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Nivolumab致甲状腺功能减退症1例

中南大学学报（医学版） 2019年第2期44卷 222-224页

作者：林常松郭梓莫朝晖中南大学湘雅三医院内分泌科长沙410013

Nivolumab是一种抗PD-1单克隆抗体,用于肿瘤免疫治疗。中南大学湘雅三医院内分泌科收治1例肠癌术后3年的73岁女性患者,用Nivolumab治疗后引起严重甲状腺功能减退症。患者接受Nivolumab治疗4个月后出现乏力、头晕、皮肤变黄及眼睑浮肿等... 详细信息

Nivolumab是一种抗PD-1单克隆抗体,用于肿瘤免疫治疗。中南大学湘雅三医院内分泌科收治1例肠癌术后3年的73岁女性患者,用Nivolumab治疗后引起严重甲状腺功能减退症。患者接受Nivolumab治疗4个月后出现乏力、头晕、皮肤变黄及眼睑浮肿等症状,FT3和FT4减低,TSH升高,随后终止Nivolumab治疗,用左甲状腺素钠片替代治疗后患者症状缓解,甲状腺功能恢复正常。临床诊断为Nivolumab诱导自身免疫甲状腺损害,为治疗中免疫相关不良反应。

关键词： Nivolumab 不良反应甲状腺功能减退症

PD-1抑制剂Nivolumab治疗相关的皮肤毒性1例

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中国肺癌杂志 2019年第4期22卷 250-254页

作者：高琳虞永峰陆舜上海交通大学附属胸科医院上海市肺部肿瘤临床医学中心上海200030

背景与目的 Nivolumab是一种与T细胞上的程序性死亡蛋白-1(programmed death-1, PD-1结合的免疫检查点抑制剂,能够阻断PD-1与程序性死亡蛋白配体(programmed death ligands,包括PD-L1和PD-L2)间的相互作用,从而阻断PD-1通路介导的免疫... 详细信息

背景与目的 Nivolumab是一种与T细胞上的程序性死亡蛋白-1(programmed death-1, PD-1结合的免疫检查点抑制剂,能够阻断PD-1与程序性死亡蛋白配体(programmed death ligands,包括PD-L1和PD-L2)间的相互作用,从而阻断PD-1通路介导的免疫抑制反应。本研究拟探讨PD-1抑制剂Nivolumab治疗相关的皮肤毒性的临床表现、诊断、治疗和预后。方法回顾性分析上海市胸科医院收治的1例晚期肺腺癌患者应用PD-1抑制剂Nivolumab治疗相关的皮肤毒性的临床资料,探讨诊断、治疗和预后分析。结果患者男性,60岁,右肺腺癌术后,术后辅助化疗复发,给予多疗程化疗、靶向治疗、局部骨转移灶放疗后病情仍进展,给予Nivolumab(3 mg/kg/q2w,静滴)治疗1个周期后,患者开始出现皮疹并逐渐加重。静脉给予足量类固醇治疗后皮疹好转,类固醇缓慢减量,皮疹控制良好,目前口服类固醇维持治疗,皮疹明显消退。肺内病灶维持稳定。结论需要提高对PD-1/PD-L1抑制剂所致免疫相关性皮疹的认识,及早发现,及时处理,预后相对良好。

关键词：免疫相关性皮肤毒性肺肿瘤 PD-1抑制剂 Nivolumab 治疗及预后

Nivolumab治疗不同类型复发难治性淋巴增殖性疾病的疗效及安全性的系统评价和荟萃分析

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Nivolumab治疗不同类型复发难治性淋巴增殖性疾病的疗效及安全性...

作者：傅译娴南昌大学

学位级别：硕士

目的:采用Meta分析的方法对Nivolumab治疗各种复发或难治性（Relapsing or refractory,R/R）淋巴增殖性疾病的疗效及安全性进行系统评价,为Nivolumab治疗淋巴增殖性疾病提供客观的指导依据。方法:检索Pubmed、Medline、Embase、Cochrane... 详细信息

