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Title: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
Authors:ID Borštnar, Simona (Author)
ID Palacova, Marketa (Author)
ID Łacko, Aleksandra (Author)
ID Timcheva, Constanta (Author)
ID Gal-Yam, Einav Nili (Author)
ID Papazisis, Konstantinos (Author)
ID Beniak, Juraj (Author)
ID Kudela, Pavol (Author)
ID Rubovszky, Gábor (Author)
Files:.pdf PDF - Presentation file, download (462,13 KB)
MD5: B4B999D036C16F5550970C551FC25443
 
Language:English
Typology:1.01 - Original Scientific Article
Organization:Logo OI - Institute of Oncology
Abstract: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. Patients and methods: Men and women of any menopausal status with HR+/HER2- ABC received once-daily oral ribociclib 600 mg (3-weeks on/1-week-off), plus letrozole 2.5 mg continuously. Men/premenopausal women also received a GnRH-agonist. The primary outcome was the number of patients with adverse events (AEs) over a timeframe of approximately 36 months. Time-to-progression, overall response rate, and clinical benefit rate were also measured. Results: Safety results in the SERCE subgroup were consistent with those in the pivotal clinical trials of ribociclib in combination with endocrine therapy. Treatment-related AEs leading to dose adjustments/interruption occurred in 63.1% of patients but led to treatment discontinuation in only 10.6%. The most common treatment-related AEs of grade ≥ 3 were neutropenia and transaminase elevations. There were no fatal treatment-related events. Conclusions: These findings from the SERCE subgroup support the safety and manageable tolerability of ribociclib in a broad range of patients with HR+/HER2- ABC more representative of patients in real-world clinical practice.
Keywords:CDK4/6 inhibitor, HER2−, HR+, advanced breast cancer, ribociclib
Publication status:Published
Publication version:Version of Record
Publication date:01.01.2022
Publisher:Association of Radiology and Oncology
Year of publishing:2022
Number of pages:str. 238-247
Numbering:Vol. 56, no. 2
Source:Ljubljana
PID:20.500.12556/DiRROS-19763 New window
UDC:618.19-006
ISSN on article:1318-2099
DOI:10.2478/raon-2022-0020 New window
COBISS.SI-ID:108184835 New window
Copyright:by Authors
Publication date in DiRROS:24.07.2024
Views:302
Downloads:251
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Record is a part of a journal

Title:Radiology and oncology
Shortened title:Radiol. oncol.
Publisher:Slovenian Medical Society - Section of Radiology, Croatian Medical Association - Croatian Society of Radiology
ISSN:1318-2099
COBISS.SI-ID:32649472 New window

Secondary language

Language:Slovenian
Keywords:inhibitor CDK4/6, HER2−, HR+, napredovali rak dojke, ribociclib


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