Cabozantinib for Advanced Hepatocellular Carcinoma in the Latest Real-World Practice: A Multicenter Retrospective Analysis.

IF 1.9 Q3 PHARMACOLOGY & PHARMACY

Drugs - Real World Outcomes Pub Date : 2023-12-01 Epub Date: 2023-07-19 DOI:10.1007/s40801-023-00379-x

Hiroaki Kanzaki, Sadahisa Ogasawara, Tomomi Okubo, Norio Itokawa, Ryohei Yoshino, Kentaro Fujimoto, Tadayoshi Kogure, Sae Yumita, Takamasa Ishino, Keita Ogawa, Terunao Iwanaga, Miyuki Nakagawa, Kisako Fujiwara, Ryuta Kojima, Keisuke Koroki, Masanori Inoue, Kazufumi Kobayashi, Naoya Kanogawa, Soichiro Kiyono, Masato Nakamura, Takayuki Kondo, Ryo Nakagawa, Shingo Nakamoto, Ryosuke Muroyama, Ei Itobayashi, Masanori Atsukawa, Jun Kato, Naoya Kato

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引用次数: 0

Abstract

Background: Cabozantinib was found to be effective as a second- or third-line treatment after sorafenib in patients with advanced hepatocellular carcinoma (HCC) in the phase 3 CELESTIAL trial. So far, as immunotherapy has substituted molecular target agents as the primary systemic therapy for advanced HCC, cabozantinib is extensively used in the latest real-world clinical practice in a greatly different position than that shown by the CELESTIAL trial. In the current analysis, we examined the safety and effectiveness of cabozantinib administration in real-life settings for patients with advanced HCC.

Methods: We retrospectively obtained data from patients with advanced HCC who received cabozantinib in three institutions in Japan between 14 September 2018 and 30 November 2021.

Results: During the study period, 23 patients with advanced HCC received cabozantinib. Our cohort included 21.7% of patients with Child-Pugh class B, and 52.2% of patients in fourth line or later. The median progression-free survival of patients given cabozantinib was 3.7 months. Regarding patients with Child-Pugh class B or administration in fourth line or later, the discontinuation rate due to adverse events in patients who initialized at 40 or 20 mg was lower than those who initialized at 60 mg (42.9% versus 75.0%). Patients who were able to continue treatment with cabozantinib for more than 3 months were more likely to undergo dose reduction than those who did not (85.7% versus 25.0%).

Conclusions: Cabozantinib has recently been administered to a diverse range of patients, including those who were not enrolled in the CELESTIAL trial. Deliberate dose reduction could potentially offer clinical benefits to patients with impaired liver function. Furthermore, managing adverse events by reducing the dose could play a crucial role in extending the duration of treatment with cabozantinib. The preprint version of this work is available on https://www.researchsquare.com/article/rs-2655181/v1 .

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卡博替尼（Cabozantinib）治疗晚期肝细胞癌的最新临床实践：多中心回顾性分析

背景：CELESTIAL三期试验发现，卡博替尼是晚期肝细胞癌（HCC）患者索拉非尼治疗后的二线或三线治疗药物。迄今为止，由于免疫疗法已取代分子靶向药物成为晚期 HCC 的主要系统疗法，卡博替尼在最新的实际临床实践中得到了广泛应用，其地位与 CELESTIAL 试验所显示的大不相同。在当前的分析中，我们研究了卡博替尼对晚期HCC患者实际用药的安全性和有效性：我们回顾性地获取了 2018 年 9 月 14 日至 2021 年 11 月 30 日期间在日本三家机构接受卡博替尼治疗的晚期 HCC 患者的数据：在研究期间，23 名晚期 HCC 患者接受了卡博替尼治疗。我们的队列包括21.7%的Child-Pugh B级患者和52.2%的四线或四线以上患者。接受卡博替尼治疗的患者的中位无进展生存期为3.7个月。对于Child-Pugh分级为B级或四线或四线以上用药的患者，初始剂量为40或20毫克的患者因不良事件而中断治疗的比例低于初始剂量为60毫克的患者（42.9%对75.0%）。能够继续使用卡博替尼治疗3个月以上的患者比没有继续使用的患者更有可能减少剂量（85.7%对25.0%）：卡博替尼最近已被用于不同类型的患者，包括那些未加入CELESTIAL试验的患者。有意减少剂量可能会给肝功能受损的患者带来临床益处。此外，通过减少剂量来控制不良反应可在延长卡博替尼治疗时间方面发挥关键作用。本论文的预印本可在 https://www.researchsquare.com/article/rs-2655181/v1 上查阅。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Drugs - Real World Outcomes PHARMACOLOGY & PHARMACY-

CiteScore

3.60

自引率

5.00%

发文量

审稿时长

8 weeks

期刊介绍： Drugs - Real World Outcomes targets original research and definitive reviews regarding the use of real-world data to evaluate health outcomes and inform healthcare decision-making on drugs, devices and other interventions in clinical practice. The journal includes, but is not limited to, the following research areas: Using registries/databases/health records and other non-selected observational datasets to investigate: drug use and treatment outcomes prescription patterns drug safety signals adherence to treatment guidelines benefit : risk profiles comparative effectiveness economic analyses including cost-of-illness Data-driven research methodologies, including the capture, curation, search, sharing, analysis and interpretation of ‘big data’ Techniques and approaches to optimise real-world modelling.