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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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“Furthermore, phase III trials covering firstline endocrine therapy plus CDK4/6 inhibitor [10,11,14] enrolled postmenopausal patients only, except MONALEESA-7 [18].”
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“With that in mind, our median PFS of 19.2 months (95%-CI 14.3-not reached) seems slightly lower than the 25.3 months (95%-CI 23.0–30.3) observed in MONALEESA-2[11], but closer to results from MONALEESA-3.”
BackgroundMethodResultInfluentialOncotherapeutic Protein Kinase Inhibitors Associated With Pro-Arrhythmic Liability
Ye, J. Z., Hansen, F. B., Mills, R. W., & Lundby, A. (2021) · JACC CardioOncology · doi:10.1016/j.jaccao.2021.01.009 · Cited by 28
“We present novel associations with AF for ribociclib (previously associated with prolonged QT), trametinib, and idelalisib (20).”
BackgroundFallah, Y., Demas, D. M., Lu, J., He, W., & Shajahan‐Haq, A. N. (2021) · Frontiers in Oncology · doi:10.3389/fonc.2021.681530 · Cited by 29
Carpintero-Fernández, P., Borghesan, M., Eleftheriadou, O., Pan‐Castillo, B., Fafián‐Labora, J., Mitchell, T. P., Yuste, A., Öğrünç, M., Nightingale, T. D., Mayán, M. D., et al. (2022) · Cell Death and Disease · doi:10.1038/s41419-022-04569-3 · Cited by 30
Therapeutic potential of CDK4/6 inhibitors in renal cell carcinoma
Sager, R., Backe, S. J., Ahanin, E. F., Smith, G., Nsouli, I. S., Woodford, M. R., Bratslavsky, G., Bourboulia, D., & Mollapour, M. (2022) · Nature Reviews Urology · doi:10.1038/s41585-022-00571-8 · Cited by 29
Bardia, A., Cortés, J., Hurvitz, S. A., Delaloge, S., Iwata, H., Shao, Z., Kanagavel, D., Cohen, P., Liu, Q., Cartot‐Cotton, S., et al. (2022) · Therapeutic Advances in Medical Oncology · doi:10.1177/17588359221083956 · Cited by 31
Self-citationHR+/HER2– Advanced Breast Cancer Treatment in the First-Line Setting: Expert Review
Jerzak, K. J., Bouganim, N., Brezden‐Masley, C., Edwards, S. J., Gelmon, K. A., Henning, J., Hilton, J. F., & Sehdev, S. R. (2023) · Current Oncology · doi:10.3390/curroncol30060411 · Cited by 31
Huang, N., Wu, Z., Hong, H., Wang, X., Yang, F., & Li, H. (2019) · Molecular Medicine Reports · doi:10.3892/mmr.2019.10134 · Cited by 29
“in spite of great advances in diagnosis and therapy for the disease, the overall 5-year survival rate for patients with Bc remains low (4,5).”
BackgroundZeverijn, L. J., Looze, E. J., Thavaneswaran, S., Henegouwen, J. M. V. B., Simes, R. J., Hoes, L. R., Sjoquist, K. M., van der Wijngaart, H., Sebastian, L. T., Geurts, B. S., et al. (2023) · International Journal of Cancer · doi:10.1002/ijc.34649 · Cited by 29
Deng, Y., Ma, G., Li, W., Wang, T. I., Zhao, Y., & Wu, Q. (2018) · Clinical Breast Cancer · doi:10.1016/j.clbc.2018.04.017 · Cited by 29
Larsson, A.-M., Roxå, A., Leandersson, K., & Bergenfelz, C. (2019) · Scientific Reports · doi:10.1038/s41598-019-49943-y · Cited by 29
Zheng, J., Wu, J., Wang, C., Zhuang, S., Chen, J., & Ye, F. (2020) · PLoS ONE · doi:10.1371/journal.pone.0233571 · Cited by 27
“As for combination schemes, 5 trials applied first-line ET strategy in our studies [12, 13, 15, 17, 19], and 4 trials included firstline and subsequent-line ET strategies simultaneously [14, 16, 18, 20].”
BackgroundMethodGagliato, D. D. M., Buzaid, A. C., Pérez-García, J. M., Llombart‐Cussac, A., & Cortés, J. (2020) · Cancers · doi:10.3390/cancers12092480 · Cited by 28
Novel Therapeutic Strategies for CDK4/6 Inhibitors in Metastatic Castrate-Resistant Prostate Cancer
Kase, A. M., Copland, J. A., & Tan, W. W. (2020) · OncoTargets and Therapy · doi:10.2147/ott.s266085 · Cited by 30
Pandey, K., Lee, E., Park, N., Hur, J., Cho, Y. B., Katuwal, N. B., Kim, S. K., Lee, S. A., Kim, I., An, H. J., et al. (2021) · Genes · doi:10.3390/genes12020159 · Cited by 26
“Cyclin-dependent kinase (CDK) 4/6 inhibitors in combination with endocrine therapy had been approved by the US Food and Drug Administration as a first-or second-line treatment of HR-positive/ HER2-negative breast cancer [3].”
MethodConcurrent inhibition of CDK2 adds to the anti-tumour activity of CDK4/6 inhibition in GIST
Schaefer, I., Hemming, M. L., Lundberg, M. Z., Serrata, M. P., Goldaracena, I., Liu, N., Yin, P., Paulo, J. A., Gygi, S. P., George, S., et al. (2022) · British Journal of Cancer · doi:10.1038/s41416-022-01990-5 · Cited by 31
“The CDK4/6 inhibitors palbociclib [15], abemaciclib [16] and ribociclib [17] have been FDA-approved for the treatment of breast cancer, in combination with aromatase inhibitors or oestrogen receptor antagonists, with impressive clinical activity, although the primary impact appears to be the induction of cell cycle ar…”
BackgroundChoupani, E., Madjd, Z., Saraygord‐Afshari, N., Kiani, J., & Hosseini, A. (2022) · PLoS ONE · doi:10.1371/journal.pone.0279522 · Cited by 28
“The proposed administration dose for Ribociclib is to start with 600 mg of the drug once a day; better to use it in combination with an aromatase inhibitor or fulvestrant [16].”
