{"title":"安洛替尼加多西紫杉醇与多西紫杉醇单药治疗先前免疫治疗过的NSCLC患者的可行性和安全性：一项回顾性探索性研究","authors":"Da-Wei Li, Ying-Dong Li, Hong Jin","doi":"10.2147/IJGM.S521360","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>This study aims to evaluate the efficacy and safety of anlotinib plus docetaxel in patients with advanced non-small cell lung cancer (NSCLC) who have previously treated with immunotherapy.</p><p><strong>Methods: </strong>This retrospective analysis was conducted on 86 previously immunotherapy-treated patients with advanced NSCLC from December 2018 to October 2024 in clinical practice. Those who received anlotinib plus docetaxel were assigned to experimental group (EG, N=43), while those who were treated with docetaxel monotherapy were deemed as control group (CG, N=43) in clinical practice. Efficacy and safety of both regimens were compared with regular follow-up for survival data collection. The primary endpoints included overall survival (OS) and secondary endpoints were progression-free survival (PFS), objective response rate (ORR) and disease control rate (DCR).</p><p><strong>Results: </strong>ORR in the experimental and control groups was 30.2% (95% CI: 17.2-46.1%) and 13.9% (95% CI: 5.3-27.9%), respectively, showing a trend towards significance (<i>P</i>=0.069). DCR was significantly higher in the EG at 79.1% (95% CI: 63.9-89.9%) compared to 51.2% (95% CI: 35.5-66.7%) in the CG (<i>P</i>=0.007). After a median follow-up of 12.8 and 8.5 months, respectively, the median PFS was 6.5 months (95% CI: 4.08-8.92) in the EG, compared to 2.9 months (95% CI: 2.53-3.27) in the CG (<i>P</i>=0.019). The median OS was 13.5 months (95% CI: 10.49-16.51) in the EG, compared to 9.2 months (95% CI: 5.73-12.67) in the CG (<i>P</i>=0.007). Adverse events of all grades occurred in 93.0% of patients in the EG and 83.7% in the CG. Grade 3 or above adverse events were detected in 51.2% and 44.2%, respectively, with similar safety profiles between the groups.</p><p><strong>Conclusion: </strong>Anlotinib plus docetaxel demonstrated preliminary efficacy and a tolerable safety profile in patients with previously immunotherapy-treated advanced NSCLC, providing a potential therapeutic option in the post-immunotherapy setting. The conclusion should be confirmed in prospective clinical trials subsequently.</p>","PeriodicalId":14131,"journal":{"name":"International Journal of General Medicine","volume":"18 ","pages":"2319-2331"},"PeriodicalIF":2.1000,"publicationDate":"2025-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12048712/pdf/","citationCount":"0","resultStr":"{\"title\":\"Feasibility and Safety of Anlotinib Plus Docetaxel versus Docetaxel Monotherapy in Patients with Previously Immunotherapy-Treated NSCLC: A Retrospective Exploratory Study.\",\"authors\":\"Da-Wei Li, Ying-Dong Li, Hong Jin\",\"doi\":\"10.2147/IJGM.S521360\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>This study aims to evaluate the efficacy and safety of anlotinib plus docetaxel in patients with advanced non-small cell lung cancer (NSCLC) who have previously treated with immunotherapy.</p><p><strong>Methods: </strong>This retrospective analysis was conducted on 86 previously immunotherapy-treated patients with advanced NSCLC from December 2018 to October 2024 in clinical practice. Those who received anlotinib plus docetaxel were assigned to experimental group (EG, N=43), while those who were treated with docetaxel monotherapy were deemed as control group (CG, N=43) in clinical practice. Efficacy and safety of both regimens were compared with regular follow-up for survival data collection. The primary endpoints included overall survival (OS) and secondary endpoints were progression-free survival (PFS), objective response rate (ORR) and disease control rate (DCR).</p><p><strong>Results: </strong>ORR in the experimental and control groups was 30.2% (95% CI: 17.2-46.1%) and 13.9% (95% CI: 5.3-27.9%), respectively, showing a trend towards significance (<i>P</i>=0.069). DCR was significantly higher in the EG at 79.1% (95% CI: 63.9-89.9%) compared to 51.2% (95% CI: 35.5-66.7%) in the CG (<i>P</i>=0.007). After a median follow-up of 12.8 and 8.5 months, respectively, the median PFS was 6.5 months (95% CI: 4.08-8.92) in the EG, compared to 2.9 months (95% CI: 2.53-3.27) in the CG (<i>P</i>=0.019). The median OS was 13.5 months (95% CI: 10.49-16.51) in the EG, compared to 9.2 months (95% CI: 5.73-12.67) in the CG (<i>P</i>=0.007). Adverse events of all grades occurred in 93.0% of patients in the EG and 83.7% in the CG. Grade 3 or above adverse events were detected in 51.2% and 44.2%, respectively, with similar safety profiles between the groups.