ArticleThe oncologist2026
Linking early and late endpoints in adjuvant immunotherapy trials: an evaluation of multiple clinical outcomes.
Article in The oncologist, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Authors and funding
5 authors.
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Abstract
backgroundOverall survival (OS) in adjuvant and perioperative immunotherapy trials requires prolonged follow-up. We examined whether treatment effects on disease-free survival (DFS) and recurrence-free survival (RFS) were associated with OS at matched 2-, 3-, and 5-year windows.
methodsThe main analysis included 23 strict-primary randomized trials. DFS and RFS were modeled separately across 6 paired time windows using 2 co-primary trial-level approaches: a conventional OS-variance-weighted regression and a conditional errors-in-variables model accounting for uncertainty in both log-HRs. Because within-trial correlations were unavailable, ρ was varied from 0 to 0.75. Eligibility-sensitivity studies were supplementary; broad-taxonomy evidence was excluded. EFS was descriptive, PFS and PFS2 were analyzed separately, and QoL regression required at least 5 verified contrasts.
resultsNineteen trials contributed 2-year same-window pairs (12 DFS; 7 RFS), 8 contributed 3-year pairs, and 5 contributed 5-year pairs. For 2-year early endpoints vs 2-year OS, weighted slopes were 0.014 (95% CI, -0.286 to 0.314) for DFS and 0.630 (95% CI, -1.243 to 2.502) for RFS. Eight of 9 fitted weighted-regression intervals included zero; the only nominally positive result involved 4 RFS trials. In errors-in-variables analyses, slopes for the largest DFS and RFS comparisons ranged from 0.011 to 0.264 and from 0.758 to 0.885, respectively, and all profile CIs included zero. Six strict-primary QoL contrasts were verified, but no window reached n = 5.
conclusionStrict-primary analyses did not demonstrate a consistent or precise early-endpoint-OS relationship. Sparse later windows and uncertainty in both treatment-effect estimates preclude surrogate validation.
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