Abstract：
BACKGROUND: Personalized dosimetry improves overall survival (OS) in patients with hepatocellular carcinoma (HCC) treated with glass 90 Y radioembolization. This study evaluated personalized tumor dose (TD) as a predictor of OS, progression-free survival (PFS), and local duration of response (DOR) in patients with surgically unresectable HCC treated with resin 90 Y radioembolization.
METHODS: This prospective, single-center, single-arm clinical trial (NCT04172714) evaluated the efficacy of scout activity of resin 90 Y versus 99m Tc-MAA for treatment planning. A secondary aim of this study was to evaluate personalized dosimetry as a predictor of OS, PFS, and DOR. Partition dosimetry model was utilized for nonsegmental therapies with targeted TD >200 Gy and nontumoral liver dose <70 Gy. Single compartment dose of 200 Gy was used for segmentectomies. OS, PFS, and local DOR from 90 Y was estimated using Kaplan-Meier estimation with log-rank analysis used to determine predictors of prolonged survival.
RESULTS: Thirty patients with treatment-naive HCC and 33 tumors (19 segmental and 14 nonsegmental) were included. Overall, 18 patients underwent segmental Y90-RE and 12 underwent non-segmental/lobar therapies. The mean 90 Y TD was 493 Gy. The median follow-up since enrollment into the study was 37 months. The mean OS was 32.2 months for the entire cohort. A total of 5 patients underwent orthotopic liver transplantation post 90 Y and were excluded from further survival analysis. The mean OS for the remainder of the cohort was 30.1 months (median not reached). The mean TD >250 Gy resulted in prolonged mean OS and PFS. The median local DOR was 32.7 months with mean TD 330 Gy predicting prolonged DOR.
CONCLUSIONS: For patients with surgically unresectable HCC treated with resin 90 Y, there is mean TD threshold predicting prolonged OS, PFS, and local DOR. Therefore, there should be further emphasis on personalized dosimetry for optimization of patient outcomes.
METHODS: This prospective, single-center, single-arm clinical trial (NCT04172714) evaluated the efficacy of scout activity of resin 90 Y versus 99m Tc-MAA for treatment planning. A secondary aim of this study was to evaluate personalized dosimetry as a predictor of OS, PFS, and DOR. Partition dosimetry model was utilized for nonsegmental therapies with targeted TD >200 Gy and nontumoral liver dose <70 Gy. Single compartment dose of 200 Gy was used for segmentectomies. OS, PFS, and local DOR from 90 Y was estimated using Kaplan-Meier estimation with log-rank analysis used to determine predictors of prolonged survival.
RESULTS: Thirty patients with treatment-naive HCC and 33 tumors (19 segmental and 14 nonsegmental) were included. Overall, 18 patients underwent segmental Y90-RE and 12 underwent non-segmental/lobar therapies. The mean 90 Y TD was 493 Gy. The median follow-up since enrollment into the study was 37 months. The mean OS was 32.2 months for the entire cohort. A total of 5 patients underwent orthotopic liver transplantation post 90 Y and were excluded from further survival analysis. The mean OS for the remainder of the cohort was 30.1 months (median not reached). The mean TD >250 Gy resulted in prolonged mean OS and PFS. The median local DOR was 32.7 months with mean TD 330 Gy predicting prolonged DOR.
CONCLUSIONS: For patients with surgically unresectable HCC treated with resin 90 Y, there is mean TD threshold predicting prolonged OS, PFS, and local DOR. Therefore, there should be further emphasis on personalized dosimetry for optimization of patient outcomes.
摘要：
背景：个性化剂量学可改善玻璃90Y放射栓塞治疗的肝细胞癌（HCC）患者的总生存期（OS）。这项研究评估了个性化肿瘤剂量(TD)作为OS的预测因子，无进展生存期（PFS），和局部反应持续时间（DOR）的患者手术不可切除的肝癌治疗树脂90Y放射栓塞。
方法：这种前瞻性，单中心,单臂临床试验(NCT04172714)评估了90Y树脂与99mTc-MAA树脂的scout活性对治疗计划的疗效.这项研究的第二个目的是评估个性化剂量测定作为OS的预测指标，PFS,和DOR。分区剂量测定模型用于靶向TD>200Gy和非肿瘤肝剂量<70Gy的非节段治疗。单室剂量为200Gy用于节段切除术。操作系统,PFS,使用Kaplan-Meier估计和对数秩分析对90Y的局部DOR进行估计,以确定延长生存期的预测因子.
结果：纳入30例初治HCC患者和33例肿瘤（19例节段和14例非节段）。总的来说,18例患者接受了节段性Y90-RE，12例接受了非节段性/叶性治疗。平均90YTD为493Gy。自纳入研究以来的中位随访时间为37个月。整个队列的平均OS为32.2个月。共有5例患者在90Y后接受了原位肝移植，并被排除在进一步的生存分析之外。其余队列的平均OS为30.1个月（中位数未达到）。平均TD>250Gy导致延长的平均OS和PFS。中位局部DOR为32.7个月，平均TD330Gy预测DOR延长。
结论：对于接受90Y树脂治疗的无法手术切除的HCC患者，有平均TD阈值预测延长的操作系统，PFS,和当地的DOR。因此,应进一步强调个性化剂量学以优化患者预后.
方法：这种前瞻性，单中心,单臂临床试验(NCT04172714)评估了90Y树脂与99mTc-MAA树脂的scout活性对治疗计划的疗效.这项研究的第二个目的是评估个性化剂量测定作为OS的预测指标，PFS,和DOR。分区剂量测定模型用于靶向TD>200Gy和非肿瘤肝剂量<70Gy的非节段治疗。单室剂量为200Gy用于节段切除术。操作系统,PFS,使用Kaplan-Meier估计和对数秩分析对90Y的局部DOR进行估计,以确定延长生存期的预测因子.
结果：纳入30例初治HCC患者和33例肿瘤（19例节段和14例非节段）。总的来说,18例患者接受了节段性Y90-RE，12例接受了非节段性/叶性治疗。平均90YTD为493Gy。自纳入研究以来的中位随访时间为37个月。整个队列的平均OS为32.2个月。共有5例患者在90Y后接受了原位肝移植，并被排除在进一步的生存分析之外。其余队列的平均OS为30.1个月（中位数未达到）。平均TD>250Gy导致延长的平均OS和PFS。中位局部DOR为32.7个月，平均TD330Gy预测DOR延长。
结论：对于接受90Y树脂治疗的无法手术切除的HCC患者，有平均TD阈值预测延长的操作系统，PFS,和当地的DOR。因此,应进一步强调个性化剂量学以优化患者预后.
