Supplementary Material for: Impact of Procedural Quality on Outcomes of Transarterial Chemoembolization for Hepatocellular Carcinoma: A Multicenter Study

Objectives: Transarterial chemoembolization (TACE) is the primary treatment modality for intermediate-stage hepatocellular carcinoma (HCC). However, the lack of standardization to optimal technique leads to a wide variation in outcomes. This study aimed to evaluate the impact of procedure quality of TACE on HCC management.
Materials and Methods: This multicenter retrospective cohort study included HCC patients with ≤4 tumors (maximum diameter ≤7 cm) treated with TACE monotherapy as first-line treatment between January 2009 and December 2022. Patients were classified into precision TACE and non-precision TACE groups based on adherence to predefined technical criteria encompassing angiography, catheterization, embolic agents, embolization endpoints, and assessment.The procedural quality further stratified using a scoring system (where points were deducted for technical deficiencies). The primary outcome was objective response rate (ORR) after first TACE (first-ORR) based on modified Response Evaluation Criteria in Solid Tumors. Secondary outcomes included overall ORR, progression-free survival (PFS), overall survival (OS), and safety profiles.
Results: The analysis included 3059 patients (median age, 58.00 years [IQR: 49.00-66.00]; 2592 males [84.7%]) with 2286 patients included in precision TACE and 773 patients included in non-precision TACE group. First-ORR was 59.4% (1359/2286) in the precision TACE group versus 47.0% (363/773) in the non-precision TACE group (P<0.001), with overall ORR of 70.6% (1615/2286) versus 59.8% (462/773) (P<0.001). Median PFS was 14.00 months (IQR: 7.13-32.80) versus 10.80 months (IQR: 5.00-25.30) (HR=0.787 [95% CI: 0.719-0.861], P<0.001), and median OS was 33.63 months (IQR: 16.13-78.21) versus 26.37 months (IQR: 13.00-55.57) (HR=0.792 [95% CI: 0.716-0.876, P<0.001). The quality scoring system demonstrated a direct correlation between procedural quality and treatment response. Patients in precision TACE group had lower rates of hepatobiliary toxicity (elevated total bilirubin, 17.4% [398/2286] vs. 33.8% [261/773], P<0.001).
Conclusions: Precision TACE was associated with improved outcomes and safety in HCC. The proposed scoring system correlates with treatment outcomes, suggesting its utility as a quality assessment tool for TACE procedures.

研究目的：经动脉化疗栓塞术（Transarterial chemoembolization, TACE）是中间期肝细胞癌（hepatocellular carcinoma, HCC）的一线治疗手段，但当前最优操作技术缺乏统一标准，导致治疗结局差异显著。本研究旨在评估TACE操作质量对肝细胞癌诊疗的影响。

材料与方法：本项多中心回顾性队列研究纳入2009年1月至2022年12月期间，以单用TACE作为一线治疗的肝细胞癌患者，入组标准为肿瘤数量≤4个、最大直径≤7 cm。根据是否符合预先定义的技术规范（涵盖血管造影、插管操作、栓塞剂选择、栓塞终点把控及疗效评估），将患者分为精准TACE组与非精准TACE组；操作质量进一步通过评分系统进行分层（技术操作缺陷将被扣分）。本研究的主要终点为首次TACE术后的客观缓解率（objective response rate, ORR），评估依据为改良实体瘤疗效评价标准（modified Response Evaluation Criteria in Solid Tumors）；次要终点包括总客观缓解率、无进展生存期（progression-free survival, PFS）、总生存期（overall survival, OS）及安全性概况。

结果：本分析共纳入3059例患者，中位年龄为58.00岁[四分位距（interquartile range, IQR）：49.00~66.00]，其中男性2592例（占比84.7%）；精准TACE组2286例，非精准TACE组773例。精准TACE组首次TACE术后ORR为59.4%（1359/2286），显著高于非精准TACE组的47.0%（363/773，P<0.001）；两组总ORR分别为70.6%（1615/2286）与59.8%（462/773，P<0.001）。精准TACE组中位PFS为14.00个月（IQR：7.13~32.80），显著长于非精准TACE组的10.80个月（IQR：5.00~25.30，风险比（hazard ratio, HR）=0.787，95%置信区间（confidence interval, CI）：0.719~0.861，P<0.001）；中位OS分别为33.63个月（IQR：16.13~78.21）与26.37个月（IQR：13.00~55.57，HR=0.792，95%CI：0.716~0.876，P<0.001）。本研究采用的质量评分系统显示，操作质量与治疗应答呈直接正相关。精准TACE组肝胆毒性（总胆红素升高）发生率为17.4%（398/2286），显著低于非精准TACE组的33.8%（261/773，P<0.001）。

结论：精准TACE可改善肝细胞癌患者的治疗结局与安全性；本研究提出的质量评分系统与治疗结局显著相关，提示其可作为TACE操作的质量评估工具。