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Time to deterioration of patient-reported outcome endpoints in cancer clinical trials: targeted literature review and best practice recommendations.

作者信息

Cocks Kim, King-Kallimanis Bellinda L, Sims Joel, Worthy Gill, Stein Julia, Ayala-Nunes Lara, Achra Monika, Cui Zhanglin Lin, Payakachat Nalin

机构信息

Adelphi Values Ltd, Patient-Centered Outcomes, Adelphi Mill, Grimshaw Lane, Bollington, Macclesfield, SK10 5JB, UK.

LUNGevity Foundation, Bethesda, MD, USA.

出版信息

J Patient Rep Outcomes. 2024 Dec 18;8(1):150. doi: 10.1186/s41687-024-00824-7.


DOI:10.1186/s41687-024-00824-7
PMID:39694990
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11655910/
Abstract

BACKGROUND: Time to deterioration (TTD) endpoints are often utilized in the analysis of patient-reported outcome (PRO) data in oncology clinical trials but different endpoint definitions and analysis frameworks exist that can impact result interpretation. This review examined the analysis, reporting and heterogeneity of TTD endpoints in the literature, the impact of analysis methods on results, and provides recommendations for future trials. METHODS: A targeted literature review of articles published between 2017 and 2022 was performed to collate TTD endpoints reported in oncology randomized controlled trials (RCTs). Details of endpoints and results were extracted including; deterioration definition, PRO assessment schedule, methods for handling intercurrent events, statistical analysis methods, main trial results (overall survival and/or progression-free survival) and TTD endpoint results. RESULTS: Seventy RCTs were included covering 849 individual TTD endpoints. There were 17 primary cancer types, with lung (26%), breast (11%), and prostate (7%) cancers the most common. Most trials (71%) were for people with advanced cancer. Full definitions of TTD endpoints were often missing. There were no clear trends for a specific TTD definition within cancer types or stages. However, statistical analysis methods were consistent among trials. CONCLUSION: The TTD definition can vary and is ultimately driven by the research question. Points to consider for successfully implementing PRO TTD endpoints in oncology include consideration of the trial setting (e.g., early vs. advanced cancer), expected treatment effect (e.g., improvement vs. worsening), likely adverse event profile (including early vs. delayed) and PRO data collection frequency in order to improve utility of these endpoints.

摘要
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/72e9/11655910/3416ff28f472/41687_2024_824_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/72e9/11655910/514dce8aeb30/41687_2024_824_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/72e9/11655910/d32c7ff07b99/41687_2024_824_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/72e9/11655910/3416ff28f472/41687_2024_824_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/72e9/11655910/514dce8aeb30/41687_2024_824_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/72e9/11655910/d32c7ff07b99/41687_2024_824_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/72e9/11655910/3416ff28f472/41687_2024_824_Fig3_HTML.jpg

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Time to deterioration of patient-reported outcome endpoints in cancer clinical trials: targeted literature review and best practice recommendations.

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本文引用的文献

[1]
The Assessment of Patient-Reported Outcomes for the Authorisation of Medicines in Europe: A Review of European Public Assessment Reports from 2017 to 2022.

Appl Health Econ Health Policy. 2023-11

[2]
A call to action to harmonize patient-reported outcomes evidence requirements across key European HTA bodies in oncology.

Future Oncol. 2022-9

[3]
Health-related Quality of Life Analysis from KEYNOTE-426: Pembrolizumab plus Axitinib Versus Sunitinib for Advanced Renal Cell Carcinoma.

Eur Urol. 2022-10

[4]
Tislelizumab versus chemotherapy as second-line treatment of advanced or metastatic esophageal squamous cell carcinoma (RATIONALE 302): impact on health-related quality of life.

ESMO Open. 2022-8

[5]
Patient-reported Outcomes from JAVELIN Bladder 100: Avelumab First-line Maintenance Plus Best Supportive Care Versus Best Supportive Care Alone for Advanced Urothelial Carcinoma.

Eur Urol. 2023-4

[6]
Health-related quality-of-life outcomes in patients with advanced renal cell carcinoma treated with lenvatinib plus pembrolizumab or everolimus versus sunitinib (CLEAR): a randomised, phase 3 study.

Lancet Oncol. 2022-6

[7]
Time to deterioration of symptoms or function using patient-reported outcomes in cancer trials.

Lancet Oncol. 2022-5

[8]
Health-related quality of life in patients with advanced well-differentiated pancreatic and extrapancreatic neuroendocrine tumors treated with surufatinib versus placebo: Results from two randomized, double-blind, phase III trials (SANET-p and SANET-ep).

Eur J Cancer. 2022-7

[9]
First-line nivolumab plus ipilimumab versus chemotherapy for the treatment of unresectable malignant pleural mesothelioma: patient-reported outcomes in CheckMate 743.

Lung Cancer. 2022-5

[10]
Health-related Quality of Life with Adjuvant Nivolumab After Radical Resection for High-risk Muscle-invasive Urothelial Carcinoma: Results from the Phase 3 CheckMate 274 Trial.

Eur Urol Oncol. 2022-10

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