Real-World Efficacy and Safety of S-1 Monotherapy in Non-Small Cell Lung Cancer Management: Insights From a Multicenter Retrospective Cohort Study

Background: S-1, an oral chemotherapy combining tegafur, gimeracil, and oteracil, has shown efficacy comparable with docetaxel for advanced non-small cell lung cancer (NSCLC) in clinical trials. However, its real-world effectiveness and safety remain underexplored. Methods: This retrospective cohort...

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Main Authors: I-Lin Tsai, Chien-Yu Lin, Po-Lan Su, Chien-Chung Lin, John Wen-Cheng Chang, Chen-Yang Huang, Yueh-Fu Fang, Ching-Fu Chang, Chih-Hsi Scott Kuo, Ping-Chih Hsu, Cheng-Ta Yang, Chiao-En Wu
Format: Article
Language:English
Published: SAGE Publishing 2025-06-01
Series:Clinical Medicine Insights: Oncology
Online Access:https://doi.org/10.1177/11795549251348367
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author I-Lin Tsai
Chien-Yu Lin
Po-Lan Su
Chien-Chung Lin
John Wen-Cheng Chang
Chen-Yang Huang
Yueh-Fu Fang
Ching-Fu Chang
Chih-Hsi Scott Kuo
Ping-Chih Hsu
Cheng-Ta Yang
Chiao-En Wu
author_facet I-Lin Tsai
Chien-Yu Lin
Po-Lan Su
Chien-Chung Lin
John Wen-Cheng Chang
Chen-Yang Huang
Yueh-Fu Fang
Ching-Fu Chang
Chih-Hsi Scott Kuo
Ping-Chih Hsu
Cheng-Ta Yang
Chiao-En Wu
author_sort I-Lin Tsai
collection DOAJ
description Background: S-1, an oral chemotherapy combining tegafur, gimeracil, and oteracil, has shown efficacy comparable with docetaxel for advanced non-small cell lung cancer (NSCLC) in clinical trials. However, its real-world effectiveness and safety remain underexplored. Methods: This retrospective cohort study was conducted at 2 tertiary referral centers: National Cheng Kung University Hospital (NCKUH) from July 1, 2012 to July 1, 2023 (last follow-up in October 31, 2023) and Linkou Chang Gung Memorial Hospital (CGMH) from February 1, 2020 to January 31, 2023 (last follow-up in August 31, 2023). The study included 132 NSCLC patients receiving S-1 monotherapy (77 from CGMH and 55 from NCKUH). After excluding 31 patients with less than 2 weeks of treatment, 101 patients were analyzed. Results: The objective response rate (ORR) was 7.9%, and the disease control rate (DCR) was 44%. Median progression-free survival (PFS) and overall survival (OS) were 2.6 and 6.0 months, respectively. First-line or second-line S-1 therapy significantly improved DCR (61.1% vs 33.8%, P  = .008) and PFS (4.2 vs 2.3 months, P  < .001) compared with third-line or later use. Cox regression analysis confirmed earlier-line S-1 treatment (⩽ 2) as an independent predictor for PFS (hazard ratio: 2.01, 95% confidence interval: 1.15-3.51, P  = .014). Severe adverse events (grade ⩾ 3) occurred in 7.9% of cases. Conclusions: S-1 monotherapy demonstrated comparable effectiveness and manageable toxicity in real-world settings, with significantly better outcomes when used as first-line or second-line treatment in NSCLC.
