Abstract:
In this study, we aimed to evaluate the efficacy and safety of atezolizumab plus bevacizumab (Atez/Bev) treatment for unresectable hepatocellular carcinoma (HCC) and to analyze the factors affecting overall survival (OS). A total of 69 patients who received Atez/Bev at our institutions for unresectable HCC were enrolled in this study. OS and progression-free survival (PFS) were estimated using the Kaplan−Meier method. Changes in clinical indicators within 3 months were defined as delta (∆) values, and the Cox proportional hazards model was used to identify which ∆ values affected OS. The median OS, PFS, objective response rate, and disease control rate were 12.5 months, 5.4 months, 23.8%, and 71.4%, respectively. During the observational period, 62 patients (92.5%) experienced AEs (hypertension (33.3%) and general fatigue), and 27 patients (47.4%) experienced grade ≥ 3 AEs (hypertension (10.1%) and anemia (7.2%)). There was a significant deterioration in the albumin-bilirubin (ALBI) score (−2.22 to −1.97; p < 0.001), and a reduction in PIVKA-II levels (32,458 to 11,584 mAU/mL; p = 0.040) within 3 months after commencing Atez/Bev. Both the worsening ∆ ALBI score (p = 0.005) and increasing ∆ PIVKA-II (p = 0.049) were significantly associated with the OS of patients.
摘要:
在这项研究中,我们旨在评估阿特珠单抗联合贝伐单抗(Atez/Bev)治疗不可切除肝细胞癌(HCC)的疗效和安全性,并分析影响总生存期(OS)的因素.本研究共招募了69名在我们机构接受Atez/Bev治疗不可切除HCC的患者。使用Kaplan-Meier方法估计OS和无进展生存期(PFS)。3个月内临床指标的变化被定义为delta(Δ)值,并使用Cox比例风险模型来识别哪些△值影响操作系统。中位数OS,PFS,客观反应率,疾病控制率为12.5个月,5.4个月,23.8%,71.4%,分别。在观察期间,62例(92.5%)患者出现不良事件(高血压(33.3%)和全身疲劳),27例(47.4%)患者出现≥3级AE(高血压(10.1%)和贫血(7.2%)).白蛋白-胆红素(ALBI)评分显著恶化(-2.22至-1.97;p<0.001),并且在开始Atez/Bev后3个月内PIVKA-II水平降低(32,458至11,584mAU/mL;p=0.040)。ALBI评分恶化(p=0.005)和PIVKA-II增加(p=0.049)与患者的OS显著相关。