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

Javier Salvador Bofill, Fernando Moreno Anton, Cesar Augusto Rodriguez Sanchez, Elena Galve Calvo, Cristina Hernando Melia, Eva Maria Ciruelos Gil, Maria Vidal, Begoña Jiménez-Rodriguez, Luis De la Cruz Merino, Noelia Martínez Jañez, Rafael Villanueva Vazquez, Ruben de Toro Salas, Antonio Anton Torres, Isabel Manuela Alvarez Lopez, Joaquin Gavila Gregori, Vanesa Quiroga Garcia, Elena Vicente Rubio, Juan De la Haba-Rodriguez, Santiago Gonzalez-Santiago, Nieves Diaz Fernandez, Agusti Barnadas Molins, Blanca Cantos Sanchez de Ibargüen, Juan Ignacio Delgado Mingorance, Meritxell Bellet Ezquerra, Sonia de Casa, Asuncion Gimeno, Miguel Martin, Javier Salvador Bofill, Fernando Moreno Anton, Cesar Augusto Rodriguez Sanchez, Elena Galve Calvo, Cristina Hernando Melia, Eva Maria Ciruelos Gil, Maria Vidal, Begoña Jiménez-Rodriguez, Luis De la Cruz Merino, Noelia Martínez Jañez, Rafael Villanueva Vazquez, Ruben de Toro Salas, Antonio Anton Torres, Isabel Manuela Alvarez Lopez, Joaquin Gavila Gregori, Vanesa Quiroga Garcia, Elena Vicente Rubio, Juan De la Haba-Rodriguez, Santiago Gonzalez-Santiago, Nieves Diaz Fernandez, Agusti Barnadas Molins, Blanca Cantos Sanchez de Ibargüen, Juan Ignacio Delgado Mingorance, Meritxell Bellet Ezquerra, Sonia de Casa, Asuncion Gimeno, Miguel Martin

Abstract

Background: Breast cancer is the most common malignancy and the second leading cause of cancer-related mortality in Spanish women. Ribociclib in combination with endocrine therapy (ET) has shown superiority in prolonging survival in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC) vs. ET alone.

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.

Keywords: Advanced breast cancer; CDK4/6 inhibitor; Postmenopausal; Premenopausal; Ribociclib.

Copyright © 2022 The Authors. Published by Elsevier Ltd.. All rights reserved.

Figures

Fig. 1
Fig. 1
Time to progression in Spanish patients and all patients enrolled in the CompLEEment-1 study. Red, Spanish patients; black, all patients enrolled in the global study. Squares denote censored events. CI, confidence interval; NE, not estimable.

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