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Article(id=1228268588000281330, tenantId=1146029695717560320, journalId=1227999776411738115, issueId=1228268587459216114, articleNumber=null, orderNo=null, doi=10.12048/j.issn.1674-229X.2025.08.009, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1724947200000, receivedDateStr=2024-08-30, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1770771651505, onlineDateStr=2026-02-11, pubDate=1756051200000, pubDateStr=2025-08-25, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1770771651505, onlineIssueDateStr=2026-02-11, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1770771651505, creator=13701087609, updateTime=1770771651505, updator=13701087609, issue=Issue{id=1228268587459216114, tenantId=1146029695717560320, journalId=1227999776411738115, year='2025', volume='35', issue='8', pageStart='561', pageEnd='640', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=1, specialIssue=null, createTime=1770771651377, creator=13701087609, updateTime=1770795163631, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1228367205105075039, tenantId=1146029695717560320, journalId=1227999776411738115, issueId=1228268587459216114, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1228367205105075040, tenantId=1146029695717560320, journalId=1227999776411738115, issueId=1228268587459216114, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=609, endPage=613, ext={EN=ArticleExt(id=1228268588209996532, articleId=1228268588000281330, tenantId=1146029695717560320, journalId=1227999776411738115, language=EN, title=Efficacy and Safety Analysis of PD-1 Inhibitors in Elderly Patients with Advanced Non-small Cell Lung Cancer, columnId=null, journalTitle=Pharmacy Today, columnName=null, runingTitle=null, highlight=null, articleAbstract=
OBJECTIVE

To investigate the efficacy and safety of programmed death protein 1 (PD-1) inhibitors in elderly patients with advanced non-small cell lung cancer (NSCLC) in a real-world setting.

METHODS

The medical records of 103 patients with advanced NSCLC who received PD-1 inhibitors from January 1, 2020 to January 1, 2023 were retrospectively analyzed 103 patients with advanced NSCLC to compare the objective response rate (ORR), disease control rate (DCR), and adverse drug reaction (ADR) incidence rates among patients aged 65 to 74 years and those 75 years and older.

ESULTS

The ORR for the 65-74 age group (n=93) and ≥75 years group (n=10) was 44.09% and 40.00%, respectively. DCR was 83.87% and 90.00%, respectively. The overall incidence of ADR was 95.70% and 100.00%, and the incidence of grade ≥3 ADR was 18.28% and 20.00%. No statistically significant differences were observed between groups.

CONCLUSION

Elderly patients with advanced NSCLC receiving PD-1 inhibitors showed similar efficacy and safety between 65-74 years and ≥75 years. However, given the small sample size in the ≥75 years group, these preliminary results warrant further validation through large-scale, prospective studies.

, correspAuthors=Weiting LIANG, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, authorCompany=null, fund=null, authors=null, authorsList=Yunhui ZHANG, Luhua ZHONG, Huanjun HUANG, Chenchen GUO, Xinyi DONG, Feng SHI, Zhuojia CHEN, Weiting LIANG), CN=ArticleExt(id=1228268588625232634, articleId=1228268588000281330, tenantId=1146029695717560320, journalId=1227999776411738115, language=CN, title=PD-1抑制剂治疗晚期非小细胞肺癌老年患者的疗效和安全性分析, columnId=1228268588277105398, journalTitle=今日药学, columnName=临床药学, runingTitle=null, highlight=null, articleAbstract=
目的

探讨真实世界中晚期非小细胞肺癌（NSCLC）老年患者接受程序性死亡受体1（PD-1）抑制剂的疗效和安全性。

方法

回顾性分析2020年1月1日至2023年1月1日接受PD-1抑制剂的103例晚期NSCLC患者。按年龄分为65~74岁组（93例）和≥75岁组（10例），比较客观缓解率（ORR）、疾病控制率（DCR）以及不良反应（ADR）发生率。

结果

65~74岁组（93例）和≥75岁组（10例）的ORR分别为44.09%、40.00%；DCR分别为83.87%、90.00%；所有级别ADR发生率分别为95.70%、100.00%；≥3级ADR发生率分别为18.28%、20.00%。ORR、DCR、ADR发生率及严重程度差异均无统计学意义。

结论

晚期NSCLC老年患者接受PD-1抑制剂后，表现出相近的疗效和安全性。然而，鉴于≥75岁组样本量小，仍需大规模前瞻性研究来进一步验证。

, correspAuthors=梁蔚婷, authorNote=null, correspAuthorsNote=
* 梁蔚婷，副主任药师，研究方向：抗肿瘤药物的临床综合评价、抗肿瘤及相关治疗药物的不良反应管理，E-mail：
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张云惠，药师，研究方向：药物不良反应管理

