Science

Sibylle Loibl: Surrogate End Points for OS in Neoadjuvant Trials for Early Breast Cancer

Sibylle Loibl/gbg.de

Feb 23, 2025, 12:04

Sibylle Loibl: Surrogate End Points for OS in Neoadjuvant Trials for Early Breast Cancer

Sibylle Loibl, Chief Executive Officer of GBG Forschungs GmbH, shared a post on LinkedIn about a paper she co-authored with colleagues published in Journal of Clinical Oncology:

“New Publication in Journal of Clinical Oncology!

I am happy to share the publication ‘Surrogate End Points for Overall Survival in Neoadjuvant Randomized Clinical Trials for Early Breast Cancer’ by Fabio Conforti et al. published in JCO.

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 for early breast cancer.

Key findings:

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 follow-up duration – from 36 months, the informative value improves significantly.
Special feature in 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 bring new therapeutic approaches into practice more quickly.”

“Surrogate End Points for Overall Survival in Neoadjuvant Randomized Clinical Trials for Early Breast Cancer”

Authors: Fabio Conforti, Valentina Nekljudova, Isabella Sala, Richard Gelber, Sibylle Loibl et al.

Sibylle Loibl: Surrogate End Points for OS in Neoadjuvant Trials for Early Breast Cancer