Ribociclib plus letrozole versus letrozole alone in patients with de novo HR+, HER2- advanced breast cancer in the randomized MONALEESA-2 trial
Jazyk angličtina Země Nizozemsko Médium print-electronic
Typ dokumentu klinické zkoušky, fáze III, srovnávací studie, časopisecké články, randomizované kontrolované studie
PubMed
29164421
PubMed Central
PMC5847028
DOI
10.1007/s10549-017-4518-8
PII: 10.1007/s10549-017-4518-8
Knihovny.cz E-zdroje
- Klíčová slova
- Breast cancer, CDK inhibitor, De novo advanced breast cancer, Endocrine therapy, Hormone receptor-positive, Ribociclib,
- MeSH
- aminopyridiny terapeutické užití MeSH
- časové faktory MeSH
- doba přežití bez progrese choroby MeSH
- dospělí MeSH
- febrilní neutropenie vyvolaná chemoterapií epidemiologie etiologie MeSH
- incidence MeSH
- Kaplanův-Meierův odhad MeSH
- kritéria léčebné odpovědi MeSH
- letrozol terapeutické užití MeSH
- leukopenie chemicky indukované epidemiologie MeSH
- lidé středního věku MeSH
- lidé MeSH
- nádory prsu farmakoterapie mortalita patologie MeSH
- postmenopauza MeSH
- protokoly protinádorové kombinované chemoterapie terapeutické užití MeSH
- prsy patologie MeSH
- puriny terapeutické užití MeSH
- receptory pro estrogeny metabolismus MeSH
- receptory progesteronu metabolismus MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze III MeSH
- randomizované kontrolované studie MeSH
- srovnávací studie MeSH
- Názvy látek
- aminopyridiny MeSH
- letrozol MeSH
- puriny MeSH
- receptory pro estrogeny MeSH
- receptory progesteronu MeSH
- ribociclib MeSH Prohlížeč
PURPOSE: Determine the efficacy and safety of first-line ribociclib plus letrozole in patients with de novo advanced breast cancer. METHODS: 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). Patients were randomized to ribociclib (600 mg/day; 3 weeks-on/1 week-off) plus letrozole (2.5 mg/day; continuous) or placebo plus letrozole until disease progression, unacceptable toxicity, death, or treatment discontinuation. The primary endpoint was investigator-assessed progression-free survival; predefined subgroup analysis evaluated progression-free survival in patients with de novo advanced breast cancer. Secondary endpoints included safety and overall response rate. RESULTS: Six hundred and sixty-eight patients were enrolled, of whom 227 patients (34%; ribociclib plus letrozole vs placebo plus letrozole arm: n = 114 vs. n = 113) presented with de novo advanced breast cancer. Median progression-free survival was not reached in the ribociclib plus letrozole arm versus 16.4 months in the placebo plus letrozole arm in patients with de novo advanced breast cancer (hazard ratio 0.45, 95% confidence interval 0.27-0.75). The most common Grade 3/4 adverse events were neutropenia and leukopenia; incidence rates were similar to those observed in the full MONALEESA-2 population. Ribociclib dose interruptions and reductions in patients with de novo disease occurred at similar frequencies to the overall study population. CONCLUSIONS: Ribociclib plus letrozole improved progression-free survival vs placebo plus letrozole and was well tolerated in postmenopausal women with HR+, HER2- de novo advanced breast cancer.
Arizona Oncology US Oncology Network 3700 W State Rte 89A Sedona AZ 86336 USA
Edinburgh Cancer Centre University of Edinburgh Crewe Rd S Edinburgh EH4 2XR UK
Highlands Oncology Group 3232 N Northhills Blvd Fayetteville AR 72703 USA
Lillebaelt Hospital Kabbeltoft 25 7100 Vejle Denmark
Masaryk Memorial Cancer Institute Žlutý kopec 543 7 656 53 Brno Czech Republic
Netherlands Cancer Institute and BOOG Study Center IJsbaanpad 9 1076 CV Amsterdam The Netherlands
Novartis Pharma AG Fabrikstrasse 2 4056 Basel Switzerland
Novartis Pharmaceuticals Corporation 1 Health Plaza East Hanover NJ 07936 USA
Sarah Cannon Research Institute Fort Myers FL 33916 USA
University of Padova and Istituto Oncologico Veneto IRCCS Via Gattamelata 64 Padua Italy
University of Texas MD Anderson Cancer Center 1515 Holcombe Blvd Houston TX 77030 USA
Vanderbilt Ingram Cancer Center 1301 Medical Center Dr 1710 Nashville TN 37232 USA
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