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二线伊匹单抗与纳武单抗联合伊匹单抗在接受一线抗PD-1抗体治疗的晚期黑色素瘤患者中的疗效比较。

Comparative effectiveness of second-line ipilimumab vs. nivolumab in combination with ipilimumab in patients with advanced melanoma who received frontline anti-PD-1 antibodies.

作者信息

Baron Kelsey, Moser Justin C, Patel Shiven, Grossmann Kenneth F, Colonna Sarah V, Hyngstrom John R

机构信息

Department of Internal Medicine, Intermountain Medical Center, Murray, USA.

HonorHealth Research Institute, Scottsdale, USA.

出版信息

J Oncol Pharm Pract. 2021 Apr;27(3):555-559. doi: 10.1177/1078155220924719. Epub 2020 May 19.

DOI:10.1177/1078155220924719
PMID:32423325
Abstract

INTRODUCTION

Anti-PD-1 antibodies are commonly used as frontline therapy for patients with metastatic melanoma. Although these medications can cause long term responses, a significant number of patients will not respond or will lose response. Optimal second-line therapy after losing response to anti-PD-1 antibodies is not well established. Therefore, we retrospectively compared the overall survival of patients who lost response to anti-PD1 antibodies between patients treated with single agent ipilimumab or ipilimumab and nivolumab.

METHODS

A de-identified U.S. nationwide electronic health record-derived database was reviewed for patients with advanced melanoma treated with single agent anti-PD1 antibodies in the frontline setting and who subsequently received second-line ipilimumab or combination ipilimumab and nivolumab. Overall survival from initiation of second-line therapy was compared using Kaplan Meier curves and log-rank analysis. Other known prognostic markers for melanoma were analyzed for correlation with survival in a similar fashion. Disease characteristics between the two groups were compared using chi-square analysis.

RESULTS

A total of 842 patients with advanced melanoma who received frontline anti-PD-1 antibodies were included for analysis. Of these, 57 received either ipilimumab ( = 22) or ipilimumab in combination with nivolumab ( = 35) in the second-line setting. Median survival from second-line therapy initiation for those treated with ipilimumab alone was 6 months and was 5.6 months for those treated with combination ipilimumab and anti-PD-1 antibodies,  = 0.81.

CONCLUSIONS

In this small, retrospective analysis, for patients who lost response to frontline anti-PD-1 therapy, patients treated with ipilimumab had similar survival to those who received ipilimumab in combination with anti-PD-1 antibodies.

摘要

引言

抗程序性死亡蛋白1(PD-1)抗体通常用作转移性黑色素瘤患者的一线治疗药物。尽管这些药物可引发长期反应,但仍有相当数量的患者无反应或会失去反应。抗PD-1抗体治疗失效后的最佳二线治疗方案尚未明确。因此,我们回顾性比较了单药伊匹单抗或伊匹单抗与纳武单抗联合治疗的患者在抗PD-1抗体治疗失效后的总生存期。

方法

对一个来自美国全国电子健康记录的去识别化数据库进行审查,纳入一线接受单药抗PD-1抗体治疗且随后接受二线伊匹单抗或伊匹单抗与纳武单抗联合治疗的晚期黑色素瘤患者。使用Kaplan-Meier曲线和对数秩检验分析比较二线治疗开始后的总生存期。以类似方式分析其他已知的黑色素瘤预后标志物与生存期的相关性。采用卡方检验比较两组间的疾病特征。

结果

共纳入842例接受一线抗PD-1抗体治疗的晚期黑色素瘤患者进行分析。其中,57例患者在二线治疗中接受了伊匹单抗(n = 22)或伊匹单抗与纳武单抗联合治疗(n = 35)。单独接受伊匹单抗治疗的患者从二线治疗开始的中位生存期为6个月,接受伊匹单抗与抗PD-1抗体联合治疗的患者为5.6个月,P = 0.81。

结论

在这项小型回顾性分析中,对于一线抗PD-1治疗失效的患者,接受伊匹单抗治疗的患者与接受伊匹单抗和抗PD-1抗体联合治疗的患者生存期相似。

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