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希腊 2015-2018 年期间一线接受免疫肿瘤或靶向治疗的晚期黑色素瘤患者的真实世界管理实践和特征。'SUMMER'研究:一项回顾性多中心图表审查项目。

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.

机构信息

First Oncology Department, Metropolitan Hospital.

First Department of Medicine, Laiko General Hospital, National and Kapodistrian University of Athens School of Medicine.

出版信息

Melanoma Res. 2024 Apr 1;34(2):152-165. doi: 10.1097/CMR.0000000000000949. Epub 2023 Dec 13.

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.

摘要

本研究主要旨在生成 2015 年 1 月 1 日至 2018 年 1 月 1 日(索引期)期间,在希腊常规环境中接受免疫肿瘤学(IO)或靶向治疗(TT)一线治疗(1LT)的晚期(不可切除 III 期/转移性)皮肤黑色素瘤患者的真实世界证据(RWE)。这是一项多中心、回顾性病历审查研究。六个肿瘤学诊所连续纳入符合条件并同意(除非死亡,否则由医院豁免同意)的患者。回顾期从知情同意或死亡开始,到初始黑色素瘤诊断结束。2021 年 6 月 9 日至 2022 年 2 月 9 日期间,共纳入 225 名符合条件的患者(均为白种人;60.4%为男性;35.6%诊断为新发晚期黑色素瘤)。在 1LT 开始时,中位年龄为 62.6 岁;2.7/6.7/90.7%的患者患有 IIIB/IIIC/IV 期疾病,9.3%的患者未经切除。最常见的转移部位是肺部(46.7%)、非区域淋巴结(33.8%)和肝脏(20.9%)。在患者中,98.2%有单一原发性黑色素瘤,45.6%疾病局限于躯干,63.6%为 BRAF 突变型。其中 45.3%的患者以 IO 为基础开始 1LT,53.3%的患者以 TT 为基础开始 1LT,3 名患者(1.3%)接受 TT 为基础治疗后转为 IO 为基础或反之亦然。最常见的 1LT 模式(频率≥10%)为 BRAFi/MEKi 联合治疗(31.6%)、抗 PD-1 单药治疗(25.3%)、BRAFi 单药治疗(21.8%)和抗 CTLA-4 单药治疗(17.8%)。最常见的方案是 Dabrafenib+Trametinib(25.3%),单药治疗分别为 Pembrolizumab/Ipilimumab/Vemurafenib/Dabrafenib(23.6%/17.8%/11.1%/10.7%)。SUMMER 提供了 2015 年 1 月 1 日至 2018 年 1 月 1 日期间,希腊接受 IO 或 TT 一线治疗的患者 1LT 策略和特征的真实世界证据。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5ffb/10906211/220fd04f2040/mr-34-152-g001.jpg

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