Evaluating the potential of relapse-free survival as a surrogate for overall survival in the adjuvant therapy of melanoma with checkpoint inhibitors. (September 2020)

• Record Type: Journal Article
• Authors: Coart, Elisabeth; Suciu, Stefan; Squifflet, Pierre; Saad, Everardo D.; Moshyk, Andriy; de Schaetzen, Gaetan; Buyse, Marc; Weber, Jeffrey S.; Eggermont, Alexander; Kotapati, Srividya
• Is Part Of: European journal of cancer. Volume 137(2020)
• Page Start: 171
• Page End: 174
• Publication Date: 2020-09
• Subjects: Melanoma -- Relapse-free survival -- Overall survival -- Surrogate end-points -- Meta-analysis -- Correlation studies; Cancer -- Periodicals; Neoplasms -- Periodicals; Cancer -- Périodiques; Cancer; Tumors; Electronic journals; Periodicals; Electronic journals; 616.994
• DOI: 10.1016/j.ejca.2020.07.011
• Languages: English
• ISSNs: 0959-8049

Abstract

Abstract: Introduction: Recent changes in the adjuvant treatment of melanoma have raised interest in confirming relapse-free survival (RFS) as a surrogate for overall survival (OS). Methods: We explore this issue with the meta-analytic framework, using individual patient data from the European Organisation for Research and Treatment of Cancer (EORTC) 18071 trial of ipilimumab and published results from other adjuvant trials. Results: The individual patient data analysis results at a median follow-up of 5.3 years showed a strong association between RFS and OS at the patient level (ρ = 0.84; 95% confidence interval [CI]: 0.82–0.87) and a moderate association at the trial level (R 2 = 0.59; 95% CI: 0.08–1.00). Conclusions: The trial-level association previously observed in interferon-based trials appeared to be maintained when the EORTC 18071 results were added to a regression analysis using published results from other trials. More data from adjuvant trials are required to confirm the strength of association between RFS and OS in this setting. Highlights: We explored relapse-free survival (RFS) as a surrogate for overall survival (OS). We used data from the European Organisation for Research and Treatment of Cancer 18071 trial and published results from other trials. We found a strong association between RFS and OS at the patient level. We found a moderate association between RFS and OS at the trial level. Our results are promising and require confirmation with a larger number of trials.