國家衛生研究院 NHRI:Item 3990099045/13596
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    题名: Atezolizumab plus bevacizumab for patients with advanced hepatocellular carcinoma and chronic hepatitis B virus infection with high viral load
    作者: Chen, S;Lai, H;Tsou, H;Shao, Y;Chang, C;Su, T;Liu, T;Chen, L;Cheng, A;Hsu, C
    贡献者: National Institute of Cancer Research
    摘要: Background: Atezolizumab plus bevacizumab (A+B) is the current standard systemic therapy for patients with advanced hepatocellular carcinoma (HCC). This study sought to clarify its safety and efficacy in HCC patients who had chronic hepatitis B virus (HBV) infection and high viral load (NCT04180072). The first 10 subjects in the study constituted the safety run-in cohort. Methods: Eligible subjects must have histologically proven, locally advanced or metastatic and/or unresectable HCC that is not amenable to curative surgical and/or locoregional therapies, no prior systemic therapy for HCC, documented chronic HBV infection with HBV DNA > 2000 IU/mL within 28 days prior to initiation of study treatment, at least one measurable (per RECIST 1.1) lesion, ECOG score 0 or 1, and Child-Pugh class A. Atezolizumab 1200 mg IV plus bevacizumab 15 mg/kg IV was given every 3 weeks until documented tumor progression or unacceptable toxicity. Anti-HBV treatment was started prior to start of A+B treatment. The primary endpoint is overall response rate as per RECIST v1.1. Key safety endpoints (according to NCI CTCAE v5.0) included the proportion of subjects with ≥ grade 3 liver-related adverse events (AE), incidence and severity of all AE and immune-related AE, and incidence of HBV reactivation. Results: From March 2020 to January 2021, 10 subjects were enrolled (men/women 10/0, median age 61.5 years, macrovascular invasion/ extra-hepatic metastasis 4/5, median alpha-fetoprotein 1722.16 ng/mL (range 2.25-80000)). Median HBV DNA levels at baseline were 35002.5 IU/mL (range 3350- 1760000). The median decrease of HBV DNA after A+B treatment (from baseline to the nadir level, in log scale) was 3.2 (range 0.7–5.1). No subjects had HBV reactivation, defined as either (1) HBV DNA increase ≧ 100 folds from baseline; (2) HBV DNA increase ≧ 10 folds from baseline and ≧ 3-fold increase in alanine aminotransferase (ALT); or (3) 2 consecutive increase in HBV DNA of ≧ 100 folds than previous nadir level. Grade 3 liver-related AE (transaminase elevation) occurred to 1 subject, who later confirmed partial response. The only other grade 3-4 treatment-related AE was hypertension (2 subjects). No subjects received steroid therapy for immune-related AE. As of February 2021, the subjects received a median of 6 cycles of A+B (range 2-14); 2 partial responses, 3 stable diseases, and 4 progressive diseases were documented in 9 evaluable subjects (1 subject with PD confirmed PR subsequently, suggesting pseudo-progression). Conclusions: A+B was safe for advanced HCC patients with high HBV viral loads at baseline. Recruitment was ongoing for better clarification of treatment efficacy and safety profile.
    日期: 2021-07
    關聯: Annals of Oncology. 2021 Jul;32(Suppl. 3):S141-S142.
    Link to: http://dx.doi.org/10.1016/j.annonc.2021.05.181
    JIF/Ranking 2023: http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=NHRI&SrcApp=NHRI_IR&KeyISSN=0923-7534&DestApp=IC2JCR
    Cited Times(WOS): https://www.webofscience.com/wos/woscc/full-record/WOS:000670004200125
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