Ribociclib as first-line therapy for HR-positive, advanced breast cancer
Open accessAbstract
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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CDK4/6 inhibitors plus endocrine therapy are standard of care for ER-positive/HER2-negative ABC.
“The last 2 years have seen the establishment of cyclin-dependent kinase (CDK)4/6 inhibitors combined with endocrine therapy (ET) as the standard of care for ER-positive/HER2-negative ABC”
From 5th ESO-ESMO international consensus guidelines for advanced breast cancer (ABC 5) (2020) · cites this paper as [44]
The Discussion reports longer progression-free survival with ribociclib plus letrozole than with letrozole alone in postmenopausal women receiving first-line treatment for HR-positive, HER2-negative advanced breast cancer. The paper supports the combination’s efficacy, but does not establish that CDK4/6 inhibitors as a class combined with endocrine therapy had become the standard of care. Its introduction instead identifies endocrine therapy as the standard of care at the time. (LLM, conf=0.87)
Experimental — accuracy not yet measuredCDK4/6 inhibitors plus endocrine therapy provide substantial PFS benefit and a favorable toxicity profile.
“substantial PFS benefit and good toxicity profile.36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57”
From 5th ESO-ESMO international consensus guidelines for advanced breast cancer (ABC 5) (2020) · cites this paper as [44]
The Discussion reports significantly longer progression-free survival with ribociclib plus letrozole and describes its adverse-event profile as acceptable for most patients. But this trial studied one CDK4/6 inhibitor with one endocrine therapy in postmenopausal women with HR-positive, HER2-negative advanced breast cancer; it does not establish the same benefit and toxicity profile for all CDK4/6 inhibitor–endocrine therapy combinations. (LLM, conf=0.86)
Experimental — accuracy not yet measuredCDK4/6 inhibitors can be combined with an aromatase inhibitor or fulvestrant and are effective across de novo or recurrent ABC, first or second line, primary or secondary resistance, postmenopausal and premenopausal women (with ovarian suppression/ablation), and men.
“These agents can be combined with an aromatase inhibitor (AI) or fulvestrant, and are effective in de novo or recurrent ABC, in first or second line, in cases of primary or secondary resistance, in postmenopausal and premenopausal women (the latter with ovarian function suppression/ablation), and in men (preferably with a luteinising hormone-releasing hormone agonist).”
From 5th ESO-ESMO international consensus guidelines for advanced breast cancer (ABC 5) (2020) · cites this paper as [44]
Split into 2 atoms — 1 confirmed, 1 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.
Experimental — accuracy not yet measuredIn the ribociclib group, median trial treatment exposure was 20.2 months (IQR 7.4-45.1), 7 months longer than at the primary PFS analysis.
“The median duration of exposure to trial treatment in the ribociclib group was 20.2 months (interquartile range, 7.4 to 45.1), which is 7 months longer than it was at the time of the primary analysis of progression-free survival. 10”
From Overall Survival with Ribociclib plus Letrozole in Advanced Breast Cancer. (2022) · cites this paper as [10]
The Treatment section reports 13.0 months as the ribociclib group's median treatment exposure at the January 2016 cutoff, supporting the claim's reference to the earlier analysis. It does not report the later 20.2-month median, the 7.4–45.1-month interquartile range, or the increase to that later value. Page number is unavailable in our copy. (LLM, conf=0.86)
Experimental — accuracy not yet measuredIn the primary and updated analyses of MONALEESA-2, median PFS was 25.3 months with ribociclib plus letrozole versus 16.0 months with placebo plus letrozole.
“In the primary and updated analyses of MONALEESA-2, progression-free survival was significantly longer with ribociclib plus letrozole than with placebo plus letrozole (median in updated analysis, 25.3 months vs. 16.0 months; hazard ratio for disease progression or death, 0.57; 95% confidence interval [CI], 0.46 to 0.70; P<0.001).”
From Overall Survival with Ribociclib plus Letrozole in Advanced Breast Cancer. (2022) · cites this paper as [10]
The Efficacy of Ribociclib plus Letrozole section reports significantly longer progression-free survival with ribociclib plus letrozole at the interim analysis. It does not report the claimed updated-analysis medians of 25.3 and 16.0 months; instead, the ribociclib median had not been reached and the placebo median was 14.7 months. No page numbers are available in our copy. (LLM, conf=0.90)
Experimental — accuracy not yet measured
At the primary and updated analyses of MONALEESA-2, the overall survival data had not matured.
“Data for overall survival were immature at the time of the primary and updated analyses.”
