20.500.12556/DiRROS-19763 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 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. CDK4/6 inhibitor HER2− HR+ advanced breast cancer ribociclib inhibitor CDK4/6 HER2− HR+ napredovali rak dojke ribociclib true false true Association of Radiology and Oncology Ljubljana Angleški jezik Slovenski jezik by Authors Neznano 2024-07-24 14:50:03 2024-07-24 14:50:04 2024-07-26 03:53:25 0000-00-00 00:00:00 2022 0 0 str. 238-247 no. 2 Vol. 56 2022 0000-00-00 Zaloznikova Objavljeno NiDoloceno 0000-00-00 0000-00-00 2022-01-01 618.19-006 1318-2099 10.2478/raon-2022-0020 108184835 RAZ_Borstnar_Simona_2022.pdf RAZ_Borstnar_Simona_2022.pdf 1 B4B999D036C16F5550970C551FC25443 ef9903869552a8af36aee6b510650317f3c3feb0b04af3825241bb19179b9fd6 a4af3566-49aa-11ef-b487-001a4af901a5 https://dirros.openscience.si/Dokument.php?lang=slv&id=27360 Onkološki inštitut Ljubljana 0 0 0