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张云惠，药师，研究方向：药物不良反应管理

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张云惠，药师，研究方向：药物不良反应管理

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Thorac Cancer, 2020, 11(3): 799-804., articleTitle=Clinical diagnosis and treatment recommendations for immune checkpoint inhibitor-related hematological adverse events, refAbstract=null), Reference(id=1228268597198389252, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1228268588000281330, doi=null, pmid=null, pmcid=null, year=2023, volume=42, issue=6, pageStart=851, pageEnd=858, url=null, language=null, rfNumber=[14], rfOrder=13, authorNames=孙文悦, 张雯雯, 蔡沅璇, journalName=医药导报, refType=null, unstructuredReference=孙文悦, 张雯雯, 蔡沅璇, 等. 基于WHO-VigiAccess的5种PD-1/PD-L1单抗不良反应特点分析[J]. 医药导报, 2023, 42(6): 851-858., articleTitle=基于WHO-VigiAccess的5种PD-1/PD-L1单抗不良反应特点分析, refAbstract=null), Reference(id=1228268597282275333, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1228268588000281330, doi=null, pmid=null, pmcid=null, year=2020, volume=25, issue=9, pageStart=840, pageEnd=848, url=null, language=null, rfNumber=[15], rfOrder=14, authorNames=秦叔逵, 马军, 李进, journalName=临床肿瘤学杂志, refType=null, unstructuredReference=秦叔逵, 马军, 李进, 等. 卡瑞利珠单抗致反应性皮肤毛细血管增生症临床诊治专家共识[J]. 临床肿瘤学杂志, 2020, 25(9): 840-848., articleTitle=卡瑞利珠单抗致反应性皮肤毛细血管增生症临床诊治专家共识, refAbstract=null), Reference(id=1228268597366161415, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1228268588000281330, doi=null, pmid=null, pmcid=null, year=2023, volume=33, issue=9, pageStart=648, pageEnd=651, url=null, language=null, rfNumber=[16], rfOrder=15, authorNames=唐浩淳, 孟珺, 夏铮铮, journalName=今日药学, refType=null, unstructuredReference=唐浩淳, 孟珺, 夏铮铮. 非小细胞肺癌患者免疫检查点抑制剂相关性肺炎的研究进展[J]. 今日药学, 2023, 33(9): 648-651., articleTitle=非小细胞肺癌患者免疫检查点抑制剂相关性肺炎的研究进展, refAbstract=null)], funds=[Fund(id=1228268594371429335, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1228268588000281330, awardId=2022-1115-28, language=CN, fundingSource=广东省药品临床综合评价项目(2022-1115-28), fundOrder=null, country=null)], companyList=[AuthorCompany(id=1228268588851725053, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1228268588000281330, xref=1., ext=[AuthorCompanyExt(id=1228268588864307966, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1228268588000281330, companyId=1228268588851725053, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1.Department of Pharmacy, State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong 510060, China), AuthorCompanyExt(id=1228268588876890879, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1228268588000281330, companyId=1228268588851725053, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1.华南恶性肿瘤防治全国重点实验室，广东省恶性肿瘤临床医学研究中心，中山大学肿瘤防治中心药学部，广东　广州　510060)]), AuthorCompany(id=1228268588952388352, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1228268588000281330, xref=2., ext=[AuthorCompanyExt(id=1228268588960776961, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1228268588000281330, companyId=1228268588952388352, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2.School of Pharmaceutical Sciences, Sun Yat-sen University, Guangzhou, Guangdong 510006, China), AuthorCompanyExt(id=1228268588969165570, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1228268588000281330, companyId=1228268588952388352, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2.中山大学药学院，广东　广州　510006)])], figs=[ArticleFig(id=1228268593784226752, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1228268588000281330, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
特征65~74岁（n=93）≥75岁（n=10）构成比/%
性别
男性78984.47
女性15115.53
BMI/（kg·m-2）
<18.5807.77
18.5~2461564.08
>2424528.16
ECOG
072877.67
121222.33
发生转移
是84889.32
否9210.68
组织学类型
腺癌58662.14
鳞癌22425.24
其他13012.62
TNM分期
Ⅲ期829.71
Ⅳ期85890.29
吸烟史
有59865.05
无34234.95
治疗方案
PD-1抑制剂单药8411.65
PD-1抑制剂+化疗72675.73
PD-1抑制剂+靶向药807.77
PD-1抑制剂+化疗+靶向药504.85
治疗线数
一线60765.05
二线20120.39
三线及以上13214.56
PD-L1 TPS
<1%13012.62
≥1%10211.65
≥50%10312.62
未知60563.11
EGFR突变情况
阳性000.00
阴性40240.78
未知53859.22
ALK突变情况
阳性000.00
阴性61362.14
未知32737.86
合并其他基础疾病
无53253.40
有40846.60
), ArticleFig(id=1228268593884890052, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1228268588000281330, language=CN, label=表1, caption=

