Terashima Takeshi, Kido Hidenori, Takata Noboru, Hayashi Tomoyuki, Seki Akihiro, Nakagawa Hidetoshi, Nio Kouki, Toyama Tadashi, Iida Noriho, Yamada Shinya, Shimakami Tetsuro, Takatori Hajime, Arai Kuniaki, Yamashita Tatsuya, Mizukoshi Eishiro, Yamashita Taro
Department of Gastroenterology, Kanazawa University Hospital, Kanazawa 920-8641, Ishikawa, Japan.
Department of Nephrology, Faculty of Medical Sciences, University of Fukui, Fukui 910-1104, Fukui, Japan.
Cancers (Basel). 2025 Jan 16;17(2):278. doi: 10.3390/cancers17020278.
: Atezolizumab and bevacizumab combination therapy has been established as a standard of care for first-line treatment; however, its efficacy and safety have not been fully evaluated for patients previously treated with systemic therapy. : In this phase II trial, patients with advanced hepatocellular carcinoma previously treated with lenvatinib were enrolled to receive a dose of 1,200 mg of atezolizumab and 15 mg/kg of bevacizumab every 3 weeks. The primary endpoint was progression-free survival. The secondary endpoints included overall survival, objective response rate, disease control rate, subsequent therapy, and frequency of adverse events. The threshold and expected progression-free survival were 3 and 6.8 months, respectively. Considering a one-sided significance level of 0.05 and a statistical power of 80%, the minimum required sample size was 26 patients. : The median progression-free survival from the start of treatment was 9.70 [90% confidence interval, 5.10-14.24] months, and the lower limit of the 90% CI was above the predefined threshold. The objective response and disease control rates were 34.6% and 73.1%, respectively. Sixteen patients (61.5%) received subsequent therapies, and the median overall survival was 17.23 [90% confidence interval, 13.18-27.85] months. Severe adverse events, adverse events leading to treatment delays, and adverse events leading to treatment discontinuation occurred in eight (30.8%), fourteen (53.8%), and five (19.2%) patients, respectively, and no treatment-related deaths occurred. : Atezolizumab and bevacizumab combination therapy is effective and can safely be administered to patients with advanced HCC previously treated with lenvatinib.
阿替利珠单抗和贝伐单抗联合疗法已被确立为一线治疗的标准治疗方案；然而，对于先前接受过全身治疗的患者，其疗效和安全性尚未得到充分评估。：在这项II期试验中，纳入了先前接受过乐伐替尼治疗的晚期肝细胞癌患者，每3周接受一次1200mg阿替利珠单抗和15mg/kg贝伐单抗的治疗。主要终点是无进展生存期。次要终点包括总生存期、客观缓解率、疾病控制率、后续治疗以及不良事件的发生频率。阈值和预期无进展生存期分别为3个月和6.8个月。考虑到单侧显著性水平为0.05和统计检验效能为80%，所需的最小样本量为26例患者。：从治疗开始计算的中位无进展生存期为9.70[90%置信区间，5.10 - 14.24]个月，90%CI的下限高于预先设定的阈值。客观缓解率和疾病控制率分别为34.6%和73.1%。16例患者（61.5%）接受了后续治疗，中位总生存期为17.23[90%置信区间，13.18 - 27.85]个月。分别有8例（30.8%）、14例（53.8%）和5例（19.2%）患者发生了严重不良事件、导致治疗延迟的不良事件以及导致治疗中断的不良事件，且未发生与治疗相关的死亡病例。：阿替利珠单抗和贝伐单抗联合疗法对先前接受过乐伐替尼治疗的晚期肝癌患者有效且可安全给药。
