Cited by 791Advanced Breast Cancer TherapiesBreast Cancer Treatment StudiesPARP inhibition in cancer therapy

The DOI matches its Crossref record; 32 of the 32 references it cites were found in a registry or an index; 25 of the 48 sources its claims cite were checked for support.

Overall Survival with Ribociclib plus Letrozole in Advanced Breast Cancer.

Open access
Hortobagyi, Gabriel N., Stemmer, Salomon M., Burris, Howard A., Yap, Yoon-Sim, Sonke, Gabe S., Hart, Lowell, Campone, Mario, Petrakova, Katarina, Winer, Eric P., Janni, Wolfgang, Conte, Pierfranco, Cameron, David A., André, Fabrice, Arteaga, Carlos L., Zarate, Juan P., Chakravartty, Arunava, Taran, Tetiana, Le Gac, Fabienne, Serra, Paolo, O’Shaughnessy, Joyce·2022·New England Journal of Medicine

Abstract

BACKGROUND: In a previous analysis of this phase 3 trial, first-line ribociclib plus letrozole resulted in significantly longer progression-free survival than letrozole alone among postmenopausal patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer. Whether overall survival would also be longer with ribociclib was not known. METHODS: Here we report the results of the protocol-specified final analysis of overall survival, a key secondary end point. Patients were randomly assigned in a 1:1 ratio to receive either ribociclib or placebo in combination with letrozole. Overall survival was assessed with the use of a stratified log-rank test and summarized with the use of Kaplan-Meier methods after 400 deaths had occurred. A hierarchical testing strategy was used for the analysis of progression-free survival and overall survival to ensure the validity of the findings. RESULTS: After a median follow-up of 6.6 years, 181 deaths had occurred among 334 patients (54.2%) in the ribociclib group and 219 among 334 (65.6%) in the placebo group. Ribociclib plus letrozole showed a significant overall survival benefit as compared with placebo plus letrozole. Median overall survival was 63.9 months (95% confidence interval [CI], 52.4 to 71.0) with ribociclib plus letrozole and 51.4 months (95% CI, 47.2 to 59.7) with placebo plus letrozole (hazard ratio for death, 0.76; 95% CI, 0.63 to 0.93; two-sided P = 0.008). No new safety signals were observed. CONCLUSIONS: First-line therapy with ribociclib plus letrozole showed a significant overall survival benefit as compared with placebo plus letrozole in patients with HR-positive, HER2-negative advanced breast cancer. Median overall survival was more than 12 months longer with ribociclib than with placebo. (Funded by Novartis; MONALEESA-2 ClinicalTrials.gov number, NCT01958021.).

Overview

Integrity signals

Registry

Crossref · 10.1056/nejmoa2114663

Cites

32 of 32 references verified0 citation errors · 0 not checkable

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  • The quote only partly states this claim. 3
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    The trial population is representative of the broader population of postmenopausal patients with HR-positive, HER2-negative advanced breast cancer.

    “Epidemiologic data explicitly for patients with HR-positive, HER2-negative metastatic breast cancer are quite limited; however, the patients in this trial were representative of patients with breast cancer overall with respect to sex and age (Table S2).”
    “Unfortunately, only 2.5% of women in the trial were Black; thus, this demographic group was underrepresented in our trial.”
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Metadata

Authors
Hortobagyi, G. N., Stemmer, S. M., Burris, H. A., Yap, Y.-S., Sonke, G. S., Hart, L., Campone, M., Petrakova, K., Winer, E. P., Janni, W., Conte, P., Cameron, D. A., André, F., Arteaga, C. L., Zarate, J. P., Chakravartty, A., Taran, T., Le Gac, F., Serra, P., & O’Shaughnessy, J.
Affiliations
  • From the Department of Breast Medical Oncology, University of Texas M.D. Anderson Cancer Center, Houston (G.N.H.), and Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center (C.L.A.), and Baylor University Medical Center, Texas Oncology, US Oncology (J.O.), Dallas — all in Texas; the Institute of Oncology, Davidoff Center, Rabin Medical Center, Tel Aviv University, Tel Aviv, Israel (S.M.S.); Sarah Cannon Research Institute, Nashville (H.A.B.); the Department of Medical Oncology, National Cancer Centre Singapore, Singapore (Y.-S.Y.); the Department of Medical Oncology, Netherlands Cancer Institute and Borstkanker Onderzoek Groep Study Center, Amsterdam (G.S.S.); Florida Cancer Specialists, Sarah Cannon Research Institute, Fort Myers (L.H.); the Department of Medical Oncology, Institut de Cancérologie de l’Ouest–René Gauducheau, Saint-Herblain (M.C.), and the Department of Medical Oncology, Institut Gustave Roussy, Medical School, Université Paris-Saclay, Villejuif (F.A.) — both...
  • The University of Texas MD Anderson Cancer Center (US)
Venue
New England Journal of Medicine
Published
2022-03-10
Volume
386
Issue
10
Pages
942-950
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
OpenAlex
W4220709633
Cited by
791
References
30
Citations by year
2026: 177 · 2025: 226 · 2024: 200 · 2023: 150 · 2022: 38
FWCI
99.29
Type
journal article
Language
en
Open access
Locations
  • New England Journal of Medicine (publishedVersion)
  • PubMed (publishedVersion)
  • Edinburgh Research Explorer (University of Edinburgh) (publishedVersion, other-oa)
Funders
Novartis Pharmaceuticals Corporation (N/A)
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, letrozole, advanced breast cancer, hormone receptor-positive HER2-negative breast cancer, overall survival, first-line therapy, CDK4/6 inhibitors, postmenopausal women, progression-free survival
MeSH terms
Letrozole, Aged, Aminopyridines, Antineoplastic Combined Chemotherapy Protocols, Breast Neoplasms, Female, Humans, Middle Aged, Neutropenia, Purines, Receptors, Estrogen, Survival Analysis, Erb-b2 Receptor Tyrosine Kinases, Intention to Treat Analysis, Neoplasm Grading

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