参与Ⅰ期肿瘤临床试验的晚期非小细胞肺癌的临床结局

Clinical outcomes of patients with advanced non-small cell lung cancer enrolled inphase I oncology clinical trials

    摘要
  • 摘要:
    目的 评估参与Ⅰ期肿瘤临床试验的晚期非小细胞肺癌（non-small cell lung cancer，NSCLC）患者的疗效及安全性。
    方法 回顾性分析2020年1月至2023年12月在蚌埠医科大学第一附属医院临床试验研究中心接受Ⅰ期抗肿瘤试验药物治疗的65例晚期NSCLC患者的临床资料，分析疗效及严重不良事件（serious adverse events，SAE）发生情况。
    结果 客观缓解率（objective response rate，ORR）为9.2%，疾病控制率（disease control rate，DCR）为61.4%，中位无进展生存期（progression-free survival，PFS）为2.9个月，中位总生存期（overall survival，OS）为15.1个月。既往2线及以上治疗史、发生SAE是PFS较短的独立危险因素（P<0.05）；既往有吸烟史、2线及以上治疗史是OS较短的独立危险因素（P<0.05）。SAE发生率为15.4%，未发生与治疗相关的死亡事件。
    结论 晚期NSCLC患者参与Ⅰ期肿瘤临床试验可获益，对于既往治疗线数较多、试验期间发生SAE的患者PFS较短，而既往无吸烟史、治疗线数较少的患者总生存期更长，总体安全性可接受。

     

    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 independent risk factors for a shorter OS (P<0.05). The SAE incidence was 15.4%, and no treatment-related deaths occurred.
    Conclusions Treatments in phase Ⅰ oncology clinical trials are beneficial for patients with advanced NSCLC. Patients with a higher number of previous treatment 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.

     

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