Background:Immunotherapy-based regimens have expanded the treatment landscape for unresectable hepatocellular carcinoma (uHCC); however, real-world data are limited.Methods:This retrospective, observational study used data from electronic medical records from Mayo Clinic sites across the United States. Patients with uHCC who initiated a first-line (1L) systemic therapy between June 2020–October 2022 with ≥2 follow-up visits were included. Treatment patterns, overall survival (OS), and post-index gastrointestinal (GI) bleeding were assessed by GI bleeding risk defined by Child–Pugh Class B or C, pre-index GI bleeding, uncontrolled hypertension, or significant varices and band ligation.Results:Of 186 included patients, 68.8% had GI bleeding risk and 31.2% did not. Atezolizumab plus bevacizumab was the most common 1L systemic therapy in patients with or without GI bleeding risk (72.7% and 29.3%, respectively). Median OS (95% confidence interval) with atezolizumab plus bevacizumab was 12.8 (8.0–19.3) months and not reached in patients with and without GI bleeding risk, respectively. OS rates with atezolizumab plus bevacizumab in patients with or without GI bleeding risk, respectively, were 52.3% and 70.6% at 12 months, 41.6% and 57.8% at 18 months, and 34.6% and 51.3% at 24 months. Post-index GI bleeding with atezolizumab plus bevacizumab occurred in 19.4% and 5.9% of patients with and without GI bleeding risk, respectively.Conclusions:During this study period, atezolizumab + bevacizumab was the most common 1L therapy for patients with uHCC, regardless of GI bleeding risk. OS rates with atezolizumab + bevacizumab were lower in patients with versus without GI bleeding risk. Findings highlight the unmet need for guidance on characteristics-driven treatment decisions.
背景:基于免疫疗法的方案拓展了不可切除肝细胞癌(uHCC)的治疗格局,但真实世界数据仍有限。本研究旨在评估美国梅奥诊所医疗系统中uHCC患者的真实世界治疗模式与临床结局。 方法:这项回顾性观察性研究使用美国梅奥诊所各院区的电子病历数据。纳入2020年6月至2022年10月期间开始一线(1L)系统治疗且至少完成2次随访的uHCC患者。根据Child-Pugh B/C级、基线胃肠道出血史、未控制的高血压或显著静脉曲张伴套扎术等胃肠道出血风险因素进行分层,评估治疗模式、总生存期(OS)及治疗后胃肠道出血事件。 结果:在纳入的186例患者中,68.8%存在胃肠道出血风险,31.2%无风险。无论是否存在出血风险,阿替利珠单抗联合贝伐珠单抗均为最常见的1L治疗方案(风险组72.7% vs 无风险组29.3%)。该联合方案在风险组与无风险组的中位OS(95%置信区间)分别为12.8(8.0-19.3)个月和未达到。两组患者接受该方案治疗的12个月OS率分别为52.3% vs 70.6%,18个月为41.6% vs 57.8%,24个月为34.6% vs 51.3%。治疗后胃肠道出血发生率在风险组为19.4%,无风险组为5.9%。 结论:在本研究期间,无论是否存在胃肠道出血风险,阿替利珠单抗联合贝伐珠单抗均是uHCC患者最常用的1L治疗方案。存在胃肠道出血风险患者的OS率显著低于无风险患者。这些发现凸显了基于患者特征制定个体化治疗决策的临床指导需求尚未得到满足。