DataSheet_1_Anlotinib combined with transarterial chemoembolization for unresectable hepatocellular carcinoma associated with hepatitis B virus: a retrospective controlled study.docx

PurposeTo investigate the efficacy and safety of combined treatment of anlotinib and transarterial chemoembolization (TACE) in patients with unresectable hepatocellular carcinoma (uHCC) associated with hepatitis B virus (HBV) infection.
MethodsWe retrospectively collected the data of 96 uHCC patients associated with HBV infection who received either TACE only (TO group; n = 64) or anlotinib combined with TACE (TA group; n = 32) from January 2017 to January 2021. The primary endpoint was overall survival (OS). The secondary outcomes included progression-free survival (PFS), tumor response according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) and RECIST 1.1, and adverse events (AEs).
ResultsThe median OS and median PFS were significantly longer in the TA group compared to the TO group (17.6 months vs. 9.4 months, p = 0.018; 6.7 months vs. 3.8 months, p = 0.003, respectively). In addition, the overall objective response rate (ORR) and disease control rate (DCR) numerically increased in the TA group (mRECIST, ORR 65.6% vs. 46.9%, p = 0.064, DCR 90.6% vs. 85.9%, p = 0.382; RECIST 1.1, ORR 46.9% vs. 15.6%, p = 0.001, DCR 90.6% vs. 85.9%, p = 0.382, respectively). It was worth noting that no treatment-related mortality occurred during the study. The most common AEs included elevated transaminases (56.3%), decreased appetite (46.9%), and abdominal pain (37.5%) in the TA group. Although the incidence rate of grade 3/4 AEs was higher in the TA group, all of them were controllable.
ConclusionsThe combination of anlotinib and TACE has shown promising results in improving outcomes for patients with HBV-related uHCC, as compared to TACE monotherapy. In addition, this combination therapy has demonstrated a controllable safety profile. However, further validation is urgently needed through randomized controlled trials with large sample sizes.

研究目的 本研究旨在探讨安罗替尼（anlotinib）联合经动脉化疗栓塞术（transarterial chemoembolization, TACE）治疗乙型肝炎病毒（hepatitis B virus, HBV）感染相关不可切除肝细胞癌（unresectable hepatocellular carcinoma, uHCC）患者的疗效与安全性。
研究方法 本研究回顾性收集2017年1月至2021年1月期间收治的96例HBV感染相关uHCC患者的临床资料，所有患者分别接受单纯经动脉化疗栓塞术治疗（单纯TACE组，n=64）或安罗替尼联合TACE治疗（联合组，n=32）。本研究的主要终点为总生存期（overall survival, OS），次要终点包括无进展生存期（progression-free survival, PFS）、基于改良实体瘤疗效评价标准（modified Response Evaluation Criteria in Solid Tumors, mRECIST）及RECIST 1.1标准评估的肿瘤应答情况，以及不良事件（adverse events, AEs）。
研究结果 联合组患者的中位OS与中位PFS均显著长于单纯TACE组（分别为17.6个月 vs 9.4个月，p=0.018；6.7个月 vs 3.8个月，p=0.003）。此外，联合组的总体客观缓解率（objective response rate, ORR）与疾病控制率（disease control rate, DCR）均呈升高趋势：mRECIST标准下，ORR为65.6% vs 46.9%（p=0.064），DCR为90.6% vs 85.9%（p=0.382）；RECIST 1.1标准下，ORR为46.9% vs 15.6%（p=0.001），DCR为90.6% vs 85.9%（p=0.382）。值得注意的是，本研究期间未发生治疗相关死亡事件。联合组最常见的不良事件为转氨酶升高（56.3%）、食欲下降（46.9%）及腹痛（37.5%）；尽管3/4级不良事件的发生率在联合组中更高，但所有不良事件均可控。
研究结论 相较于单纯TACE治疗，安罗替尼联合TACE可改善HBV相关uHCC患者的临床结局，且疗效可观。此外，该联合治疗方案的安全性可控。然而，仍需开展大样本量随机对照试验以进一步验证该研究结论。