Real-world management practices and characteristics of patients with advanced melanoma initiated on immuno-oncology or targeted therapy in the first-line setting during the period 2015-2018 in Greece. The 'SUMMER' study: a retrospective multicenter chart review project.

IF 1.5 4区医学 Q3 DERMATOLOGY

Melanoma Research Pub Date : 2023-12-13 DOI:10.1097/cmr.0000000000000949

Dimitrios Bafaloukos, Panagiotis Kouzis, Panagiotis Gouveris, Ioannis Boukovinas, Konstantinos Kalbakis, Sofia Baka, Georgios Kyriakakis, Despoina Moschou, Aristea Molfeta, Stamatia Demiri, Dimitrios Mavroudis, Spanoudi Filio, Ioannis Dimitriadis, Helen Gogas

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引用次数: 0

Abstract

This study primarily aimed to generate real-world evidence (RWE) on the profile and first-line treatment (1LT) patterns of patients with advanced (unresectable Stage III/metastatic) cutaneous melanoma initiated on immuno-oncology (IO)- or targeted therapy (TT)-based 1LT between 1 January 2015 and 1 January 2018 (index period), in routine settings of Greece. This was a multicenter, retrospective chart review study. Eligible consented (unless deceased, for whom consent was waived by the hospital) patients were consecutively included by six oncology clinics. The look-back period extended from informed consent or death to initial melanoma diagnosis. Between 9 Junuary 2021 and 9 February 2022, 225 eligible patients (all Caucasians; 60.4% male; 35.6% diagnosed with de novo advanced melanoma) were included. At 1LT initiation, median age was 62.6 years; 2.7/6.7/90.7% of the patients had Stage IIIB/IIIC/IV disease and 9.3% were unresected. Most frequent metastatic sites were the lung (46.7%), non-regional nodes (33.8%), and liver (20.9%). Among patients, 98.2% had single primary melanoma, 45.6% had disease localized on the trunk, and 63.6% were BRAF-mutant. Of the patients, 45.3% initiated 1LT with an IO-based, 53.3% with a TT-based regimen, and three patients (1.3%) received TT-based followed by IO-based or vice versa. Most common 1LT patterns (frequency ≥10%) were BRAFi/MEKi combination (31.6%), anti-PD-1 monotherapy (25.3%), BRAFi monotherapy (21.8%), and anti-CTLA-4 monotherapy (17.8%). Most frequent regimens were Dabrafenib+Trametinib in 25.3%, and monotherapies with Pembrolizumab/Ipilimumab/Vemurafenib/Dabrafenib in 23.6/17.8/11.1/10.7% of patients, respectively. SUMMER provides RWE on 1LT strategies and profile of patients initiated 1L IO- or TT-based therapy in Greece during the 3-year index period.

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2015-2018年期间，希腊一线接受免疫肿瘤学或靶向治疗的晚期黑色素瘤患者的实际管理实践和特点。SUMMER "研究：一项回顾性多中心病历审查项目。

本研究的主要目的是提供真实世界的证据（RWE），说明2015年1月1日至2018年1月1日（指标期）期间，在希腊常规治疗环境下，晚期（不可切除的III期/转移性）皮肤黑色素瘤患者开始接受基于免疫肿瘤学（IO）或靶向治疗（TT）的一线治疗（1LT）的概况和模式。这是一项多中心、回顾性病历审查研究。六家肿瘤诊所连续纳入了符合条件的同意患者（除非已死亡，医院放弃同意）。回溯期从知情同意或死亡到初次黑色素瘤诊断。在2021年1月9日至2022年2月9日期间，共有225名符合条件的患者（均为白种人；60.4%为男性；35.6%确诊为新发晚期黑色素瘤）被纳入其中。开始1LT时，中位年龄为62.6岁；2.7/6.7/90.7%的患者为IIIB/IIIC/IV期，9.3%的患者未切除。最常见的转移部位是肺部（46.7%）、非区域性结节（33.8%）和肝脏（20.9%）。患者中98.2%为单发原发性黑色素瘤，45.6%的病灶位于躯干，63.6%为BRAF突变。在患者中，45.3%的患者采用了以 IO 为基础的 1LT 方案，53.3%的患者采用了以 TT 为基础的方案，还有三名患者（1.3%）在接受 TT 方案后又接受了以 IO 为基础的方案，反之亦然。最常见的1LT模式（频率≥10%）是BRAFi/MEKi联合疗法（31.6%）、抗PD-1单药疗法（25.3%）、BRAFi单药疗法（21.8%）和抗CTLA-4单药疗法（17.8%）。最常见的治疗方案是Dabrafenib+Trametinib，占25.3%；Pembrolizumab/Ipilimumab/Vemurafenib/Dabrafenib单药治疗分别占23.6/17.8/11.1/10.7%。SUMMER提供了关于1LT策略的RWE，以及在3年指标期间希腊开始使用1L IO或TT疗法的患者概况。

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

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.