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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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“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]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“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]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“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]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“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]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“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]
Experimental — accuracy not yet measured
The source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“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]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“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]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“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]
Experimental — accuracy not yet measuredThe cited source says what the claim attributes to it.
In the citing paper
“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]
In the citing paper
“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
In the citing paper
“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
In the citing paper
“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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“1–3), ribociclib (KISQALI; ref.”
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P16 methylation increases the sensitivity of cancer cells to the CDK4/6 inhibitor palbociclib
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“Of note, in the absence of IBC-specific data, it remains uncertain how the recent integration of CDK4/6 inhibitors to the therapeutic management of HRþ/HER2 metastatic IBC will impact outcomes.(20-23) Similarly, other therapeutics with potential for improving OS in TN subtypes, such as immune checkpoint inhibitors, ha…”
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“The introduction of cyclin-dependent kinase 4 and 6 inhibitors (CDK4/6Is) in combination with ET is the standard treatment for advanced HR-positive/HER2-negative disease [70–72] and preclinical data suggest that CDK4/6I are active also in HER2-positive cell lines [73,74].”
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“In particular, CDK4/6 inhibitors prolong progression-free survival and are now approved for use in estrogen receptor-positive breast cancer [97,98].”
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“The MONALEESA-2 [11,12], PALOMA-2 [13,14] and MONARCH-3 [15,16] trials, respectively, tested ribociclib, palbociclib, and abemaciclib in combination with AIs as first-line treatment for luminal BC.”
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“17 CDK4/6 inhibitor recently approved for breast cancer treatment in combination with ER-targeted agents in as early as first line of therapy (45-47), was selected for this study.”
MethodPotential biomarkers of CDK4/6 inhibitors in hormone receptor-positive advanced breast cancer
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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)
- 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
- 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 › 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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