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Progression-Free Survival: Meaningful or Simply Measurable?
Journal of Clinical Oncology, 2012The last few years have seen an increase in the number of randomized controlled trials (RCTs) of new agents in metastatic solid tumors using progression-free survival (PFS) as the primary end point. Some trials showing improvement in PFS, without a correspondingincreaseinoverallsurvival(OS),haveledtoapprovalofnew drugs and/or changes in standard of ...
Christopher M, Booth +1 more
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The Cancer Journal, 2009
In clinical trials of oncology drugs, overall survival (OS) is a direct measure of clinical efficacy and is considered the gold standard primary efficacy end point. The purpose of this study was to discuss the difficulties in using OS as a primary efficacy end point in the setting of evolving cancer therapies.
David, Lebwohl +4 more
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In clinical trials of oncology drugs, overall survival (OS) is a direct measure of clinical efficacy and is considered the gold standard primary efficacy end point. The purpose of this study was to discuss the difficulties in using OS as a primary efficacy end point in the setting of evolving cancer therapies.
David, Lebwohl +4 more
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Population kinetics of progression free survival (PFS).
Journal of Clinical Oncology, 2019e18251 Background: We assessed drug type impact on whether PFS curves could be fit by 2 phase decay models on nonlinear regression analysis (NLRA). Methods: We digitized 894 published PFS curves for incurable cancers. We used GraphPad Prism 7 for 1 phase and 2 phase decay NLRA, with constraints Y0 = 100 and plateau = 0. We defined curves as fitting 2
David J. Stewart +8 more
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Mitotic Index and Progression-Free Survival in Atypical Meningiomas
World Neurosurgery, 2020Extent of resection and tumor grade are considered the most important predictors of progression-free survival (PFS) in meningiomas. However, adjuvant therapy for atypical meningiomas remains controversial, with variable PFS rates of up to 40%. The current mitotic index (MI) range for atypical meningiomas is broad, comprising all tumors with >4 and
Ricardo A. Domingo +5 more
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Sensitivity analysis of progression‐free survival with dependent withdrawal
Statistics in Medicine, 2008AbstractWe develop a sensitivity analysis method for comparing treatment‐specific distributions where the endpoint is progression‐free survival (PFS). The censoring process may be informative due to selective patient withdrawal, which occurs whenever disease evaluation has been discontinued without progression being documented. The sensitivity analysis
Ping K, Ruan, Robert J, Gray
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Elacestrant Prolongs Progression-Free Survival in Advanced Breast Cancer
Cancer Discovery, 2022Abstract Prolonged progression-free survival was seen with elacestrant versus standard-of-care endocrine therapy.
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Alternatives to the Kaplan–Meier estimator of progression-free survival
The International Journal of Biostatistics, 2020Abstract Progression-free survival (PFS), defined as the time from randomization to progression of disease or death, has been indicated as an endpoint to support accelerated approval of certain cancer drugs by the U.S. FDA. The standard Kaplan–Meier (KM) estimator of PFS, however, can result in significantly biased estimates.
Zhang, Jenny J. +3 more
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Relationship Between Progression-Free Survival and Overall Survival Benefit: A Simulation Study
Therapeutic Innovation & Regulatory Science, 2013This study evaluated the circumstances under which the observed progression-free survival (PFS) benefit may translate into an overall survival (OS) benefit.A simulation study, based on PFS and OS joint model decomposition, was conducted to evaluate the impact of crossover rates, survival post progression (SPP) lengths, and magnitudes of difference in ...
Lijun, Zhang +3 more
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Progression-Free Survival Is a Surrogate for Survival in Advanced Colorectal Cancer
Journal of Clinical Oncology, 2007Purpose The traditional end point for assessing efficacy of first-line chemotherapies for advanced cancer is overall survival (OS), but this end point requires prolonged follow-up and is potentially confounded by the effects of second-line therapies. We investigated whether progression-free survival (PFS) could be considered a valid surrogate for OS in
Marc, Buyse +8 more
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Health insurance status and cancer stage at diagnosis and survival in the United States
Ca-A Cancer Journal for Clinicians, 2022Jingxuan Zhao +2 more
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