Preliminary evidence of safety and tolerability of atezolizumab plus bevacizumab in patients with hepatocellular carcinoma and Child-Pugh A and B cirrhosis: A real-world study.
Preliminary evidence of safety and tolerability of atezolizumab plus bevacizumab in patients with hepatocellular carcinoma and Child-Pugh A and B cirrhosis: A real-world study.
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肝细胞癌患者和儿童 - 恐怖症患者和B cirrhosos的患者中，Atezolizumab加上贝伐单抗的安全性和耐受性的初步证据：一项现实世界中的研究。
DOI：
10.1002/hep.32468
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发表时间：
2022-10
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Atezolizumab联合贝伐单抗（AtezoBev）是一线治疗不可切除HCC的标准治疗方案。没有证据表明它在肝功能受损患者的常规临床实践中使用。在11个三级中心连续接受AtezoBev治疗的216例HCC患者中，我们根据不良事件通用术语标准v5.0回顾性评估治疗相关不良事件（trAEs）分级(G)，包括所有根据标签治疗的患者（n = 202,94%）。我们还评估了实体瘤反应评价标准v1.1定义的总生存期（OS）、无进展生存期（PFS）、总缓解期（ORR）和疾病控制率（DCR）。疾病主要继发于病毒性肝炎，即丙型肝炎（72例，36%）和乙型肝炎（35例，17%）。154例（76%）患者肝功能分级为Child - Pugh （CP）‐A级，48例（24%）患者肝功能分级为CP‐B级。143例（71%）患者报告了任何级别的trae，其中53例（26%）为G3, 3例（2%）为G4。与CP‐A相比，CP‐B患者的trAEs发生率相当。食管胃十二指肠镜检查前静脉曲张的存在和程度与出血事件无关。中位随访9.0个月后（95% CI, 7.8-10.1），中位OS为14.9个月（95% CI, 13.6-16.3），而中位PFS为6.8个月（95% CI, 5.2-8.5）。ORR和DCR分别为25%和73%，不同CP类别间无差异。本研究在常规实践中证实了AtezoBev的可重复性安全性和有效性。与CP‐A患者相比，CP‐B患者报告了相似的耐受性，这保证了AtezoBev在缺乏治疗的人群中的前瞻性评估。在这项对216名接受Atezolizumab和Bevacizumab联合治疗的患者的现实生活队列的回顾性研究中，该组合没有显示出任何意外的安全性信号。治疗相关不良事件在Child - Pugh （CP）类别中具有可比性。尽管生存结果较差，但CP‐B患者的有效率与CP‐A患者相似。
Atezolizumab plus bevacizumab (AtezoBev) is the standard of care for first‐line treatment of unresectable HCC. No evidence exists as to its use in routine clinical practice in patients with impaired liver function. In 216 patients with HCC who were consecutively treated with AtezoBev across 11 tertiary centers, we retrospectively evaluated treatment‐related adverse events (trAEs) graded (G) according to Common Terminology Criteria for Adverse Events v5.0, including in the analysis all patients treated according to label (n = 202, 94%). We also assessed overall survival (OS), progression‐free survival (PFS), overall response (ORR), and disease control rates (DCR) defined by Response Evaluation Criteria in Solid Tumors v1.1. Disease was mostly secondary to viral hepatitis, namely hepatitis C (n = 72; 36%) and hepatitis B infection (n = 35, 17%). Liver function was graded as Child‐Pugh (CP)‐A in 154 patients (76%) and CP‐B in 48 (24%). Any grade trAEs were reported by 143 patients (71%), of which 53 (26%) were G3 and 3 (2%) G4. Compared with CP‐A, patients with CP‐B showed comparable rates of trAEs. Presence and grade of varices at pretreatment esophagogastroduodenoscopy did not correlate with bleeding events. After a median follow‐up of 9.0 months (95% CI, 7.8–10.1), median OS was 14.9 months (95% CI, 13.6–16.3), whereas median PFS was 6.8 months (95% CI, 5.2–8.5). ORR and DCR were respectively 25% and 73%, with no difference across CP classes. This study confirms reproducible safety and efficacy of AtezoBev in routine practice. Patients with CP‐B reported similar tolerability compared with CP‐A, warranting prospective evaluation of AtezoBev in this treatment‐deprived population. In this retrospective study on a real‐life cohort of 216 patients treated with Atezolizumab plus Bevacizumab, the combination did not show any unexpected safety signals. Treatment‐related adverse events were comparable across Child‐Pugh (CP) classes. CP‐B patients achieved similar response rates to CP‐A patients, despite inferior survival outcomes.
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