目的:采用Meta分析的方法对Nivolumab治疗各种复发或难治性（Relapsing or refractory,R/R）淋巴增殖性疾病的疗效及安全性进行系统评价,为Nivolumab治疗淋巴增殖性疾病提供客观的指导依据。方法:检索Pubmed、Medline、Embase、Cochrane Library、Web of science、美国临床试验注册中心、中国临床试验注册中心、中国知网、万方、中国生物医学文献等数据库,研究从建库至2021年9月为止公开发表的关于Nivolumab治疗复发难治性恶性淋巴增殖性患者的研究。客观缓解率（Objective response rate,ORR）、完全缓解率（Complete remission rate,CRR）、部分缓解率（Partial remission rate）、无进展生存期（Progression free survival,PFS）、总生存期（Overall Survival,OS）及3级以上不良事件发生率（Adverse events,AEs）作为结局指标,采用Meta分析汇总发生率。结果:经过筛选共检索出文献1082篇,符合纳入标准的文献有11篇,研究有19项,共646例病例,结果如下:1、纳入的19项研究中总ORR为40%,CRR为9%,PRR为25%。B细胞肿瘤组的ORR为8%,CRR为2%,PRR为4%。T和自然杀伤（Natural Killer,NK）细胞肿瘤组的ORR为18%,CRR为2%,PRR为13%。霍奇金淋巴瘤（Hodgkin’s lymphoma,HL）组的ORR为72%,CRR为18%,HL组的PRR为50%。2、HL组中既往治疗中位线＜4的ORR为70%,CRR为29%,PRR为40%,既往治疗中位线≥4的ORR为74%,CRR为17%,PRR为56%。3、HL组按给药方案1的ORR为90%,CRR为16%,PRR为16%,而方案2的结果显示ORR为68%,CRR为17%,PRR为49%。（方案1:第1周、第4周静脉注射（IV）Nivolumab 3mg/kg,之后每2周注射1次,持续2年。方案2:Nivolumab 3mg/kg IV每2周1次）。4、HL组中既往治疗为BV的患者合并ORR为69%,CRR为24%,PRR为38%,而既往治疗为BV+ASCT组的合并ORR为73%,CRR为11%,PRR为60%。5、HL组年龄＜35岁的患者ORR为66%,CRR为23%,PRR为38%,而年龄≥35岁组的ORR为77%,CRR为16%,PRR为62%。6、在给出6个月PFS率的7篇研究中总PFS率为41%,NHL组的合并PFS率为12%。HL组的合并PFS率为85%。7、在给出OS率的8篇研究中,NHL组的合并6个月OS率为57%,HL组合并的1年OS率为94%。8、在给出发生3级以上AEs人数的9例研究中,总发生率为26%,给药方案1的3级以上AEs发生率为22%,方案2的3级以上AEs发生率为25%,既往治疗中位线≥4的3级以上AEs发生率为17%,既往治疗中位线＜4分的3级以上AEs发生率为25%,年龄中位数或平均数≤63岁的3级以上AEs发生率为31%,年龄中位数或平均数＞63岁的3级以上AEs发生率为26%。结论:1、Nivolumab对HL的有效率和生存率最佳,其次为T和NK细胞肿瘤组,B细胞肿瘤最差。2、在第1周和第4周3 mg/kg静脉注射Nivolumab,然后每2周重复1次,持续2年,这一给药方式在HL患者中有着较高的有效率,且这一给药方式的总体AEs发生率较低。3、HL组中既往治疗较多的患者对Nivolumab的有效率更高,AEs发生率更低,但CRR也更低。4、Nivolumab治疗既往治疗为BV的HL患者较BV+ASCT的患者更易取得CR。

关键词： Nivolumab 淋巴增殖性疾病 Meta分析疗效评估

Unusual Ovarian Cancer Relapse Managed by Nivolumab in a Long-term Surviving Patient with PD-L1 Mutation

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Chinese Medical Journal 2017年第9期130卷 1125-1126页

作者： Jie Yang Jun-Jun Yang Jun Zhao Tong Ren Feng-Zhi Feng Xi-Run Wan Yang Xiang Department of Obstetrics and Gynecology Peking Union Medical College Hospital Beijing 100730 China

INTRODUCTION This report describes a case of ovarian cancer recurrent as sternal and costal metastasis long after initial treatment. The whole-exome sequencing suggested programmed death-ligand I （PD-L1） mutation. The patient responded well to Nivolumab, an anti-PD-1 monoclonal antibody. We discuss the case and review the literature.

