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抗 PD-1 抗体一线治疗晚期/转移性黑色素瘤:波兰多中心经验。

First-line treatment of advanced/metastatic melanoma with anti-PD-1 antibodies: multicenter experience in Poland.

机构信息

Department of Clinical Oncology, Maria Sklodowska-Curie National Research Institute of Oncology, Cracow Branch, 31-115 Krakow, Poland.

Department of Anatomy, Jagiellonian University, Medical College, 31-543 Krakow, Poland.

出版信息

Immunotherapy. 2021 Mar;13(4):297-307. doi: 10.2217/imt-2020-0217. Epub 2020 Dec 23.

Abstract

To evaluate treatment results in advanced/metastatic melanoma patients treated with anti-PD-1 immunotherapy in routine practice in oncology centers in Poland. Multicenter retrospective analysis included 499 patients with unresectable/metastatic (stage IIIC-IV) melanoma treated with anti-PD-1 in first-line therapy. Estimated median overall survival (OS) and progression-free survival (PFS) were 19.9 and 7.9 months, respectively. Multivariate analysis confirmed that ECOG 0, no brain metastases, normal lactate dehydrogenase level and occurrence of immune-related adverse events (irAEs) were statistically significantly associated with improved OS and PFS. Any irAE occurred in 24% of patients. Grade 3 or Grade 4 irAEs occurred in 6% of patients. Analysis revealed a slightly worse OS in real-world treatment in comparison to clinical trials (KEYNOTE-006 and CheckMate 066). Polish population treatment results are similar to other studies of real-world data. PFS and ORR are similar in our research and clinical trials.

摘要

评估在波兰肿瘤中心常规实践中接受抗 PD-1 免疫治疗的晚期/转移性黑色素瘤患者的治疗结果。这项多中心回顾性分析纳入了 499 例不可切除/转移性(IIIC-IV 期)黑色素瘤患者,他们在一线治疗中接受了抗 PD-1 治疗。估计的中位总生存期(OS)和无进展生存期(PFS)分别为 19.9 个月和 7.9 个月。多因素分析证实 ECOG 0、无脑转移、正常乳酸脱氢酶水平和发生免疫相关不良事件(irAEs)与 OS 和 PFS 的改善显著相关。24%的患者发生任何 irAE。3 级或 4 级 irAE 发生在 6%的患者中。分析显示,与临床试验(KEYNOTE-006 和 CheckMate 066)相比,真实世界治疗中的 OS 略差。波兰人群的治疗结果与其他真实世界数据研究相似。我们的研究和临床试验中的 PFS 和 ORR 相似。

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