دورية أكاديمية
Updated overall survival from the MONALEESA-3 trial in postmenopausal women with HR+/HER2- advanced breast cancer receiving first-line ribociclib plus fulvestrant.
| العنوان: | Updated overall survival from the MONALEESA-3 trial in postmenopausal women with HR+/HER2- advanced breast cancer receiving first-line ribociclib plus fulvestrant. |
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| المؤلفون: | Neven, P, Fasching, P A, Chia, S, Jerusalem, Guy, De Laurentiis, M, Im, S-A, Petrakova, K, Bianchi, G V, Martín, M, Nusch, A, Sonke, G S, De la Cruz-Merino, L, Beck, J T, Zarate, J P, Wang, Y, Chakravartty, A, Wang, C, Slamon, D J |
| المصدر: | Breast Cancer Research, 25 (1), 103 (2023-08-31) |
| بيانات النشر: | BioMed Central Ltd, 2023. |
| سنة النشر: | 2023 |
| مصطلحات موضوعية: | Advanced breast cancer, CDK4/6 inhibitor, First line, Overall survival, Ribociclib, Fulvestrant, ribociclib, Humans, Female, Proportional Hazards Models, Postmenopause, Breast Neoplasms/drug therapy, Breast Neoplasms, Oncology, Cancer Research, Human health sciences, Sciences de la santé humaine, Oncologie |
| الوصف: | [en] BACKGROUND: The phase III MONALEESA-3 trial included first- (1L) and second-line (2L) patients and demonstrated a significant overall survival (OS) benefit for ribociclib + fulvestrant in patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced breast cancer (ABC) in the final protocol-specified and exploratory (longer follow-up) OS analyses. At the time of these analyses, the full OS benefit of 1L ribociclib was not completely characterized because the median OS (mOS) was not reached. As CDK4/6 inhibitor (CDK4/6i) + endocrine therapy (ET) is now a preferred option for 1L HR+/HER2- ABC, we report an exploratory analysis (median follow-up, 70.8 months; 14.5 months longer than the prior analysis) to fully elucidate the OS benefit in the MONALEESA-3 1L population.METHODS: Postmenopausal patients with HR+/HER2- ABC were randomized 2:1 to 1L/2L fulvestrant + ribociclib or placebo. OS in 1L patients (de novo disease or relapse > 12 months from completion of [neo]adjuvant ET) was assessed by Cox proportional hazards model and Kaplan-Meier methods. Progression-free survival 2 (PFS2) and chemotherapy-free survival (CFS) were analyzed. MONALEESA-3 is registered with ClinicalTrials.gov (NCT02422615).RESULTS: At data cutoff (January 12, 2022; median follow-up time, 70.8 months), mOS was 67.6 versus 51.8 months with 1L ribociclib versus placebo (hazard ratio (HR) 0.67; 95% CI 0.50-0.90); 16.5% and 8.6% of ribociclib and placebo patients, respectively, were still receiving treatment. PFS2 (HR 0.64) and CFS (HR 0.62) favored ribociclib versus placebo. Among those who discontinued treatment, 16.7% and 35.0% on ribociclib or placebo, respectively, received a subsequent CDK4/6i. No new safety signals were observed.CONCLUSIONS: This analysis of MONALEESA-3 reports the longest mOS thus far (67.6 months) for 1L patients in a phase III ABC trial. These results in a 1L population show that the OS benefit of ribociclib was maintained through extended follow-up, further supporting its use in HR+/HER2- ABC. |
| نوع الوثيقة: | journal article http://purl.org/coar/resource_type/c_6501Test article peer reviewed |
| اللغة: | English |
| العلاقة: | urn:issn:1465-5411; urn:issn:1465-542X |
| DOI: | 10.1186/s13058-023-01701-9 |
| الوصول الحر: | https://orbi.uliege.be/handle/2268/313198Test |
| حقوق: | open access http://purl.org/coar/access_right/c_abf2Test info:eu-repo/semantics/openAccess |
| رقم الانضمام: | edsorb.313198 |
| قاعدة البيانات: | ORBi |
| DOI: | 10.1186/s13058-023-01701-9 |
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