</p><p><strong>Conclusion: </strong>Anlotinib plus docetaxel demonstrated preliminary efficacy and a tolerable safety profile in patients with previously immunotherapy-treated advanced NSCLC, providing a potential therapeutic option in the post-immunotherapy setting. The conclusion should be confirmed in prospective clinical trials subsequently.</p>\",\"PeriodicalId\":14131,\"journal\":{\"name\":\"International Journal of General Medicine\",\"volume\":\"18 \",\"pages\":\"2319-2331\"},\"PeriodicalIF\":2.1000,\"publicationDate\":\"2025-04-28\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12048712/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"International Journal of General Medicine\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.2147/IJGM.S521360\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q2\",\"JCRName\":\"MEDICINE, GENERAL & INTERNAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"International Journal of General Medicine","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.2147/IJGM.S521360","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/1/1 0:00:00","PubModel":"eCollection","JCR":"Q2","JCRName":"MEDICINE, GENERAL & INTERNAL","Score":null,"Total":0}
Feasibility and Safety of Anlotinib Plus Docetaxel versus Docetaxel Monotherapy in Patients with Previously Immunotherapy-Treated NSCLC: A Retrospective Exploratory Study.
Objective: This study aims to evaluate the efficacy and safety of anlotinib plus docetaxel in patients with advanced non-small cell lung cancer (NSCLC) who have previously treated with immunotherapy.
Methods: This retrospective analysis was conducted on 86 previously immunotherapy-treated patients with advanced NSCLC from December 2018 to October 2024 in clinical practice. Those who received anlotinib plus docetaxel were assigned to experimental group (EG, N=43), while those who were treated with docetaxel monotherapy were deemed as control group (CG, N=43) in clinical practice. Efficacy and safety of both regimens were compared with regular follow-up for survival data collection. The primary endpoints included overall survival (OS) and secondary endpoints were progression-free survival (PFS), objective response rate (ORR) and disease control rate (DCR).
Results: ORR in the experimental and control groups was 30.2% (95% CI: 17.2-46.1%) and 13.9% (95% CI: 5.3-27.9%), respectively, showing a trend towards significance (P=0.069). DCR was significantly higher in the EG at 79.1% (95% CI: 63.9-89.9%) compared to 51.2% (95% CI: 35.5-66.7%) in the CG (P=0.007). After a median follow-up of 12.8 and 8.5 months, respectively, the median PFS was 6.5 months (95% CI: 4.08-8.92) in the EG, compared to 2.9 months (95% CI: 2.53-3.27) in the CG (P=0.019). The median OS was 13.5 months (95% CI: 10.49-16.51) in the EG, compared to 9.2 months (95% CI: 5.73-12.67) in the CG (P=0.007). Adverse events of all grades occurred in 93.0% of patients in the EG and 83.7% in the CG. Grade 3 or above adverse events were detected in 51.2% and 44.2%, respectively, with similar safety profiles between the groups.
Conclusion: Anlotinib plus docetaxel demonstrated preliminary efficacy and a tolerable safety profile in patients with previously immunotherapy-treated advanced NSCLC, providing a potential therapeutic option in the post-immunotherapy setting. The conclusion should be confirmed in prospective clinical trials subsequently.
期刊介绍：
The International Journal of General Medicine is an international, peer-reviewed, open access journal that focuses on general and internal medicine, pathogenesis, epidemiology, diagnosis, monitoring and treatment protocols. The journal is characterized by the rapid reporting of reviews, original research and clinical studies across all disease areas.
A key focus of the journal is the elucidation of disease processes and management protocols resulting in improved outcomes for the patient. Patient perspectives such as satisfaction, quality of life, health literacy and communication and their role in developing new healthcare programs and optimizing clinical outcomes are major areas of interest for the journal.
As of 1st April 2019, the International Journal of General Medicine will no longer consider meta-analyses for publication.
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