Randomized trial comparing a web-mediated follow-up via patient-reported outcomes (PRO) vs. routine surveillance in lung cancer patients: Final results.

Abstract

6500 Background: In a previous interim analysis, we found a 7-month median overall survival (OS) benefit (p = 0.002) associated with web-based monitoring to detect recurrence in lung cancer patients after initial treatment, vs. scheduled imaging. We hypothesized that benefit was due to earlier detection of symptoms and relapses, prompting earlier treatment and supportive care. Final results with 2-year follow-up is presented. Methods: Advanced-stage lung cancer patients without evidence of disease progression after initial treatment were randomly assigned to compare a web-mediated follow-up (experimental arm) based on weekly self-scoring of 13 common patient symptoms with a routine follow-up (control arm) with 3-6 months repeated CT-scans. In the experimental arm, an alert email was sent to the oncologist when self-scored symptoms matched predefined criteria. The IRB protocol-specified primary outcome was OS. After a pre-planned interim analysis in which OS improvement was observed, the IDMC suggested a cessation of further recruitment in 1-2016 and recommended to offer eligible patients in the control arm to cross over to the intervention. Results: From 6-2014 to 1-2016, 121 patients were included in the intent-to-test survival (ITT) analysis. Ten out of 34 living patients in the control arm were eligible to cross over following the interim analysis. With 2 years of follow-up and 70 deaths observed, the median OS was 23.0 months in the experimental arm and 14.8 months without adjustment for crossover in the control arm (HR 0.62, 95% CI 0.39 to 0.995, p= 0.048). Censoring crossover resulted in a hazard ratio of 0.53 (95% CI 0.33 to 0.85, p = 0.009) with consistent results also observed based on a rank-preserving structural failure time model (psi = -0.55, 95% CI -1.09 to -0.03). Conclusions: With a longer follow-up and although eligible patients from the control arm crossed over to receive intervention after the preplanned interim analysis, the OS remained significantly larger with the web-mediated follow-up based on PRO than with routine disease follow-up by CT scans alone. This is the first study to show the benefits of PROs during surveillance in cancer patients. Clinical trial information: NCT02361099.