ReviewClinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico2026
Do progression-free survival benefits justify increased toxicity and treatment burden? A meta-regression analysis of phase III immune checkpoint inhibitor trials from a value-based oncology perspective.
Review in Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico, 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
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Abstract
purposeWhether PFS reliably predicts overall survival (OS) in ICI trials, and whether PFS gains justify the toxicity they impose, is unclear. We quantified both relationships across phase III ICI trials from a value-based oncology perspective.
methodsWe analysed 80 phase III randomized ICI trials (48,415 patients). Pooled hazard ratios (HRs) were estimated by random-effects meta-analysis, and the trial-level PFS-OS association by weighted least squares meta-regression with prespecified stratification by treatment type and models for non-linearity. Treatment burden was the between-arm difference in grade ≥3 adverse events (primary measure), serious adverse events, and treatment discontinuation. Only trial-level aggregate data were available.
resultsPooled PFS HR was 0.717 (95% CI 0.676-0.762; I
conclusionsPFS showed a limited and treatment-type-dependent association with OS, and PFS gains frequently accompanied increased toxicity. Formal surrogate validation requires individual-level data and was not undertaken.
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