{"title":"anlotinib相关治疗方案在先前免疫检查点抑制剂治疗的晚期NSCLC患者中的有效性和安全性：一项真实世界的探索性研究","authors":"Xue-Sen Fang, Tie-Song Zhang, Shao-Jun Li, Yun-Long Zhao, Jing-Bo Li, Hui Xia, Ren-Tao Wang","doi":"10.2147/DDDT.S535615","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>This study aimed to identify the effectiveness and safety of anlotinib-related therapeutic regimens in patients with previously immune checkpoint inhibitors (ICIs)-treated advanced non-small cell lung cancer (NSCLC).</p><p><strong>Methods: </strong>A total of 107 patients with previously ICIs-treated advanced NSCLC who received anlotinib-related regimens or single-agent chemotherapy in clinical practice were included in this study retrospectively. The anlotinib group (AG) included 54 patients who received anlotinib-related regimens, and the chemotherapy group (CG) consisted of 53 patients who received single-agent chemotherapy. This study retrospectively collected the efficacy and safety data during the patients' therapeutic process and performed regular follow-up to obtain long-term survival data. Clinical outcomes and safety profiles between AG and CG were analyzed and compared.</p><p><strong>Results: </strong>Best overall response of the 107 patients with previously ICIs-treated advanced NSCLC suggested that objective response rates of AG and CG were 24.1% and 11.3%, respectively; no statistically significant difference was observed (<i>P</i> = 0.084). Disease control rates were 79.6% and 54.7%, respectively (<i>P</i> = 0.006). Furthermore, the median PFS of AG and CG were 6.3 months (95% CI = 0.91-11.69) and 2.8 months (95% CI = 2.32-3.28), respectively, which showed a statistically significant difference (<i>P</i> = 0.002). The median OS in AG and CG were 16.1 months (95% CI = 12.28-19.92) and 10.1 months (95% CI = 3.99-16.21), respectively, which also exhibited a statistically significant difference (<i>P</i> = 0.015). Incidence of adverse reactions with all grades in AG and CG were 85.2% and 83.0%, respectively, grade ≥3 adverse reactions occurred in 40.7% and 45.3%, respectively. Common adverse reactions of patients in AG included fatigue, hypertension, nausea and vomiting, and hematologic toxicity, while patients in CG commonly experienced fatigue, hematologic toxicity, nausea and vomiting, and liver toxicity.</p><p><strong>Conclusion: </strong>Among patients with previously ICIs-treated advanced NSCLC, anlotinib-related therapeutic regimens demonstrated encouraging efficacy and a tolerable safety profile compared with the single-agent chemotherapy regimen. This conclusion still needs further validation in prospective clinical trials.</p>","PeriodicalId":11290,"journal":{"name":"Drug Design, Development and Therapy","volume":"19 ","pages":"7527-7540"},"PeriodicalIF":5.1000,"publicationDate":"2025-08-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12406031/pdf/","citationCount":"0","resultStr":"{\"title\":\"Effectiveness and Safety of Anlotinib-Related Therapeutic Regimens in Patients with Previously Immune Checkpoint Inhibitors-Treated Advanced NSCLC: A Real-World Exploratory Study.\",\"authors\":\"Xue-Sen Fang, Tie-Song Zhang, Shao-Jun Li, Yun-Long Zhao, Jing-Bo Li, Hui Xia, Ren-Tao Wang\",\"doi\":\"10.2147/DDDT.S535615\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>This study aimed to identify the effectiveness and safety of anlotinib-related therapeutic regimens in patients with previously immune checkpoint inhibitors (ICIs)-treated advanced non-small cell lung cancer (NSCLC).