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
Por:
Salvador Bofill J., Moreno Anton F., Rodriguez Sanchez C.A., Galve Calvo E., Hernando Melia C., Ciruelos Gil E.M., Vidal M., Jiménez-Rodriguez B., De la Cruz Merino L., Martínez Jañez N., Villanueva Vazquez R., de Toro Salas R., Anton Torres A., Alvarez Lopez I.M., Gavila Gregori J., Quiroga Garcia V., Vicente Rubio E., De la Haba-Rodriguez J., Gonzalez-Santiago S., Diaz Fernandez N., Barnadas Molins A., Cantos Sanchez de Ibargüen B., Delgado Mingorance J.I., Bellet Ezquerra M., de Casa S., Gimeno A., Martin M.
Publicada:
1 ene 2022
Resumen:
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 © 2022 The Authors
Filiaciones:
Salvador Bofill J.:
Hospital Universitario Virgen del Rocío, Instituto de Biomedicina de Sevilla (IBIS), Sevilla, Spain
Moreno Anton F.:
Hospital Clínico San Carlos, Madrid, Spain
Rodriguez Sanchez C.A.:
Departamento de Oncología Médica, Hospital Universitario de Salamanca-IBSAL, Salamanca, Spain
Galve Calvo E.:
Hospital Universitario de Basurto, Bilbao, Spain
Hernando Melia C.:
Servicio de Oncología, Hospital Clínico Universitario de Valencia e Instituto de Investigación Sanitaria INCLIVA, Valencia, Spain
Ciruelos Gil E.M.:
Hospital Universitario 12 de Octubre, Madrid, Spain
Vidal M.:
Department of Medical Oncology, Hospital Clinic, Barcelona, Spain, Translational Genomics and Targeted Therapies in Solid Tumors, IDIBAPS, Barcelona, Spain, Department of Medicine, University of Barcelona, Barcelona, Spain
Jiménez-Rodriguez B.:
UGCI Oncología Médica Hospitales Regional y Virgen de la Victoria, Málaga, Spain
De la Cruz Merino L.:
Hospital Universitario Virgen de la Macarena, Sevilla, Spain
Martínez Jañez N.:
Hospital Universitario Ramón y Cajal, Madrid, Spain
Villanueva Vazquez R.:
Institut Català d'Oncologia, Hospital Duran i Reynals, Barcelona, Spain
de Toro Salas R.:
Hospital Universitario de Jerez, Jerez, Spain
Anton Torres A.:
Hospital Universitario Miguel Servet, Zaragoza, Spain
Alvarez Lopez I.M.:
Hospital Universitario Donostia-BioDonostia, Donostia, Spain
Gavila Gregori J.:
Fundacion Instituto Valenciano de Oncologia, Valencia, Spain
Quiroga Garcia V.:
Departamento de Oncología, Badalona-Applied Research Group in Oncology (B-ARGO Group), Institut Català d'Oncologia, Badalona, Spain
Vicente Rubio E.:
Hospital Universitario Insular Gran Canaria, Gran Canaria, Spain
De la Haba-Rodriguez J.:
Instituto Maimonides de Investigacion Biomedica (IMIBIC), Hospital Reina Sofía, Universidad de Córdoba, Spain
Gonzalez-Santiago S.:
Hospital Universitario San Pedro de Alcántara, Cáceres, Spain
Diaz Fernandez N.:
Hospital Universitario San Juan de Alicante, Alicante, Spain
Barnadas Molins A.:
Hospital Universitari Santa Creu i Sant Pau and CIBERONC Breast Cancer Programme, Department of Medicine, Universitat Autonoma Barcelona, Barcelona, Spain
Cantos Sanchez de Ibargüen B.:
Hospital Puerta de Hierro Majadahonda, Madrid, Spain
Delgado Mingorance J.I.:
Hospital Universitario Infanta Cristina, Badajoz, Spain
Bellet Ezquerra M.:
Hospital Universitari Vall d'Hebron, Barcelona and Institut Oncològic Vall d'Hebron (VHIO), Barcelona, Spain
de Casa S.:
Novartis Pharmaceuticals Spain, Barcelona, Spain
Gimeno A.:
Novartis Pharmaceuticals Spain, Barcelona, Spain
Martin M.:
Hospital Universitario Gregorio Marañón, Madrid, Spain
All Open Access; Green
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