利莫gene laherparepvec或白细胞介素2治疗III期黑色素瘤患者的比较现实结果

IF 4.3 2区 医学 Q2 ONCOLOGY
Therapeutic Advances in Medical Oncology Pub Date : 2025-04-01 eCollection Date: 2025-01-01 DOI:10.1177/17588359251324035
Markus Reitmajer, Lena Nanz, Nina Müller, Ulrike Leiter, Teresa Amaral, Valentin Aebischer, Lukas Flatz, Andrea Forschner
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引用次数: 0

摘要

背景:Talimogene laherparepvec (T-VEC)和白细胞介素-2 (IL-2)均用于黑色素瘤皮肤转移的病灶内治疗。T-VEC于2015年获得了欧洲药品管理局和美国食品和药物管理局的监管批准,而IL-2多年来一直在标签外用于此目的。尽管它们在临床实践中使用,但缺乏关于这些治疗的有效性和安全性的比较数据。目的:本回顾性研究旨在比较2016年1月至2024年9月在单一中心治疗的不可切除的III期黑色素瘤患者的瘤内T-VEC和IL-2的疗效和安全性。方法:我们使用中央恶性黑色素瘤登记处和当地大学医院药房数据库确定符合条件的患者。计算总生存期(OS)和无进展生存期(PFS)。此外,比较T-VEC组和IL-2组的最佳缓解率和不良事件(ae)发生率。允许同时进行全身治疗。结果:共纳入62例患者,其中37例接受T-VEC, 25例接受IL-2作为一线治疗。10名患者随后接受了两种治疗。该队列的中位PFS为5.0个月,中位OS为34.0个月。两组间PFS (p = 0.790)、OS (p = 0.894)和最佳有效率(p = 0.468)均无显著差异。常见的不良反应包括局部注射部位反应和发热,没有导致医生停药的严重事件。结论:IL-2治疗与T-VEC治疗在PFS、OS或最佳缓解率方面无显著差异。治疗的选择可能受到诸如可获得性、医生偏好和患者特定考虑等因素的影响。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Comparative real-world outcomes of stage III melanoma patients treated with talimogene laherparepvec or interleukin 2.

Background: Talimogene laherparepvec (T-VEC) and interleukin-2 (IL-2) are both used in the intralesional treatment of melanoma skin metastases. T-VEC received regulatory approval from the European Medicines Agency and the U.S. Food and Drug Administration in 2015, while IL-2 has been used off-label for this purpose for many years. Despite their use in clinical practice, there is a lack of comparative data on the efficacy and safety of these treatments.

Objectives: This retrospective study aimed to compare the efficacy and safety of intralesional T-VEC and IL-2 in non-resectable stage III patients with melanoma treated at a single center between January 2016 and September 2024.

Methods: We identified eligible patients using the Central Malignant Melanoma Registry and the local University Hospital Pharmacy database. Overall survival (OS) and progression-free survival (PFS) were calculated. Furthermore, best response rates and occurrence of adverse events (AEs) were compared between the T-VEC and the IL-2 group. Concomitant systemic treatment was allowed.

Results: A total of 62 patients were included, with 37 receiving T-VEC and 25 receiving IL-2 as first-line therapy. Ten patients received both therapies subsequently. The median PFS for the cohort was 5.0 months, and the median OS was 34.0 months. No significant differences in PFS (p = 0.790), OS (p = 0.894), or best response rates (p = 0.468) were found between groups. Common AEs included local injection site reactions and fever, with no severe events leading to discontinuation by a physician.

Conclusion: No significant differences in PFS, OS, or best response rates were observed between IL-2 and T-VEC treatments. The choice of therapy may be influenced by factors such as availability, physician preference, and patient-specific considerations.

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来源期刊
CiteScore
8.20
自引率
2.00%
发文量
160
审稿时长
15 weeks
期刊介绍: Therapeutic Advances in Medical Oncology is an open access, peer-reviewed journal delivering the highest quality articles, reviews, and scholarly comment on pioneering efforts and innovative studies in the medical treatment of cancer. The journal has a strong clinical and pharmacological focus and is aimed at clinicians and researchers in medical oncology, providing a forum in print and online for publishing the highest quality articles in this area. This journal is a member of the Committee on Publication Ethics (COPE).
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