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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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“Two CDK 4/6 inhibitors combined with endocrine therapy prolong PFS and are FDA approved in the first line setting: palbociclib (86,87) and ribociclib (88).”
BackgroundOverall Survival with Fulvestrant plus Anastrozole in Metastatic Breast Cancer
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“For example, the oncology drug ribociclib inhibited BSEP activity in vitro, and formed reactive metabolites that could be trapped using reduced glutathione and that bound covalently to human liver microsomal proteins.(104) Although quantitative comparisons between potencies of these in vitro effects and in vivo drug e…”
BackgroundCherny, N. I., de Vries, E. G. E., Dafni, U. G., Garrett-Mayer, E. S., McKernin, S. E., Piccart, M. J., Latino, N. J., Douillard, J.-Y., Schnipper, L. E., Somerfield, M. R., et al. (2019) · Journal of Clinical Oncology · doi:10.1200/jco.18.00729 · Cited by 125
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“In addition, the incidences of grade 3/4 AST and ALT increases were lower in TRINITI-1 than in the ribociclib arms of MONALEESA-2 or -3 (21, 22).”
BackgroundSelf-citationPalafox, M., Monserrat, L., Bellet, M., Villacampa, G. J., González-Pérez, A., Oliveira, M., Brasó‐Maristany, F., Ibrahimi, N., Kannan, S., Mina, L. B., et al. (2022) · Nature Communications · doi:10.1038/s41467-022-32828-6 · Cited by 126
“In closing, therapies for metastatic BC that progress on or after CDK4/6i treatment currently being tested in the clinic include: (1) ET or more potent SERDs in endocrine sensitive patients, albeit this patient population is difficult to identify (NCT02338349, NCT03616587); (2) continuation of CDK4/6i with a different…”
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The Evolving Role of the Estrogen Receptor Mutations in Endocrine Therapy-Resistant Breast Cancer
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Targeting the Estrogen Receptor for the Treatment of Breast Cancer: Recent Advances and Challenges
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Highlights in Resistance Mechanism Pathways for Combination Therapy
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Malorni, L., Curigliano, G., Minisini, A. M., Cinieri, S., Tondini, C. A., D’Hollander, K., Arpino, G., Bernardo, A., Martignetti, A., Criscitiello, C., et al. (2018) · Annals of Oncology · doi:10.1093/annonc/mdy214 · Cited by 109
O’Shaughnessy, J., Petráková, K., Sonke, G. S., Conte, P., Arteaga, C. L., Cameron, D., Hart, L. L., Villanueva, C., Jakobsen, E. H., Beck, J. T., et al. (2017) · Breast Cancer Research and Treatment · doi:10.1007/s10549-017-4518-8 · Cited by 112
“This predefined subgroup analysis of the MONALEESA-2 trial demonstrates that postmenopausal women with de novo HR+, HER2− advanced breast cancer at diagnosis who received ribociclib in combination with letrozole had prolonged progression-free survival compared with those who received placebo plus letrozole, with an ap…”
BackgroundMethodResultInfluentialSelf-citationAcquired resistance to aromatase inhibitors: where we stand!
Augusto, T. V., Correia‐da‐Silva, G., Rodrigues, C., Teixeira, N. A. A., & Amaral, C. (2018) · Endocrine Related Cancer · doi:10.1530/erc-17-0425 · Cited by 114
Kwan, T. T., Bardia, A., Spring, L. M., Giobbie‐Hurder, A., Kalinich, M., Dubash, T. D., Sundaresan, T. K., Hong, X., LiCausi, J. A., Ho, U. K., et al. (2018) · Cancer Discovery · doi:10.1158/2159-8290.cd-18-0432 · Cited by 113
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“In MONALEESA 2, QT prolongation led to dose adjustments in < 1% of treated patients [23].”
BackgroundZhang, P., Zhang, Q., Tong, Z., Sun, T., Li, W., Ouyang, Q., Hu, X., Cheng, Y., Yan, M., Pan, Y., et al. (2023) · The Lancet Oncology · doi:10.1016/s1470-2045(23)00172-9 · Cited by 112
O’Brien, N. A., Conklin, D. F., Beckmann, R. P., Luo, T., Chau, K., Thomas, J. D., Nulty, A. M., Marchal, C. C., Kalous, O., von Euw, E., et al. (2018) · Molecular Cancer Therapeutics · doi:10.1158/1535-7163.mct-17-0290 · Cited by 108
“ERþ/HER2 metastatic breast cancer (13, 21–23) and subsequently, a second CDK4/6 inhibitor, ribociclib in the same breast cancer subtype (15).”
