RT Journal Article
T1 Ribociclib with letrozole vs letrozole alone in elderly patients with hormone receptor-positive, HER2-negative breast cancer in the randomized MONALEESA-2 trial.
A1 Sonke, Gabe S
A1 Hart, Lowell L
A1 Campone, Mario
A1 Erdkamp, Frans
A1 Janni, Wolfgang
A1 Verma, Sunil
A1 Villanueva, Cristian
A1 Jakobsen, Erik
A1 Alba, Emilio
A1 Wist, Erik
A1 Favret, Anne M
A1 Bachelot, Thomas
A1 Hegg, Roberto
A1 Wheatley-Price, Paul
A1 Souami, Farida
A1 Sutradhar, Santosh
A1 Miller, Michelle
A1 Germa, Caroline
A1 Burris, Howard A
K1 Breast cancer
K1 CDK inhibitor
K1 Elderly
K1 Endocrine therapy
K1 Hormone receptor-positive
K1 Ribociclib
AB Determine the efficacy and safety of first-line ribociclib plus letrozole in elderly patients with HR+, HER2- advanced breast cancer. 668 postmenopausal women with HR+, HER2- advanced breast cancer and no prior systemic therapy for advanced disease were enrolled in the Phase III MONALEESA-2 trial (NCT01958021); 295 patients were aged ≥ 65 years. Patients were randomized to ribociclib (600 mg/day; 3-weeks-on/1-week-off) plus letrozole (2.5 mg/day) or placebo plus letrozole until disease progression, unacceptable toxicity, death, or treatment discontinuation. The primary endpoint was PFS, which was evaluated in elderly (≥ 65 years) and younger ( Ribociclib plus letrozole significantly improved PFS vs placebo plus letrozole in elderly (hazard ratio: 0.608; 95% CI 0.394-0.937) and younger patients (hazard ratio: 0.523; 95% CI 0.378-0.723). Overall response rates were numerically higher in the ribociclib vs placebo arm, regardless of age. Ribociclib plus letrozole was well tolerated in elderly patients, with the safety profile similar to the overall study population. Nausea, vomiting, alopecia, and diarrhea were > 10% more frequent in the ribociclib plus letrozole vs placebo plus letrozole arm in both subgroups; most events were grade 1/2. In elderly patients, grade 1/2 anemia and fatigue were > 10% more frequent in the ribociclib plus letrozole vs placebo plus letrozole arm and discontinuation rates were similar in both arms. Addition of ribociclib to letrozole is a valid therapeutic option for elderly patients with HR+, HER2- advanced breast cancer in the first-line setting.
YR 2017
FD 2017-10-22
LK http://hdl.handle.net/10668/11714
UL http://hdl.handle.net/10668/11714
LA en
DS RISalud
RD Apr 9, 2025