Cited by 2,039Advanced Breast Cancer TherapiesBreast Cancer Treatment StudiesPARP inhibition in cancer therapy

The DOI matches its Crossref record; 24 of the 24 references it cites were found in a registry or an index.

Ribociclib as First-Line Therapy for HR-Positive, Advanced Breast Cancer

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Abstract

BACKGROUND: 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). METHODS: . RESULTS: 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<0.001). Common grade 3 or 4 adverse events that were reported in more than 10% of the patients in either group were neutropenia (59.3% in the ribociclib group vs. 0.9% in the placebo group) and leukopenia (21.0% vs. 0.6%); the rates of discontinuation because of adverse events were 7.5% and 2.1%, respectively. CONCLUSIONS: 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 .).

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Crossref · 10.1056/nejmoa1609709

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  1. Infante JR, Clin Cancer Res
  2. Vuppalanchi R, Hepatology

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Metadata

Authors
Hortobagyi, G. N., Stemmer, S. M., Burris, H. A., Yap, Y.-S., Sonke, G. S., Paluch-Shimon, S., Campone, M., Blackwell, K. L., André, F., Winer, E. P., Janni, W., Verma, S., Conte, P., Arteaga, C. L., Cameron, D. A., Petrakova, K., Hart, L. L., Villanueva, C., Chan, A., Jakobsen, E., Nusch, A., Burdaeva, O., Grischke, E.-M., Alba, E., Wist, E., Marschner, N., Favret, A. M., Yardley, D., Bachelot, T., Tseng, L.-M., Blau, S., Xuan, F., Souami, F., Miller, M., Germa, C., Hirawat, S., & O’Shaughnessy, J.
Affiliations
  • From the University of Texas M.D. Anderson Cancer Center, Houston (G.N.H.), and Texas Oncology–Baylor Charles A. Sammons Cancer Center and the U.S. Oncology Network, Dallas (J.O.) — all in Texas; Davidoff Center, Rabin Medical Center, Tel Aviv University, Tel Aviv (S.M.S.), and Sheba Medical Center, Ramat Gan (S.P.-S.) — both in Israel; the Sarah Cannon Research Institute (H.A.B., D.Y.), Vanderbilt–Ingram Cancer Center (C.L.A.), and Tennessee Oncology (D.Y.) — all in Nashville; National Cancer Center...
  • The University of Texas MD Anderson Cancer Center (US)
  • Université Paris-Sud (FR)
  • Oslo University Hospital (NO)
  • Novartis (Switzerland) (CH)
Venue
New England Journal of Medicine
Published
2016-11-03
Volume
375
Issue
18
Pages
1738-1748
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
OpenAlex
W2528767298
Cited by
2,039
References
24
Citations by year
2026: 167 · 2025: 218 · 2024: 203 · 2023: 214 · 2022: 187 · 2021: 247 · 2020: 206 · 2019: 173 · 2018: 237 · 2017: 166 · 2016: 17
FWCI
176.67
Type
journal article
Language
en
Open access
Locations
  • New England Journal of Medicine (publishedVersion)
  • PubMed (publishedVersion)
  • Edinburgh Research Explorer (University of Edinburgh) (submittedVersion, other-oa)
  • Padua Research Archive (University of Padova) (submittedVersion, other-oa)
  • RISalud Institutional Health Repository of Andalucía (submittedVersion, other-oa)
Funders
  • Amgen
  • Bristol-Myers Squibb
  • Eli Lilly and Company
  • Pfizer
  • AstraZeneca
  • GlaxoSmithKline
  • Sanofi
  • Spectrum Pharmaceuticals
  • Celgene
  • Exelixis
  • Celldex Therapeutics
  • TG Therapeutics
  • Astex Pharmaceuticals
  • Agios Pharmaceuticals
  • Jounce Therapeutics
  • Mersana Therapeutics
  • Incyte
  • G1 Therapeutics
  • Eisai
  • Astellas Pharma
  • Ipsen
  • Genentech
  • Chugai Pharmaceutical
  • Novartis Institutes for BioMedical Research
  • Loxo Oncology
Topics
  • Health Sciences › Medicine › Oncology › Advanced Breast Cancer Therapies
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Breast Cancer Treatment Studies
  • Health Sciences › Medicine › Oncology › PARP inhibition in cancer therapy
Keywords
ribociclib, CDK4/6 inhibitors, hormone receptor-positive HER2-negative breast cancer, advanced breast cancer, first-line therapy, letrozole, endocrine therapy resistance, progression-free survival, myelosuppression, neutropenia, leukopenia
MeSH terms
Letrozole, Adult, Aged, Aged, 80 and over, Aminopyridines, Antineoplastic Combined Chemotherapy Protocols, Breast Neoplasms, Double-Blind Method, Drug Administration Schedule, Female, Humans, Middle Aged, Neoplasm Staging, Nitriles, Purines, Receptors, Estrogen, Receptors, Progesterone, Triazoles, Disease-Free Survival, Erb-b2 Receptor Tyrosine Kinases, Kaplan-Meier Estimate

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