ArticleESMO real world data and digital oncology2026
Developing and evaluating definitions of real-world clinical endpoints for patients with early-stage triple-negative breast cancer using a United States of America secondary database.
Article in ESMO real world data and digital oncology, 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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Abstract
Background: The KEYNOTE-522 trial showed that neoadjuvant chemotherapy (NAC) plus adjuvant pembrolizumab improved overall survival, event-free survival (EFS), and pathological complete response (pCR) in high-risk early-stage triple-negative breast cancer. As treatments evolve, evaluating real-world (RW) effectiveness is key to understanding trial generalizability. This study benchmarked RW efficacy endpoints in early-stage triple-negative breast cancer patients treated with NAC. Materials and methods: This retrospective study used RW data from United States community practices abstracted by oncology data specialists. Eligible patients received NAC regimens similar to the KEYNOTE-522 control arm. Control arm patients received no adjuvant therapy, while the RW cohort could receive adjuvant capecitabine. Two RW endpoints were assessed: rwpCR (ypT0/Tis ypN0 or clinical pCR with Results: In the RW cohort ( Conclusions: Although pCR rates were higher in the KEYNOTE-522 control arm compared with the RW cohort, rwEFS was comparable with EFS in the KEYNOTE-522 control arm. This study highlights the value of combining structured data with custom abstraction to assess RW endpoints and support future research.
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