Evaluation of Major Pathologic Response and Pathologic Complete Response as Surrogate End Points for Survival in Randomized Controlled Trials of Neoadjuvant Immune Checkpoint Blockade in Resectable in NSCLC.
Jacobi B HinesRobert B CameronAlessandra EspositoLeeseul KimLuca PorcuAntonio NuccioGiuseppe ViscardiRoberto FerraraGiulia VeronesiPatrick M FordeJanis TaubeEverett VokesChristine M BestvinaJames M DolezalMatteo SaccoMarta MonteforteTina CasconeMarina C GarassinoValter TorriPublished in: Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer (2024)
Our analyses reveal a robust correlation between pCR and MPR with 2-year EFS but not OS. Trial-level surrogacy was moderate but imprecise. More mature follow-up and data to assess the impact of study crossover are needed.
Keyphrases
- locally advanced
- neoadjuvant chemotherapy
- rectal cancer
- randomized controlled trial
- squamous cell carcinoma
- small cell lung cancer
- radiation therapy
- study protocol
- clinical trial
- lymph node
- electronic health record
- open label
- big data
- genome wide
- phase iii
- high intensity
- single cell
- phase ii
- dna methylation
- double blind
- tyrosine kinase
- meta analyses
- artificial intelligence
- data analysis
- liver metastases