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纳武利尤单抗与伊匹木单抗联合用于八旬和九旬黑色素瘤患者

Combined Nivolumab and Ipilimumab in Octogenarian and Nonagenarian Melanoma Patients.

作者信息

Reichert Constance, Baldini Capucine, Mezghani Sarah, Maubec Eve, Longvert Christine, Mortier Laurent, Quereux Gaëlle, Jannic Arnaud, Machet Laurent, de Quatrebarbes Julie, Nardin Charlée, Beneton Nathalie, Amini Adle Mona, Funck-Brentano Elisa, Descamps Vincent, Hachon Lorry, Malissen Nausicaa, Baroudjian Barouyr, Brunet-Possenti Florence

机构信息

Department of Dermatology, Hôpital Bichat AP-HP, Université Paris Cité, 75018 Paris, France.

Drug Development Department, Institut Gustave Roussy, CNRS-UMS 3655 and INSERM US23, 94805 Villejuif, France.

出版信息

Cancers (Basel). 2023 Aug 30;15(17):4330. doi: 10.3390/cancers15174330.

Abstract

Data regarding elderly melanoma patients treated with anti-PD-1 or anti-CTLA-4 antibodies are in favor of tolerability outcomes that are similar to those of younger counterparts. However, there are very few studies focusing on elderly patients receiving nivolumab combined with ipilimumab (NIVO + IPI). Here, we ask what are the current prescribing patterns of NIVO + IPI in the very elderly population and analyze the tolerance profile. This French multicenter retrospective study was conducted on 60 melanoma patients aged 80 years and older treated with NIVO + IPI between January 2011 and June 2022. The mean age at first NIVO + IPI administration was 83.7 years (range: 79.3-93.3 years). Fifty-five patients (92%) were in good general condition and lived at home. Two dosing regimens were used: NIVO 1 mg/kg + IPI 3 mg/kg Q3W (NIVO1 + IPI3) in 27 patients (45%) and NIVO 3 mg/kg + IPI 1 mg/kg Q3W (NIVO3 + IPI1) in 33 patients (55%). NIVO + IPI was a first-line treatment in 39 patients (65%). The global prevalence of immune-related adverse events was 63% (38/60), with 27% (16/60) being of grade 3 or higher. Grade ≥ 3 adverse events were less frequent in patients treated with NIVO3 + IPI1 compared with those treated with NIVO1 + IPI3 (12% versus 44%, = 0.04). In conclusion, the prescribing patterns of NIVO + IPI in very elderly patients are heterogeneous in terms of the dosing regimen and line of treatment. The safety profile of NIVO + IPI is reassuring; whether or not the low-dose regimen NIVO3 + IPI1 should be preferred over NIVO1 + IPI3 in patients aged 80 years or older remains an open question.

摘要

关于接受抗PD-1或抗CTLA-4抗体治疗的老年黑色素瘤患者的数据表明,其耐受性结果与年轻患者相似。然而,很少有研究关注接受纳武单抗联合伊匹木单抗(NIVO + IPI)治疗的老年患者。在此,我们探讨NIVO + IPI在高龄人群中的当前处方模式,并分析耐受性特征。这项法国多中心回顾性研究对2011年1月至2022年6月期间接受NIVO + IPI治疗的60例80岁及以上黑色素瘤患者进行。首次给予NIVO + IPI时的平均年龄为83.7岁(范围:79.3 - 93.3岁)。55例患者(92%)一般状况良好,居家生活。采用了两种给药方案:27例患者(45%)采用NIVO 1 mg/kg + IPI 3 mg/kg每3周一次(NIVO1 + IPI3),33例患者(55%)采用NIVO 3 mg/kg + IPI 1 mg/kg每3周一次(NIVO3 + IPI1)。NIVO + IPI作为一线治疗的有39例患者(65%)。免疫相关不良事件的总体发生率为63%(38/60),其中27%(16/60)为3级或更高等级。与接受NIVO1 + IPI3治疗的患者相比,接受NIVO3 + IPI1治疗的患者中≥3级不良事件的发生率较低(12%对44%,P = 0.04)。总之,NIVO + IPI在高龄患者中的处方模式在给药方案和治疗线方面存在异质性。NIVO + IPI的安全性令人放心;在80岁及以上患者中,低剂量方案NIVO3 + IPI1是否应优于NIVO1 + IPI3仍是一个悬而未决的问题。

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