Lenvatinib在现实世界中治疗的晚期胸腺癌患者

IF 7.1 2区医学 Q1 ONCOLOGY

ESMO Open Pub Date : 2025-06-01 DOI:10.1016/j.esmoop.2025.105301

K. Takagi , G. Saito , H. Tanaka , S. Kubo , T. Shukuya , R. Tsugitomi , T. Sasaki , T. Oba , N. Mamesaya , T. Yamanaka , M. Tachihara , H. Gyotoku , H. Nagashima , M. Tamiya , H. Kanemura , T. Tozuka , M. Furuta , S. Sakata , A. Mouri , H. Miwa , T. Suzuki

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引用次数: 0

摘要

背景：REMORA试验证明lenvatinib治疗晚期胸腺癌的有效性和安全性。然而，需要更多关于其在临床实践中的应用的数据。该多中心回顾性研究纳入了在2021年3月23日至2022年10月31日期间开始lenvatinib治疗的连续晚期胸腺癌患者。主要终点是先前治疗组的客观缓解率，阈值和期望值基于REMORA试验和其他关键药物试验的结果。根据REMORA试验资格标准或年龄进行亚组分析。结果既往治疗组87例患者入组[中位年龄64岁（38-79岁）；56（64%）男性]。大多数患者[82例（94%）]的表现状态为0或1；51例（59%）符合试验资格标准。客观有效率为30%[90%可信区间（CI） 21.3% ~ 39.1%]，疾病控制率为93% （95% CI 84.6% ~ 97.2%）。中位无进展生存期、治疗失败时间和总生存期分别为10.2个月（95% CI 7.0-13.2个月）、11.6个月（95% CI 6.9-17.0个月）和未达到(NR；95% CI 18.3个月- nr)。73名患者（84%）由于不良事件需要减量，包括高血压（22%）、蛋白尿（20%）和掌足底红觉不良综合征（16%）。20名患者（23%）因不良事件停用lenvatinib，包括厌食症（6%）、左心室收缩功能障碍（2%）和疲劳或不适（2%）。2例（2%）患者死于不良事件。符合试验条件的患者的无进展生存期明显长于不符合试验条件的患者(14.7个月对7.7个月；P = 0.03)。老年患者不良事件发生率较高。结论主要终点未达到；然而，lenvatinib在先前治疗过的胸腺癌患者中显示出相对有利的疗效和安全性，即使在涉及不同人群的真实临床实践中也是如此。

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Lenvatinib for patients with previously treated advanced thymic carcinoma in real-world settings

Background

The REMORA trial demonstrated efficacy and safety of lenvatinib in patients previously treated for advanced thymic carcinoma. However, more data regarding its use in clinical practice are required.

Methods

This multicenter retrospective study included consecutive patients with advanced thymic carcinoma who began lenvatinib treatment between 23 March 2021 and 31 October 2022. The primary outcome was the objective response rate in the previously treated group, with threshold and expected values based on the results of the REMORA trial and trials of other key drugs. Subgroup analyses were carried out based on REMORA trial eligibility criteria or age.

Results

Eighty-seven patients were enrolled in the previously treated group [median age, 64 years (range 38-79 years); 56 (64%) males]. Most patients [82 (94%)] had a performance status of 0 or 1; 51 (59%) met the trial eligibility criteria. The objective response rate and the disease control rate were 30% [90% confidence interval (CI) 21.3% to 39.1%] and 93% (95% CI 84.6% to 97.2%), respectively. The median progression-free survival, time to treatment failure, and overall survival were 10.2 months (95% CI 7.0-13.2 months), 11.6 months (95% CI 6.9-17.0 months), and not reached (NR; 95% CI 18.3 months-NR), respectively. Seventy-three patients (84%) required dose reduction owing to adverse events, including hypertension (22%), proteinuria (20%), and palmar–plantar erythrodysesthesia syndrome (16%). Twenty patients (23%) discontinued lenvatinib due to adverse events, including anorexia (6%), left ventricular systolic dysfunction (2%), and fatigue or malaise (2%). Two patients (2%) died of adverse events. Trial-eligible patients had significantly longer progression-free survival than that in trial-ineligible patients (14.7 months versus 7.7 months; P = 0.03). The incidence of adverse events was higher in older patients.

Conclusions

The primary endpoint was unmet; however, lenvatinib demonstrated relatively favorable efficacy and safety in patients with previously treated thymic carcinoma, even in real-world clinical practice involving diverse populations.

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来源期刊

ESMO Open Medicine-Oncology

CiteScore

11.70

自引率

2.70%

发文量

255

审稿时长

10 weeks

期刊介绍： ESMO Open is the online-only, open access journal of the European Society for Medical Oncology (ESMO). It is a peer-reviewed publication dedicated to sharing high-quality medical research and educational materials from various fields of oncology. The journal specifically focuses on showcasing innovative clinical and translational cancer research. ESMO Open aims to publish a wide range of research articles covering all aspects of oncology, including experimental studies, translational research, diagnostic advancements, and therapeutic approaches. The content of the journal includes original research articles, insightful reviews, thought-provoking editorials, and correspondence. Moreover, the journal warmly welcomes the submission of phase I trials and meta-analyses. It also showcases reviews from significant ESMO conferences and meetings, as well as publishes important position statements on behalf of ESMO. Overall, ESMO Open offers a platform for scientists, clinicians, and researchers in the field of oncology to share their valuable insights and contribute to advancing the understanding and treatment of cancer. The journal serves as a source of up-to-date information and fosters collaboration within the oncology community.