Ballester María Pilar, Abril Carlos, Merino Víctor, Alós Manuel, Segarra Gloria, Tosca Joan, Montón Cristina, Casasus Nuria, Lluch Paloma
Servicio de Medicina Digestiva, Hospital Clínico Universitario, Valencia, Spain.
Instituto de Investigación Sanitaria INCLIVA, Valencia, Spain.
Cancer Diagn Progn. 2024 Sep 1;4(5):623-630. doi: 10.21873/cdp.10373. eCollection 2024 Sep-Oct.
BACKGROUND/AIM: Atezolizumab/bevacizumab (atez/bev) has been established as first-line systemic treatment for hepatocellular carcinoma (HCC). However, concerns regarding safety and efficacy have been raised, and no biomarkers to predict response have yet been identified. We aimed to evaluate the real-life experience of atez/bev in a Spanish tertiary hospital and identify factors associated with overall survival (OS).
A prospective study of consecutive patients with HCC treated with atez/bev was conducted from December 2020 to December 2022. Efficacy was assessed through OS and progression-free survival (PFS), whereas safety was evaluated based on adverse events (AE). Twenty-three patients were included; 91% were males with a mean of 70 years. Thirteen patients were classified as having BCLC-C.
The median treatment duration was 126 days (range=567). Median OS was 381 days (95%CI=205-557) with a cumulative probability of death of 13%, 30%, and 49% at 3, 6 and 12-month follow-up, respectively. The only factor associated with OS was the ALBI score (HR=5.03; 95%CI=1.3-19.1), which showed an AUROC of 0.906 (95%CI=0.78-1.00) for the risk of death at 18 months follow up. Median PFS was 141 days (95%CI=110-172). Twenty (86.9%) patients experienced AE, which in nine (39.1%) cases led to the definitive discontinuation of the treatment, four of them (17.4%) due to an AE grade 5.
The initial experience with atez/bev at our center demonstrated poorer outcomes compared to the original trial (IMbrave150). A careful assessment of the ALBI score may serve as a crucial factor in the selection of systemic treatment for patients with HCC.
背景/目的：阿替利珠单抗/贝伐珠单抗（阿替/贝伐）已被确立为肝细胞癌（HCC）的一线全身治疗方案。然而，人们对其安全性和疗效提出了担忧，且尚未发现预测反应的生物标志物。我们旨在评估西班牙一家三级医院中阿替/贝伐的实际应用经验，并确定与总生存期（OS）相关的因素。
对2020年12月至2022年12月期间连续接受阿替/贝伐治疗的HCC患者进行了一项前瞻性研究。通过OS和无进展生存期（PFS）评估疗效，而基于不良事件（AE）评估安全性。纳入了23例患者；91%为男性，平均年龄70岁。13例患者被归类为BCLC-C期。
中位治疗持续时间为126天（范围=567天）。中位OS为381天（95%置信区间=205-557），在3、6和12个月随访时的累积死亡概率分别为13%、30%和49%。与OS相关的唯一因素是ALBI评分（风险比=5.03；95%置信区间=1.3-19.1），在18个月随访时，其预测死亡风险的受试者工作特征曲线下面积（AUROC）为0.906（95%置信区间=0.78-1.00）。中位PFS为141天（95%置信区间=110-172）。20例（86.9%）患者发生AE，其中9例（39.1%）导致治疗最终中断，4例（17.4%）因5级AE中断。
与原试验（IMbrave150）相比，我们中心阿替/贝伐的初始应用经验显示预后较差。仔细评估ALBI评分可能是HCC患者全身治疗选择的关键因素。
