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  • 1.
    Etekal, Tommy
    et al.
    Umeå universitet, Medicinska fakulteten, Institutionen för strålningsvetenskaper.
    Koehn, Kelly
    Division of Hematological Malignancies and Cellular Therapeutics, University of Kansas, KS, Lawrence, United States.
    Sborov, Douglas W.
    Division of Hematology and Hematological Malignancies, University of Utah, UT, Salt Lake City, United States.
    McClune, Brian
    Division of Hematology and Hematological Malignancies, University of Utah, UT, Salt Lake City, United States.
    Prasad, Vinay
    Division of Hematology/Oncology, University of California San Francisco, CA, San Francisco, United States.
    Haslam, Alyson
    Department of Epidemiology/Biostatistics, University of California San Francisco, CA, San Francisco, United States.
    Berger, Katherine
    Patient Advocate, University of Hartford, CT, West Hartford, United States.
    Booth, Christopher
    Division of Cancer Care and Epidemiology, Queen's University Cancer Research Institute, ON, Kingston, Canada.
    Al Hadidi, Samer
    Myeloma Institute, The University of Arkansas for Medical Sciences, AR, Little Rock, United States.
    Abdallah, Al-Ola
    Division of Hematological Malignancies and Cellular Therapeutics, University of Kansas, KS, Lawrence, United States.
    Goodman, Aaron
    Division of Blood and Marrow Transplantation, University of California San Diego, CA, La Jolla, United States.
    Mohyuddin, Ghulam Rehman
    Division of Hematology and Hematological Malignancies, University of Utah, UT, Salt Lake City, United States.
    Time-to-event surrogate end-points in multiple myeloma randomised trials from 2005 to 2019: a surrogacy analysis2023Ingår i: British Journal of Haematology, ISSN 0007-1048, E-ISSN 1365-2141, Vol. 200, nr 5, s. 587-594Artikel i tidskrift (Refereegranskat)
    Abstract [en]

    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.

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