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阿替利珠单抗联合贝伐单抗与乐伐替尼作为肝细胞癌一线全身化疗的疗效和安全性比较。

Comparison of atezolizumab plus bevacizumab and lenvatinib in terms of efficacy and safety as primary systemic chemotherapy for hepatocellular carcinoma.

作者信息

Maesaka Kazuki, Sakamori Ryotaro, Yamada Ryoko, Doi Akira, Tahata Yuki, Miyazaki Masanori, Ohkawa Kazuyoshi, Mita Eiji, Iio Sadaharu, Nozaki Yasutoshi, Yakushijin Takayuki, Imai Yasuharu, Kodama Takahiro, Hikita Hayato, Tatsumi Tomohide, Takehara Tetsuo

机构信息

Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Suita, Osaka, Japan.

Department of Gastroenterology and Hepatology, Osaka Police Hospital, Osaka, Osaka, Japan.

出版信息

Hepatol Res. 2022 Jul;52(7):630-640. doi: 10.1111/hepr.13771. Epub 2022 Apr 25.

DOI:10.1111/hepr.13771
PMID:35417606
Abstract

AIM

Atezolizumab plus bevacizumab and lenvatinib have each shown efficacy as primary systemic chemotherapies for hepatocellular carcinoma (HCC) in clinical trials. However, comparative trials of these two treatments have not been conducted. This study aimed to compare the therapeutic outcomes of these two treatments.

METHODS

This prospectively registered multicenter study analyzed 272 patients with HCC who received atezolizumab plus bevacizumab (the Atezo + Beva group; n = 90) or lenvatinib (the Len group; n = 182) as primary systemic chemotherapy. After propensity score matching (PSM), 66 patients were assigned to each group.

RESULTS

After PSM, the median progression-free survival (PFS) was significantly longer in the Atezo + Beva group than in the Len group (8.8 vs. 5.2 months; p = 0.012). No significant differences were noted between the two groups in terms of median overall survival (not reached vs. 20.6 months; p = 0.577), objective response rates (43.8% vs. 52.4%; p = 0.330), and disease control rates (76.6% vs. 82.5%; p = 0.404). The percentage of patients with modified albumin-bilirubin grades of one or 2a was maintained during treatment in the Atezo + Beva group but decreased over time in the Len group. The rate of discontinuation due to adverse events (AEs) was lower in the Atezo + Beva group than in the Len group (12.1% vs. 28.8%; p = 0.018).

CONCLUSIONS

Atezolizumab plus bevacizumab showed prolonged PFS, maintained hepatic reserve, and had lower rates of severe AEs compared with that on using lenvatinib as primary systemic chemotherapy for HCC.

摘要

目的

在临床试验中,阿替利珠单抗联合贝伐单抗以及乐伐替尼各自均已显示出作为肝细胞癌(HCC)一线全身化疗的疗效。然而,尚未开展这两种治疗方法的对比试验。本研究旨在比较这两种治疗方法的治疗效果。

方法

这项前瞻性注册多中心研究分析了272例接受阿替利珠单抗联合贝伐单抗(阿替利珠单抗+贝伐单抗组;n = 90)或乐伐替尼(乐伐替尼组;n = 182)作为一线全身化疗的HCC患者。在进行倾向评分匹配(PSM)后,每组分配66例患者。

结果

PSM后,阿替利珠单抗+贝伐单抗组的中位无进展生存期(PFS)显著长于乐伐替尼组(8.8个月对5.2个月;p = 0.012)。两组在中位总生存期(未达到对20.6个月;p = 0.577)、客观缓解率(43.8%对52.4%;p = 0.330)和疾病控制率(76.6%对82.5%;p = 0.404)方面未观察到显著差异。在阿替利珠单抗+贝伐单抗组中,治疗期间改良白蛋白-胆红素分级为1级或2a级的患者比例保持稳定,而在乐伐替尼组中随时间下降。阿替利珠单抗+贝伐单抗组因不良事件(AE)停药的发生率低于乐伐替尼组(12.1%对28.8%;p = 0.018)。

结论

与使用乐伐替尼作为HCC一线全身化疗相比,阿替利珠单抗联合贝伐单抗显示出更长的PFS、维持了肝脏储备,且严重AE的发生率更低。

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