意大利nivolumab扩展访问计划在黑色素瘤辅助设置:患者的结果和安全性概况
Paolo A Ascierto1, Anna M Di Giacomo2, Vanna Chiarion Sileni3
1Unit of Melanoma and Innovative Therapies, IRCCS Istituto Nazionale Tumori Fondazione G. Pascale, Napoli, Italy.
概括
尼沃卢马布在切除的III-IV阶段黑色素瘤患者中显著改善了无复发的生存率. 这种扩展访问程序证实了nivolumab的存在.
科学领域:
- 在瘤学瘤学.
- 免疫治疗是一种免疫疗法.
- 黑色素瘤研究 黑色素瘤研究
背景情况:
- 在CheckMate 238研究中,在切除的IIIB-C/IV阶段黑色素瘤中,尼沃卢马布比伊皮利穆马布更有好处.
- 辅助治疗对于预防高风险黑色素瘤患者复发至关重要.
研究的目的:
- 在意大利扩大获取计划 (EAP) 中评估nivolumab的疗效和安全性,用于切除的III-IV阶段黑色素瘤.
- 为了确认nivolumab在辅助剂环境中的实际有效性.
主要方法:
- 611名患有III-IV期切除黑色素瘤 (NED) 的患者被纳入意大利Nivolumab EAP.
- 患者接受了尼沃卢马布作为辅助疗法.
- 随访时间中位数为23个月.
主要成果:
- 在ITT人群中,1年无复发生存率 (RFS) 为76.6%,2年RFS为59.6%.
- 一年整体存活率为93.8%,两年整体存活率为85.5%.
- 与治疗相关的3-4级不良事件发生在11.5%的患者中.
结论:
- 尼沃卢马布在切除的III-IV期黑色素瘤的辅助治疗中表现出显著的临床活性和可容忍的安全性.
- 这些结果与关键的CheckMate 238试验一致,支持在现实环境中使用nivolumab.
- 庞大的队列和延长的随访突出显示了显著的临床需求,并为辅助尼沃卢马布治疗提供了可靠的数据.
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