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Time-to-event surro...
Time-to-event surrogate end-points in multiple myeloma randomised trials from 2005 to 2019 : a surrogacy analysis
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- Etekal, Tommy (author)
- Umeå universitet,Institutionen för strålningsvetenskaper
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- Koehn, Kelly (author)
- Division of Hematological Malignancies and Cellular Therapeutics, University of Kansas, KS, Lawrence, United States
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- Sborov, Douglas W. (author)
- Division of Hematology and Hematological Malignancies, University of Utah, UT, Salt Lake City, United States
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- McClune, Brian (author)
- Division of Hematology and Hematological Malignancies, University of Utah, UT, Salt Lake City, United States
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- Prasad, Vinay (author)
- Division of Hematology/Oncology, University of California San Francisco, CA, San Francisco, United States
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- Haslam, Alyson (author)
- Department of Epidemiology/Biostatistics, University of California San Francisco, CA, San Francisco, United States
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- Berger, Katherine (author)
- Patient Advocate, University of Hartford, CT, West Hartford, United States
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- Booth, Christopher (author)
- Division of Cancer Care and Epidemiology, Queen's University Cancer Research Institute, ON, Kingston, Canada
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- Al Hadidi, Samer (author)
- Myeloma Institute, The University of Arkansas for Medical Sciences, AR, Little Rock, United States
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- Abdallah, Al-Ola (author)
- Division of Hematological Malignancies and Cellular Therapeutics, University of Kansas, KS, Lawrence, United States
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- Goodman, Aaron (author)
- Division of Blood and Marrow Transplantation, University of California San Diego, CA, La Jolla, United States
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- Mohyuddin, Ghulam Rehman (author)
- Division of Hematology and Hematological Malignancies, University of Utah, UT, Salt Lake City, United States
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(creator_code:org_t)
- 2022-12-10
- 2023
- English.
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In: British Journal of Haematology. - : John Wiley & Sons. - 0007-1048 .- 1365-2141. ; 200:5, s. 587-594
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Abstract
Subject headings
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- Use of surrogate end-points such as progression-free survival (PFS) and other time-to-event (TTE) end-points is common in multiple myeloma (MM) clinical trials. This systematic review characterises all published randomised controlled trials (RCTs) in MM using PFS or other TTE end-points between 2005 and 2019 and assesses strength of surrogacy of PFS for overall survival (OS). The association between OS hazard ratios (HRs) and PFS HRs was evaluated with linear regression, and the coefficient of determination with Pearson's correlation. We identified 88 RCTs of which 67 (76%) used PFS as the primary/co-primary end-point. One trial indicated whether progression was biochemical or clinical. Of the variance in OS, 39% was due to variance in PFS. Correlation between PFS and OS was weak (0.62, 95% confidence interval [CI] 0.38–0.78). In newly diagnosed MM, 43% of the variance in OS was due to changes in PFS. The correlation between PFS and OS was weak (0.65, 95% CI 0.30–0.84). In relapsed/refractory MM, 58% of the variance in OS was due to changes in PFS. Correlation between PFS and OS was medium (0.76, 95% CI 0.42–0.91). We demonstrate that PFS and progression characteristics are characterised poorly in MM trials and that PFS is a poor surrogate for OS in MM.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Hematologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Hematology (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Cancer och onkologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cancer and Oncology (hsv//eng)
Keyword
- end-point
- multiple myeloma
- overall survival
- progression-free survival
- randomised controlled trial
Publication and Content Type
- ref (subject category)
- art (subject category)
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- By the author/editor
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Etekal, Tommy
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Koehn, Kelly
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Sborov, Douglas ...
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McClune, Brian
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Prasad, Vinay
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Haslam, Alyson
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Berger, Katherin ...
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Booth, Christoph ...
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Al Hadidi, Samer
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Abdallah, Al-Ola
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Goodman, Aaron
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Mohyuddin, Ghula ...
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- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Hematology
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Cancer and Oncol ...
- Articles in the publication
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British Journal ...
- By the university
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Umeå University