On the restricted mean survival time curve in survival analysis

• Published in: Biometrics Vol. 72; no. 1; pp. 215 - 221
• Main Authors: Zhao, Lihui, Claggett, Brian, Tian, Lu, Uno, Hajime, Pfeffer, Marc A., Solomon, Scott D., Trippa, Lorenzo, Wei, L. J.
• Format: Journal Article
• Language: English
• Published: United States Blackwell Publishing Ltd 01.03.2016; International Biometric Society
• Subjects: BIOMETRIC PRACTICE; biometry; Cardiology; Clinical trials; Computer Simulation; Data Interpretation, Statistical; Endpoint Determination - methods; Equivalence/noninferiority study; Gaussian process; Humans; Kaplan-Meier Estimate; Life Expectancy; Martingale; Medical research; Models, Statistical; Oncology; Population studies; probability; Reproducibility of Results; Sensitivity and Specificity; Simultaneous confidence band; Stochastic Processes; Survival; Survival analysis; Survival function; Survival Rate; Equivalence/noninferiority study; Gaussian process; Survival function; Simultaneous confidence band; Martingale
• ISSN: 0006-341X; 1541-0420; 1541-0420
• DOI: 10.1111/biom.12384

For a study with an event time as the endpoint, its survival function contains all the information regarding the temporal, stochastic profile of this outcome variable. The survival probability at a specific time point, say t, however, does not transparently capture the temporal profile of this endpoint up to t. An alternative is to use the restricted mean survival time (RMST) at time t to summarize the profile. The RMST is the mean survival time of all subjects in the study population followed up to t, and is simply the area under the survival curve up to t. The advantages of using such a quantification over the survival rate have been discussed in the setting of a fixed-time analysis. In this article, we generalize this approach by considering a curve based on the RMST over time as an alternative summary to the survival function. Inference, for instance, based on simultaneous confidence bands for a single RMST curve and also the difference between two RMST curves are proposed. The latter is informative for evaluating two groups under an equivalence or noninferiority setting, and quantifies the difference of two groups in a time scale. The proposal is illustrated with the data from two clinical trials, one from oncology and the other from cardiology.