| 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 |
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| 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) |
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| Files: |  PDF - Presentation file, download (462,13 KB)
MD5: B4B999D036C16F5550970C551FC25443
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| Language: | English |
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| Typology: | 1.01 - Original Scientific Article |
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| Organization: |  OI - Institute of Oncology
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| 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. |
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| Keywords: | CDK4/6 inhibitor, HER2−, HR+, advanced breast cancer, ribociclib |
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| Publication status: | Published |
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| Publication version: | Version of Record |
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| Publication date: | 01.01.2022 |
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| Publisher: | Association of Radiology and Oncology |
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| Year of publishing: | 2022 |
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| Number of pages: | str. 238-247 |
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| Numbering: | Vol. 56, no. 2 |
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| Source: | Ljubljana |
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| PID: | 20.500.12556/DiRROS-19763  |
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| UDC: | 618.19-006 |
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| ISSN on article: | 1318-2099 |
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| DOI: | 10.2478/raon-2022-0020 |
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| COBISS.SI-ID: | 108184835 |
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| Copyright: | by Authors |
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| Publication date in DiRROS: | 24.07.2024 |
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| Views: | 901 |
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| Downloads: | 434 |
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