دورية أكاديمية
Overall Survival with Palbociclib and Fulvestrant in Advanced Breast Cancer.
| العنوان: | Overall Survival with Palbociclib and Fulvestrant in Advanced Breast Cancer. |
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| المؤلفون: | Turner, NC, Slamon, DJ, Ro, J, Bondarenko, I, Im, S-A, Masuda, N, Colleoni, M, DeMichele, A, Loi, S, Verma, S, Iwata, H, Harbeck, N, Loibl, S, André, F, Puyana Theall, K, Huang, X, Giorgetti, C, Huang Bartlett, C, Cristofanilli, M |
| المساهمون: | Turner, Nicholas |
| بيانات النشر: | MASSACHUSETTS MEDICAL SOC |
| سنة النشر: | 2018 |
| المجموعة: | The Institute of Cancer Research (ICR): Publications Repository |
| مصطلحات موضوعية: | Humans, Breast Neoplasms, Piperazines, Pyridines, Estradiol, Receptors, Steroid, Antineoplastic Combined Chemotherapy Protocols, Protein Kinase Inhibitors, Survival Analysis, Double-Blind Method, Aged, Middle Aged, Female, ErbB Receptors, Fulvestrant |
| الوصف: | BACKGROUND: The cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor palbociclib, in combination with fulvestrant therapy, prolongs progression-free survival among patients with hormone-receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer. We report the results of a prespecified analysis of overall survival. METHODS: We randomly assigned patients with hormone-receptor-positive, HER2-negative advanced breast cancer who had progression or relapse during previous endocrine therapy to receive palbociclib plus fulvestrant or placebo plus fulvestrant. We analyzed overall survival; the effect of palbociclib according to the prespecified stratification factors of presence or absence of sensitivity to endocrine therapy, presence or absence of visceral metastatic disease, and menopausal status; the efficacy of subsequent therapies after disease progression; and safety. RESULTS: Among 521 patients who underwent randomization, the median overall survival was 34.9 months (95% confidence interval [CI], 28.8 to 40.0) in the palbociclib-fulvestrant group and 28.0 months (95% CI, 23.6 to 34.6) in the placebo-fulvestrant group (hazard ratio for death, 0.81; 95% CI, 0.64 to 1.03; P=0.09; absolute difference, 6.9 months). CDK4/6 inhibitor treatment after the completion of the trial regimen occurred in 16% of the patients in the placebo-fulvestrant group. Among 410 patients with sensitivity to previous endocrine therapy, the median overall survival was 39.7 months (95% CI, 34.8 to 45.7) in the palbociclib-fulvestrant group and 29.7 months (95% CI, 23.8 to 37.9) in the placebo-fulvestrant group (hazard ratio, 0.72; 95% CI, 0.55 to 0.94; absolute difference, 10.0 months). The median duration of subsequent therapy was similar in the two groups, and the median time to the receipt of chemotherapy was 17.6 months in the palbociclib-fulvestrant group, as compared with 8.8 months in the placebo-fulvestrant group (hazard ratio, 0.58; 95% CI, 0.47 to 0.73; P<0.001). No new safety signals were ... |
| نوع الوثيقة: | article in journal/newspaper |
| وصف الملف: | Print-Electronic; 1936; application/pdf |
| اللغة: | English |
| تدمد: | 0028-4793 1533-4406 |
| العلاقة: | The New England journal of medicine, 2018, 379 (20), pp. 1926 - 1936; https://repository.icr.ac.uk/handle/internal/2912Test |
| DOI: | 10.1056/nejmoa1810527 |
| الإتاحة: | https://doi.org/10.1056/nejmoa1810527Test https://repository.icr.ac.uk/handle/internal/2912Test |
| حقوق: | https://www.rioxx.net/licenses/under-embargo-all-rights-reservedTest |
| رقم الانضمام: | edsbas.5E359D64 |
| قاعدة البيانات: | BASE |
| تدمد: | 00284793 15334406 |
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| DOI: | 10.1056/nejmoa1810527 |