持续静脉注射rh-恩度他汀联合铂类双联化疗治疗晚期非小细胞肺癌的有效性和安全性。

IF 3 3区 医学 Q2 ONCOLOGY Investigational New Drugs Pub Date : 2024-06-01 Epub Date: 2024-05-03 DOI:10.1007/s10637-024-01439-x
Xinyi Liu, Zihan Guo, Lin Su, Anli Zuo, Min Gao, Xiang Ji, Jiameng Lu, Shuran Yang, Yunxiu Jiang, Degan Lu
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引用次数: 0

摘要

背景:铂类双药化疗常用于治疗非小细胞肺癌(NSCLC)。越来越多的证据表明,在铂类化疗中加入抗血管生成药物可提高 NSCLC 患者的生存率。目的:本研究旨在探讨5天连续静脉输注rh-内司他丁联合化疗治疗晚期NSCLC患者的有效性和安全性。方法:这是一项前瞻性单臂多组研究:这项前瞻性、单臂多中心研究在2021年1月至2022年12月期间共招募了48名经组织学或细胞学确诊但之前未接受过任何治疗的晚期NSCLC患者。化疗前,这些患者使用输液泵在120小时内持续静脉输注rh-内司他汀(210毫克)。化疗方案包括铂与培美曲塞或紫杉醇的组合,以21天为一个周期。研究的主要终点是中位无进展生存期(mPFS),次要终点包括中位总生存期(mOS)、客观反应率(ORR)、疾病控制率(DCR)以及不良事件(AEs)评估:mPFS为6.5个月(95%置信区间(CI):3.8-9.1个月),mOS为12.3个月(95%置信区间(CI):7.6-18.5个月)。ORR和DCR分别为52.1%和75.0%。白细胞减少(52.1%)、贫血(33.3%)和血小板减少(20.8%)是最常见的不良反应,这些毒性被认为是可以接受和控制的。此外,血清癌胚抗原(CEA)水平升高与 PFS 和 OS 下降之间存在相关性:结论:在以铂类为基础的双联化疗中连续5天静脉输注rh-内托铂,在晚期NSCLC的治疗中表现出了安全性和有效性。此外,血清中CEA的基线水平有可能作为NSCLC患者联合化疗时rh-endostatin疗效的预测指标:GOV:NCT05574998。
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The efficacy and safety of continuous intravenous infusion of rh-endostatin combined with platinum-based doublet chemotherapy for advanced non-small-cell lung cancer.

Background: Platinum-based doublet chemotherapy is commonly used in the treatment of non-small cell lung cancer (NSCLC). A growing body of evidence indicates that incorporating antiangiogenic agents into platinum-based chemotherapy may enhance the survival outcomes for NSCLC patients. However, the optimal administration protocol for intravenous recombinant human endostatin (rh-endostatin), an antiangiogenic agent, remains uncertain at present.

Aim: This study aims to investigate the efficacy and safety of 5-d continuous intravenous infusion of rh-endostatin in combination with chemotherapy for patients with advanced NSCLC. The predictive biomarkers for this treatment regimen were further probed.

Methods: This prospective, single-arm multicenter study enrolled a total of 48 patients with advanced NSCLC who were histologically or cytologically confirmed but had not received any prior treatment from January 2021 to December 2022. Prior to the chemotherapy, these patients received a continuous intravenous infusion of rh-endostatin (210 mg) over a period of 120 h, using an infusion pump. The chemotherapy regimen included a combination of platinum with either pemetrexed or paclitaxel, given in 21-day cycles. The primary endpoint of the study was median progression-free survival (mPFS), and the secondary endpoints included median overall survival (mOS), objective response rate (ORR), disease control rate (DCR), and assessment of adverse events (AEs).

Results: The mPFS was 6.5 months (95% confidence interval (CI): 3.8-9.1 m) while the mOS was 12.3 months (95% CI: 7.6-18.5 m). The ORR and DCR was 52.1% and 75.0%, respectively. Leukopenia (52.1%), anemia (33.3%), and thrombocytopenia (20.8%) were the most common adverse effects and these toxicities were deemed acceptable and manageable. In addition, a correlation was noted between elevated serum carcinoembryonic antigen (CEA) levels and decreased PFS and OS.

Conclusions: The incorporation of a 5-day continuous intravenous infusion of rh-endostatin into platinum-based doublet chemotherapy has demonstrated both safety and efficacy in the treatment of advanced NSCLC. Furthermore, the baseline serum levels of CEA may potentially function as a predictor for the efficacy of rh-endostatin when combined with chemotherapy in NSCLC patients.

Clinicaltrials: GOV: NCT05574998.

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来源期刊
CiteScore
7.60
自引率
0.00%
发文量
121
审稿时长
1 months
期刊介绍: The development of new anticancer agents is one of the most rapidly changing aspects of cancer research. Investigational New Drugs provides a forum for the rapid dissemination of information on new anticancer agents. The papers published are of interest to the medical chemist, toxicologist, pharmacist, pharmacologist, biostatistician and clinical oncologist. Investigational New Drugs provides the fastest possible publication of new discoveries and results for the whole community of scientists developing anticancer agents.
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