ArticleJNCI cancer spectrum2025
Do trial benefits predict real-world gains in metastatic castration resistant prostate cancer.
Article in JNCI cancer spectrum, 2025. 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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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Authors and funding
7 authors.
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No grant is acknowledged in the PubMed record.
Abstract
backgroundIt is important to understand the relationship between drug efficacy measured in randomized clinical trials (RCTs) and real-world drug effectiveness. We estimate how RCT overall survival (OS) and RCT radiographic progression-free survival (rPFS) benefits predict the association between treatments and real-world OS gains for metastatic castration-resistant prostate cancer (mCRPC) drugs.
methodsUsing the National Cancer Institute list of approved cancer drugs and the National Comprehensive Cancer Network Treatment Guidelines, we identified all pharmaceutical therapies for mCRPC approved between 2010 and 2019. We obtained RCT OS and rPFS hazard ratios from the pivotal trials used for Food and Drug Administration (FDA) approval, and we estimated real-world OS hazard ratios using the Optum Clinformatics Extended DataMart Databases. We modeled real-world OS hazard ratios as a function of both RCT OS and RCT rPFS hazard ratios using Cox proportional hazards regressions, adjusted for year of diagnosis, age, race, and Elixhauser Comorbidity Index.
resultsWhen we did not account for nonrandom real-world selection of patients into receiving a newly approved therapy (ie, "treatment selection bias"), real-world OS gains were 15% lower than associated RCT OS and RCT rPFS benefits. However, after accounting for treatment selection bias in real-world settings, real-world OS gains were almost 28% greater than RCT OS and RCT rPFS benefits. Association between treatment and OS gains increased the longer a new therapy was on the market.
conclusionsAfter adjusting for treatment selection bias, RCT OS and RCT rPFS estimates serve as useful, or even conservative, predictors of RW OS gains.
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