Ribociclib plus letrozole in patients with hormone receptor-positive, HER2-negative advanced breast cancer with no prior endocrine therapy: subgroup safety analysis from the phase 3b CompLEEment-1 trial

Autor: Borstnar Simona, Palacova Marketa, Łacko Aleksandra, Timcheva Constanta, Gal-Yam Einav Nili, Papazisis Konstantinos, Beniak Juraj, Kudela Pavol, Rubovszky Gábor
Jazyk: angličtina
Rok vydání: 2022
Předmět:
Zdroj: Radiology and Oncology, Vol 56, Iss 2, Pp 238-247 (2022)
Druh dokumentu: article
ISSN: 1581-3207
DOI: 10.2478/raon-2022-0020
Popis: The CDK4/6 inhibitor, ribociclib in combination with endocrine therapy significantly improved progression-free survival in the first line setting in post-menopausal patients with HR+/HER2− advanced breast cancer (ABC) in a pivotal phase 3, placebo-controlled trial (MONALEESA-2) and demonstrated superior overall survival in premenopausal patients with HR+/HER2− ABC (MONALEESA-7). The multinational, phase 3b, CompLEEment-1 trial, which assessed the safety and efficacy of ribociclib plus letrozole in a broader population of patients who have not received prior endocrine therapy for advanced disease, is the largest phase 3 clinical trial to date to evaluate the safety and efficacy of a CDK4/6 inhibitor. We report a subanalysis of data from patients (N = 339) enrolled in the central and south European countries of the SERCE (Southern Europe, RUC, Central Europe) cluster of CompLEEment-1.
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