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
Salvador Bofill, Javier (Hospital Universitario Virgen del Rocío (Sevilla, Andalusia))
Moreno Anton, Fernando (Hospital Clínico San Carlos (Madrid))
Rodriguez Sanchez, Cesar Augusto (Hospital Universitario de Salamanca-IBSAL)
Galve Calvo, Elena (Hospital de Basurto (Bilbao, Biscaia))
Hernando Melia, Cristina (Hospital Clínic Universitari (València))
Ciruelos, Eva (Hospital Universitario 12 de Octubre (Madrid))
Vidal Losada, Maria (Hospital Clínic i Provincial de Barcelona)
Jiménez-Rodriguez, Begoña (Hospital Universitario Virgen de la Victoria (Màlaga, Andalusia))
de la Cruz Merino, Luis (Hospital Universitario Virgen Macarena (Sevilla, Andalusia))
Martínez Jañez, Noelia (Hospital Universitario Ramón y Cajal (Madrid))
Villanueva Vazquez, Rafael (Institut Català d'Oncologia)
de Toro Salas, Ruben (Hospital Universitario de Jerez (Jerez de la Frontera))
Antón, Antonio (Hospital Universitario Miguel Servet (Saragossa))
Alvarez Lopez, Isabel Manuela (Biodonostia Osasun Ikerketako Institutura (País Basc))
Gavila Gregori, Joaquin (Fundació Institut Valencià d'Oncologia)
Quiroga Garcia, Vanesa (Institut Català d'Oncologia)
Vicente Rubio, Elena (Hospital Universitario Insular de Gran Canaria)
de la Haba Rodríguez, Juan Rafael (Universidad de Córdoba)
Gonzalez-Santiago, Santiago (Hospital Universitario San Pedro de Alcántara)
Diaz Fernandez, Nieves (Hospital Universitario San Juan de Alicante)
Barnadas i Molins, Agustí (Hospital de la Santa Creu i Sant Pau (Barcelona, Catalunya))
Cantos Sanchez de Ibargüen, Blanca (Hospital Universitario Puerta de Hierro Majadahonda (Madrid))
Delgado Mingorance, Juan Ignacio (Hospital Universitario Infanta Cristina)
Bellet Ezquerra, Meritxell (Vall d'Hebron Institut d'Oncologia)
de Casa, Sonia (Novartis Farmacèutica, SA)
Gimeno, Asuncion (Novartis Farmacèutica, SA)
Martin, Miguel (Hospital General Universitario Gregorio Marañón)
Universitat Autònoma de Barcelona

Data:	2022
Resum:	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. 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. 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. 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). NCT02941926.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Advanced breast cancer ; CDK4/6 inhibitor ; Postmenopausal ; Premenopausal ; Ribociclib
Publicat a:	Breast, Vol. 66 (september 2022) , p. 77-84, ISSN 1532-3080

DOI: 10.1016/j.breast.2022.09.006
PMID: 36206609

8 p, 641.4 KB

El registre apareix a les col·leccions:
Articles > Articles de recerca
Articles > Articles publicats