Disease-free survival as a surrogate endpoint for overall survival in adults with early-stage pancreatic cancer: A trial-level surrogacy analysis.

• DOI: 10.1200/jco.2025.43.4_suppl.708
• Publication Date: 2025-01-27T14:31:24Z
• Authors: Luís Felipe Leite...; Luiz F. Costa Alm...; Mariana Macambira...; Lucas Diniz da Co...; Marcos Belotto; Thais Baccili Cur...; Renata D'Alpino P...
• Keywords: Surrogate endpoint; Clinical endpoint

708 Background: In early-stage cancer, overall survival (OS) is the gold-standard endpoint for assessing therapeutic efficacy. However, long follow-up periods make OS challenging and costly to measure in clinical trials. Disease-free (DFS), which captures time recurrence or death, has been proposed as a surrogate pancreatic cancer (PC). This surrogacy relationship could allow more rapid assessment of treatment benefits, but its validity requires robust analysis across Understanding trial-level correlation between DFS crucial optimizing trial design grant accelerated drug approval. Methods: We conducted systematic search Embase, PubMed, Cochrane databases through August 2024, identifying randomized controlled trials (RCTs) that evaluated adjuvant neoadjuvant systemic therapies adult patients with PC. Included studies reported both outcomes. Hazard ratios (HR_DFS) were analyzed endpoints (HR_OS). Statistical analyses utilized linear regression models, weighted by sample sizes, determine strength correlation. Surrogacy was categorized coefficient determination (R²), R² ≥ 0.7 indicating strong correlation, 0.69–0.5 moderate values < 0.5 weak Results: Out 3,048 screened, 30 RCTs met inclusion criteria, comprising 5,275 therapy 557 The median duration ranged from 16 53.5 months, 12 phase II included. Overall, showed (R² = 0.70; 95% CI, 0.50–0.91). Subgroup indicated III 0.71; 0.46–0.96) 0.67; 0.21–1.00). strongest observed incorporating radiation 0.81; 0.52–1.00). trials, HR-DFS also presented 0.90; 0.56–1.00). Conclusions: There particularly therapy. this varies depending on setting design.