Paolo Tarantino, 2025 Yvonne’s “Top Voice” Award Winner and Associate Editor for Breast Cancer at ESMO Open, shared a post on X about a paper by Elisabeth M. Jongbloed et al. published in Nature Medicine:
“ctDNA analysis of SONIA published in Nature Medicine.
34% of the patients had high ctDNA before entering the study, and derived a PFS2 benefit from an early (first line) use of CDK4/6-inhibitors. Patients with low ctDNA, instead, derived no benefit.
Sherene Loi, Medical Oncologist, Lab Head, Lead of Breast Oncology Clinical Trials at Peter MacCallum Cancer Centre, shared this post, adding:
“Nice POC study, but caveats:
- This ctDNA test is not commercially available and has low sensitivity>=10% tumor fraction. Therefore, this test is really reading out tumor burden (and not mutations such as ESR1 )
- No OS data
- No comparison to other cheaper markers, CA153, and LDH.
- ctDNA analysis was only done in 39% of ITT.
- No independent validation.
This limits understanding of who these patients who benefited actually were.”
Title: Early versus deferred use of CDK4/6 inhibitors in advanced breast cancer: circulating tumor DNA analysis of a randomized phase 3 trial
Authors: Elisabeth M. Jongbloed, Noor Wortelboer, Vanja de Weerd, Corine M. Beaufort, Kirsten Ruigrok-Ritstier, Mai N. Van, Jaco Kraan, Annette A. van Zweeden, Annemieke van der Padt-Pruijsten, Lisanne C. Hamming, Inge R. Konings, Gabe S. Sonke, Esther Oomen-de Hoop, John W. M. Martens, Agnes Jager, Saskia M. Wilting
You can read the Full Article in Nature Medicine.
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