Pearl study

1 Dataset 1 Publication

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Dataset ID	Description	Technology	Samples
EGAD00001007979	Biomarkers to identify patients without benefit from adding everolimus to endocrine treatment in metastatic breast cancer (MBC) are needed. We report the results of the Pearl trial conducted in five Belgian centers assessing 18F-FDG-PET/CT non-response (n=45) and ctDNA detection (n=46) after 14 days of exemestane-everolimus (EXE-EVE) to identify MBC patients who will not benefit. Metabolic non-response rate was 66.6%. Median PFS in non-responding patients (using as cut-off 25% for SUVmax decrease) was 3.1 months compared to 6.0 months in those showing response (HR: 0.77, 95% CI: 0.40-1.50, p=0.44). Difference was significant when using a “post-hoc” cut-off of 15% (PFS 2.2 months vs 6.4 months). ctDNA detection at D14 was associated with PFS: 2.1 months vs 5.0 months (HR-2.5, 95% CI: 1.3-5.0, p=0.012). Detection of ctDNA and/or the absence of 18F-FDG-PET/CT response after 14 days of EXE-EVE identifies patients with a low probability of benefiting from treatment. Independent validation is needed.	Ion Torrent S5 XL	126

Publications	Citations
FDG positron emission tomography imaging and ctDNA detection as an early dynamic biomarker of everolimus efficacy in advanced luminal breast cancer. Gombos A, Venet D, Ameye L, Vuylsteke P, Neven P, Richard V, Duhoux FP, Laes JF, Rothe F, Sotiriou C, Paesmans M, Awada A, Guiot T, Flamen P, Piccart-Gebhart M, Ignatiadis M, Gebhart G. NPJ Breast Cancer 7: 2021 125	8