BackgroundLiu, D. (2019) · Journal of Hematology & Oncology · doi:10.1186/s13045-019-0819-1 · Cited by 112
Zhang, Q. Y., Sun, T., Yin, Y. M., Li, H. P., Yan, M., Tong, Z. S., Oppermann, C. P., Liu, Y. P., Costa, R. L. D. P., Li, M., et al. (2020) · Therapeutic Advances in Medical Oncology · doi:10.1177/1758835920963925 · Cited by 107
CDK inhibitors from past to present: A new wave of cancer therapy
Jameel, M., Bhadresha, K. P., & Kwok, H. F. (2022) · Seminars in Cancer Biology · doi:10.1016/j.semcancer.2022.12.006 · Cited by 111
Ribociclib: First Global Approval
Syed, Y. Y. (2017) · Drugs · doi:10.1007/s40265-017-0742-0 · Cited by 103
Nexus between PI3K/AKT and Estrogen Receptor Signaling in Breast Cancer
Khatpe, A. S., Adebayo, A. K., Herodotou, C., Kumar, B., & Nakshatri, H. (2021) · Cancers · doi:10.3390/cancers13030369 · Cited by 107
“In the MONARCH-3 trial, abemaciclib with a nonsteroidal AI was used in postmenopausal ERα+ breast cancer and this treatment regime was associated with significantly increased median PFS [148].”
MethodInfluentialDieras, V. C., Rugo, H. S., Schnell, P., Gelmon, K. A., Cristofanilli, M., Loi, S., Colleoni, M. A., Lu, D. R., Mori, A., Gauthier, E. R., et al. (2018) · JNCI Journal of the National Cancer Institute · doi:10.1093/jnci/djy109 · Cited by 105
“With regard to QTc prolongation, which has been shown to be a concern with certain CDK4/6 inhibitors, even in patients not considered to be at high risk for such an event (14), the recent results for corrected QT (QTc) evaluations in PALOMA-2 patients indicated that palbociclib plus letrozole does not prolong QTc to a…”
ResultSlamon, D. J., Fasching, P. A., Hurvitz, S. A., Chia, S., Crown, J. P., Martín, M., Barrios, C. H., Bardia, A., Im, S., Yardley, D. A., et al. (2023) · Therapeutic Advances in Medical Oncology · doi:10.1177/17588359231178125 · Cited by 110
“60 61–63 The 400-mg starting dose of ribociclib in the adjuvant setting, in the absence of tumor burden, is expected to improve the tolerability of ribociclib further by reducing dose-dependent AEs, potentially leading to improved adherence without compromising the intended efficacy.”
BackgroundSelf-citationMayer, I. A., Prat, A., Egle, D., Blau, S. H., Fidalgo, J. A. P., Gnant, M., Fasching, P. A., Colleoni, M. A., Wolff, A. C., Winer, E. P., et al. (2019) · Clinical Cancer Research · doi:10.1158/1078-0432.ccr-18-3160 · Cited by 100
“The combination of targeted therapy and endocrine therapy in metastatic HRþ breast cancer has improved clinical outcomes such as progression-free survival (10, 11); however, the question of whether combining targeted agents with endocrine therapy can further improve treatment outcomes in the neoadjuvant setting is sti…”
BackgroundSelf-citationColón‐Otero, G., Zanfagnin, V., Hou, X., Foster, N. R., Asmus, E. J., Hendrickson, A. W., Jatoi, A., Block, M. S., Langstraat, C., Glaser, G. E., et al. (2020) · ESMO Open · doi:10.1136/esmoopen-2020-000926 · Cited by 99
A Combination CDK4/6 and IGF1R Inhibitor Strategy for Ewing Sarcoma
Guenther, L. M., Dharia, N. V., Ross, L. S., Conway, A. S., Robichaud, A. L., Catlett, J. L., Wechsler, C. S., Frank, E. S., Goodale, A. B., Church, A. J., et al. (2018) · Clinical Cancer Research · doi:10.1158/1078-0432.ccr-18-0372 · Cited by 95
“Clin Cancer Res; 25(4) February 15, 2019 Clinical Cancer Research 1348”
BackgroundInfluentialIntrinsic and acquired resistance to CDK4/6 inhibitors and potential overcoming strategies
Xu, X., Pan, X., Wang, T., Wang, J., Yang, B., He, Q., & Ding, L. (2020) · Acta Pharmacologica Sinica · doi:10.1038/s41401-020-0416-4 · Cited by 103
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Kalinsky, K. M., Bianchini, G., Hamilton, E. P., Graff, S. L., Park, K. H., Jeselsohn, R. M., Demırcı, U., Martín, M., Layman, R. M., Hurvitz, S. A., et al. (2024) · Journal of Clinical Oncology · doi:10.1200/jco-24-02086 · Cited by 108
Niu, Y., Xu, J., & Sun, T. (2019) · Journal of Cancer · doi:10.7150/jca.32628 · Cited by 102
“668 postmenopausal HR-positive and HER2-negative ABC patients who had not received prior treatment were randomized 1:1 to receive ribociclib plus letrozole or placebo plus letrozole [68].”
