Safety and efficacy of ribociclib plus letrozole in patients with HR+, HER2- advanced breast cancer: Results from the Spanish sub-population of the phase 3b CompLEEment-1 trial.
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Ошибки и ограничения
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Salvador Bofill Javier, Moreno Anton Fernando, Rodriguez Sanchez Cesar Augusto, Galve Calvo Elena, Hernando Melia Cristina, Ciruelos Gil Eva Maria, Vidal Maria, Jiménez-Rodriguez Begoña, De la Cruz Merino Luis, Martínez Jañez Noelia, Villanueva Vazquez Rafael, de Toro Salas Ruben, Anton Torres Antonio, Alvarez Lopez Isabel Manuela, Gavila Gregori Joaquin, Quiroga Garcia Vanesa, Vicente Rubio Elena, De la Haba-Rodriguez Juan, Gonzalez-Santiago Santiago, Diaz Fernandez Nieves, Barnadas Molins Agusti, Cantos Sanchez de Ibargüen Blanca, Delgado Mingorance Juan Ignacio, Bellet Ezquerra Meritxell, de Casa Sonia, Gimeno Asuncion, Martin Miguel
Аннотация
METHODS: CompLEEment-1 is a single-arm, open-label phase 3b trial evaluating ribociclib plus letrozole in a broad population of patients with HR+, HER2- ABC. The primary endpoints were safety and tolerability. Here we report data for Spanish patients enrolled in CompLEEment-1.
RESULTS: A total of 526 patients were evaluated (median follow-up: 26.97 months). Baseline characteristics showed a diverse population with a median age of 54 years. At study entry, 56.5% of patients had visceral metastases and 8.7% had received prior chemotherapy for advanced disease. Rates of all-grade and Grade ≥3 adverse events (AEs) were 99.0% and 76.2%, respectively; 21.3% of patients experienced a serious AE, and 15.8% of AEs led to treatment discontinuation. AEs of special interest of neutropenia, increased alanine aminotransferase, increased aspartate aminotransferase and QTcF prolongation occurred in 77.8%, 14.8%, 11.4% and 4.0% of patients, respectively. Patients aged >70 years experienced increased rates of all-grade and Grade ≥3 neutropenia and anemia. Efficacy results were consistent with the global study.
CONCLUSIONS: Results from Spanish patients enrolled in CompLEEment-1 are consistent with global data showing efficacy and a manageable safety profile for ribociclib plus letrozole treatment in patients with HR+, HER2- ABC, including populations of interest (NCT02941926).
TRIAL REGISTRATION: ClinicalTrials.gov NCT02941926.