From Overall Survival with Ribociclib plus Letrozole in Advanced Breast Cancer. (2022) · cites this paper as [10]
The Characteristic section states that overall survival results were not mature at the interim analysis, supporting the claim about the primary analysis. This 2016 paper does not report an updated analysis or establish whether overall survival data were still immature then. (LLM, conf=0.87)
Experimental — accuracy not yet measuredIn the primary and updated analyses of MONALEESA-2, the hazard ratio for disease progression or death with ribociclib plus letrozole versus placebo plus letrozole was 0.57 (95% CI 0.46 to 0.70; P<0.001).
“In the primary and updated analyses of MONALEESA-2, progression-free survival was significantly longer with ribociclib plus letrozole than with placebo plus letrozole (median in updated analysis, 25.3 months vs. 16.0 months; hazard ratio for disease progression or death, 0.57; 95% confidence interval [CI], 0.46 to 0.70; P<0.001).”
From Overall Survival with Ribociclib plus Letrozole in Advanced Breast Cancer. (2022) · cites this paper as [10]
The Efficacy of Ribociclib plus Letrozole section reports significantly longer progression-free survival with ribociclib plus letrozole in the primary interim analysis. It gives a hazard ratio of 0.56 (95% CI, 0.43 to 0.72), not the claimed 0.57 (95% CI, 0.46 to 0.70); our copy does not report the cited updated-analysis figures. (LLM, conf=0.88)
Experimental — accuracy not yet measuredUse of CDK4/6 inhibitors such as ribociclib, abemaciclib, and palbociclib improved PFS in this population and led to regulatory approvals.
“The use of CDK4/6 inhibitors (ribociclib, abemaciclib, and palbociclib) improved progression-free survival in this patient population, leading to regulatory approvals. 9-13”
From Overall Survival with Ribociclib plus Letrozole in Advanced Breast Cancer. (2022) · cites this paper as [10]
The Results and Discussion report significantly longer progression-free survival with ribociclib plus letrozole than with placebo plus letrozole in postmenopausal women with HR-positive, HER2-negative advanced breast cancer. The paper describes CDK4/6 inhibition more broadly and cites palbociclib studies, but it does not establish a progression-free-survival benefit for abemaciclib or say that these findings led to regulatory approvals. (LLM, conf=0.88)
Experimental — accuracy not yet measuredIn an earlier analysis of this phase 3 study, adding ribociclib to first-line letrozole yielded significantly longer progression-free survival than letrozole alone among postmenopausal women with hormone receptor-positive, HER2-negative advanced breast cancer.
“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.”
From Overall Survival with Ribociclib plus Letrozole in Advanced Breast Cancer. (2022) · cites this paper as [10]
About 10% of patients treated with abemaciclib develop grade 3 diarrhea, which is very rare with the other two inhibitors.
“However, 10% of the patients treated with abemaciclib develop grade 3 diarrhea, which is very rare with the other two inhibitors (Asghar et al., 2015; Hortobagyi et al., 2016).”
From CDK4/6 Inhibitors: The Mechanism of Action May Not Be as Simple as Once Thought (2018) · cites this paper as Hortobagyi et al., 2016
Abemaciclib is better tolerated overall, with 55% of patients having significant adverse events versus 70-80% for ribociclib and palbociclib, and only 21% having grade 3-4 neutropenia.
“Abemaciclib appears to be better tolerated overall, with only 55% of patients experiencing significant adverse events (as compared to 70–80% with ribociclib and palbociclib) and only 21% with grade 3–4 neutropenia.”
From CDK4/6 Inhibitors: The Mechanism of Action May Not Be as Simple as Once Thought (2018) · cites this paper as Hortobagyi et al., 2016
Grade 3-4 neutropenia occurs in about 60% of patients taking palbociclib or ribociclib.
“Grade 3–4 neutropenia is observed in approximately 60% of patients taking palbociclib and ribociclib (Asghar et al., 2015; Hortobagyi et al., 2016).”
From CDK4/6 Inhibitors: The Mechanism of Action May Not Be as Simple as Once Thought (2018) · cites this paper as Hortobagyi et al., 2016
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- 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)
- ORCID
- Stemmer, Salomon M.
- Burris, Howard A.
- Yap, Yoon-Sim
- Sonke, Gabe S.
- Campone, Mario
- Blackwell, Kimberly L.
- André, Fabrice
- Winer, Eric P.
- Janni, Wolfgang
- Verma, Sunil
- Conte, Pierfranco
- Arteaga, Carlos L.
- Cameron, David A.
- Chan, Arlene
- Jakobsen, Erik
- Grischke, Eva-Maria
- Alba, Emilio
- Wist, Erik
- Marschner, Norbert
- Favret, Anne M.
- Yardley, Denise
- Bachelot, Thomas
- Tseng, Ling-Ming
- Blau, Sibel
- Xuan, Fengjuan
- Miller, Michelle
- Germa, Caroline
- O’Shaughnessy, Joyce
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- 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 · 2015: 1 · 2013: 1
- FWCI
- 176.67
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- 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 › Pulmonary and Respiratory Medicine › 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
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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