RT Journal Article
T1 Ribociclib as First-Line Therapy for HR-Positive, Advanced Breast Cancer.
A1 Hortobagyi, Gabriel N
A1 Stemmer, Salomon M
A1 Burris, Howard A
A1 Yap, Yoon-Sim
A1 Sonke, Gabe S
A1 Paluch-Shimon, Shani
A1 Campone, Mario
A1 Blackwell, Kimberly L
A1 André, Fabrice
A1 Winer, Eric P
A1 Janni, Wolfgang
A1 Verma, Sunil
A1 Conte, Pierfranco
A1 Arteaga, Carlos L
A1 Cameron, David A
A1 Petrakova, Katarina
A1 Hart, Lowell L
A1 Villanueva, Cristian
A1 Chan, Arlene
A1 Jakobsen, Erik
A1 Nusch, Arnd
A1 Burdaeva, Olga
A1 Grischke, Eva-Maria
A1 Alba, Emilio
A1 Wist, Erik
A1 Marschner, Norbert
A1 Favret, Anne M
A1 Yardley, Denise
A1 Bachelot, Thomas
A1 Tseng, Ling-Ming
A1 Blau, Sibel
A1 Xuan, Fengjuan
A1 Souami, Farida
A1 Miller, Michelle
A1 Germa, Caroline
A1 Hirawat, Samit
A1 O'Shaughnessy, Joyce
AB The inhibition of cyclin-dependent kinases 4 and 6 (CDK4/6) could potentially overcome or delay resistance to endocrine therapy in advanced breast cancer that is positive for hormone receptor (HR) and negative for human epidermal growth factor receptor 2 (HER2). In this randomized, placebo-controlled, phase 3 trial, we evaluated the efficacy and safety of the selective CDK4/6 inhibitor ribociclib combined with letrozole for first-line treatment in 668 postmenopausal women with HR-positive, HER2-negative recurrent or metastatic breast cancer who had not received previous systemic therapy for advanced disease. We randomly assigned the patients to receive either ribociclib (600 mg per day on a 3-weeks-on, 1-week-off schedule) plus letrozole (2.5 mg per day) or placebo plus letrozole. The primary end point was investigator-assessed progression-free survival. Secondary end points included overall survival, overall response rate, and safety. A preplanned interim analysis was performed on January 29, 2016, after 243 patients had disease progression or died. Prespecified criteria for superiority required a hazard ratio of 0.56 or less with P The duration of progression-free survival was significantly longer in the ribociclib group than in the placebo group (hazard ratio, 0.56; 95% CI, 0.43 to 0.72; P=3.29×10-6 for superiority). The median duration of follow-up was 15.3 months. After 18 months, the progression-free survival rate was 63.0% (95% confidence interval [CI], 54.6 to 70.3) in the ribociclib group and 42.2% (95% CI, 34.8 to 49.5) in the placebo group. In patients with measurable disease at baseline, the overall response rate was 52.7% and 37.1%, respectively (P Among patients receiving initial systemic treatment for HR-positive, HER2-negative advanced breast cancer, the duration of progression-free survival was significantly longer among those receiving ribociclib plus letrozole than among those receiving placebo plus letrozole, with a higher rate of myelosuppression in the ribociclib group. (Funded by Novartis Pharmaceuticals; ClinicalTrials.gov number, NCT01958021 .).
YR 2016
FD 2016-10-07
LK http://hdl.handle.net/10668/10515
UL http://hdl.handle.net/10668/10515
LA en
DS RISalud
RD Apr 17, 2025