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Please use this identifier to cite or link to this item: http://hdl.handle.net/1942/28692

Title: Understanding and Communicating Measures of Treatment Effect on Survival: Can We Do Better?
Authors: Saad, Everardo D.
Zalcberg, John R.
Peron, Julien
Coart, Elisabeth
Burzykowski, Tomasz
Buyse, Marc
Issue Date: 2018
Abstract: Time-to-event end points are the most frequent primary end points in phase III oncology trials, both in the adjuvant and advanced settings. The evaluation of these end points is important to inform clinical practice. However, although different measures can be used to describe the effect of treatment on these end points, we believe that any treatment benefit in a given trial is best reported using various absolute and relative measures. Our goal is to help clinicians understand the strengths and limitations of the traditional and novel measures used to denote the effect of treatment in randomized trials. Although none of these measures can reliably predict the outcome of individual patients, some measures could be added to the commonly used hazard ratio to provide a more patient-oriented assessment of treatment benefit. In particular, the difference of mean survival times quantifies the average survival benefit for a patient receiving a new treatment compared with a patient treated with standard of care, whereas the net benefit quantifies the probability of a patient receiving the new treatment to live longer by at least m months (for any number of months m of interest) than a patient receiving the standard treatment. We encourage statisticians and clinical scientists to include various measures of treatment benefit in the reports of phase III trials, acknowledging that different clinical situations may call for different measures of treatment effect. By using the various available measures, we may better inform ourselves and communicate results to our patients.
Notes: [Saad, Everardo D.; Coart, Elisabeth; Burzykowski, Tomasz] Int Inst Drug Dev, Ave Prov 30, B-1340 Louvain La Neuve, Belgium. [Zalcberg, John R.] Monash Univ, Sch Publ Hlth & Prevent Med, Melbourne, Vic, Australia. [Peron, Julien] Hosp Civils Lyon, Dept Med Oncol, Pierre Benite, France. [Peron, Julien] Univ Lyon, Equipe Biostat Sante, Lab Biometrie & Biol Evolut, CNRS,UMR 5558, Lyon, France. [Burzykowski, Tomasz; Buyse, Marc] Hasselt Univ, Interuniv Inst Biostat & Stat Bioinformat I BioSt, Diepenbeek, Belgium. [Buyse, Marc] Int Inst Drug Dev, San Francisco, CA USA.
URI: http://hdl.handle.net/1942/28692
DOI: 10.1093/jnci/djx179
ISI #: 000417247600004
ISSN: 0027-8874
Category: A1
Type: Journal Contribution
Appears in Collections: Research publications

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