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Adverse events during immunotherapy in Slovenian patients with metastatic melanoma reveal a positive correlation with better treatment outcomes.
Radiology and Oncology ( IF 2.4 ) Pub Date : 2021-05-04 , DOI: 10.2478/raon-2021-0019
Tanja Mesti 1 , Vid Ceplak Mencin 1 , Biljana Mileva Boshkoska 2, 3 , Janja Ocvirk 1, 4
Affiliation  

BACKGROUND Immunotherapy with CTLA-4 inhibitors and PD1 checkpoint inhibitors has initiated a breakthrough in the treatment and prognosis of patients with metastatic melanoma. The survival of these patients has increased from the expected survival time of less than 12 months to at least forty months. However, immunotherapy with either anti-CTLA-4 antibodies or PD1 inhibitors alone or in combination has a broad palette of significant immune-related adverse events. The aim of the study was to assess the correlation of immune-related adverse events with treatment outcomes defined as significant differences in the overall response rate (ORR) and progression-free survival (PFS) of patients, who developed immune-related adverse events during immunotherapy. PATIENTS AND METHODS A retrospective analysis of patients with metastatic melanoma treated with immunotherapy in 2020 at the Oncology Institute of Ljubljana was performed. Only patients with radiological evaluation of the immunotherapy response were included. The patients were divided into two cohorts: a cohort of patients with immune-related adverse events (irAE group) and a cohort of patients with no immune-related adverse events (NirAE group). Significantly better overall response and progression-free survival in the irAE cohort defined the primary aim of our study. To investigate the differences in progression-free survival between the irAE cohort and NirAE cohort, we used survival analysis. In particular, a Cox proportional hazards model with covariates of time to progression and adverse events was used for survival analysis. The Kruskal-Wallis H-test was applied, and a p-value of p <= 0.05 was considered the cut-off point for a statistically significant difference between the groups. RESULTS Among the 120 patients treated with immunotherapy, radiological response evaluation was performed for 99 patients: 38 patients in the irAE cohort and 61 patients in the NirAE cohort. The ORRs for the irAE and NirAE cohorts were 57% and 37%, respectively. The PFS was significantly better for the irAE cohort (301.6 days) than for the NirAE cohort (247.29 days). The results of the survival regression analysis showed a significant increase in the survival probability from less than 60% for the NirAE cohort to almost 80% for the irAE cohort. CONCLUSIONS Patients with metastatic melanoma treated with immunotherapy who developed immune-related adverse events showed better treatment outcomes with longer times to disease progression and better overall response rates than patients treated with immunotherapy who did not develop immune-related adverse events, with a significant increase in the survival probability from less than 60% for the NirAE cohort to almost 80% for the irAE cohort.

中文翻译:

斯洛文尼亚转移性黑色素瘤患者在免疫治疗期间的不良事件显示与更好的治疗效果呈正相关。

背景技术用CTLA-4抑制剂和PD1检查点抑制剂的免疫疗法已经在转移性黑素瘤患者的治疗和预后方面取得了突破。这些患者的生存期从不到12个月的预期生存时间增加到至少40个月。但是,单独使用抗CTLA-4抗体或PD1抑制剂或联合使用抗CTLA-4抗体进行的免疫治疗具有广泛的重要免疫相关不良事件。该研究的目的是评估免疫相关不良事件与治疗结果之间的相关性,治疗结果定义为在治疗期间发生免疫相关不良事件的患者的总体缓解率(ORR)和无进展生存期(PFS)的显着差异。免疫疗法。患者和方法卢布尔雅那肿瘤研究所于2020年对接受免疫疗法治疗的转移性黑色素瘤患者进行了回顾性分析。仅包括对免疫治疗反应进行放射学评估的患者。将患者分为两个队列:一组患有免疫相关不良事件的患者(irAE组)和一组没有免疫相关不良事件的患者(NirAE组)。irAE队列中总体反应显着改善和无进展生存期是我们研究的主要目标。为了研究irAE队列和NirAE队列之间无进展生存的差异,我们使用了生存分析。特别是,将具有进展时间和不良事件时间的协变量的Cox比例风险模型用于生存分析。应用Kruskal-Wallis H检验,p值p <= 0.05被视为临界值,这是两组之间在统计学上的显着差异。结果在接受免疫治疗的120例患者中,对99例患者进行了放射学评估:irAE队列38例,NirAE队列61例。irAE和NirAE队列的ORR分别为57%和37%。irAE队列(301.6天)的PFS明显优于NirAE队列(247.29天)。生存回归分析的结果表明,生存概率从NirAE队列的不到60%显着增加到irAE队列的近80%。
更新日期:2021-05-04
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