Atezolizumab plus bevacizumab treatment for unresectable hepatocellular carcinoma: Early clinical experience.
Atezolizumab plus bevacizumab treatment for unresectable hepatocellular carcinoma: Early clinical experience.
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DOI：
10.1002/cnr2.1464
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发表时间：
2022-03
期刊：
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通讯作者：
Real-life Practice Experts for HCC (RELPEC) Study Group, and HCC 48 Group (Hepatocellular Carcinoma Experts from 48 Clinics in Japan)
中科院分区：
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作者：
Hiraoka A;Kumada T;Tada T;Hirooka M;Kariyama K;Tani J;Atsukawa M;Takaguchi K;Itobayashi E;Fukunishi S;Tsuji K;Ishikawa T;Tajiri K;Ochi H;Yasuda S;Toyoda H;Ogawa C;Nishimura T;Hatanaka T;Ohama H;Nouso K;Morishita A;Tsutsui A;Nagano T;Itokawa N;Okubo T;Arai T;Imai M;Koizumi Y;Nakamura S;Joko K;Iijima H;Hiasa Y;Kudo M;Real-life Practice Experts for HCC (RELPEC) Study Group, and HCC 48 Group (Hepatocellular Carcinoma Experts from 48 Clinics in Japan)
尽管阿替唑单抗联合贝伐单抗(ATEZ/BEV)治疗不能切除的肝细胞癌(u-HCC)已经被开发出来，但在治疗过程中肝功能的变化还没有报道。这项回顾性临床研究旨在阐明对ATEZ/BEV的早期反应。从2020年9月至2021年4月，171例接受ATEZ/BEV治疗的u-HCC患者入选(BCLC分期A：B：C：D=568：96：2)。在这些人中，75人以前没有系统治疗史。用白蛋白-胆红素(ALBI)评分和实体瘤反应评价标准(RECIST，VER)评价肝功能和治疗反应的相对变化。1.1。在最初的影像检查中，6周后早期肿瘤缩小和疾病控制的客观有效率( -6W/DCR6W)为10.6%/79.6%。在有和没有系统治疗史的患者中观察到了类似的反应结果(ORR-6W/DCR-6W=99.7%/77.8%和12.2%/82.9%)，以及使用ATEZ/BEV作为Lenvatinib后进展治疗的患者(ORR-6W/DCR-6W=67.7%/79.5%)，尚未建立有效的进展后治疗。在接受6周观察期的患者中，ALBI评分在使用ATEZ/BEV后3 周显著恶化(−2.525 ± 0.419 vs−2.323 ± 0.445，p <； .001)，但随后在6周恢复(−2.403 ± 0.452)，与3周相比(p=0.001)。在观察期间，最常见的不良事件是食欲不振(所有级别)(12.3%)、全身疲劳/高血压(所有级别)(分别为11.1%)和尿蛋白(所有级别)(10.5%)。ATEZ/BEV可能不仅作为现有分子靶向药物的首个治疗药物，而且还可能作为后续治疗药物。此外，由于目前的患者表现出良好的初始治疗反应，这种药物组合在早期对肝功能的影响可能较小。
Although atezolizumab plus bevacizumab (Atez/bev) treatment has been developed for unresectable hepatocellular carcinoma (u‐HCC), changes in hepatic function during therapy have yet to be reported. This retrospective clinical study aimed to elucidate early responses to Atez/Bev. From September 2020 to April 2021, 171 u‐HCC patients undergoing Atez/Bev treatment were enrolled (BCLC stage A:B:C:D = 5:68:96:2). Of those, 75 had no prior history of systemic treatment. Relative changes in hepatic function and therapeutic response were assessed using albumin‐bilirubin (ALBI) score and Response Evaluation Criteria in Solid Tumors (RECIST), ver. 1.1, respectively. In initial imaging examination findings, objective response rates for early tumor shrinkage and disease control after 6 weeks (ORR‐6W/DCR‐6W) were 10.6%/79.6%. Similar response results were observed in patients with and without a past history of systemic treatment (ORR‐6W/DCR‐6W = 9.7%/77.8% and 12.2%/82.9%), as well as patients in whom Atez/Bev was used as post‐progression treatment following lenvatinib (ORR‐6W/DCR‐6W = 7.7%/79.5%), for which no known effective post‐progression treatment has been established. In 111 patients who underwent a 6‐week observation period, ALBI score was significantly worsened at 3 weeks after introducing Atez/Bev (−2.525 ± 0.419 vs −2.323 ± 0.445, p < .001), but then recovered at 6‐weeks (−2.403 ± 0.452) as compared to 3‐weeks (p = .001). During the observation period, the most common adverse events were appetite loss (all grades) (12.3%), general fatigue/hypertension (all grades) (11.1%, respectively), and urine protein (all grades) (10.5%). Atez/Bev might have therapeutic potential not only as first but also later‐line treatment of existing molecular target agents. In addition, this drug combination may have less influence on hepatic function during the early period, as the present patients showed a good initial therapeutic response.