BackgroundMasurkar, P. P., Damgacioglu, H., Deshmukh, A. A., & Trivedi, M. V. (2023) · PharmacoEconomics · doi:10.1007/s40273-023-01245-y · Cited by 28
Discovery of CDK5 Inhibitors through Structure-Guided Approach
Khair, N. Z., Lenjisa, J. L., Tadesse, S., Kumarasiri, M., Basnet, S. K. C., Mekonnen, L. B., Li, M., Diab, S., Sykes, M. J., Albrecht, H., et al. (2019) · ACS Medicinal Chemistry Letters · doi:10.1021/acsmedchemlett.9b00029 · Cited by 28
Chandarlapaty, S., & Razavi, P. (2019) · Journal of Clinical Oncology · doi:10.1200/jco.19.00090 · Cited by 29
Cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors: existing and emerging differences
Johnston, S. R. D., Emde, A., Barrios, C. H., Srock, S., Neven, P., Martin, M., Cameron, D., Janni, W., & Gnant, M. (2023) · JNCI Cancer Spectrum · doi:10.1093/jncics/pkad045 · Cited by 30
Self-citationAromatase inhibitors: the journey from the state of the art to clinical open questions
Generali, D., Berardi, R., Caruso, M., Cazzaniga, M. E., Garrone, O., Minchella, I., Paris, I., Pinto, C., & Placido, S. D. (2023) · Frontiers in Oncology · doi:10.3389/fonc.2023.1249160 · Cited by 27
Sbitti, Y., Slimani, K. A., Debbagh, A., Mokhlis, A., Kadiri, H., Laraqui, A., Errihani, H. H., & Ichou, M. (2017) · World Journal of Oncology · doi:10.14740/wjon1043w · Cited by 27
“Large phase III randomized controlled trials have demonstrated the superior efficacy of these treatments compared to conventional endocrine monotherapies [9-12].”
BackgroundLu, Y., Lee, K. S., Chao, T.-Y., Tseng, L., Chitapanarux, I., Chen, S., Liu, C.-T., Sohn, J., Kim, J. H., Chang, Y., et al. (2020) · Clinical Cancer Research · doi:10.1158/1078-0432.ccr-20-1008 · Cited by 27
“Treatment options for premenopausal patients with HR+, HER2–, advanced breast cancer (ABC [includes locally advanced and metastatic disease]) remain limited, and are mostly inferred from trials that enrolled postmenopausal women (7-12).”
BackgroundSelf-citationPalma, F. D. E. D., Monaco, V. D., Pol, J. G., Kremer, M., D’Argenio, V., Stoll, G., Montanaro, D., Uszczyńska-Ratajczak, B., Klein, C. C., Vlasova, A. V., et al. (2020) · Pharmacological Research · doi:10.1016/j.phrs.2020.105249 · Cited by 27
Buller, W., Pallan, L., Chu, T., & Khoja, L. (2023) · Journal of Oncology Pharmacy Practice · doi:10.1177/10781552231163121 · Cited by 30
Investigational drugs for nasopharyngeal carcinoma
Ma, B. B. Y., Hui, E. P., & Chan, A. T. �. (2017) · Expert Opinion on Investigational Drugs · doi:10.1080/13543784.2017.1324568 · Cited by 27
“(RibociclibTM, Novartis) has been shown to improve PFS in hormone–receptor-positive breast cancer [65].”
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“…Institute for Health and Clinical Excellence (NICE) 13 was conducted and identified 2 relevant Phase III RCTs and 1 relevant Phase II RCT: MONALEESA-2 12 , RIBO and LET (CLEE011A2301 Clinical Study Report, Novartis Data on File); PALOMA-2 20 , PALBO and LET; and PALOMA-1 10 , PALBO and LET.”
Zhang, J., Zhang, Y., Tang, S., Jiang, L., He, Q., Hamblin, L. T., He, J., Wu, J., Wu, J., Chen, Y., et al. (2018) · BMJ Open · doi:10.1136/bmjopen-2017-017240 · Cited by 27
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Inhibition of CSF1R and AKT by (±)-kusunokinin hinders breast cancer cell proliferation
Rattanaburee, T., Tipmanee, V., Tedasen, A., Thongpanchang, T., & Graidist, P. (2020) · Biomedicine & Pharmacotherapy · doi:10.1016/j.biopha.2020.110361 · Cited by 28
Treatment of De-Differentiated Liposarcoma in the Era of Immunotherapy
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Overcoming Therapeutic Resistance of Triple Positive Breast Cancer with CDK4/6 Inhibition
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“Comparable efficacy in patients with HR+/HER2-metastatic breast cancer was demonstrated for ribociclib and letrozole combination in the MONALEESA-2 trial [79] and for abemaciclib and antihormonal therapy combination in theMONARCH-2 and MONARCH-3 clinical trials [80, 81].”
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CDK Inhibitors as Sensitizing Agents for Cancer Chemotherapy
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“…most patients with human epidermal growth factor receptor 2 negative (HER2−), HR+, advanced breast cancer (aBC) with substantial improvement in progression‐free survival (PFS) and overall response rate (ORR) and manageable toxicity (Finn et al., 2016; Goetz et al., 2017; Hortobagyi et al., 2016).”
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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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