Mali Barbi, Medical Oncologist at Northwell Health, shared a post on X:
“The BioItaLEE results in AACR CCR establish a “One-Month Rule” for 1L ribociclib + letrozole. Achieving ctDNA clearance by C2D1 correlates with a 56% reduction in progression risk (HR=0.44), while persistent TP53 or MYC alterations identify primary refractory disease months before the first scan. While the prognostic value is now settled, the predictive value of escalation is the new frontier. We must prove that intervening at C2D1 improves outcomes vs. waiting for radiographic progression.
Next step: “Molecular Switch” trial designs using C2D1 non-clearance as a randomized trigger for escalation.
Title: Role of ctDNA in predicting the outcome of patients with hormone receptor–positive, HER2-negative advanced breast cancer treated with first-line ribociclib and letrozole: BioItaLEE trial
Authors: Giampaolo Bianchini, Luca Malorni, Roberta Caputo, Alberto Zambelli, Fabio Puglisi, Giulia V. Bianchi, Lucia Del Mastro, Ida Paris, Filippo Montemurro, Marco Colleoni, Giacomo Allegrini, Stefano Tamberi, Claudio Zamagni, Marina E. Cazzaniga, Michele Orditura, Valentina Guarneri, Vincenzo Adamo, Emanuela Romagnoli, Maria Rosaria Valerio, Saverio Cinieri, Matteo Benelli, Maurizio Callari, Diletta Valsecchi, Daniela Castelletti, Donatella Grasso, Nicola Fenderico, Grazia Arpino, Michelino De Laurentiis
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