國家衛生研究院 NHRI:Item 3990099045/15370
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    题名: Atezolizumab plus bevacizumab for patients with unresectable hepatocellular carcinoma and high hepatitis B viral load: Focusing on hepatic safety and viral kinetics
    作者: Chen, SC;Tsou, HHS;Lee, TY;Wang, HW;Chen, YH;Wang, TE;Su, YY;Yang, S;Chiu, CF;Liu, TW;Cheng, AL;Chen, LT;Hsu, C
    贡献者: Institute of Population Health Sciences
    摘要: Background and aims: The safety of immune checkpoint inhibitor therapy for hepatitis B (HBV)-related unresectable hepatocellular carcinoma (uHCC) with high viral load was not clear. This study, sponsored by Taiwan Cooperative Oncology Group (ClinicalTrials.gov: NCT04180072), aimed to clarify the liver-related adverse events (AE) of atezolizumab (atezo) plus bevacizumab (bev) for uHCC with high HBV viral load. Method: Eligible patients were histologically proven uHCC, Child A liver function, HBV DNA >2000 IU/ml, and ≧ 1 measurable tumor by RECIST 1.1. Patients with VP4 portal vein invasion or tumors occupying >50% of liver volume were excluded. Atezo 1200 mg plus bev 15 mg/kg were given on day 1 every 3 weeks until tumor progression or occurrence of unacceptable toxicity. Anti-HBV nucleoside analogs were given prior to start of and during atezo + bev therapy. The primary end point was overall response rate (ORR) by RECIST v1.1. Secondary end points included ≧ grade 3 liver-related AE, HBV reactivation, and patient survival. Results: Thirty patients were enrolled (mean age 58.6 years, M/F 29/ 1, macrovascular invasion 11, distant metastasis 11, median baseline HBV DNA 134,500 IU/ml (range 2010–1760000)). Seventeen patients achieved virological response (VR, defined as HBV DNA decrease to <25 IU/ml). The median time to VR was 2.1 months and was not correlated with baseline viral load. No HBV seroconversion occurred. All-grade liver AE occurred to 13 patients and 6 of them considered immune-related (grade 3, 1 patient; grade 1–2, 5 patients). This grade 3 liver immune-related AE (hepatitis), along with grade 4 StevensJohnson syndrome, occurred after 2 cycles of atezo + bev therapy, and resolved after methylprednisolone treatment. No patients experienced HBV reactivation. Five partial responses and 15 stable diseases according to RECIST 1.1 were documented among 28 evaluable patients. One additional patient with documented partial response, after initial progressive disease, that lasted for about 8 months. As of December 31, 2022 (median follow-up 8.21 months, range 1.90–30.03), the median progression-free and overall survival was 6.28 months (95% CI 3.75–8.34) and 19.70 months (95% CI 7.79-NR). Conclusion: Atezo + bev was generally safe and efficacious in uHCCpatients with high HBV viral load (grant support T2219, MOHW112-TDU-B-221-124007).
    日期: 2023-06
    關聯: Journal of Hepatology. 2023 Jun;78:S588-S589.
    Link to: https://doi.org/10.1016/S0168-8278(23)01394-6
    JIF/Ranking 2023: http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=NHRI&SrcApp=NHRI_IR&KeyISSN=0168-8278&DestApp=IC2JCR
    Cited Times(WOS): https://www.webofscience.com/wos/woscc/full-record/WOS:001037135102173
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