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乐伐替尼治疗晚期或复发性胸腺癌的真实世界疗效与安全性:日本一项多中心回顾性研究

Real-World Efficacy and Safety of Lenvatinib in Advanced or Recurrent Thymic Carcinoma: A Multicenter Retrospective Study in Japan.

作者信息

Miyamoto Satoshi, Tsukaguchi Akihiro, Kuhara Hanako, Otsuki Taiichiro, Shiroyama Takayuki, Tamiya Motohiro, Tamiya Akihiro, Nishino Kazumi, Takeda Yoshito, Kijima Takashi, Okumura Meinoshin, Kumanogoh Atsushi, Mori Masahide

机构信息

Department of Thoracic Oncology, NHO Osaka Toneyama Medical Center, Osaka, Japan.

Department of Respiratory Medicine and Clinical Immunology, Graduate School of Medicine, Osaka University, Osaka, Japan.

出版信息

Thorac Cancer. 2025 Mar;16(6):e70047. doi: 10.1111/1759-7714.70047.

DOI:10.1111/1759-7714.70047
PMID:40123148
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11930915/
Abstract

BACKGROUND

Lenvatinib is recommended for the treatment of advanced and recurrent thymic carcinomas. However, there is a paucity of data on lenvatinib's use in real-world clinical practice. The aim of this study was to evaluate the efficacy and safety of lenvatinib in patients with thymic carcinoma.

METHODS

This multicenter retrospective cohort study assessed the efficacy and tolerability of lenvatinib in the treatment of patients with advanced or recurrent thymic carcinoma between March 2021 and March 2024.

RESULTS

Twenty-seven patients from six institutions in Japan were enrolled in this study. The median progression-free survival (PFS), objective response rate (ORR), and disease control rate (DCR) were 9.0 months (95% confidence interval [CI] 4.8-14.5), 33% (95% CI 16.5%-54%), and 85% (95% CI 66.3%-95.8%), respectively. Although the number of patients was small, the median PFS of the first-, second-, and third- or later-line treatment groups was 21.3 months (n = 5), 9.0 months (n = 13), and 5.8 months (n = 9) (p = 0.171), respectively. Dose reduction was required in all patients, with 17 (63%) presenting grade ≥ 3 adverse events, including hypertension in seven patients and proteinuria in six. No grade ≥ 4 adverse events were observed.

CONCLUSION

The real-world efficacy and safety of lenvatinib are consistent with those reported in previous clinical trials of second-line lenvatinib. Furthermore, despite the relatively small sample size, our findings suggest that lenvatinib may be effective for the treatment of thymic carcinoma.

摘要

背景

乐伐替尼被推荐用于治疗晚期和复发性胸腺癌。然而,关于乐伐替尼在实际临床实践中的应用数据较少。本研究的目的是评估乐伐替尼治疗胸腺癌患者的疗效和安全性。

方法

这项多中心回顾性队列研究评估了2021年3月至2024年3月期间乐伐替尼治疗晚期或复发性胸腺癌患者的疗效和耐受性。

结果

来自日本6家机构的27例患者纳入本研究。中位无进展生存期(PFS)、客观缓解率(ORR)和疾病控制率(DCR)分别为9.0个月(95%置信区间[CI]4.8 - 14.5)、33%(95%CI 16.5% - 54%)和85%(95%CI 66.3% - 95.8%)。尽管患者数量较少,但一线、二线和三线及后续治疗组的中位PFS分别为21.3个月(n = 5)、9.0个月(n = 13)和5.8个月(n = 9)(p = 0.171)。所有患者均需要减量,17例(63%)出现≥3级不良事件,包括7例高血压和6例蛋白尿。未观察到≥4级不良事件。

结论

乐伐替尼的实际疗效和安全性与先前二线乐伐替尼临床试验报告的一致。此外,尽管样本量相对较小,但我们的研究结果表明乐伐替尼可能对胸腺癌治疗有效。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/43b9/11930915/966cf5a09a36/TCA-16-e70047-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/43b9/11930915/04625af868c7/TCA-16-e70047-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/43b9/11930915/966cf5a09a36/TCA-16-e70047-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/43b9/11930915/04625af868c7/TCA-16-e70047-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/43b9/11930915/966cf5a09a36/TCA-16-e70047-g002.jpg

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