New publication Surrogate Endpoints for Overall Survival in Neoadjuvant Randomized Clinical Trials in Early Breast Cancer by Fabio Conforti et al. in Journal of Clinical Oncology.
In our analysis of over 12,000 patients from 11 randomized clinical trials, we examined whether pathological complete response (pCR) and invasive disease-free survival (iDFS) are reliable surrogate endpoints for overall survival (OS) in neoadjuvant trials in early breast cancer.
Key results:
✔️ iDFS with sufficient follow-up can reliably predict OS in many subgroups.
✔️ pCR shows a weak association with OS and is therefore insufficient as a sole surrogate endpoint.
✔️ The value of iDFS as a surrogate endpoint depends on the duration of follow-up – from 36 months onwards, the informative value improves considerably.
✔️ Special feature of HR+ breast cancer: here, the role of OS as an endpoint remains critically questionable.
📌 Our results provide valuable insights for the future design of clinical trials and could help to translate new therapeutic approaches into practice more quickly.
Read the publication here
