J Immunother Cancer:PD1抑制剂联合ipilimumab在伴有自身免疫疾病晚期黑素色瘤患者的疗效与安全性

2021-05-13 yd2015 MedSci原创

PD1抑制剂联合ipilimumab在伴有自身免疫疾病晚期黑素色瘤患者有效,但是对于某些初始免疫抑制患者有加重自身免疫疾病风险,临床上值得注意

免疫治疗相关的临床试验一般排除既往有自身免疫性疾病的患者。已有回顾性研究报道了伊匹单抗(ipilimumab)和PD1抑制剂单药治疗有自身免疫疾病患者的安全性和有效性。但是两者联合治疗在自身免疫性疾病患者是否增加毒性没有报道。因此,有学者在J Immunother Cancer杂志报道了相关研究,该研究主要评估了在伴有自身免疫疾病晚期黑素色瘤患者的疗效与安全性。

这是一项多中心的回顾性研究,纳入2015年3月至2020年2月使用过伊匹单抗(ipilimumab)和PD1抑制剂联合治疗的伴有自身免疫疾病晚期黑素色瘤患者。纳入患者的相关临床特征被收集。分析伴有的自身免疫类型、治疗、毒性以及预后等。研究最终纳入55例患者,中位年龄63岁(范围23-83),其中46例患者接受ipilimumab 联合 nivolumab治疗,9例患者接受ipilimumab 联合 pembrolizumab治疗。

研究数据表明,18(33%)例患者自身免疫疾病加重,包含4例的类风湿关节炎,3例牛皮癣,5例炎症性肠病,3例甲状腺炎,1例干燥综合征,1例多发肌痛,1例Behcet综合征。8(44%)例患者因自身免疫疾病加重停止治疗。37(67%)例患者出现非免疫相关的不良事件(irAEs),20 (36%)例患者因irAEs停止治疗。没有治疗相关死亡出现。总体ORR为 55%, 包括30% 部分缓解(PR)和25% 完全缓解(CR)。

                  临床获益

中位PFS为10 个月 (95% CI 0.01 to 32.10),中位OS为24 个月 (95% CI 15.88 to 32.12)。

            中位PFS和OS

出现自身免疫疾病加重的患者,其中位PFS为5个月,而没有加重的患者,PFS为11个月,但是统计学没有意义(p=0.73)。中位OS为19 vs 24 个月,同样没有达到统计学差异 (p=0.37)。

        自身免疫疾病加重或不加重患者的PFS和OS

对初始伴有免疫抑制的患者,中位PFS为3 个月(95% CI 0.71 to 5.30) ,没有伴有免疫抑制的患者为33个月 (95% CI 8.38 to 57.62) ,两者有明显的统计学差异(p=0.012)。中位OS为11 个月 (95% CI 3.42 to 18.58) vs 31 个月(95% CI 20.89 to 41.11),有显著统计学差异(p=0.005)。初始伴有免疫抑制的患者更容易出现自身免疫疾病加重(OR 4.59; p=0.03)。

    伴有或不伴有初始免疫抑制患者的PFS和OS

19 (35%) 例患者接受后续免疫联合或多线治疗。11 (58%)例患者使用其他PD1抑制剂,8 (42%)例患者使用BRAF- MEK 抑制剂,1例(5%)患者使用化疗,5 (26%)例患者参加临床试验。在接受后续治疗的患者中,58%的患者仍取得了部分缓解的疗效。

综上,PD1抑制剂联合ipilimumab在伴有自身免疫疾病晚期黑素色瘤患者有效,但是对于某些初始免疫抑制患者有加重自身免疫疾病风险,临床上值得注意。

原始出处:

Brown LJ, Weppler A,Bhave P, et al. Combination anti- PD1 and ipilimumab therapy in patients with advanced melanoma and pre-existing autoimmune disorders. Journal for ImmunoTherapy of Cancer 2021;9:e002121.doi:10.1136/jitc-2020-002121。

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    2021-11-01 jklm09
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  5. 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createdBy=f0620, createdName=内科新手, createdTime=Thu May 13 17:20:16 CST 2021, time=2021-05-13, status=1, ipAttribution=)]
    2021-05-14 snf701207
  6. 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  7. 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  8. 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createdBy=f0620, createdName=内科新手, createdTime=Thu May 13 17:20:16 CST 2021, time=2021-05-13, status=1, ipAttribution=)]
    2021-05-13 内科新手

    谢谢梅斯提供这么好的信息,学到很多

    0

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