دورية أكاديمية
Ribociclib plus fulvestrant for postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer in the phase III randomized MONALEESA-3 trial: updated overall survival.
| العنوان: | Ribociclib plus fulvestrant for postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer in the phase III randomized MONALEESA-3 trial: updated overall survival. |
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| المؤلفون: | Slamon, D J, Neven, P, Chia, S, JERUSALEM, Guy, De Laurentiis, M, Im, S, Petrakova, K, Valeria Bianchi, G, Martín, M, Nusch, A, Sonke, G S, De la Cruz-Merino, L, Beck, J T, Ji, Y, Wang, C, Deore, U, Chakravartty, A, Zarate, J P, Taran, T, Fasching, P A |
| المصدر: | Annals of Oncology, 32 (8), 1015-1024 (2021) |
| بيانات النشر: | Elsevier Ltd, 2021. |
| سنة النشر: | 2021 |
| مصطلحات موضوعية: | CDK4/6 inhibitor, advanced breast cancer, overall survival, ribociclib, Aminopyridines, Purines, Receptors, Estrogen, Receptors, Progesterone, Fulvestrant, ERBB2 protein, human, Receptor, ErbB-2, Adolescent, Antineoplastic Combined Chemotherapy Protocols/adverse effects, Double-Blind Method, Female, Humans, Postmenopause, Breast Neoplasms/drug therapy, Antineoplastic Combined Chemotherapy Protocols, Breast Neoplasms, Hematology, Oncology, Human health sciences, Sciences de la santé humaine, Oncologie |
| الوصف: | [en] BACKGROUND: Ribociclib plus fulvestrant demonstrated significant progression-free survival (PFS) and overall survival (OS) benefits in patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced breast cancer (ABC). Here we present a new landmark in survival follow-up for a phase III cyclin-dependent kinases 4 and 6 inhibitor clinical trial in patients with ABC (median, 56.3 months).PATIENTS AND METHODS: This phase III, randomized, double-blind, placebo-controlled trial was conducted at 174 sites (30 countries). Patients were men and postmenopausal women (age ≥18 years) with histologically/cytologically confirmed HR+/HER2- ABC. Patients could have received ≤1 line of endocrine therapy (ET) but no chemotherapy for ABC. Patients, assigned 2:1, were stratified by the presence/absence of liver/lung metastases and previous ET. Patients received intramuscular fulvestrant (500 mg, day 1 of each 28-day cycle plus day 15 of cycle 1) with oral ribociclib (600 mg/day, 3 weeks on, 1 week off) or placebo. Efficacy analyses were by intention to treat. Safety was assessed in patients receiving ≥1 dose study treatment. OS was a secondary endpoint. MONALEESA-3 is registered with ClinicalTrials.gov (NCT02422615; no longer enrolling).RESULTS: Between 18 June 2015 and 10 June 2016, 726 patients were randomly assigned (484, ribociclib; 242, placebo). At data cut-off (30 October 2020), median OS (mOS) was 53.7 months (ribociclib) versus 41.5 months (placebo) [hazard ratio (HR), 0.73; 95% confidence interval (CI) 0.59-0.90]. Subgroup analyses were consistent with overall population. In the first-line setting, most patients in the ribociclib arm (∼60%) lived longer than median follow-up; mOS was 51.8 months in the placebo arm (HR, 0.64; 95% CI 0.46-0.88). In the second-line setting, mOS was 39.7 months (ribociclib) versus 33.7 months (placebo) (HR, 0.78; 95% CI 0.59-1.04). No apparent drug-drug interaction between ribociclib and fulvestrant or new safety signals were observed.CONCLUSIONS: This analysis reported extended OS follow-up in MONALEESA-3. mOS was ∼12 months longer in patients with HR+/HER2- ABC treated with ribociclib plus fulvestrant compared with fulvestrant monotherapy. |
| نوع الوثيقة: | journal article http://purl.org/coar/resource_type/c_6501Test article |
| اللغة: | English |
| العلاقة: | https://api.elsevier.com/content/article/PII:S0923753421015532?httpAccept=text/xmlTest; urn:issn:0923-7534; urn:issn:1569-8041 |
| DOI: | 10.1016/j.annonc.2021.05.353 |
| الوصول الحر: | https://orbi.uliege.be/handle/2268/292335Test |
| حقوق: | open access http://purl.org/coar/access_right/c_abf2Test info:eu-repo/semantics/openAccess |
| رقم الانضمام: | edsorb.292335 |
| قاعدة البيانات: | ORBi |
| DOI: | 10.1016/j.annonc.2021.05.353 |
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