2023 World Conference on Lung Cancer (Posters)-P1.25. Complete Pathologic Response (pCR) as a Surrogate Endpoint in Neoadjuvant Immunotherapy Clinical Trials for NSCLC: A Meta-analysis

P1.25. Complete Pathologic Response (pCR) as a Surrogate Endpoint in Neoadjuvant Immunotherapy Clinical Trials for NSCLC: A Meta-analysis - PDF(Abstract)

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This abstract presents the findings of a meta-analysis on the use of complete pathologic response (pCR) as a surrogate endpoint in neoadjuvant immunotherapy clinical trials for early-stage non-small cell lung cancer (NSCLC). The authors conducted a systematic literature review and analyzed the outcomes of neoadjuvant immune-based therapy trials reported on PubMed and international conference proceedings until November 2022.<br /><br />The analysis included four randomized clinical trials (RCTs) and ten single-arm trials, comprising a total of 1,030 patients. The association between pCR and event-free survival (EFS) was evaluated using hazard ratios (HRs), and the surrogacy of pCR as a clinical endpoint for EFS was assessed using odds ratios (ORs) for pCR and HRs for EFS.<br /><br />The results showed a statistically significant association between pCR and EFS benefit across multiple clinical trials (HR 0.23; 95%CI 0.11-0.47, p < 0.0001; I2 <3%). However, the analysis did not establish surrogacy between pCR and EFS. The proportion of variation in EFS effect explained by pCR effect was low (R2 0.108; 95%CI 0-1), and the increase in EFS treatment effect for each ten or points increase in pCR was not significant (p = 0.672).<br /><br />The authors conclude that while a robust association between pCR and EFS benefit exists, it is unclear if pCR can be considered a surrogate clinical endpoint for EFS in neoadjuvant immunotherapy trials for NSCLC. They suggest that the lack of surrogacy might be due to the large and multifaceted heterogeneity in trial procedures and emphasize the need for efforts to harmonize and standardize these procedures.<br /><br />In summary, this meta-analysis highlights the association between pCR and EFS benefit in neoadjuvant immunotherapy clinical trials for NSCLC. However, it does not provide evidence to support the use of pCR as a surrogate endpoint for EFS.

Asset Subtitle

Jacobi Hines

Meta Tag

Speaker Jacobi Hines

Topic Early-Stage NSCLC: Changing Paradigms & Outcomes

Keywords

complete pathologic response

pCR

neoadjuvant immunotherapy

clinical trials

non-small cell lung cancer

NSCLC

meta-analysis

event-free survival

hazard ratios

odds ratios