Association between chemotherapy use and prognosis in young patients with stage I-II ER+ /HER2-negative breast cancer according to Prosigna®: An international real-world analysis with propensity-score matching.
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Di Grazia Giuseppe, Di Lauro Vincenzo, Morchón-Araujo Daniel, Nucera Sabrina, Figuero-Pérez Luis, Calleja-Holgado Francisco Javier, Pelegrina Sánchez David, Wallbaum Benjamin, Rivera Vargas Pablo, Palleschi Michela, Musolino Antonino, Zatta Cobos Gastón, López Paradís Assumpció, Barroso Gimena, Cano Cano Ona, Dalmau Portulas Elsa, Caltavituro Aldo, Buono Giuseppe, Jerez Gillaranz Yolanda, Echavarría Isabel, López-Tarruella Sara, Bergamino Sirvén Milana, Martínez-Sáez Olga, Adamo Barbara, Muñoz Mateu Montserrat, Arpino Grazia, Sánchez Bayona Rodrigo, De Laurentiis Michelino, Rodríguez César A, Pascual Tomás, Vidal Losada María, Schettini Francesco
Аннотация
METHODS: We retrospectively included 567 women aged≤ 50 years with stage I-II ER+ /HER2 - BC tested with Prosigna® across 10 hospitals in Spain/Italy (2014-2023). Patients received endocrine therapy (ET) with/without (neo)adjuvant CT. Event-free survival (EFS) was analyzed using Kaplan-Meier curves, log-rank tests, and Cox regression. Propensity score matching (PSM) was applied. 5-year EFS rates were numerically compared with those of OncotypeDX® trials.
RESULTS: Of 567 patients, 73.7% were N0 and 26.3% N1, 39.7% were Prosigna risk-of-relapse (ROR)-low (RL), 33.0% ROR-intermediate (RI), 27.3% ROR-high (RH) and 48.3% received CT. CT independently improved EFS in N0/RI and N1/RL-RI (5-year EFS 97.9% vs. 86.6%; adjusted hazard ratio=0.07, p = 0.018). In premenopausal women, CT benefit persisted only when adjuvant gonadotropin-releasing hormone analogue was not administered (p = 0.008), especially in N0/RI (p = 0.023). Results were confirmed after PSM. CT-treated N0/RH showed similar EFS to CT-treated N0/RI+N1/RL-RI, while N1/RH showed poor prognosis despite CT use. 5-year EFS rates were generally consistent with OncotypeDX® trials.
CONCLUSION: Prosigna can help identify young women with stage I-II ER+ /HER2- BC who gain benefit from (neo)adjuvant CT and those in need of further escalated treatments. In premenopausal N0/RI and N1/RL-RI disease, the effect of CT seems to be driven by ovarian function suppression. Prospective validation is required.