Journal of clinical epidemiology The Importance of Reporting CT Scan Intervals in Real-World Oncology Studies: A Simulation Analysis of Afatinib in Advanced-Stage Non-Small Cell Lung Cancer.

Abstract

Objectives: In real-world oncology studies, progression-free survival (PFS) is often used as a surrogate endpoint. However, the interval of the CT scans, which might impact PFS, is usually not mentioned in publications based on real-world data. This study aims to determine the relationship between CT scan interval and PFS captured across different assessment frequencies (captured PFS or cPFS). The secondary objective is to identify appropriate correction factors for median PFS (mPFS) in real-world data, necessary for comparisons with clinical trials.

Study design and setting: A simulation was conducted to create theoretical PFS data. Time-to-event analyses, including Kaplan-Meier survival curves, Cox regression models, parametric survival models, and multilevel survival regression models, were used to assess the effect of various CT scan intervals on cPFS durations. The Laplace regression model was employed to compute fiftieth-percentile ratios.

Results: The mPFS (95% CI) captured by cPFS6, cPFS12, cPFS16, and cPFS20 were 11.56 (10.78, 12.71), 12.42 (11.17, 13.80), 12.98 (11.70, 13.96), and 13.80 (12.71, 14.49) months, respectively. There was a significant difference in mPFS durations captured at different CT scan intervals. The correction factors for converting mPFS from cPFS12, cPFS16, and cPFS20 to cPFS6 were 1.06, 1.09, and 1.14, respectively.

Conclusions: Longer CT intervals resulted in longer mPFS, leading to a systematic overestimation of about 1-2 months.