Phase III Randomized Study of Ribociclib and Fulvestrant in Hormone Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative Advanced Breast Cancer: MONALEESA-3
| العنوان: | Phase III Randomized Study of Ribociclib and Fulvestrant in Hormone Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative Advanced Breast Cancer: MONALEESA-3 |
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| المؤلفون: | Xavier Pivot, Michelle Miller, Seock-Ah Im, Francisco J. Esteva, Yingbo Wang, Miguel Martin, Arnd Nusch, Luis de la Cruz-Merino, Karen Rodriguez Lorenc, Patrick Neven, Dennis J. Slamon, K. Petrakova, Peter A. Fasching, J. Thaddeus Beck, Stephen Chia, Michelino De Laurentiis, Gena Vidam, Guy Jerusalem, Giulia Val Bianchi, Gabe S. Sonke, Tetiana Taran |
| المساهمون: | Slamon, D. J., Neven, P., Chia, S., Fasching, P. A., De Laurentiis, M., Im, S. -A., Petrakova, K., Val Bianchi, G., Esteva, F. J., Martin, M., Nusch, A., Sonke, G. S., De La Cruz-Merino, L., Beck, J. T., Pivot, X., Vidam, G., Wang, Y., Lorenc, K. R., Miller, M., Taran, T., Jerusalem, G. |
| المصدر: | Journal of Clinical Oncology. 36:2465-2472 |
| بيانات النشر: | American Society of Clinical Oncology (ASCO), 2018. |
| سنة النشر: | 2018 |
| مصطلحات موضوعية: | Adult, 0301 basic medicine, Oncology, Cancer Research, medicine.medical_specialty, Receptor, ErbB-2, Aminopyridines, Anastrozole, Breast Neoplasms, Kaplan-Meier Estimate, Palbociclib, Gene mutation, 03 medical and health sciences, 0302 clinical medicine, Double-Blind Method, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, Progression-free survival, Fulvestrant, Purine, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocol, business.industry, Goserelin, Middle Aged, medicine.disease, Metastatic breast cancer, Progression-Free Survival, Aminopyridine, 030104 developmental biology, Receptors, Estrogen, Purines, 030220 oncology & carcinogenesis, Hormonal therapy, Female, Receptors, Progesterone, business, Breast Neoplasm, Human, medicine.drug |
| الوصف: | Purpose This phase III study evaluated ribociclib plus fulvestrant in patients with hormone receptor–positive/human epidermal growth factor receptor 2–negative advanced breast cancer who were treatment naïve or had received up to one line of prior endocrine therapy in the advanced setting. Patients and Methods Patients were randomly assigned at a two-to-one ratio to ribociclib plus fulvestrant or placebo plus fulvestrant. The primary end point was locally assessed progression-free survival. Secondary end points included overall survival, overall response rate, and safety. Results A total of 484 postmenopausal women were randomly assigned to ribociclib plus fulvestrant, and 242 were assigned to placebo plus fulvestrant. Median progression-free survival was significantly improved with ribociclib plus fulvestrant versus placebo plus fulvestrant: 20.5 months (95% CI, 18.5 to 23.5 months) versus 12.8 months (95% CI, 10.9 to 16.3 months), respectively (hazard ratio, 0.593; 95% CI, 0.480 to 0.732; P < .001). Consistent treatment effects were observed in patients who were treatment naïve in the advanced setting (hazard ratio, 0.577; 95% CI, 0.415 to 0.802), as well as in patients who had received up to one line of prior endocrine therapy for advanced disease (hazard ratio, 0.565; 95% CI, 0.428 to 0.744). Among patients with measurable disease, the overall response rate was 40.9% for the ribociclib plus fulvestrant arm and 28.7% for placebo plus fulvestrant. Grade 3 adverse events reported in ≥ 10% of patients in either arm (ribociclib plus fulvestrant v placebo plus fulvestrant) were neutropenia (46.6% v 0%) and leukopenia (13.5% v 0%); the only grade 4 event reported in ≥ 5% of patients was neutropenia (6.8% v 0%). Conclusion Ribociclib plus fulvestrant might represent a new first- or second-line treatment option in hormone receptor–positive/human epidermal growth factor receptor 2–negative advanced breast cancer. |
| تدمد: | 1527-7755 0732-183X |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::7e5fd49962d219aec82400b1e61f8756Test https://doi.org/10.1200/jco.2018.78.9909Test |
| حقوق: | CLOSED |
| رقم الانضمام: | edsair.doi.dedup.....7e5fd49962d219aec82400b1e61f8756 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 15277755 0732183X |
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