transplantation (N = 3) or radiofrequency ablation (N = 1).
Single-session SIRT appeared to be as safe and had a similar impact on HRQoL as multiple sessions of TACE, suggesting that SIRT might be an alternative option for patients eligible for TACE.
比较选择性内放射治疗（SIRT）与经动脉化疗栓塞术（TACE，中期不可切除肝细胞癌（HCC）的标准治疗方法）作为一线治疗的效果。
SIRTACE是一项开放标签的多中心随机对照试验研究，前瞻性地比较TACE和SIRT治疗后主要的安全性和健康相关生活质量（HRQoL）变化。不可切除HCC患者，Child-Pugh≤B7，东部肿瘤协作组（ECOG）体能状态≤2且肝脏病灶≤5个（最大直径总和≤20 cm）且无肝外转移，被随机分配接受TACE（每6周一次，直至MRI未观察到肿瘤强化或疾病进展）或单次SIRT（钇-90树脂微球）。
28例BCLC分期为A期（32.1%）、B期（46.4%）或C期（21.4%）的患者接受了平均3.4次（中位数2次）TACE干预（N = 15）或单次SIRT（N = 13）。两种治疗耐受性均良好。尽管SIRT组患者在基线时身体功能明显较差，但在第12周时，通过癌症治疗功能评估-肝胆总分或其分量表测量，两种治疗对HRQoL的影响均无显著差异。TACE和SIRT对肝肿瘤的局部控制均有效。目标病灶的最佳总体缓解率（RECIST 1.0）分别为13.3%和30.8%，TACE和SIRT的疾病控制率分别为73.3%和76.9%。每组各有2例患者因肝移植（N = 3）或射频消融（N = 1）而分期降低。
单次SIRT似乎与多次TACE一样安全，对HRQoL的影响相似，这表明SIRT可能是适合TACE治疗患者的替代选择。
