Clinical outcomes of patients with advanced non-small cell lung cancer enrolled in phase Ⅰ oncology clinical trials
10.12354/j.issn.1000-8179.2025.20250840
- VernacularTitle:参与Ⅰ期肿瘤临床试验的晚期非小细胞肺癌的临床结局
- Author:
Li LUFENG
1
;
Zhang CHI
;
Li ZHI
;
Zhang ZIYI
;
Li HUI
;
Li HAIPENG
;
Li HONGTAO
Author Information
1. 蚌埠医科大学第一附属医院,临床试验研究中心,创新药物药学研究与临床评价安徽省联合共建学科重点实验室(蚌埠市 233000)
- Publication Type:Journal Article
- Keywords:
phase Ⅰ clinical trial;
advanced non-small cell lung cancer;
efficacy;
safety
- From:
Chinese Journal of Clinical Oncology
2025;52(15):769-775
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To evaluate the efficacy and safety of treatments in phase Ⅰ oncology clinical trials in patients with advanced non-small-cell lung cancer(NSCLC).Methods:We retrospectively analyzed the clinical data of 65 patients with advanced NSCLC who received phase Ⅰ antitumor trial drugs at the Clinical Trial Research Center of The First Affiliated Hospital of Bengbu Medical University from January 2020 to December 2023.The efficacy and occurrence of serious adverse events(SAEs)were analyzed.Results:The objective response rate(ORR)and disease control rate(DCR)were 9.2%and 61.4%,respectively,whereas the median progression-free survival(PFS)and overall survival(OS)were 2.9 and 15.1 months,respectively.Previously receiving second-line or more lines of treatment and SAE occurrence were independent risk factors for a shorter PFS(P<0.05).A history of smoking and previous second-line or more lines of treatment were inde-pendent risk factors for a shorter OS(P<0.05).The SAE incidence was 15.4%,and no treatment-related deaths occurred.Conclusions:Treat-ments in phase Ⅰ oncology clinical trials are beneficial for patients with advanced NSCLC.Patients with a higher number of previous treat-ment lines and those who experienced SAEs during the trial had a shorter PFS,whereas patients with no smoking history and fewer previous treatment lines had a longer overall survival.The overall safety of the treatments was acceptable.
