达非尼和曲美替尼佐剂治疗BRAF突变黑色素瘤切除患者:DESCRIBE-AD真实世界回顾性观察研究。

IF 1.5 4区 医学 Q3 DERMATOLOGY
Melanoma Research Pub Date : 2023-10-01 Epub Date: 2023-03-28 DOI:10.1097/CMR.0000000000000888
José L Manzano, Juan Martin-Liberal, Luis A Fernández-Morales, Gretel Benítez, Javier Medina Martínez, María Quindós, Almudena García-Castaño, Ovidio Fernández, Rocío V Simo, Margarita Majem, Lorena Bellido, Pablo Ayala de Miguel, Begoña Campos, Enrique Espinosa, José A Macías Cerrolaza, Irene Gil-Arnaiz, David Lorente, Alvaro Rodriguez-Lescure, Victor N Perez, Rafael López Castro, María G Gramaje, Teresa Puértolas, Juan F Rodriguez Moreno, Laia Espasa Font, Guillermo Belaustegui Ferrández, Pablo Cerezuela-Fuentes
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引用次数: 0

摘要

BRAF和MEK抑制剂,达非尼加曲美替尼,辅助治疗对BRAF-V600突变的高危切除黑色素瘤患者有效。然而,现实世界的证据是有限的。我们旨在确定这种疗法在常规临床实践中的可行性。DESCRIBE-AD是一项回顾性观察性研究,收集了西班牙25家医院的真实世界数据。年龄≥18岁经组织学证实并切除BRAF突变黑色素瘤患者 包括既往接受达非尼加曲美替尼辅助治疗的患者。主要目标是停药率和停药时间。次要目标包括安全性和有效性。从2020年10月到2021年3月,纳入了65名患者。任何级别的治疗相关不良事件(TRAE)引起的达非尼和曲美替尼停药率为9%。停药的其他原因包括患者的决定(6%)、医生的决定(60%)、无关不良事件(3%)、疾病进展(5%)和其他(5%)。中断治疗的中位时间为9 月[95%置信区间(CI),5-11]。G3-4 TRAE发生在21.5%的患者中,最常见的是发热(3%)、乏力(3%)和腹泻(3%)。非计划住院和临床检查分别发生在6%和22%的患者中。经过20个月的中位随访(95%CI,18-22),9%的患者因疾病进展而退出,12个月无复发生存率和总生存率分别为95.3%和100%。Dabrafenib和trametinib辅助治疗在现实世界中被证明对黑色素瘤患者有效,毒性可控。毒性频率较低,导致计划外就诊、检查和中断治疗的发生率较低。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Adjuvant dabrafenib and trametinib for patients with resected BRAF -mutated melanoma: DESCRIBE-AD real-world retrospective observational study.

Adjuvant dabrafenib and trametinib for patients with resected BRAF -mutated melanoma: DESCRIBE-AD real-world retrospective observational study.

Adjuvant dabrafenib and trametinib for patients with resected BRAF -mutated melanoma: DESCRIBE-AD real-world retrospective observational study.

Adjuvant dabrafenib and trametinib for patients with resected BRAF -mutated melanoma: DESCRIBE-AD real-world retrospective observational study.

BRAF and MEK inhibitor, dabrafenib plus trametinib, adjuvant therapy is effective for high-risk resected melanoma patients with BRAF - V600 mutations. However, real-world evidence is limited. We aimed to determine the feasibility of this therapy in routine clinical practice. DESCRIBE-AD, a retrospective observational study, collected real-world data from 25 hospitals in Spain. Histologically confirmed and resected BRAF -mutated melanoma patients aged ≥18 years who were previously treated with dabrafenib plus trametinib adjuvant therapy, were included. The primary objectives were treatment discontinuation rate and time to discontinuation. The secondary objectives included safety and efficacy. From October 2020 to March 2021, 65 patients were included. Dabrafenib and trametinib discontinuation rate due to treatment-related adverse events (TRAEs) of any grade was 9%. Other reasons for discontinuation included patients' decisions (6%), physician decisions (6%), unrelated adverse events (3%), disease progression (5%), and others (5%). The median time to treatment discontinuation was 9 months [95% confidence interval (CI), 5-11]. G3-4 TRAEs occurred in 21.5% of patients, the most common being pyrexia (3%), asthenia (3%), and diarrhoea (3%). Unscheduled hospitalisations and clinical tests occurred in 6 and 22% of patients, respectively. After 20-month median follow-up (95% CI, 18-22), 9% of patients had exitus due to disease progression, with a 12-month relapse-free survival and overall survival rates of 95.3% and 100%, respectively. Dabrafenib and trametinib adjuvant therapy proved effective for melanoma patients in a real-world setting, with a manageable toxicity profile. Toxicity frequencies were low leading to low incidence of unscheduled medical visits, tests, and treatment discontinuations.

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来源期刊
Melanoma Research
Melanoma Research 医学-皮肤病学
CiteScore
3.40
自引率
4.50%
发文量
139
审稿时长
6-12 weeks
期刊介绍: ​​​​​​Melanoma Research is a well established international forum for the dissemination of new findings relating to melanoma. The aim of the Journal is to promote the level of informational exchange between those engaged in the field. Melanoma Research aims to encourage an informed and balanced view of experimental and clinical research and extend and stimulate communication and exchange of knowledge between investigators with differing areas of expertise. This will foster the development of translational research. The reporting of new clinical results and the effect and toxicity of new therapeutic agents and immunotherapy will be given emphasis by rapid publication of Short Communications. ​Thus, Melanoma Research seeks to present a coherent and up-to-date account of all aspects of investigations pertinent to melanoma. Consequently the scope of the Journal is broad, embracing the entire range of studies from fundamental and applied research in such subject areas as genetics, molecular biology, biochemistry, cell biology, photobiology, pathology, immunology, and advances in clinical oncology influencing the prevention, diagnosis and treatment of melanoma.
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