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极低的体能状态是否会系统性地排除单药抗PD-1免疫治疗?一项对35例连续患者的多中心研究。

Does Very Poor Performance Status Systematically Preclude Single Agent Anti-PD-1 Immunotherapy? A Multicenter Study of 35 Consecutive Patients.

作者信息

Gounant Valérie, Duruisseaux Michael, Soussi Ghassen, Van Hulst Sylvie, Bylicki Olivier, Cadranel Jacques, Wislez Marie, Trédaniel Jean, Spano Jean-Philippe, Helissey Carole, Chouaid Christos, Molinier Olivier, Dhalluin Xavier, Doucet Ludovic, Hureaux José, Cazes Aurélie, Zalcman Gérard

机构信息

Department of Thoracic Oncology, Bichat Claude Bernard Hospital, APHP, CIC Inserm 1425, Université de Paris, 75018 Paris, France.

Respiratory Department, Louis Pradel Hospital, Hospices Civils de Lyon, 69002 Lyon, France.

出版信息

Cancers (Basel). 2021 Mar 2;13(5):1040. doi: 10.3390/cancers13051040.

DOI:10.3390/cancers13051040
PMID:33801285
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7958129/
Abstract

Anti-PD-1 antibodies prolong survival of performance status (PS) 0-1 advanced non-small-cell lung cancer (aNSCLC) patients. Their efficacy in PS 3-4 patients is unknown. Conse- cutive PS 3-4 aNSCLC patients receiving compassionate nivolumab were accrued by 12 French thoracic oncology departments, over 24 months. Overall survival (OS) was calculated using the Kaplan-Meier method. Prognostic variables were assessed using Cox proportional hazards models. Overall, 35 PS 3-4 aNSCLC patients (median age 65 years) received a median of 4 nivolumab infusions (interquartile range [IQR], 1-7) as first- ( = 6) or second-line ( = 29) therapy. At a median of 52-month follow-up (95%CI, 41-63), 32 (91%) patients had died. Median progression-free survival was 2.1 months (95%CI, 1.1-3.2). Median OS was 4.4 months (95%CI, 0.5-8.2). Overall, 20% of patients were alive at 1 year, and 14% at 2 years. Treatment-related adverse events occurred in 8/35 patients (23%), mostly of low-grade. After adjustment, brain metastases (HR = 5.2; 95%CI, 9-14.3, = 0.001) and <20 pack-years (HR = 4.8; 95%CI, 1.7-13.8, = 0.003) predicted worse survival. PS improvement from 3-4 to 0-1 ( = 9) led to a median 43-month (95%CI, 0-102) OS. Certain patients with very poor general condition could derive long-term benefit from nivolumab salvage therapy.

摘要

抗程序性死亡蛋白1(PD-1)抗体可延长体能状态(PS)为0 - 1的晚期非小细胞肺癌(aNSCLC)患者的生存期。其在PS为3 - 4的患者中的疗效尚不清楚。法国12个胸科肿瘤科室在24个月内连续纳入了接受同情用药纳武单抗治疗的PS为3 - 4的aNSCLC患者。采用Kaplan-Meier方法计算总生存期(OS)。使用Cox比例风险模型评估预后变量。总体而言,35例PS为3 - 4的aNSCLC患者(中位年龄65岁)接受了中位4次纳武单抗输注(四分位间距[IQR],1 - 7)作为一线(n = 6)或二线(n = 29)治疗。在中位52个月的随访期(95%CI,41 - 63)时,32例(91%)患者死亡。中位无进展生存期为2.1个月(95%CI,1.1 - 3.2)。中位OS为4.4个月(95%CI,0.5 - 8.2)。总体而言,20%的患者在1年时存活,14%在2年时存活。8/35例患者(23%)发生了与治疗相关的不良事件,大多为低级别。调整后,脑转移(HR = 5.2;95%CI,9 - 14.3,P = 0.001)和<20包年(HR = 4.8;95%CI,1.7 - 13.8,P = 0.003)预示生存期较差。PS从3 - 4改善至0 - 1(n = 9)导致中位OS为43个月(95%CI,0 - 102)。某些全身状况非常差的患者可能从纳武单抗挽救治疗中获得长期益处。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8446/7958129/45335689d038/cancers-13-01040-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8446/7958129/31d3acc25099/cancers-13-01040-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8446/7958129/8a57c25b6583/cancers-13-01040-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8446/7958129/5b20ee7ae70a/cancers-13-01040-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8446/7958129/45335689d038/cancers-13-01040-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8446/7958129/31d3acc25099/cancers-13-01040-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8446/7958129/8a57c25b6583/cancers-13-01040-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8446/7958129/5b20ee7ae70a/cancers-13-01040-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8446/7958129/45335689d038/cancers-13-01040-g004.jpg

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