关键词： Extra Peritoneal Metastasis Long Survival Nivolumab Ovarian Cancer Programmed Death-ligand 1

Nivolumab和Pembrolizumab治疗晚期非小细胞肺癌疗效和安全性对比

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Nivolumab和Pembrolizumab治疗晚期非小细胞肺癌疗效和安全性对比

作者：蒋顺达暨南大学

学位级别：硕士

目的:1.通过收集临床病例数据,比较Pembrolizumab和Nivolumab应用于晚期非小细胞肺癌的近期疗效及不良反应,进一步分析近期疗效的影响因素。2.统计免疫相关不良反应,为临床合理用药提供参考。方法:通过查阅住院及门诊病例、电话随访等方... 详细信息

目的:1.通过收集临床病例数据,比较Pembrolizumab和Nivolumab应用于晚期非小细胞肺癌的近期疗效及不良反应,进一步分析近期疗效的影响因素。2.统计免疫相关不良反应,为临床合理用药提供参考。方法:通过查阅住院及门诊病例、电话随访等方式,搜集本科病例库从2019年01月01日至2022年12月30日期间正在使用Nivolumab(纳武利尤单抗,简称O药)和Pembrolizumab(帕博丽珠单抗,简称K药)的病例共60例,其中Pembrolizumab组50例,Nivolumab组10例,记录患者的年龄、性别、病理类型、吸烟史、PD-L1表达、MSS、TMB、Her-2表达、疗效评价、PFS、OS及不良反应,比较两组患者的近期疗效差异及影响因素。结果:在使用帕博丽珠单抗的107例患者中,经过筛查,排除新辅助治疗、辅助治疗、失访人数,最终收集50例。在帕博丽珠单抗组最终50例患者中,ECOG评分均在0-2分,中位年龄65岁,中位PFS 8.0个月。发生免疫相关不良反应为8人(16%),其中1例出现甲状腺功能减退(G3),3例发生免疫相关性肺炎(分别为G2、G3、G4),3例患者出现乏力(分别为G1、G2、G2),1例患者出现皮疹、瘙痒(G2)。纳武利尤单抗组10例,ECOG评分均在0-2分,中位年龄69岁,中位PFS为4.05个月,全部10例患者中均未记录到ir AEs。结论:1.在晚期非小细胞肺癌患者治疗中,帕博丽珠单抗组中位PFS 8.0个月,纳武利尤单抗组中位PFS为4.05个月。2.帕博丽珠单抗治疗晚期非小细胞肺癌的PFS与PD-L1表达水平相关,PD-L1高表达(≥50%)患者疗效优于低表达(<50%)患者。3.免疫相关不良反应发生率少,且大多为1、2级不良反应,耐受性及安全性良好。

关键词： Pembrolizumab Nivolumab 免疫抑制剂(ICIs) 非小细胞肺癌 PD-L1

Nivolumab-induced severe bullous pemphigoid in a patient with renal cancer:a case report and literature review

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Journal of Cancer Metastasis and Treatment 2020年第1期6卷 492-500页

作者： Xiaorong Wu Sreekanth Palvai Awais Jalil Department of Medical Oncology Southend University Hospital NHS Foundation TrustPrittlewell ChaseWestcliff-on-SeaEssex SS00RYUnited Kingdom

With the widespread use of immunotherapy in numerous solid tumours,immunotherapy-related adverse events(irAEs)have started to emerge and bring new challenges for clinicians to manage.Among established irAEs,dermatologic toxicity is one of the most common toxicities;it is often mild but can be severe and potentially life-threatening,such as bullous pemphigoid.Here,we report a case of Nivolumab-mediated severe,extensive,refractory bullous pemphigoid involving both skin and oral mucosa in a patient with metastatic renal cancer.We also summarise a list of selected case reports of immunotherapy-induced bullous pemphigoid by literature review.We highlight various presentations,investigations and managements of this type of skin irAEs.Meantime,we would like to discuss the correlation of skin irAEs incidence rate with immunotherapy drug benefit and resistance.

