[Effectiveness and safety of atezolizumab plus bevacizumab versus lenvatinib in patients with unresectable HBV-related hepatocellular carcinoma].
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Objective: To evaluate the efficacy and safety of first-line treatment with atezolizumab plus bevacizumab compared to lenvatinib in patients with unresectable hepatocellular carcinoma (HCC) associated with hepatitis B virus (HBV) infection. Methods: This retrospective study included patients with unresectable HBV-related HCC from October 2020 to December 2024 at General Hospital of Tianjin Medical University. Baseline clinical characteristics, treatment response, and adverse events were collected. According to the different first-line treatment, patients were divided into the observation group (receiving atezolizumab combined with bevacizumab) and the control group (receiving oral lenvatinib monotherapy). Kaplan-Meier analysis was used for making survival curve. The overall survival (OS) and progression-free survival (PFS) were compared between two groups. And log-rank test was used to compare the survival differences between the two groups. Tumor response was evaluated per modified response evaluation criteria in solid tumors (mRECIST). The objective response rate (ORR), disease control rate (DCR) and safety were compared between the two groups. Results: A total of 110 patients were included, of whom 56 were in the observation group, with an age of [M(Q1, Q3)] 61 (39, 77) years, and 44 males; 54 were in the control group, with an age of 62 (38, 75) years, and 41 males. Overall, patients were predominantly classified as Child-Pugh class A for liver function, with a median follow-up time of 15.9 months. The median OS was significantly longer in the observation group compared to the control group (20.4 months vs 14.5 months), with 2-year OS rates of 33.7% vs 20.2%, respectively (P=0.018). Median PFS was also longer in the observation group (7.5 months vs 5.6 months) with 1-year PFS rates of 37.2% vs 14.8% (P=0.006). The ORR in the observation group and the control group was 32.1% and 20.4%, respectively, while the DCR was 75.0% and 72.2%, respectively. Grade≥3 treatment-related adverse events occurred in 46.4% (26/56) of patients in the atezolizumab plus bevacizumab group and 38.9% (21/54) in the lenvatinib group, with no statistically significant difference (P=0.424). The most common adverse events differed between groups: in the observation group, fatigue (73.2%, 41/56), gastrointestinal reactions (62.5%, 35/56), hypertension (28.6%, 16/56), proteinuria (21.4%, 12/56) and liver toxicity (17.9%, 10/56) were more frequent; in the control group, fatigue (61.1%, 33/54), hypertension (48.1%, 26/54) and hand-foot skin reaction (24.1%, 13/54) were more common. No severe liver failure or treatment-related deaths were observed. Conclusion: In patients with unresectable HBV-related HCC, atezolizumab plus bevacizumab demonstrated a longer OS and higher ORR compared to lenvatinib with a manageable safety profile.