

浏览全部资源
扫码关注微信
1.重庆医科大学附属第一医院药学部,重庆 400016
2.重庆医科大学药学院,重庆 400016
3.中江县人民医院临床药学科,四川 德阳 618100
Received:30 April 2024,
Revised:2024-07-12,
Accepted:30 July 2024,
Published:30 August 2024
移动端阅览
谭逢艳,唐一丁,蒙龙,等.卡瑞利珠单抗联合培美曲塞和奈达铂治疗EGFR/ALK野生型晚期非鳞状NSCLC的临床观察 [J].中国药房,2024,35(16):2013-2017.
TAN Fengyan,TANG Yiding,MENG Long,et al.Clinical observation of camrelizumab combined with pemetrexed and nedaplatin in the treatment of EGFR/ALK wild-type advanced non-squamous non-small cell lung cancer[J].ZHONGGUO YAOFANG,2024,35(16):2013-2017.
谭逢艳,唐一丁,蒙龙,等.卡瑞利珠单抗联合培美曲塞和奈达铂治疗EGFR/ALK野生型晚期非鳞状NSCLC的临床观察 [J].中国药房,2024,35(16):2013-2017. DOI: 10.6039/j.issn.1001-0408.2024.16.13.
TAN Fengyan,TANG Yiding,MENG Long,et al.Clinical observation of camrelizumab combined with pemetrexed and nedaplatin in the treatment of EGFR/ALK wild-type advanced non-squamous non-small cell lung cancer[J].ZHONGGUO YAOFANG,2024,35(16):2013-2017. DOI: 10.6039/j.issn.1001-0408.2024.16.13.
目的
2
观察卡瑞利珠单抗联合培美曲塞和奈达铂治疗表皮生长因子受体(
EGFR
)和间变性淋巴瘤激酶(
ALK
)野生型晚期非鳞状非小细胞肺癌(NSCLC)的疗效和安全性。
方法
2
回顾性收集2021年8月至2023年5月于重庆医科大学附属第一医院就诊的92例
EGFR/ALK
野生型晚期非鳞状NSCLC患者资料,根据治疗方案的不同分为奈达铂组(46例)和卡铂组(46例)。奈达铂组患者给予注射用卡瑞利珠单抗+注射用奈达铂+注射用培美曲塞二钠;卡铂组患者给予注射用卡瑞利珠单抗+卡铂注射液+注射用培美曲塞二钠。两组均以21 d为1个周期,所有患者至少完成2个周期的治疗。观察两组患者的近期疗效和不良反应发生情况,分析影响患者无进展生存期(PFS)的因素。
结果
2
两组患者的客观缓解率、疾病控制率、中位PFS、3~5级治疗相关不良事件(TRAE)发生率比较,差异均无统计学意义(
P
>0.05)。奈达铂组患者的1~2级肾脏和泌尿系统TRAE、心慌、心包积液发生率均显著低于卡铂,恶心、呕吐和食欲降低发生率显著高于卡铂组(
P
<0.05)。患者的性别、年龄、有无吸烟史、美国东部肿瘤协作组织评分和TNM分期均不是影响患者PFS的因素(
P
>0.05)。
结论
2
卡瑞利珠单抗联合培美曲塞和奈达铂治疗
EGFR/ALK
野生型晚期非鳞状NSCLC的疗效显著,安全性较好。
OBJECTIVE
2
To observe the efficacy and safety of camrelizumab combined with pemetrexed and nedaplatin in the treatment of epidermal growth factor receptor (
EGFR
) and anaplastic lymphoma kinase (
ALK
) wild-type advanced non-squamous non-small cell lung cancer (NSCLC).
METHODS
2
The data of 92 patients with
EGFR
/
ALK
wild-type advanced non-squamous NSCLC patients who visited the First Affiliated Hospital of Chongqing Medical University from August 2021 to May 2023 were collected and divided into nedaplatin group (46 cases) and carboplatin group (46 cases) based on different treatment regimens. Nedaplatin group was given camrelizumab for injection+nedaplatin for injection+pemetrexed disodium for injection; carboplatin group was given camrelizumab for injection+carboplatin i
njection+pemetrexed disodium for injection. Both groups received treatment with 21 days as one cycle, and all patients would be treated at least two cycles. The recent efficacy and the incidence of adverse drug reactions were observed in two groups, and the factors affecting progression-free survival (PFS) of patients were analyzed.