患者临床基本情况［n（%）］

, figureFileSmall=null, figureFileBig=null, tableContent=
特征65~74岁（n=93）≥75岁（n=10）构成比/%
性别
男性78984.47
女性15115.53
BMI/（kg·m-2）
<18.5807.77
18.5~2461564.08
>2424528.16
ECOG
072877.67
121222.33
发生转移
是84889.32
否9210.68
组织学类型
腺癌58662.14
鳞癌22425.24
其他13012.62
TNM分期
Ⅲ期829.71
Ⅳ期85890.29
吸烟史
有59865.05
无34234.95
治疗方案
PD-1抑制剂单药8411.65
PD-1抑制剂+化疗72675.73
PD-1抑制剂+靶向药807.77
PD-1抑制剂+化疗+靶向药504.85
治疗线数
一线60765.05
二线20120.39
三线及以上13214.56
PD-L1 TPS
<1%13012.62
≥1%10211.65
≥50%10312.62
未知60563.11
EGFR突变情况
阳性000.00
阴性40240.78
未知53859.22
ALK突变情况
阳性000.00
阴性61362.14
未知32737.86
合并其他基础疾病
无53253.40
有40846.60
), ArticleFig(id=1228268593993941960, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1228268588000281330, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
分组n客观缓解疾病控制
CR+PRORR/%CR+PR+SDDCR/%
总体1034543.698784.47
65~74岁934144.097883.87
≥75岁10440.00990.00
), ArticleFig(id=1228268594090410955, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1228268588000281330, language=CN, label=表2, caption=

不同年龄组疗效比较

, figureFileSmall=null, figureFileBig=null, tableContent=
分组n客观缓解疾病控制
CR+PRORR/%CR+PR+SDDCR/%
总体1034543.698784.47
65~74岁934144.097883.87
≥75岁10440.00990.00
), ArticleFig(id=1228268594161714127, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1228268588000281330, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
ADR类型总体65~74岁≥75岁
1~5级≥3级1~5级≥3级
血液系统
贫血84（81.55）77（82.80）3（3.23）7（70.00）0（0.00）
淋巴细胞计数降低28（27.18）23（24.73）2（2.15）5（50.00）0（0.00）
血小板计数降低14（13.59）12（12.90）5（5.38）2（20.00）1（10.00）
中性粒细胞计数降低11（10.68）11（11.83）4（4.30）0（0.00）0（0.00）
白细胞数降低9（8.74）9（9.68）2（2.15）0（0.00）0（0.00）
呼吸系统
咳嗽19（18.45）16（17.20）0（0.00）3（30.00）0（0.00）
咳痰8（7.77）8（8.60）0（0.00）0（0.00）0（0.00）
呼吸急促5（4.85）5（5.38）0（0.00）0（0.00）0（0.00）
咯血4（3.88）4（4.30）0（0.00）0（0.00）0（0.00）
肺炎4（3.88）3（3.23）1（1.08）1（10.00）1（10.00）
胸部不适3（2.91）3（3.23）0（0.00）0（0.00）0（0.00）
鼻塞1（0.97）1（1.08）0（0.00）0（0.00）0（0.00）
流涕1（0.97）1（1.08）0（0.00）0（0.00）0（0.00）
全身性疾病及各种反应
乏力16（15.53）16（17.20）0（0.00）0（0.00）0（0.00）
胸闷3（2.91）3（3.23）0（0.00）0（0.00）0（0.00）
疼痛3（2.91）3（3.23）0（0.00）0（0.00）0（0.00）
发热2（1.94）2（2.15）0（0.00）0（0.00）0（0.00）
水肿2（1.94）2（2.15）0（0.00）0（0.00）0（0.00）
发冷1（0.97）1（1.08）0（0.00）0（0.00）0（0.00）
胃肠系统
恶心5（4.85）5（5.38）0（0.00）0（0.00）0（0.00）
腹泻5（4.85）5（5.38）0（0.00）0（0.00）0（0.00）
口腔黏膜炎4（3.88）4（4.30）0（0.00）0（0.00）0（0.00）
胃食管反流3（2.91）3（3.23）0（0.00）0（0.00）0（0.00）
便秘2（1.94）2（2.15）0（0.00）0（0.00）0（0.00）
口干2（1.94）2（2.15）0（0.00）0（0.00）0（0.00）
打嗝2（1.94）2（2.15）0（0.00）0（0.00）0（0.00）
腹胀1（0.97）1（1.08）0（0.00）0（0.00）0（0.00）
牙龈肿痛1（0.97）1（1.08）0（0.00）0（0.00）0（0.00）
腹痛1（0.97）1（1.08）0（0.00）0（0.00）0（0.00）
皮肤及皮下组织
皮疹7（6.80）5（5.38）1（1.08）2（20.00）0（0.00）
毛细血管增生症6（5.83）6（6.45）2（2.15）0（0.00）0（0.00）
瘙痒4（3.88）3（3.23）0（0.00）1（10.00）0（0.00）
皮肤色素沉着1（0.97）1（1.08）0（0.00）0（0.00）0（0.00）
盗汗1（0.97）1（1.08）0（0.00）0（0.00）0（0.00）
脱发1（0.97）1（1.08）0（0.00）0（0.00）0（0.00）
皮炎1（0.97）1（1.08）1（1.08）0（0.00）0（0.00）
代谢及营养类
食欲下降15（14.56）15（16.13）0（0.00）0（0.00）0（0.00）
痛风1（0.97）1（1.08）0（0.00）0（0.00）0（0.00）
神经系统
麻木7（6.80）7（7.53）0（0.00）0（0.00）0（0.00）
头晕4（3.88）4（4.30）0（0.00）0（0.00）0（0.00）
周围神经病1（0.97）1（1.08）0（0.00）0（0.00）0（0.00）
头痛1（0.97）1（1.08）0（0.00）0（0.00）0（0.00）
肌肉骨骼及结缔组织
肌肉骨骼疼痛9（8.74）9（9.68）0（0.00）0（0.00）0（0.00）
内分泌系统
甲状腺功能减退7（6.80）6（6.45）1（1.08）1（10.00）0（0.00）
甲状腺功能亢进2（1.94）2（2.15）0（0.00）0（0.00）0（0.00）
肾功能异常
肌酐升高8（7.77）8（8.60）0（0.00）0（0.00）0（0.00）
肝功能异常
AST升高2（1.94）2（2.15）0（0.00）0（0.00）0（0.00）
ALT升高1（0.97）1（1.08）0（0.00）0（0.00）0（0.00）
精神病类
失眠2（1.94）2（2.15）0（0.00）0（0.00）0（0.00）
心脏器官类
心肌炎1（0.97）1（1.08）0（0.00）0（0.00）0（0.00）
), ArticleFig(id=1228268594253988819, tenantId=1146029695717560320, journalId=1227999776411738115, articleId=1228268588000281330, language=CN, label=表3, caption=