</p><p><strong>Methods: </strong>A total of 107 patients with previously ICIs-treated advanced NSCLC who received anlotinib-related regimens or single-agent chemotherapy in clinical practice were included in this study retrospectively. The anlotinib group (AG) included 54 patients who received anlotinib-related regimens, and the chemotherapy group (CG) consisted of 53 patients who received single-agent chemotherapy. This study retrospectively collected the efficacy and safety data during the patients' therapeutic process and performed regular follow-up to obtain long-term survival data. Clinical outcomes and safety profiles between AG and CG were analyzed and compared.</p><p><strong>Results: </strong>Best overall response of the 107 patients with previously ICIs-treated advanced NSCLC suggested that objective response rates of AG and CG were 24.1% and 11.3%, respectively; no statistically significant difference was observed (<i>P</i> = 0.084). Disease control rates were 79.6% and 54.7%, respectively (<i>P</i> = 0.006). Furthermore, the median PFS of AG and CG were 6.3 months (95% CI = 0.91-11.69) and 2.8 months (95% CI = 2.32-3.28), respectively, which showed a statistically significant difference (<i>P</i> = 0.002). The median OS in AG and CG were 16.1 months (95% CI = 12.28-19.92) and 10.1 months (95% CI = 3.99-16.21), respectively, which also exhibited a statistically significant difference (<i>P</i> = 0.015). Incidence of adverse reactions with all grades in AG and CG were 85.2% and 83.0%, respectively, grade ≥3 adverse reactions occurred in 40.7% and 45.3%, respectively. Common adverse reactions of patients in AG included fatigue, hypertension, nausea and vomiting, and hematologic toxicity, while patients in CG commonly experienced fatigue, hematologic toxicity, nausea and vomiting, and liver toxicity.</p><p><strong>Conclusion: </strong>Among patients with previously ICIs-treated advanced NSCLC, anlotinib-related therapeutic regimens demonstrated encouraging efficacy and a tolerable safety profile compared with the single-agent chemotherapy regimen. This conclusion still needs further validation in prospective clinical trials.</p>\",\"PeriodicalId\":11290,\"journal\":{\"name\":\"Drug Design, Development and Therapy\",\"volume\":\"19 \",\"pages\":\"7527-7540\"},\"PeriodicalIF\":5.1000,\"publicationDate\":\"2025-08-29\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12406031/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Drug Design, Development and Therapy\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.2147/DDDT.S535615\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q1\",\"JCRName\":\"CHEMISTRY, MEDICINAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Drug Design, Development and Therapy","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.2147/DDDT.S535615","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/1/1 0:00:00","PubModel":"eCollection","JCR":"Q1","JCRName":"CHEMISTRY, MEDICINAL","Score":null,"Total":0}
引用次数: 0
摘要
目的：本研究旨在确定anlotinib相关治疗方案在先前免疫检查点抑制剂（ICIs）治疗的晚期非小细胞肺癌（NSCLC）患者中的有效性和安全性。方法：回顾性研究共纳入107例既往接受过icis治疗的晚期NSCLC患者，这些患者在临床实践中接受过anlotinib相关方案或单药化疗。安洛替尼组（AG）包括54例接受安洛替尼相关方案的患者，化疗组（CG）包括53例接受单药化疗的患者。本研究回顾性收集患者治疗过程中的疗效和安全性数据，并定期随访，获取长期生存数据。分析和比较AG和CG的临床结果和安全性。结果：107例既往接受icis治疗的晚期NSCLC患者的最佳总缓解表明，AG和CG的客观缓解率分别为24.1%和11.3%；差异无统计学意义（P = 0.084）。疾病控制率分别为79.6%和54.7% （P = 0.006）。此外，AG和CG的中位PFS分别为6.3个月（95% CI = 0.91-11.69）和2.8个月（95% CI = 2.32-3.28），差异有统计学意义（P = 0.002）。AG组和CG组的中位OS分别为16.1个月（95% CI = 12.28 ~ 19.92）和10.1个月（95% CI = 3.99 ~ 16.21），差异也有统计学意义（P = 0.015）。AG和CG各分级不良反应发生率分别为85.2%和83.0%，≥3级不良反应发生率分别为40.7%和45.3%。AG组患者常见的不良反应有疲劳、高血压、恶心呕吐、血液学毒性，而CG组患者常见的不良反应有疲劳、血液学毒性、恶心呕吐、肝毒性。结论：在先前接受过icis治疗的晚期NSCLC患者中，与单药化疗方案相比，anlotinib相关治疗方案显示出令人鼓舞的疗效和可耐受的安全性。这一结论仍需在前瞻性临床试验中进一步验证。
Effectiveness and Safety of Anlotinib-Related Therapeutic Regimens in Patients with Previously Immune Checkpoint Inhibitors-Treated Advanced NSCLC: A Real-World Exploratory Study.