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series Clinical Medicine Insights: Oncology
spelling doaj-art-6c0fe3b3143549eeaa6381697fafe45b2025-08-20T03:29:14ZengSAGE PublishingClinical Medicine Insights: Oncology1179-55492025-06-011910.1177/11795549251348367Real-World Efficacy and Safety of S-1 Monotherapy in Non-Small Cell Lung Cancer Management: Insights From a Multicenter Retrospective Cohort StudyI-Lin Tsai0Chien-Yu Lin1Po-Lan Su2Chien-Chung Lin3John Wen-Cheng Chang4Chen-Yang Huang5Yueh-Fu Fang6Ching-Fu Chang7Chih-Hsi Scott Kuo8Ping-Chih Hsu9Cheng-Ta Yang10Chiao-En Wu11Department of Internal Medicine, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan CityInstitute of Clinical Medicine, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan CityDepartment of Internal Medicine, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan CityDepartment of Biochemistry and Molecular Biology, College of Medicine, National Cheng Kung University, Tainan CityDivision of Hematology-Oncology, Department of Internal Medicine, Linkou Chang Gung Memorial Hospital, College of Medicine, Chang Gung University, Taoyuan CityDivision of Hematology-Oncology, Department of Internal Medicine, Linkou Chang Gung Memorial Hospital, College of Medicine, Chang Gung University, Taoyuan CityDivision of Thoracic Oncology, Department of Thoracic Medicine, Linkou Chang Gung Memorial Hospital, College of Medicine, Chang Gung University, Taoyuan CityDivision of Hematology-Oncology, Department of Internal Medicine, Linkou Chang Gung Memorial Hospital, College of Medicine, Chang Gung University, Taoyuan CityDivision of Thoracic Oncology, Department of Thoracic Medicine, Linkou Chang Gung Memorial Hospital, College of Medicine, Chang Gung University, Taoyuan CityDivision of Thoracic Oncology, Department of Thoracic Medicine, Linkou Chang Gung Memorial Hospital, College of Medicine, Chang Gung University, Taoyuan CityDivision of Thoracic Oncology, Department of Thoracic Medicine, Linkou Chang Gung Memorial Hospital, College of Medicine, Chang Gung University, Taoyuan CityDivision of Hematology-Oncology, Department of Internal Medicine, New Taipei Municipal TuCheng Hospital, New Taipei CityBackground: S-1, an oral chemotherapy combining tegafur, gimeracil, and oteracil, has shown efficacy comparable with docetaxel for advanced non-small cell lung cancer (NSCLC) in clinical trials. However, its real-world effectiveness and safety remain underexplored. Methods: This retrospective cohort study was conducted at 2 tertiary referral centers: National Cheng Kung University Hospital (NCKUH) from July 1, 2012 to July 1, 2023 (last follow-up in October 31, 2023) and Linkou Chang Gung Memorial Hospital (CGMH) from February 1, 2020 to January 31, 2023 (last follow-up in August 31, 2023). The study included 132 NSCLC patients receiving S-1 monotherapy (77 from CGMH and 55 from NCKUH). After excluding 31 patients with less than 2 weeks of treatment, 101 patients were analyzed. Results: The objective response rate (ORR) was 7.9%, and the disease control rate (DCR) was 44%. Median progression-free survival (PFS) and overall survival (OS) were 2.6 and 6.0 months, respectively. First-line or second-line S-1 therapy significantly improved DCR (61.1% vs 33.8%, P  = .008) and PFS (4.2 vs 2.3 months, P  < .001) compared with third-line or later use. Cox regression analysis confirmed earlier-line S-1 treatment (⩽ 2) as an independent predictor for PFS (hazard ratio: 2.01, 95% confidence interval: 1.15-3.51, P  = .014). Severe adverse events (grade ⩾ 3) occurred in 7.9% of cases. Conclusions: S-1 monotherapy demonstrated comparable effectiveness and manageable toxicity in real-world settings, with significantly better outcomes when used as first-line or second-line treatment in NSCLC.https://doi.org/10.1177/11795549251348367
spellingShingle I-Lin Tsai
Chien-Yu Lin
Po-Lan Su
Chien-Chung Lin
John Wen-Cheng Chang
Chen-Yang Huang
Yueh-Fu Fang
Ching-Fu Chang
Chih-Hsi Scott Kuo
Ping-Chih Hsu
Cheng-Ta Yang
Chiao-En Wu
Real-World Efficacy and Safety of S-1 Monotherapy in Non-Small Cell Lung Cancer Management: Insights From a Multicenter Retrospective Cohort Study
Clinical Medicine Insights: Oncology
title Real-World Efficacy and Safety of S-1 Monotherapy in Non-Small Cell Lung Cancer Management: Insights From a Multicenter Retrospective Cohort Study
title_full Real-World Efficacy and Safety of S-1 Monotherapy in Non-Small Cell Lung Cancer Management: Insights From a Multicenter Retrospective Cohort Study
title_fullStr Real-World Efficacy and Safety of S-1 Monotherapy in Non-Small Cell Lung Cancer Management: Insights From a Multicenter Retrospective Cohort Study
title_full_unstemmed Real-World Efficacy and Safety of S-1 Monotherapy in Non-Small Cell Lung Cancer Management: Insights From a Multicenter Retrospective Cohort Study
title_short Real-World Efficacy and Safety of S-1 Monotherapy in Non-Small Cell Lung Cancer Management: Insights From a Multicenter Retrospective Cohort Study
title_sort real world efficacy and safety of s 1 monotherapy in non small cell lung cancer management insights from a multicenter retrospective cohort study
url https://doi.org/10.1177/11795549251348367
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