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. 2024 Apr 29:46:101077.
doi: 10.1016/j.lanwpc.2024.101077. eCollection 2024 May.

Improvements in the health-related quality-of-life benefit of cancer drugs approved in China, 2005-2020: an observational study

Lan Zhang  1 , Yichen Zhang  1 , Huangqianyu Li  2 , Luwen Shi  1   2 , Xiaodong Guan  1   2
Affiliations

Improvements in the health-related quality-of-life benefit of cancer drugs approved in China, 2005-2020: an observational study

Lan Zhang et al. Lancet Reg Health West Pac. .

Abstract

Background: 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.

Methods: 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.

Findings: 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%).

Interpretation: 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.

Funding: National Natural Science Foundation of China (72274004).

Keywords: Anticancer drugs; Patient-reported outcome; Quality of life; Regulatory reform.

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Conflict of interest statement

The authors declare that there are no conflicts of interest.

Figures

Fig. 1
Fig. 1
Classification of HRQoL instruments and analysis metrics used in cancer clinical trials with different indications. (a) The Venn diagram illustrates the use of multiple different types of HRQoL measurements in a cancer indication. (b) The Venn diagram illustrates the use of multiple different types of HRQoL analysis metric in a cancer indication. Abbreviation: HRQoL, health-related quality of life.
See this image and copyright information in PMC

References

    1. Arciero V., Delos Santos S., Koshy L., et al. Assessment of food and drug administration– and European medicines agency–approved systemic oncology therapies and clinically meaningful improvements in quality of life. JAMA Netw Open. 2021;4 - PMC - PubMed
    1. Haslam A., Herrera-Perez D., Gill J., Prasad V. Patient experience captured by quality-of-life measurement in oncology clinical trials. JAMA Netw Open. 2020;3 - PMC - PubMed
    1. Baldwin M., Spong A., Doward L., Gnanasakthy A. Patient-reported outcomes, patient-reported information: from randomized controlled trials to the social web and beyond. Patient. 2011;4:11–17. - PMC - PubMed
    1. Kluetz P.G., O'Connor D.J., Soltys K. Incorporating the patient experience into regulatory decision making in the USA, Europe, and Canada. Lancet Oncol. 2018;19:e267–e274. - PubMed
    1. Velikova G., Coens C., Efficace F., et al. Health-Related Quality of Life in EORTC clinical trials — 30 years of progress from methodological developments to making a real impact on oncology practice. Eur J Cancer. 2012;10:141–149.

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