MethodAhlin, C., Lundgren, C., Varro, E. E., Jirström, K., BLOMQVIST, C. P., & Fjällskog, M.-L. (2017) · Breast Cancer Research and Treatment · doi:10.1007/s10549-017-4294-5 · Cited by 95
“inhibitors palbociclib [65, 66] or ribociclib [67] have shown impressive results in ER-positive breast cancer combined with letrozole [66, 67] or fulvestrant [65].”
BackgroundMiglietta, F., Bottosso, M., Griguolo, G., Dieci, M. V., & Guarneri, V. (2022) · ESMO Open · doi:10.1016/j.esmoop.2022.100409 · Cited by 99
Clinical Implications of ESR1 Mutations in Hormone Receptor-Positive Advanced Breast Cancer
Reinert, T., Saad, E. D., Barrios, C. H., & Bines, J. (2017) · Frontiers in Oncology · doi:10.3389/fonc.2017.00026 · Cited by 97
“Data from clinical trials demonstrating clinical benefits have been reported for two other inhibitors of CDK4 and CDK6 (namely, ribociclib and abemaciclib) (42, 48).”
BackgroundInhibiting CDK in Cancer Therapy: Current Evidence and Future Directions
Vijayaraghavan, S., Moulder, S., Keyomarsi, K., & Layman, R. M. (2017) · Targeted Oncology · doi:10.1007/s11523-017-0541-2 · Cited by 93
Kim, S., Tiedt, R., Loo, A. T., Horn, T. L., Delach, S. M., Kovats, S., Haas, K., Engstler, B. S., Cao, Z. A., Pinzon-Ortiz, M. C., et al. (2018) · Oncotarget · doi:10.18632/oncotarget.26215 · Cited by 95
Transcription and Translation Inhibitors in Cancer Treatment
Laham-Karam, N., Pinto, G., Poso, A., & Kokkonen, P. (2020) · Frontiers in Chemistry · doi:10.3389/fchem.2020.00276 · Cited by 93
“It showed similar efficacy to palbociclib with a similar toxicity profile, with the addition of higher hepatotoxicity and rare cardiac QT time prolongation effects (Hortobagyi et al., 2016).”
BackgroundBurris, H. A., Chan, A., Bardia, A., Beck, J. T., Sohn, J., Neven, P., Tripathy, D., Im, S., Chia, S., Esteva, F. J., et al. (2021) · British Journal of Cancer · doi:10.1038/s41416-021-01415-9 · Cited by 99
Self-citationYeruva, S. L. H., Zhao, F., Miller, K. D., Tevaarwerk, A. J., Wagner, L. I., Gray, R. J., Sparano, J. A., & Connolly, R. M. (2018) · npj Breast Cancer · doi:10.1038/s41523-017-0053-3 · Cited by 96
“The primary objective of E2112 is to determine whether the addition of entinostat to exemestane improves PFS and/or OS in patients with HR-positive and HER2-negative locally advanced or metastatic breast cancer who have progressed on prior nonsteroidal AI.”
ResultInfluentialVerma, S., O’Shaughnessy, J., Burris, H. A., Campone, M., Alba, E., Chandiwana, D., Dalal, A. A., Sutradhar, S., Monaco, M., & Janni, W. (2018) · Breast Cancer Research and Treatment · doi:10.1007/s10549-018-4769-z · Cited by 95
“Table 1 Patient demographics and baseline characteristics [4]”
BackgroundInfluentialSelf-citation
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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