关键词： Bullous pemphigoid mucous membrane pemphigoid immunotherapy dermatologic toxicity Nivolumab

Treatment of Skin Reaction Induced by Nivolumab Combined with Radiotherapy in Non-small Cell Lung Cancer:A Case Report

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Chinese Medical Sciences Journal 2018年第3期33卷 183-187页

作者： Zhimei Zhao Shichao Liu Xiajuan Xu Zhongfa Zhang Keke Nie Youxin Ji Department of Oncology Affiliated Qingdao Central Hospital of Qingdao UniversityQingdaoShandong 266042China Department of Oncology Qingdao Cancer HospitalQingdaoShandong 266042China

Skin reaction or dermatological toxicities induced by immunotherapy is common.It usually manifests skin rash or erythema and can be cured by skin lotion or steroid.Nivolumab,a human IgG4 programmed cell death protein 1(PD-1)inhibitor,blocks T cells activation preventing signal and allows the immune system to clear cancer cells.Nivolumab was approved in the second-line therapy in squamous cell lung cancer by FDA,with less than 10%unusual skin reaction,like sensory neuropathy,peeling skin,erythema multiforme,vitiligo,and psoriasis.Radiotherapy could aggravate this skin reaction through inflammatory response and promotion of immunity.The combined treatment of anti-PD-1 and radiotherapy represented a new promising therapeutic approach in many studies,but the risk of side effects may be high.We reported a patient with advanced squamous cell lung cancer who suffered from serious skin immune-related adverse events when he was treated with Nivolumab and radiotherapy.The immune overreaction of the treatment of anti-PD-1 treatment and radiotherapy might cause these serious skin adverse events.Our report warranted careful workup to reduce the risk of side effects by combinative therapy with anti-PD-1 and radiotherapy.

关键词： skin reaction Nivolumab immunotherapy radiotherapy non-small cell lung cancer

Severe Pneumonitis after Nivolumab Treatment Accompanied by Acute Pulmonary Embolism in a Patient with Lung Adenocarcinoma

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Chinese Medical Journal 2017年第22期130卷 2755-2756页

作者： Ji-Ping Liao Li-Gong Nie Cheng-Li Que Xiang-Dong Mu Department of Pulmonary and Critical Care Medicine Peking University First Hospital Peking University Beijing 100034 China

A 75-year-old Han Chinese man presented with a 1-day history of acute shortness of breath. His medical history included hmg adenocarcinoma, hepatitis B virus （carrier）, hypertension, previous deep vein thrombosis （DVT）, smoking for 45 years, and drinking for 35 years. He underwent dissection of his right upper and middle lobes and mediastinal lymph nodes 5 years previously and developed pleural and multiple pulmonary metastasis 3 months postoperatively. Molecular tests for epidermal growth factor receptor, KRAS,

关键词： Nivolumab Pneumonitis Pulmonary Embolism

Immunoglobulin G4 associated autoimmune cholangitis and pancreatitis following the administration of Nivolumab:A case report

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World Journal of Clinical Cases 2022年第20期10卷 7124-7129页

作者： Rohit Agrawal Grace Guzman Saman Karimi Pier Cristoforo Giulianotti Alfredo Jose Mena Lora Shikha Jain Meshaal Khan Brian R Boulay Yolande Chen Department of Gastroenterology and Hepatology University of IllinoisChicagoIL 60607United States Department of Pathology University of IllinoisChicagoIL 60607United States Department of Surgery University of IllinoisChicagoIL 60607United States Department of Infectious Disease University of IllinoisChicagoIL 60607United States Department of Hematology and Oncology University of IllinoisChicagoIL 60607United States Division of Gastroenterology and Hepatology Department of MedicineUniversity of Illinois Hospital and Health Sciences SystemChicagoIL 60612United States

BACKGROUND Immune checkpoint inhibitors have significantly improved survivals for an increasing range of malignancies but at the cost of several immune-related adverse events,the management of which can be challenging due to its mimicry of other autoimmune related disorders such as immunoglobulin G4(IgG4)related disease when the pancreaticobiliary system is affected.Nivolumab,an IgG4 monoclonal antibody,has been associated with cholangitis and pancreatitis,however its association with IgG4 related disease has not been reported to date.CASE SUMMARY We present a case of immune-related pancreatitis and cholangiopathy in a patient who completed treatment with Nivolumab for anal squamous cell carcinoma.Patients IgG4 levels was normal on presentation.She responded to steroids but due to concerns for malignant biliary stricture,she opted for surgery,the pathology of which suggested IgG4 related disease.CONCLUSION We hypothesize this case of IgG4 related cholangitis and pancreatitis was likely triggered by Nivolumab.

关键词： Nivolumab Immunoglobulin G4 related disease Cholangitis Biliary stricture Pancreatitis Case report