不同年龄组接受PD-1抑制剂后ADR发生情况［n（%）］

, figureFileSmall=null, figureFileBig=null, tableContent=
ADR类型总体65~74岁≥75岁
1~5级≥3级1~5级≥3级
血液系统
贫血84（81.55）77（82.80）3（3.23）7（70.00）0（0.00）
淋巴细胞计数降低28（27.18）23（24.73）2（2.15）5（50.00）0（0.00）
血小板计数降低14（13.59）12（12.90）5（5.38）2（20.00）1（10.00）
中性粒细胞计数降低11（10.68）11（11.83）4（4.30）0（0.00）0（0.00）
白细胞数降低9（8.74）9（9.68）2（2.15）0（0.00）0（0.00）
呼吸系统
咳嗽19（18.45）16（17.20）0（0.00）3（30.00）0（0.00）
咳痰8（7.77）8（8.60）0（0.00）0（0.00）0（0.00）
呼吸急促5（4.85）5（5.38）0（0.00）0（0.00）0（0.00）
咯血4（3.88）4（4.30）0（0.00）0（0.00）0（0.00）
肺炎4（3.88）3（3.23）1（1.08）1（10.00）1（10.00）
胸部不适3（2.91）3（3.23）0（0.00）0（0.00）0（0.00）
鼻塞1（0.97）1（1.08）0（0.00）0（0.00）0（0.00）
流涕1（0.97）1（1.08）0（0.00）0（0.00）0（0.00）
全身性疾病及各种反应
乏力16（15.53）16（17.20）0（0.00）0（0.00）0（0.00）
胸闷3（2.91）3（3.23）0（0.00）0（0.00）0（0.00）
疼痛3（2.91）3（3.23）0（0.00）0（0.00）0（0.00）
发热2（1.94）2（2.15）0（0.00）0（0.00）0（0.00）
水肿2（1.94）2（2.15）0（0.00）0（0.00）0（0.00）
发冷1（0.97）1（1.08）0（0.00）0（0.00）0（0.00）
胃肠系统
恶心5（4.85）5（5.38）0（0.00）0（0.00）0（0.00）
腹泻5（4.85）5（5.38）0（0.00）0（0.00）0（0.00）
口腔黏膜炎4（3.88）4（4.30）0（0.00）0（0.00）0（0.00）
胃食管反流3（2.91）3（3.23）0（0.00）0（0.00）0（0.00）
便秘2（1.94）2（2.15）0（0.00）0（0.00）0（0.00）
口干2（1.94）2（2.15）0（0.00）0（0.00）0（0.00）
打嗝2（1.94）2（2.15）0（0.00）0（0.00）0（0.00）
腹胀1（0.97）1（1.08）0（0.00）0（0.00）0（0.00）
牙龈肿痛1（0.97）1（1.08）0（0.00）0（0.00）0（0.00）
腹痛1（0.97）1（1.08）0（0.00）0（0.00）0（0.00）
皮肤及皮下组织
皮疹7（6.80）5（5.38）1（1.08）2（20.00）0（0.00）
毛细血管增生症6（5.83）6（6.45）2（2.15）0（0.00）0（0.00）
瘙痒4（3.88）3（3.23）0（0.00）1（10.00）0（0.00）
皮肤色素沉着1（0.97）1（1.08）0（0.00）0（0.00）0（0.00）
盗汗1（0.97）1（1.08）0（0.00）0（0.00）0（0.00）
脱发1（0.97）1（1.08）0（0.00）0（0.00）0（0.00）
皮炎1（0.97）1（1.08）1（1.08）0（0.00）0（0.00）
代谢及营养类
食欲下降15（14.56）15（16.13）0（0.00）0（0.00）0（0.00）
痛风1（0.97）1（1.08）0（0.00）0（0.00）0（0.00）
神经系统
麻木7（6.80）7（7.53）0（0.00）0（0.00）0（0.00）
头晕4（3.88）4（4.30）0（0.00）0（0.00）0（0.00）
周围神经病1（0.97）1（1.08）0（0.00）0（0.00）0（0.00）
头痛1（0.97）1（1.08）0（0.00）0（0.00）0（0.00）
肌肉骨骼及结缔组织
肌肉骨骼疼痛9（8.74）9（9.68）0（0.00）0（0.00）0（0.00）
内分泌系统
甲状腺功能减退7（6.80）6（6.45）1（1.08）1（10.00）0（0.00）
甲状腺功能亢进2（1.94）2（2.15）0（0.00）0（0.00）0（0.00）
肾功能异常
肌酐升高8（7.77）8（8.60）0（0.00）0（0.00）0（0.00）
肝功能异常
