转移性黑色素瘤患者的现实世界治疗模式和结果

IF 0.2 4区 医学 Q4 MEDICINE, GENERAL & INTERNAL
Dejan Djokanovic, Bojana Lazic, Z. Gojković, Željka Cvijetić, E. Sokolović, T. Cerić, S. Jungić
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引用次数: 0

摘要

介绍/目标。本研究的目的是评估在一个资源有限的国家,在新药供应有限和较晚的情况下,在日常临床实践中治疗转移性黑色素瘤的不同方法的有效性,并将这些参数与临床研究报告和其他现实世界数据进行比较。方法。主要方法包括总生存期(OS)和无进展生存期(PFS)的评估。如果患者接受了放射学/病理学证实的转移性黑色素瘤的一线或二线全身治疗,则纳入研究。根据患者接受的治疗类型将患者分为四组:化疗(达卡巴嗪)、BRAF抑制剂(vemurafenib)、BRAF/MEK抑制剂(vemurafenib/cobimetinib和trametinib/dabrafenib)和抗PD-1治疗(pembrolizumab)。结果。无论采用何种治疗方案,化疗和vemurafenib组计算的中位生存期为9个月。BRAF/MEK抑制剂组的中位生存期为14个月,派姆单抗组为15个月。化疗组的中位PFS为4个月,vemurafenib组为7个月,BRAF/MEK抑制剂组为9个月,派姆单抗组为6个月。在派姆单抗组中,一线和二线治疗的生存率有统计学上的显著差异。结论。我们的结果显示,与临床试验报告的数据相比,中位OS和PFS较低。与现实世界中存在新药延迟报销问题的其他国家的数据相比,我们的研究显示了类似的结果。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Real-world treatment patterns and outcomes in patients with metastatic melanoma
Introduction/Objective. The purpose of this study was to assess the effectiveness of different approaches in the treatment of metastatic melanoma in daily clinical practice in a situation with limited and late availability of new drugs in a resource-limited country and to compare these parameters with those reported in clinical studies and from other real-world data. Methods. Main methods included assessment of overall survival (OS) and progression-free survival (PFS). Patients were included in the study if they were treated with first or second-line systemic therapy for radiologically/pathologically confirmed metastatic melanoma. Patients were divided into four groups based on the type of therapy they received: chemotherapy (dacarbazin), BRAF inhibitor (vemurafenib), BRAF/MEK inhibitors (vemurafenib/cobimetinib and trametinib/dabrafenib) and anti PD-1 therapy with pembrolizumab. Results. Regardless of the line of therapy, the calculated median OS in chemotherapy and vemurafenib group was nine months. The median OS in the BRAF/MEK inhibitor group was 14 months and 15 months in the pembrolizumab group. Median PFS in the chemotherapy group was four months, seven months for vemurafenib, in the BRAF/MEK inhibitor group nine months and in the pembrolizumab group six months. There was a statistically significant difference in survival between first and second-line therapy in the pembrolizumab group. Conclusion. Our results showed lower median OS and PFS in comparison to reported data from clinical trials. Compared to other real-world data from countries with similar problems related to the late reimbursement of new drugs, our research has shown similar results.
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来源期刊
Srpski arhiv za celokupno lekarstvo
Srpski arhiv za celokupno lekarstvo MEDICINE, GENERAL & INTERNAL-
CiteScore
0.40
自引率
50.00%
发文量
104
审稿时长
4-8 weeks
期刊介绍: Srpski Arhiv Za Celokupno Lekarstvo (Serbian Archives of Medicine) is the Journal of the Serbian Medical Society, founded in 1872, which publishes articles by the members of the Serbian Medical Society, subscribers, as well as members of other associations of medical and related fields. The Journal publishes: original articles, communications, case reports, review articles, current topics, articles of history of medicine, articles for practitioners, articles related to the language of medicine, articles on medical ethics (clinical ethics, publication ethics, regulatory standards in medicine), congress and scientific meeting reports, professional news, book reviews, texts for "In memory of...", i.e. In memoriam and Promemoria columns, as well as comments and letters to the Editorial Board. All manuscripts under consideration in the Serbian Archives of Medicine may not be offered or be under consideration for publication elsewhere. Articles must not have been published elsewhere (in part or in full).
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