RESULTS
2
There was no statistically significant difference in the objective response rate, disease control rate, median PFS, and the incidence of grade 3-5 treatment-related adverse event (TRAE) between the two groups (
P
>0.05). While the incidence of grade 1-2 renal and urinary system TREA, palpitations and pericardial effusion in nedaplatin group were significantly lower than carboplatin group, the incidence of nausea, vomiting and decreased appetite were significantly higher than carboplatin group (
P
<0.05). The patient’s gender, age, smoking history, Eastern United States Cancer Collaboration score, and TNM staging were not significant factors affecting patient’s PFS (
P
>0.05).
CONCLUSIONS
2
Camrelizumab combined with pemetrexed and nedaplatin has significant efficacy in the treatment of
EGFR
/
ALK
wild-type advanced non-squamous NSCLC, with good safety.
SONG H , LIU X L , JIANG L , et al . Current status and prospects of camrelizumab,a humanized antibody against programmed cell death receptor 1 [J ] . Recent Pat Anticancer Drug Discov , 2021 , 16 ( 3 ): 312 - 332 .
FU J , WANG F , DONG L H , et al . Preclinical evaluation of the efficacy,pharmacokinetics and immunogenicity of JS-001,a programmed cell death protein-1(PD-1)monoclonal antibody [J ] . Acta Pharmacol Sin , 2017 , 38 ( 5 ): 710 - 718 .
ETTINGER D S , WOOD D E , AISNER D L , et al . Non-small cell lung cancer,version 3.2022,NCCN clinical practice guidelines in oncology [J ] . J Natl Compr Canc Netw , 2022 , 20 ( 5 ): 497 - 530 .
JAIYESIMI I A , LEIGHL N B , ISMAILA N , et al . Therapy for stage Ⅳ non-small cell lung cancer without driver alterations:ASCO living guideline,version 2023.3 [J ] . J Clin Oncol , 2024 , 42 ( 11 ): e23 - e43 .
WANG R , SHI M Q , JI M , et al . Real world experience with camrelizumab in patients with advanced non-small cell lung cancer:a prospective multicenter cohort study(NOAH-LC-101) [J ] . Transl Lung Cancer Res , 2023 , 12 ( 4 ): 786 - 796 .
XU C R , CHEN Q X , ZHOU C Z , et al . Effectiveness and safety of camrelizumab in inoperable or advanced non-small cell lung cancer patients:a multicenter real-world retrospective observational study(CTONG2004-ADV) [J ] . Transl Lung Cancer Res , 2023 , 12 ( 1 ): 127 - 140 .
LIU S Y , CHEN Q X , ZHOU C Z , et al . Neoadjuvant camrelizumab for non-small cell lung cancer:a retrospective multicenter,real-world study(CTONG2004) [J ] . Cancer Immunol Immunother , 2023 , 72 ( 7 ): 2257 - 2265 .
ZHOU C C , CHEN G Y , HUANG Y C , et al . Camrelizumab plus carboplatin and pemetrexed versus chemotherapy alone in chemotherapy-naive patients with advanced non-squamous non-small-cell lung cancer(CameL):a randomised,open-label,multicentre,phase 3 trial [J ] . Lancet Respir Med , 2021 , 9 ( 3 ): 305 - 314 .
ZHOU C C , CHEN G Y , HUANG Y C , et al . Camrelizumab plus carboplatin and pemetrexed as first-line treatment for advanced nonsquamous NSCLC:extended follow-up of CameL phase 3 trial [J ] . J Thorac Oncol , 2023 , 18 ( 5 ): 628 - 639 .
中国临床肿瘤学会指南工作委员会 . 中国临床肿瘤学会(CSCO)非小细胞肺癌诊疗指南2023 [M ] . 北京 : 人民卫生出版社 , 2023 : 125 - 126 .
Guidelines Working Committee of the Chinese Society of Clinical Oncology . Chinese Society of Clinical Oncology(CSCO)guidelines for diagnosis and treatment of non small cell lung cancer 2023 [M ] . Beijing : People’s Medical Publishing House , 2023 : 125 - 126 .
WHEATE N J , WALKER S , CRAIG G E , et al . The status of platinum anticancer drugs in the clinic and in clinical trials [J ] . Dalton Trans , 2010 , 39 ( 35 ): 8113 - 8127 .