AST升高2（1.94）2（2.15）0（0.00）0（0.00）0（0.00）
ALT升高1（0.97）1（1.08）0（0.00）0（0.00）0（0.00）
精神病类
失眠2（1.94）2（2.15）0（0.00）0（0.00）0（0.00）
心脏器官类
心肌炎1（0.97）1（1.08）0（0.00）0（0.00）0（0.00）
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PD-1抑制剂治疗晚期非小细胞肺癌老年患者的疗效和安全性分析
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张云惠 1 , 钟陆华 1 , 黄焕均 1 , 郭晨晨 2 , 董心仪 2 , 石凤 2 , 陈卓佳 1 , 梁蔚婷 1, *
今日药学 | 临床药学 2025,35(8): 609-613
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今日药学 | 临床药学 2025, 35(8): 609-613
PD-1抑制剂治疗晚期非小细胞肺癌老年患者的疗效和安全性分析
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张云惠1, 钟陆华1, 黄焕均1, 郭晨晨2, 董心仪2, 石凤2, 陈卓佳1, 梁蔚婷1, *
作者信息
  • 1.华南恶性肿瘤防治全国重点实验室，广东省恶性肿瘤临床医学研究中心，中山大学肿瘤防治中心药学部，广东　广州　510060
  • 2.中山大学药学院，广东　广州　510006

    • 张云惠，药师，研究方向：药物不良反应管理

通讯作者:

* 梁蔚婷，副主任药师，研究方向：抗肿瘤药物的临床综合评价、抗肿瘤及相关治疗药物的不良反应管理，E-mail：
Efficacy and Safety Analysis of PD-1 Inhibitors in Elderly Patients with Advanced Non-small Cell Lung Cancer
Yunhui ZHANG1, Luhua ZHONG1, Huanjun HUANG1, Chenchen GUO2, Xinyi DONG2, Feng SHI2, Zhuojia CHEN1, Weiting LIANG1, *
Affiliations
  • 1.Department of Pharmacy, State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong 510060, China
  • 2.School of Pharmaceutical Sciences, Sun Yat-sen University, Guangzhou, Guangdong 510006, China
出版时间: 2025-08-25 doi: 10.12048/j.issn.1674-229X.2025.08.009
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摘要
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目的

探讨真实世界中晚期非小细胞肺癌（NSCLC）老年患者接受程序性死亡受体1（PD-1）抑制剂的疗效和安全性。

方法

回顾性分析2020年1月1日至2023年1月1日接受PD-1抑制剂的103例晚期NSCLC患者。按年龄分为65~74岁组（93例）和≥75岁组（10例），比较客观缓解率（ORR）、疾病控制率（DCR）以及不良反应（ADR）发生率。

结果

65~74岁组（93例）和≥75岁组（10例）的ORR分别为44.09%、40.00%；DCR分别为83.87%、90.00%；所有级别ADR发生率分别为95.70%、100.00%；≥3级ADR发生率分别为18.28%、20.00%。ORR、DCR、ADR发生率及严重程度差异均无统计学意义。

结论

晚期NSCLC老年患者接受PD-1抑制剂后，表现出相近的疗效和安全性。然而，鉴于≥75岁组样本量小，仍需大规模前瞻性研究来进一步验证。

程序性死亡受体1抑制剂  /  非小细胞肺癌  /  老年患者  /  疗效  /  安全性
OBJECTIVE

To investigate the efficacy and safety of programmed death protein 1 (PD-1) inhibitors in elderly patients with advanced non-small cell lung cancer (NSCLC) in a real-world setting.

