Cancers
Survival-Inferred Fragility Index in Phase III Colorectal Cancer Trials: A Systematic Review
By Guo L, Yuan J, Zhang X and 7 others.
Abstract
Background
Conventional measures such as p-values and hazard ratios (HRs) do not directly quantify the sensitivity of time-to-event outcomes to small changes in individual outcomes. The Survival-Inferred Fragility Index (SIFI) evaluates the minimum number of survival-outcome changes required to reverse trial conclusions and provides complementary information on result robustness.
Methods
This systematic review (PROSPERO: CRD420251182325) identified phase III colorectal cancer randomized controlled trials (RCTs) published from 2015 to 2025 via PubMed, Embase, and Cochrane. SIFI was calculated using Bomze's framework with the "flip best" strategy. The fragility quotient (FQ) and the relationship between SIFI and withdrawals or losses to follow-up (WCLFU) were assessed. Analyses used R version 4.5.1.