دورية أكاديمية
The Effect of Abemaciclib Plus Fulvestrant on Overall Survival in Hormone Receptor-Positive, ERBB2-Negative Breast Cancer That Progressed on Endocrine Therapy - MONARCH 2: A Randomized Clinical Trial
| العنوان: | The Effect of Abemaciclib Plus Fulvestrant on Overall Survival in Hormone Receptor-Positive, ERBB2-Negative Breast Cancer That Progressed on Endocrine Therapy - MONARCH 2: A Randomized Clinical Trial |
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| المؤلفون: | Sledge G. W., Toi M., Neven P., Sohn J., Inoue K., Pivot X., Burdaeva O., Okera M., Masuda N., Kaufman P. A., Koh H., Grischke E. -M., Conte P., Lu Y., Barriga S., Hurt K., Frenzel M., Johnston S., Llombart-Cussac A. |
| المساهمون: | Sledge, G. W., Toi, M., Neven, P., Sohn, J., Inoue, K., Pivot, X., Burdaeva, O., Okera, M., Masuda, N., Kaufman, P. A., Koh, H., Grischke, E. -M., Conte, P., Lu, Y., Barriga, S., Hurt, K., Frenzel, M., Johnston, S., Llombart-Cussac, A. |
| بيانات النشر: | American Medical Association |
| سنة النشر: | 2020 |
| المجموعة: | Padua Research Archive (IRIS - Università degli Studi di Padova) |
| الوصف: | Importance: Statistically significant overall survival (OS) benefits of CDK4 and CDK6 inhibitors in combination with fulvestrant for hormone receptor (HR)-positive, ERBB2 (formerly HER2)-negative advanced breast cancer (ABC) in patients regardless of menopausal status after prior endocrine therapy (ET) has not yet been demonstrated. Objective: To compare the effect of abemaciclib plus fulvestrant vs placebo plus fulvestrant on OS at the prespecified interim of MONARCH 2 (338 events) in patients with HR-positive, ERBB2-negative advanced breast cancer that progressed during prior ET. Design, Setting, and Participants: MONARCH 2 was a global, randomized, placebo-controlled, double-blind phase 3 trial of abemaciclib plus fulvestrant vs placebo plus fulvestrant for treatment of premenopausal or perimenopausal women (with ovarian suppression) and postmenopausal women with HR-positive, ERBB2-negative ABC that progressed during ET. Patients were enrolled between August 7, 2014, and December 29, 2015. Analyses for this report were conducted at the time of database lock on June 20, 2019. Interventions: Patients were randomized 2:1 to receive abemaciclib or placebo, 150 mg, every 12 hours on a continuous schedule plus fulvestrant, 500 mg, per label. Randomization was stratified based on site of metastasis (visceral, bone only, or other) and resistance to prior ET (primary vs secondary). Main Outcomes and Measures: The primary end point was investigator-assessed progression-free survival. Overall survival was a gated key secondary end point. The boundary P value for the interim analysis was.02. Results: Of 669 women enrolled, 446 (median [range] age, 59 [32-91] years) were randomized to the abemaciclib plus fulvestrant arm and 223 (median [range] age, 62 [32-87] years) were randomized to the placebo plus fulvestrant arm. At the prespecified interim, 338 deaths (77% of the planned 441 at the final analysis) were observed in the intent-to-treat population, with a median OS of 46.7 months for abemaciclib plus fulvestrant and ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| العلاقة: | info:eu-repo/semantics/altIdentifier/pmid/31563959; info:eu-repo/semantics/altIdentifier/wos/WOS:000506583600017; volume:6; issue:1; firstpage:116; lastpage:124; numberofpages:9; journal:JAMA ONCOLOGY; http://hdl.handle.net/11577/3362237Test; info:eu-repo/semantics/altIdentifier/scopus/2-s2.0-85072756648 |
| DOI: | 10.1001/jamaoncol.2019.4782 |
| الإتاحة: | https://doi.org/10.1001/jamaoncol.2019.4782Test http://hdl.handle.net/11577/3362237Test |
| رقم الانضمام: | edsbas.1603E434 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1001/jamaoncol.2019.4782 |
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