METHODS

The medical records of 103 patients with advanced NSCLC who received PD-1 inhibitors from January 1, 2020 to January 1, 2023 were retrospectively analyzed 103 patients with advanced NSCLC to compare the objective response rate (ORR), disease control rate (DCR), and adverse drug reaction (ADR) incidence rates among patients aged 65 to 74 years and those 75 years and older.

ESULTS

The ORR for the 65-74 age group (n=93) and ≥75 years group (n=10) was 44.09% and 40.00%, respectively. DCR was 83.87% and 90.00%, respectively. The overall incidence of ADR was 95.70% and 100.00%, and the incidence of grade ≥3 ADR was 18.28% and 20.00%. No statistically significant differences were observed between groups.

CONCLUSION

Elderly patients with advanced NSCLC receiving PD-1 inhibitors showed similar efficacy and safety between 65-74 years and ≥75 years. However, given the small sample size in the ≥75 years group, these preliminary results warrant further validation through large-scale, prospective studies.

programmed death protein 1inhibitor  /  non-small cell lung cancer  /  elderly patients  /  efficacy  /  safety
张云惠, 钟陆华, 黄焕均, 郭晨晨, 董心仪, 石凤, 陈卓佳, 梁蔚婷. PD-1抑制剂治疗晚期非小细胞肺癌老年患者的疗效和安全性分析. 今日药学, 2025 , 35 (8) : 609 -613 . DOI: 10.12048/j.issn.1674-229X.2025.08.009
Yunhui ZHANG, Luhua ZHONG, Huanjun HUANG, Chenchen GUO, Xinyi DONG, Feng SHI, Zhuojia CHEN, Weiting LIANG. Efficacy and Safety Analysis of PD-1 Inhibitors in Elderly Patients with Advanced Non-small Cell Lung Cancer[J]. Pharmacy Today, 2025 , 35 (8) : 609 -613 . DOI: 10.12048/j.issn.1674-229X.2025.08.009
正文
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根据国家癌症中心的数据[1]显示，中国肺癌发病率和死亡率随年龄增长而呈上升趋势。其中，60~64岁新发病例数最多，≥60岁死亡率占比达79.8%。美国食品药品监督管理局数据表明，在2005~2015年抗肿瘤临床试验发现，≥65岁的老年患者占41%，≥75岁的患者仅占12%[2]。在肺癌免疫疗法关键临床试验中，纳入的患者中位年龄（61~65岁）常低于肺癌新诊断时的中位年龄（≥70岁），提示高龄患者在临床试验中的代表性不足[3]。程序性死亡受体1（programmed death protein 1，PD-1）抑制剂已有多项适应证获批用于治疗非小细胞肺癌（non-small cell lung cancer，NSCLC），但还需更多在真实世界中针对老年患者群体（≥65岁及≥75岁）使用PD-1抑制剂的研究数据以为临床治疗决策提供参考。本研究旨在通过回顾性分析在真实世界中PD-1抑制剂在老年晚期NSCLC患者中的疗效及安全性。
1　资料与方法
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1.1　研究对象
回顾性收集2020年1月1日至2023年1月1日在某院接受PD-1抑制剂治疗的晚期NSCLC患者（病理分期为Ⅲb或Ⅳ期）临床资料。纳入标准：①经细胞学或病理学确诊为NSCLC；②年龄≥65岁；③接受PD-1抑制剂治疗≥2个周期；④进行PD-1抑制剂治疗前完善常规基线检查。排除标准：①有自身免疫性疾病史或正在接受类固醇或者其他免疫抑制药物；②伴随另一种肿瘤疾病或合并可能影响患者生命的严重疾病；③伴有严重肝肾功能不全、心功能损害；④一般信息及诊疗信息大量缺失，病历资料不完整。
