Radiology and Imaging Sciences, Clinical Center, National Institutes of Health, 9000 Rockville Pike, Building 10, Room 3N320, Bethesda, MD 20892.
Biostatistics and Clinical Epidemiology Service, Clinical Center, National Institutes of Health, 9000 Rockville Pike, Building 10, Room 3N320, Bethesda, MD 20892.
J Vasc Interv Radiol. 2019 Dec;30(12):1908-1914. doi: 10.1016/j.jvir.2019.04.023. Epub 2019 Aug 10.
To determine whether burn time per tumor volume (BPV) (min/mL), where burn time is the total time during which radiofrequency (RF) energy is being applied, is correlated with hepatocellular carcinoma (HCC) treatment outcomes using RF ablation and lyso-thermosensitive liposomal doxorubicin (LTLD).
The HEAT study was a double-blind, randomized controlled phase III trial of RF ablation only versus RF ablation + LTLD in patients with HCCs 3-7 cm in diameter. Effect of BPV on progression-free survival and overall survival (OS) was analyzed.
BPV demonstrated statistically significant differences between study groups for OS (P = .038, hazard ratio [HR] = 0.85), but not for progression-free survival (P = .389, HR = 1.059). In a separate analysis, treatment groups were independently analyzed to determine the effect of BPV within each individual group. OS improved as BPV increased for patients receiving RF ablation + LTLD (P = .017, HR = 0.836, confidence interval [0.722, 0.968]). This same association was not observed in patients receiving RF ablation only (P = .57, HR = 0.99).
BPV may be a useful metric for RF ablation + LTLD combination therapy for solitary HCC. The analysis suggested that the burn time for the tumor needs to be adjusted depending on the tumor volume. Because this is a post hoc study, the results are only suggestive and need to be confirmed with prospective studies.
确定射频消融联合溶酶体热敏脂质体阿霉素（LTLD）治疗肝细胞癌（HCC）时，肿瘤容积每单位烧蚀时间（BPV）（min/mL）与 HCC 治疗结果是否相关，BPV 是指施加射频（RF）能量的总时间。
HEAT 研究是一项 RF 消融与 RF 消融+LTLD 治疗直径 3-7cm HCC 的双盲、随机对照 III 期研究。分析 BPV 对无进展生存期（PFS）和总生存期（OS）的影响。
OS 方面，BPV 在两组间存在统计学显著差异（P=0.038，风险比 [HR]0.85），但 PFS 方面无显著差异（P=0.389，HR1.059）。在单独分析中，将治疗组独立分析以确定每个组内 BPV 的影响。接受 RF 消融+LTLD 的患者，随着 BPV 的增加 OS 得到改善（P=0.017，HR0.836，置信区间 [0.722, 0.968]）。仅接受 RF 消融的患者未观察到这种关联（P=0.57，HR0.99）。
BPV 可能是 RF 消融联合 LTLD 治疗单发 HCC 的有用指标。分析表明，需要根据肿瘤体积调整肿瘤的烧蚀时间。由于这是一项事后研究，结果仅具有提示性，需要前瞻性研究进行验证。
