Neoadjuvant camrelizumab plus chemotherapy or apatinib for resectable stage IIA-IIIA NSCLC: a multicenter, two-arm, phase II exploratory trial.

IF 7 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL
Shuyu Ji, Zhenxin Sheng, Dongliang Bian, Minwei Bao, Kaiqi Jin, Wentian Zhang, Xinsheng Zhu, Fenghuan Sun, Haoran Xia, Han Zhang, Ziyun Shen, Huansha Yu, Lele Zhang, Jie Huang, Zhang Peng, Nan Song, Haifeng Wang, Biyun Qian, Yuming Zhu
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引用次数: 0

Abstract

Background: This study aimed to evaluate the efficacy and safety of camrelizumab, an anti-PD-1 antibody, combined with either chemotherapy or apatinib, a VEGFR-2 inhibitor, as neoadjuvant treatment for stage IIA-IIIA NSCLC.

Methods: This prospective, multicenter, dual-arm, non-randomized phase II trial enrolled participants from four hospitals in China between September 2020 and March 2022. Patients received 2-4 cycles of neoadjuvant treatment followed by surgery. Arm-AR (n = 28) included patients treated with camrelizumab (200 mg every 3 weeks) plus platinum-based chemotherapy, regardless of PD-L1 status. Arm-BR (n = 10) included PD-L1-positive patients treated with camrelizumab (200 mg every 3 weeks) plus apatinib (250 mg daily). The primary endpoint was the major pathological response (MPR) rate. Secondary endpoints included pathological complete response (pCR) rate, objective response rate (ORR), disease control rate (DCR), event-free survival (EFS), overall survival (OS), and safety profiles.

Results: In the ITT population, MPR rates were 25.0% (95% CI 10.7-44.9) in arm-AR and 60.0% (95% CI 26.2-87.8) in arm-BR. The 24-month EFS rates were 53.6% and 70.0%, respectively, after a median follow-up of 30.5 months. Grade 3 or higher treatment-related adverse events (TRAEs) occurred in 25% of arm-AR patients and 10% of arm-BR patients.

Conclusions: Camrelizumab combined with platinum-based chemotherapy demonstrated promising efficacy and tolerability for resectable IIA-IIIA NSCLC, regardless of PD-L1 status. In PD-L1-positive patients, camrelizumab plus apatinib showed improved safety and effectiveness, highlighting a potential treatment option for this subgroup.

Trial registration: NCT04379739, initiated on July 26, 2020.

新辅助camrelizumab联合化疗或阿帕替尼治疗可切除的IIA-IIIA期NSCLC:一项多中心、双臂、II期探索性试验
背景:本研究旨在评估抗pd -1抗体camrelizumab联合化疗或VEGFR-2抑制剂apatinib作为iiia - iiia期NSCLC新辅助治疗的有效性和安全性。方法:这项前瞻性、多中心、双臂、非随机II期试验于2020年9月至2022年3月在中国四家医院招募了参与者。患者接受2-4个周期的新辅助治疗,然后进行手术。Arm-AR (n = 28)包括接受camrelizumab(每3周200 mg)加铂类化疗的患者,无论PD-L1状态如何。Arm-BR (n = 10)包括接受camrelizumab(每3周200 mg)加阿帕替尼(每天250 mg)治疗的pd - l1阳性患者。主要终点为主要病理反应(MPR)率。次要终点包括病理完全缓解率(pCR)、客观缓解率(ORR)、疾病控制率(DCR)、无事件生存期(EFS)、总生存期(OS)和安全性。结果:ITT人群中,ar臂的MPR为25.0% (95% CI 10.7-44.9), br臂的MPR为60.0% (95% CI 26.2-87.8)。在中位随访30.5个月后,24个月的EFS率分别为53.6%和70.0%。3级或更高级别治疗相关不良事件(TRAEs)发生在25%的臂部ar患者和10%的臂部br患者中。结论:Camrelizumab联合铂基化疗对可切除的IIA-IIIA NSCLC显示出良好的疗效和耐受性,无论PD-L1状态如何。在pd - l1阳性患者中,camrelizumab联合阿帕替尼显示出更高的安全性和有效性,突出了该亚组的潜在治疗选择。试验注册:NCT04379739,于2020年7月26日启动。
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来源期刊
BMC Medicine
BMC Medicine 医学-医学:内科
CiteScore
13.10
自引率
1.10%
发文量
435
审稿时长
4-8 weeks
期刊介绍: BMC Medicine is an open access, transparent peer-reviewed general medical journal. It is the flagship journal of the BMC series and publishes outstanding and influential research in various areas including clinical practice, translational medicine, medical and health advances, public health, global health, policy, and general topics of interest to the biomedical and sociomedical professional communities. In addition to research articles, the journal also publishes stimulating debates, reviews, unique forum articles, and concise tutorials. All articles published in BMC Medicine are included in various databases such as Biological Abstracts, BIOSIS, CAS, Citebase, Current contents, DOAJ, Embase, MEDLINE, PubMed, Science Citation Index Expanded, OAIster, SCImago, Scopus, SOCOLAR, and Zetoc.
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