KUWAHARA A , YAMAMORI M , NISHIGUCHI K , et al . Replacement of cisplatin with nedaplatin in a definitive 5-fluorouracil/cisplatin-based chemoradiotherapy in Japanese patients with esophageal squamous cell carcinoma [J ] . Int J Med Sci , 2009 , 6 ( 6 ): 305 - 311 .
广东省药学会 . 铂类药物临床应用与不良反应管理专家共识 [J ] . 今日药学 , 2019 , 29 ( 9 ): 577 - 585 .
Guangdong Pharmaceutical Association . Expert consensus on clinical application of platinum drugs and adverse reaction management [J ] . Pharm Today , 2019 , 29 ( 9 ): 577 - 585 .
LU S , CHEN Z W , HU C P , et al . Nedaplatin plus docetaxel versus cisplatin plus docetaxel as first-line chemotherapy for advanced squamous cell carcinoma of the lung:a multicenter,open-label,randomized,phase Ⅲ trial [J ] . J Thorac Oncol , 2018 , 13 ( 11 ): 1743 - 1749 .
GE L , LI N , YUAN G W , et al . Nedaplatin and paclitaxel compared with carboplatin and paclitaxel for patients with platinum-sensitive recurrent ovarian cancer [J ] . Am J Cancer Res , 2018 , 8 ( 6 ): 1074 - 1082 .
UEHARA T , TSUCHIYA N , TORII M , et al . Amelioration of nedaplatin-induced nephrotoxicity by continuous infusion in rats [J ] . J Toxicol Pathol , 2007 , 20 ( 3 ): 141 - 147 .
VAN DER GAAG S , LABOTS M , SWART E L , et al . Reducing renal function assessment prior to platinum-based chemotherapy:a real-world evaluation [J ] . Acta Oncol , 2024 , 63 : 169 - 174 .
BURSAC D S , SARCEV T , VELIKIC D S , et al . Cardiotoxic effects of gemcitabine/cisplatin vs paclitaxel/carboplatin first-line chemotherapy in patients with advanced non-small cell lung cancer [J ] . Ann Oncol , 2016 , 27 : vi415 .
YANGUI F , ZAIEM A , ANTIT S , et al . Acute myocar-ditis during carboplatin and pemetrexed chemotherapy for lung adenocarcinoma [J ] . Therapie , 2021 , 76 ( 5 ): 486 - 488 .
中国临床肿瘤学会抗肿瘤药物安全管理专家委员会 , 中国临床肿瘤学会免疫治疗专家委员会 . 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 .
Expert Committee on Safety Management of Antitumor Drugs of the Chines Society of Clinical Oncology , Expert Committee on Immunotherapy of the Chinese Society of Clinical Oncology . Expert consensus on the clinical diagnosis and treatment of camrelizumab induced reactive cutaneous capillary endothelial proliferation [J ] . Chin Clin Oncol , 2020 , 25 ( 9 ): 840 - 848 .
QU W , WANG F , QIN S , et al . Reactive cutaneous capillary endothelial proliferation following camrelizumab monotherapy or combination therapy for multi-cancers:a large-scale pooled analysis of 10 studies in China [J ] . Ther Adv Med Oncol , 2024 , 16 : 17588359241242607 .
FANG W F , YANG Y P , MA Y X , et al . Camrelizumab(SHR-1210)alone or in combination with gemcitabine plus cisplatin for nasopharyngeal carcinoma:results from two single-arm,phase 1 trials [J ] . Lancet Oncol , 2018 , 19 ( 10 ): 1338 - 1350 .
PANG H M , HUANG G M , QIN X L , et al . Reactive cutaneous capillary endothelial proliferation caused by camrelizumab:sixteen case reports [J ] . Indian J Dermatol , 2023 , 68 ( 3 ): 318 - 326 .
POLLACK R , ASHASH A , CAHN A , et al . Immune checkpoint inhibitor-induced thyroid dysfunction is associ-ated with higher body mass index [J ] . J Clin Endocrinol Metab , 2020 , 105 ( 10 ): dgaa458 .
POLLACK R M , KAGAN M , LOTEM M , et al . Baseline TSH level is associated with risk of anti-PD-1-induced thyroid dysfunction [J ] . Endocr Pract , 2019 , 25 ( 8 ): 824 - 829 .
0
Views
131
下载量
0
CSCD
Publicity Resources
Related Articles
Related Author
Related Institution
公网安备50010302001817