First Oncology Department, Metropolitan Hospital.
First Department of Medicine, Laiko General Hospital, National and Kapodistrian University of Athens School of Medicine.
Melanoma Res. 2024 Apr 1;34(2):152-165. doi: 10.1097/CMR.0000000000000949. Epub 2023 Dec 13.
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.
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。