1.2　方法
本研究考察的PD-1抑制剂包括帕博利珠单抗、纳武利尤单抗和卡瑞利珠单抗。患者接受PD-1抑制剂单药或联合化疗、靶向药物等治疗。收集患者的年龄、性别、身高、体重、东部肿瘤协作组体能状况评分（eastern cooperative oncology group performance status，ECOG PS）、病理类型、药物治疗方案及线数、吸烟史、药物不良反应（adverse drug reaction，ADR）等信息。
根据《实体瘤免疫治疗疗效评价标准（iRECIST）》进行疗效评价，包括完全缓解（complete response，CR）、部分缓解（partial response，PR）、疾病稳定（stable disease，SD）和疾病进展（progressive disease，PD）。客观缓解率（objective response rate，ORR）定义为最佳疗效为CR和PR患者的比例，疾病控制率（disease control rate，DCR）定义为最佳疗效为CR、PR和SD患者的比例。根据不良事件的通用术语标准（CTCAE）5.0版进行ADR评价。最后一次随访时间至2023年4月28日。
1.3　统计学处理方法
应用SPSS 25.0统计软件进行分析。计数资料以例（n）或百分率（%）表示，组间比较采用连续校正χ2或Fisher精确检验。以P<0.05为差异有统计学意义。
2　结果
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2.1　患者基本情况
本研究最终纳入103例患者，中位年龄为68岁（65~88岁）。65~74岁年龄组有93人，≥75岁年龄组有10人，基本情况详见表1。腺癌和鳞癌占主要组织学类型（87.38%），TNM分期大多数为Ⅳ期（90.29%）。使用PD-1抑制剂帕博利珠单抗71例（68.93%）、纳武利尤单抗5例（4.85%）、卡瑞利珠单抗27例（26.21%）。治疗方案为PD-1抑制剂联合化疗占比最多（75.73%）。一线治疗人数67例（65.05%），二线有21例（20.39%），三线及以上有15例（14.56%）。
2.2　不同年龄组的疗效分析
截至随访日期，103例患者中无CR者，45例患者表现为PR，42例患者表现为SD，16例患者疾病进展。总人群的ORR为43.69%，DCR为84.47%（表2）。65~74岁年龄组和≥75岁年龄组的ORR分别为44.09%、40.00%；DCR分别为83.87%、90.00%，均无统计学意义（P>0.05）。
2.3　不同年龄组的安全性分析
总人群中有99例（96.12%）患者发生治疗相关性ADR，其中19例发生3级以上ADR（18.45%）。65~74岁年龄组有89例发生ADR（95.70%），大多数为1~2级，3级以上ADR有17例，占比18.28%；≥75岁年龄组有10例患者发生ADR，2例发生3级以上ADR（20.00%）。65~74岁和≥75岁年龄组发生所有级别和3级以上ADR的比例相近，差异均无统计学意义（P>0.05）。
表3列出了ADR种类，主要涉及到血液系统、呼吸系统、全身性疾病及各种反应、胃肠系统、皮肤及皮下组织等，多为轻度不良反应，通过及时对症处理可缓解。发生率排名前3的ADR依次为贫血（81.55%）、淋巴细胞计数降低（27.18%）、咳嗽（18.45%）。
3　讨论
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PD-1抑制剂广泛应用于肺癌治疗中，显著改善患者生存期。但在真实世界中，其对晚期NSCLC老年患者群体的疗效和安全性还需进一步探讨。因此，本研究回顾性分析某院2021~2023年的患者数据，探讨PD-1抑制剂在晚期NSCLC老年患者中的疗效和安全性。
本研究结果显示，两组的ORR分别为44.09%与40.00%，DCR分别为83.87%与90.00%，差异无统计学意义。该结果与既往1项含肺癌亚组的老年肿瘤患者真实世界研究基本一致，提示PD-1抑制剂在65~74岁和≥75岁患者中疗效相似[4]。1项关于转移性NSCLC患者的真实世界研究显示，接受纳武利尤单抗或帕博利珠单抗治疗的中位年龄为69岁，≥75岁患者占比27.1%[5]，表明使用PD-1抑制剂治疗的NSCLC患者年龄普遍偏高，且其中不乏高龄患者。邱学佳等[6]分析了成年组（<65岁）和老年组（≥65岁）晚期NSCLC患者的疗效，发现老年组使用PD-1/PD-L1抑制剂在一线治疗中疗效低于成年组，而二线治疗中则与成年组相近，但该研究老年组患者纳入年龄范围在68~74岁，未覆盖≥75岁的高龄患者。因此，本研究通过补充≥75岁NSCLC患者的数据，填补了高龄患者使用PD-1抑制剂的空白。
值得注意的是，本研究多数患者接受联合用药方案，单用PD-1抑制剂治疗仅占11.65%，无论是否联用，两组患者的疗效差异均无统计学意义[3]。本研究所得老年患者ORR及DCR均略低于KEYNOTE-189临床试验中PD-1抑制剂联合化疗的全人群疗效（ORR：58.7%，DCR：96.8%）[7]，推测与真实世界中老年患者常伴器官储备功能下降、免疫衰老、慢性炎症等因素相关[8]。综上所述，老年晚期NSCLC患者均可从PD-1抑制剂治疗中获益，但仍需要更大样本的前瞻性研究验证。
