PDF(Pubmed)
Abstract：
UNASSIGNED: Health-related quality of life (HRQoL), along with overall survival (OS), is a critical study endpoint for measuring the clinical benefits of cancer drugs. Previous studies have examined the OS benefit of new cancer drugs approved in China. However, their HRQoL benefits have not been systematically evaluated. We aimed to characterise the measurement and improvement of HRQoL associated with cancer drugs approved in China.
UNASSIGNED: This mixed-methods study comprises of a literature review and a cross-sectional study, including all antineoplastic agents approved in China between January 1, 2005 and December 31, 2020. A systematic search was conducted on December 31, 2023 to extract HRQoL information of identified drugs. We extracted information on the characteristics of HRQoL assessment and statistically significant HRQoL gains compared with the control treatment.
UNASSIGNED: A total of 64 novel cancer drugs, corresponding to 115 cancer indications, supported by randomised clinical trials were approved in China between 2005 and 2020. Among the indications, 78 (67.8%) used HRQoL as an endpoint in the pivotal trial. By December 31, 2023, after a median follow-up of 5.3 (range, 3.0-18.8) years from approval, HRQoL information was available for more than half of the indications (75, 65.2%). Thirty-three indications (28.7%) reported statistically significant improvement in HRQoL, with 22 (19.1%) also having documented OS benefit. Approximately one-third of the indications (39, 33.9%) showed no difference in HRQoL, with 21 (18.3%) having documented OS gains. Three indications (2.6%) reported worsening HRQoL. The most commonly used HRQoL measurements were individual disease-specific instruments (62 of 75, 82.7%) while the most frequently employed analysis metric was the mean change scores from baseline (56 of 75, 74.7%).
UNASSIGNED: Fewer than one-third of cancer indications approved in China had shown HRQoL improvements. There was considerable heterogeneity in the analysis and reporting of HRQoL benefits associated with new cancer drugs approved in China. These findings emphasise the important role of HRQoL evaluation and analysis in clinical research and the necessity of improving the standardization of HRQoL assessment.
UNASSIGNED: National Natural Science Foundation of China (72274004).
UNASSIGNED: This mixed-methods study comprises of a literature review and a cross-sectional study, including all antineoplastic agents approved in China between January 1, 2005 and December 31, 2020. A systematic search was conducted on December 31, 2023 to extract HRQoL information of identified drugs. We extracted information on the characteristics of HRQoL assessment and statistically significant HRQoL gains compared with the control treatment.
UNASSIGNED: A total of 64 novel cancer drugs, corresponding to 115 cancer indications, supported by randomised clinical trials were approved in China between 2005 and 2020. Among the indications, 78 (67.8%) used HRQoL as an endpoint in the pivotal trial. By December 31, 2023, after a median follow-up of 5.3 (range, 3.0-18.8) years from approval, HRQoL information was available for more than half of the indications (75, 65.2%). Thirty-three indications (28.7%) reported statistically significant improvement in HRQoL, with 22 (19.1%) also having documented OS benefit. Approximately one-third of the indications (39, 33.9%) showed no difference in HRQoL, with 21 (18.3%) having documented OS gains. Three indications (2.6%) reported worsening HRQoL. The most commonly used HRQoL measurements were individual disease-specific instruments (62 of 75, 82.7%) while the most frequently employed analysis metric was the mean change scores from baseline (56 of 75, 74.7%).
UNASSIGNED: Fewer than one-third of cancer indications approved in China had shown HRQoL improvements. There was considerable heterogeneity in the analysis and reporting of HRQoL benefits associated with new cancer drugs approved in China. These findings emphasise the important role of HRQoL evaluation and analysis in clinical research and the necessity of improving the standardization of HRQoL assessment.
UNASSIGNED: National Natural Science Foundation of China (72274004).
摘要：
■与健康相关的生活质量（HRQoL），连同总生存率(OS)，是衡量癌症药物临床益处的关键研究终点。先前的研究已经检查了在中国批准的新癌症药物的OS益处。然而,他们的HRQoL获益尚未得到系统评估。我们旨在描述与中国批准的癌症药物相关的HRQoL的测量和改善。
■这项混合方法研究包括文献综述和横断面研究，包括2005年1月1日至2020年12月31日在中国批准的所有抗肿瘤药。2023年12月31日进行了系统搜索，以提取已识别药物的HRQoL信息。我们提取了有关HRQoL评估特征的信息，以及与对照治疗相比具有统计学意义的HRQoL增益。
■共有64种新型抗癌药物，对应于115种癌症适应症，2005年至2020年期间，中国批准了由随机临床试验支持的临床试验。在适应症中，78（67.8%）在关键试验中使用HRQoL作为终点。到2023年12月31日，在中位随访5.3(范围，自批准之日起3.0-18.8)年，HRQoL信息可用于超过一半的适应症（75，65.2％）。33个适应症（28.7%）报告了HRQoL的统计学显着改善，22人(19.1%)也有记录在案的操作系统优势。大约三分之一的适应症（39，33.9%）显示HRQoL无差异，21（18.3%）有记录的操作系统增益。三个适应症（2.6%）报告HRQoL恶化。最常用的HRQoL测量是个体疾病特异性仪器（75中的62，82.7％），而最常用的分析度量是从基线的平均变化分数（75中的56，74.7％）。
■在中国批准的癌症适应症中，不到三分之一的患者显示出HRQoL改善。在与中国批准的新癌症药物相关的HRQoL益处的分析和报告中存在相当大的异质性。这些发现强调了HRQoL评估和分析在临床研究中的重要作用以及提高HRQoL评估标准化的必要性。
■国家自然科学基金(72274004).
■这项混合方法研究包括文献综述和横断面研究，包括2005年1月1日至2020年12月31日在中国批准的所有抗肿瘤药。2023年12月31日进行了系统搜索，以提取已识别药物的HRQoL信息。我们提取了有关HRQoL评估特征的信息，以及与对照治疗相比具有统计学意义的HRQoL增益。
■共有64种新型抗癌药物，对应于115种癌症适应症，2005年至2020年期间，中国批准了由随机临床试验支持的临床试验。在适应症中，78（67.8%）在关键试验中使用HRQoL作为终点。到2023年12月31日，在中位随访5.3(范围，自批准之日起3.0-18.8)年，HRQoL信息可用于超过一半的适应症（75，65.2％）。33个适应症（28.7%）报告了HRQoL的统计学显着改善，22人(19.1%)也有记录在案的操作系统优势。大约三分之一的适应症（39，33.9%）显示HRQoL无差异，21（18.3%）有记录的操作系统增益。三个适应症（2.6%）报告HRQoL恶化。最常用的HRQoL测量是个体疾病特异性仪器（75中的62，82.7％），而最常用的分析度量是从基线的平均变化分数（75中的56，74.7％）。
■在中国批准的癌症适应症中，不到三分之一的患者显示出HRQoL改善。在与中国批准的新癌症药物相关的HRQoL益处的分析和报告中存在相当大的异质性。这些发现强调了HRQoL评估和分析在临床研究中的重要作用以及提高HRQoL评估标准化的必要性。
■国家自然科学基金(72274004).
