Christos Chouaid, Francesco Grossi, Christine Ta Thanh Minh, Romain Raymond, Joaquim Bosch-Barrera
{"title":"晚期 NSCLC 患者口服长春瑞滨单药的汇总分析。","authors":"Christos Chouaid, Francesco Grossi, Christine Ta Thanh Minh, Romain Raymond, Joaquim Bosch-Barrera","doi":"10.1080/17581966.2025.2477418","DOIUrl":null,"url":null,"abstract":"<p><strong>Objectives: </strong>This was a pooled analysis of data from weekly vinorelbine (VNR) treatment arms of four individual open-label, phase II studies to assess and refine the efficacy and tolerance of weekly oral VNR in a larger cohort of patients with advanced NSCLC.</p><p><strong>Materials and methods: </strong>All patients included in this pooled analysis received oral VNR at the dose of 60 mg/m<sup>2</sup> weekly at cycle 1 (3-week cycle), followed by an increase to 80 mg/m<sup>2</sup> weekly for subsequent cycles until disease progression or toxicity. Efficacy was based on objective response rate (ORR), progression-free survival (PFS), and disease control rate (DCR).</p><p><strong>Results: </strong>A total of 247 patients were included. The ORR and DCR were 8.9% and 57.5% respectively, median PFS and OS were 3.3 and 8.5 months, respectively. Less than half (40.7%) of patients reported ≥1 serious AE (regardless of causality), with 12.3% reporting ≥1 treatment-related serious AE (grade ≥3: 11.1%). The most reported grade ≥3 AEs were neutropenia (17.6%), fatigue (5.8%), and decreased appetite (4.9%).</p><p><strong>Conclusion: </strong>This pooled analysis showed that weekly oral VRN is a valid option, with an acceptable safety profile, in this population of patients with advanced NSCLC, confirming results from previous individual studies.</p>","PeriodicalId":43551,"journal":{"name":"Lung Cancer Management","volume":"14 1","pages":"2477418"},"PeriodicalIF":0.9000,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11938966/pdf/","citationCount":"0","resultStr":"{\"title\":\"Pooled analysis of oral vinorelbine as single agents in patients with advanced NSCLC.\",\"authors\":\"Christos Chouaid, Francesco Grossi, Christine Ta Thanh Minh, Romain Raymond, Joaquim Bosch-Barrera\",\"doi\":\"10.1080/17581966.2025.2477418\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objectives: </strong>This was a pooled analysis of data from weekly vinorelbine (VNR) treatment arms of four individual open-label, phase II studies to assess and refine the efficacy and tolerance of weekly oral VNR in a larger cohort of patients with advanced NSCLC.</p><p><strong>Materials and methods: </strong>All patients included in this pooled analysis received oral VNR at the dose of 60 mg/m<sup>2</sup> weekly at cycle 1 (3-week cycle), followed by an increase to 80 mg/m<sup>2</sup> weekly for subsequent cycles until disease progression or toxicity. Efficacy was based on objective response rate (ORR), progression-free survival (PFS), and disease control rate (DCR).</p><p><strong>Results: </strong>A total of 247 patients were included. The ORR and DCR were 8.9% and 57.5% respectively, median PFS and OS were 3.3 and 8.5 months, respectively. Less than half (40.7%) of patients reported ≥1 serious AE (regardless of causality), with 12.3% reporting ≥1 treatment-related serious AE (grade ≥3: 11.1%). The most reported grade ≥3 AEs were neutropenia (17.6%), fatigue (5.8%), and decreased appetite (4.9%).</p><p><strong>Conclusion: </strong>This pooled analysis showed that weekly oral VRN is a valid option, with an acceptable safety profile, in this population of patients with advanced NSCLC, confirming results from previous individual studies.</p>\",\"PeriodicalId\":43551,\"journal\":{\"name\":\"Lung Cancer Management\",\"volume\":\"14 1\",\"pages\":\"2477418\"},\"PeriodicalIF\":0.9000,\"publicationDate\":\"2025-12-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11938966/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Lung Cancer Management\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1080/17581966.2025.2477418\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/3/21 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q4\",\"JCRName\":\"RESPIRATORY SYSTEM\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Lung Cancer Management","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1080/17581966.2025.2477418","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/3/21 0:00:00","PubModel":"Epub","JCR":"Q4","JCRName":"RESPIRATORY SYSTEM","Score":null,"Total":0}
Pooled analysis of oral vinorelbine as single agents in patients with advanced NSCLC.
Objectives: This was a pooled analysis of data from weekly vinorelbine (VNR) treatment arms of four individual open-label, phase II studies to assess and refine the efficacy and tolerance of weekly oral VNR in a larger cohort of patients with advanced NSCLC.
Materials and methods: All patients included in this pooled analysis received oral VNR at the dose of 60 mg/m2 weekly at cycle 1 (3-week cycle), followed by an increase to 80 mg/m2 weekly for subsequent cycles until disease progression or toxicity. Efficacy was based on objective response rate (ORR), progression-free survival (PFS), and disease control rate (DCR).
Results: A total of 247 patients were included. The ORR and DCR were 8.9% and 57.5% respectively, median PFS and OS were 3.3 and 8.5 months, respectively. Less than half (40.7%) of patients reported ≥1 serious AE (regardless of causality), with 12.3% reporting ≥1 treatment-related serious AE (grade ≥3: 11.1%). The most reported grade ≥3 AEs were neutropenia (17.6%), fatigue (5.8%), and decreased appetite (4.9%).
Conclusion: This pooled analysis showed that weekly oral VRN is a valid option, with an acceptable safety profile, in this population of patients with advanced NSCLC, confirming results from previous individual studies.
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