此外，本研究也针对老年NSCLC患者接受PD-1抑制剂治疗后的安全性进行了分析。研究结果显示，总人群中有96.12%的患者发生治疗相关性ADR，其中3级以上ADR占18.45%。1项真实世界研究显示[9]，65岁以上NSCLC老年患者在接受PD-1抑制剂单药治疗后，73.0%（46/63）的患者出现不同级别的ADR，3级以上ADR占14.3%（9/63）。Meta分析显示PD-1/PD-L1抑制剂联合化疗在一线治疗晚期NSCLC中具有较好的疗效，但ADR发生率也较高[10]。1项汇集分析通过对比KEYNOTE-010、KEYNOTE-024和KEYNOTE-042大型临床试验数据发现，≥75岁患者使用帕博利珠单抗单药发生所有级别ADR的比例小于联合化疗方案（68.5% vs.94.3%）[11]。本研究中PD-1抑制剂联合化疗方案占比较高（75.73%），对比PD-1抑制剂单药治疗显现出较高的ADR发生率。有研究表明在同一天内，先输注PD-1抑制剂再使用化疗药物或抗血管生成药物，相较于其他用药顺序方案，ADR的发生率更低[12]。这提示临床实践中应考虑联合用药的先后顺序。因此，严格评估老年患者的耐受性，及早预测、发现并预防相关ADR，是联合给药治疗过程中至关重要的环节。ADR主要累及的系统-器官为血液系统，贫血（81.55%）为发生率最高的安全性事件。由PD-1抑制剂引起的免疫介导性贫血发生率远低于联合化疗方案，而其诊断与治疗手段也与化疗引起的贫血不同[13,14]。免疫介导不良反应大多可通过中断PD-1抑制剂、皮质类固醇治疗和/或支持治疗来处理。回顾本研究103例患者数据，有42例患者基线即为1级贫血，其用药后贫血分级为1级、2级、3级的分别有21例、13例、3例。临床试验显示75岁及以上患者使用帕博利珠单抗联合化疗方案后贫血发生率为45.7%[11]，远低于本研究的真实世界数据。本研究中，共有6例患者（6/27，22.22%）接受卡瑞利珠单抗后出现毛细血管增生症，2例患者因该不良反应而改换其他PD-1抑制剂。17例患者接受了卡瑞利珠单抗联合化疗方案，其中5例患者（5/17，29.41%）发生毛细血管增生症。国内外临床研究表明，在不同瘤种及给药方案下，卡瑞利珠单抗所致毛细血管增生症的发生率有所不同[15]。毛细血管增生症是卡瑞利珠单抗最常见的皮肤不良反应，其确切的发病机制尚不清楚，但已知涉及免疫和血管生成过程。中国临床肿瘤学会发布的《卡瑞利珠单抗致反应性皮肤毛细血管增生症临床诊治专家共识》指出，卡瑞利珠单抗与抗血管生成药物或化疗药物联合使用可显著降低毛细血管增生症的发生率[15]。另外，本研究中PD-1抑制剂还引起较高比例的呼吸系统不良反应，包括严重的肺炎等。免疫相关行肺炎的危险因素较多，各大指南推荐基于临床严重程度对其进行以糖皮质激素为基础，必要时辅以经验性抗菌药物和免疫抑制剂的分级治疗[16]。总体来说，老年NSCLC患者接受PD-1抑制剂治疗时安全性基本可控。
本研究初步证明了PD-1抑制剂在晚期NSCLC老年患者中疗效较好，安全可耐受，为在晚期NSCLC老年患者群体中使用PD-1抑制剂治疗提供参考数据。需注意的是，本研究为单中心小样本研究，尤其是≥75岁年龄组患者数量较少，随访时间短，需要在更大样本中进行验证。
基金
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  • 广东省药品临床综合评价项目(2022-1115-28)
文献
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参考文献 引证文献
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2025年第35卷第8期
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doi: 10.12048/j.issn.1674-229X.2025.08.009
  • 接收时间：2024-08-30
  • 首发时间：2026-02-11
  • 出版时间：2025-08-25
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  • 收稿日期：2024-08-30
基金
广东省药品临床综合评价项目(2022-1115-28)
作者信息
    1.华南恶性肿瘤防治全国重点实验室，广东省恶性肿瘤临床医学研究中心，中山大学肿瘤防治中心药学部，广东　广州　510060
    2.中山大学药学院，广东　广州　510006

通讯作者:

* 梁蔚婷，副主任药师，研究方向：抗肿瘤药物的临床综合评价、抗肿瘤及相关治疗药物的不良反应管理，E-mail：
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2种不同金属材料的力学参数
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genus		 种数
Number of
species		 占总种数比例
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total species (%)		 属
Genus		 种数
Number of
species		 占总种数比例
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鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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