Objective: This study aimed to identify the effectiveness and safety of anlotinib-related therapeutic regimens in patients with previously immune checkpoint inhibitors (ICIs)-treated advanced non-small cell lung cancer (NSCLC).
Methods: A total of 107 patients with previously ICIs-treated advanced NSCLC who received anlotinib-related regimens or single-agent chemotherapy in clinical practice were included in this study retrospectively. The anlotinib group (AG) included 54 patients who received anlotinib-related regimens, and the chemotherapy group (CG) consisted of 53 patients who received single-agent chemotherapy. This study retrospectively collected the efficacy and safety data during the patients' therapeutic process and performed regular follow-up to obtain long-term survival data. Clinical outcomes and safety profiles between AG and CG were analyzed and compared.
Results: Best overall response of the 107 patients with previously ICIs-treated advanced NSCLC suggested that objective response rates of AG and CG were 24.1% and 11.3%, respectively; no statistically significant difference was observed (P = 0.084). Disease control rates were 79.6% and 54.7%, respectively (P = 0.006). Furthermore, the median PFS of AG and CG were 6.3 months (95% CI = 0.91-11.69) and 2.8 months (95% CI = 2.32-3.28), respectively, which showed a statistically significant difference (P = 0.002). The median OS in AG and CG were 16.1 months (95% CI = 12.28-19.92) and 10.1 months (95% CI = 3.99-16.21), respectively, which also exhibited a statistically significant difference (P = 0.015). Incidence of adverse reactions with all grades in AG and CG were 85.2% and 83.0%, respectively, grade ≥3 adverse reactions occurred in 40.7% and 45.3%, respectively. Common adverse reactions of patients in AG included fatigue, hypertension, nausea and vomiting, and hematologic toxicity, while patients in CG commonly experienced fatigue, hematologic toxicity, nausea and vomiting, and liver toxicity.
Conclusion: Among patients with previously ICIs-treated advanced NSCLC, anlotinib-related therapeutic regimens demonstrated encouraging efficacy and a tolerable safety profile compared with the single-agent chemotherapy regimen. This conclusion still needs further validation in prospective clinical trials.
期刊介绍：
Drug Design, Development and Therapy is an international, peer-reviewed, open access journal that spans the spectrum of drug design, discovery and development through to clinical applications.
The journal is characterized by the rapid reporting of high-quality original research, reviews, expert opinions, commentary and clinical studies in all therapeutic areas.
Specific topics covered by the journal include:
Drug target identification and validation
Phenotypic screening and target deconvolution
Biochemical analyses of drug targets and their pathways
New methods or relevant applications in molecular/drug design and computer-aided drug discovery*
Design, synthesis, and biological evaluation of novel biologically active compounds (including diagnostics or chemical probes)
Structural or molecular biological studies elucidating molecular recognition processes
Fragment-based drug discovery
Pharmaceutical/red biotechnology
Isolation, structural characterization, (bio)synthesis, bioengineering and pharmacological evaluation of natural products**
Distribution, pharmacokinetics and metabolic transformations of drugs or biologically active compounds in drug development
Drug delivery and formulation (design and characterization of dosage forms, release mechanisms and in vivo testing)
Preclinical development studies
Translational animal models
Mechanisms of action and signalling pathways
Toxicology
Gene therapy, cell therapy and immunotherapy
Personalized medicine and pharmacogenomics
Clinical drug evaluation
Patient safety and sustained use of medicines.
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