Department of Pharmacy, University Hospital Gran Canaria Doctor Negrín, Las Palmas.
Department of Pharmacy, Catalan Institute of Oncology, L'Hospitalet de Llobregat, Barcelona.
Am J Clin Oncol. 2023 Oct 1;46(10):433-438. doi: 10.1097/COC.0000000000001031. Epub 2023 Jul 31.
To analyze the evolution of clinical outcomes derived from clinical trials on first-line therapies for advanced or metastatic non-small cell lung cancer (NSCLC) published between 2010 and 2020, focusing on how these outcomes impact survival rates and management of patients.
A systematic review of phase III and pivotal phase II clinical trials was conducted by a structured search on Medline and Embase. A comprehensive set of variables was collected to assess their influence on survival rates. We also estimated the clinical benefit by applying the ESMO-MCBS v1.1 and extracted the authors' conclusions.
Sixty-six studies involving 34,951 patients were included. Best survival outcomes were found for nonsquamous non-small cell lung cancer (OS and progression-free survival medians: 19.4 and 10.2 mo) and for those expressing molecular targets (OS and progression-free survival medians: 23.8 and 11.0 mo). No significant influence on survival rates was observed for industry funding and disease stage (IIIB/IV vs. IV). ESMO-MCBS v1.1 was applied in 45 positive studies and resulted in a meaningful clinical benefit score in 37.8%. Quality of life (QoL) was reported in 57.6% of the original publications and showed statistical significance favoring the experimental arm in 33.3%. Positive authors' conclusions (75.7% of trials) were based on OS and/or QoL in 34% and on surrogate endpoints in 66%.
Extended survival times and a steady improvement in QoL have been observed. However, there were more than twice as many studies reporting positive authors' conclusions as studies meeting the ESMO threshold for meaningful clinical benefit.
分析 2010 年至 2020 年间发表的关于晚期或转移性非小细胞肺癌（NSCLC）一线治疗的临床试验的临床结果演变，重点关注这些结果如何影响生存率和患者管理。
通过对 Medline 和 Embase 的结构化搜索，对 III 期和关键 II 期临床试验进行了系统评价。收集了一整套变量来评估它们对生存率的影响。我们还根据 ESMO-MCBS v1.1 评估了临床获益，并提取了作者的结论。
纳入了 66 项涉及 34951 名患者的研究。非鳞状非小细胞肺癌（OS 和无进展生存期中位数：19.4 和 10.2 个月）和表达分子靶标的患者（OS 和无进展生存期中位数：23.8 和 11.0 个月）的最佳生存结果。行业资助和疾病分期（IIIB/IV 与 IV）对生存率没有显著影响。ESMO-MCBS v1.1 在 45 项阳性研究中得到应用，其中 37.8%具有有意义的临床获益评分。57.6%的原始出版物报告了生活质量（QoL），其中 33.3%的研究显示实验组具有统计学意义的优势。75.7%的试验的阳性作者结论是基于 OS 和/或 QoL（34%）和替代终点（66%）。
观察到延长的生存时间和 QoL 的稳步改善。然而，报告阳性作者结论的研究数量是符合 ESMO 有意义临床获益阈值的研究数量的两倍多。
