The DOI matches its Crossref record; 24 of the 24 references it cites were found in a registry or an index.
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 .).
Overview
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Integrity signals
Registry
Cites
Statistics
Verification
Claims the paper makes
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
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
“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
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
The self-check needs the paper’s full text.
Citations
Cites
New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1)
Eisenhauer, E. A., Therasse, P., Bogaerts, J., Schwartz, L. H., Sargent, D., Ford, R., Dancey, J., Arbuck, S., Gwyther, S., Mooney, M., et al. (2009) · European Journal of Cancer · doi:10.1016/j.ejca.2008.10.026 · Cited by 29,534
Comprehensive molecular portraits of human breast tumours
The Cancer Genome Atlas Network (2012) · Nature · doi:10.1038/nature11412 · Cited by 12,129
Toxicity and response criteria of the Eastern Cooperative Oncology Group
Oken, M. M., Creech, R. H., Tormey, D. C., Horton, J., Davis, T. E., Mcfadden, E. T., & Carbone, P. P. (1982) · American Journal of Clinical Oncology · doi:10.1097/00000421-198212000-00014 · Cited by 11,686
Peto, R., Pike, M. C., Armitage, P., Breslow, N. E., Cox, D. R., Howard, S. V., Mantel, N., McPherson, K., Peto, J., & Smith, P. G. (1976) · British Journal of Cancer · doi:10.1038/bjc.1976.220 · Cited by 2,294
Finn, R. S., Crown, J. P., Lang, I., Boer, K., Bondarenko, I. M., Kulyk, S. O., Ettl, J., Patel, R., Pinter, T., Schmidt, M., et al. (2015) · The Lancet Oncology · doi:10.1016/s1470-2045(14)71159-3 · Cited by 1,900
Cristofanilli, M., Turner, N. C., Bondarenko, I., Ro, J., Im, S.-A., Masuda, N., Colleoni, M., DeMichele, A., Loi, S., Verma, S., et al. (2016) · The Lancet Oncology · doi:10.1016/s1470-2045(15)00613-0 · Cited by 1,827
Self-citationPalbociclib in hormone-receptor-positive advanced breast cancer
Turner, N. C., Ro, J., André, F., Loi, S., Verma, S., Iwata, H., Harbeck, N., Loibl, S., Huang Bartlett, C., Zhang, K., et al. (2015) · New England Journal of Medicine · doi:10.1056/nejmoa1505270 · Cited by 1,590
Self-citationMECHANISMS OF ENDOCRINE RESISTANCE IN BREAST CANCER
Osborne, C., & Schiff, R. (2011) · Annual Review of Medicine · doi:10.1146/annurev-med-070909-182917 · Cited by 1,205
Di Leo, A., Jerusalem, G., Petruzelka, L., Torres, R., Bondarenko, I. N., Khasanov, R., Verhoeven, D., Pedrini, J. L., Smirnova, I., Lichinitser, M. R., et al. (2010) · Journal of Clinical Oncology · doi:10.1200/jco.2010.28.8415 · Cited by 636
Anderson, W. F., Chatterjee, N., Ershler, W. B., & Brawley, O. W. (2002) · Breast Cancer Research and Treatment · doi:10.1023/a:1020299707510 · Cited by 589
Research works printed but not linked: 2
- Infante JR, Clin Cancer Res
- Vuppalanchi R, Hepatology
Cited by
Sorted by citations
Items 301–400 of 1,000
Hartkopf, A. D., Huober, J., Volz, B., Nabieva, N., Taran, F., Schwitulla, J., Overkamp, F., Kolberg, H., Hadji, P., Tesch, H., et al. (2017) · The Breast · doi:10.1016/j.breast.2017.10.002 · Cited by 61
Self-citationHorr, C., & Buechler, S. A. (2021) · npj Breast Cancer · doi:10.1038/s41523-021-00345-2 · Cited by 63
Fradley, M. G., Nguyen, N., Madnick, D. L., Chen, Y., DeMichele, A. M., Makhlin, I., Dent, S. F., Lefebvre, B., Carver, J. R., Upshaw, J. N., et al. (2023) · Journal of the American Heart Association · doi:10.1161/jaha.123.029361 · Cited by 61
“17 With the exception of ribociclib-induced QTc prolongation, 4 there is otherwise a paucity of data regarding the incidence of CVAEs and outcomes with the use of these agents.”
Personalizing Adjuvant Endocrine Therapy for Early-Stage Hormone Receptor–Positive Breast Cancer
Pistilli, B., Lohrisch, C. A., Sheade, J. B., & Fleming, G. F. (2022) · American Society of Clinical Oncology Educational Book · doi:10.1200/edbk_350358 · Cited by 64
Im, S., Gennari, A., Park, Y. H., Kim, J. H., Jiang, Z., Gupta, S., Fadjari, T. H., Tamura, K., Mastura, M. Y., Abesamis-Tiambeng, M. L. T., et al. (2023) · ESMO Open · doi:10.1016/j.esmoop.2023.101541 · Cited by 62
Self-citationKim, S. S., Armand, J., Safonov, A. M., Zhang, M., Soni, R. K., Schwartz, G. K., McGuinness, J. E., Hibshoosh, H. H., Razavi, P., Kim, M., et al. (2023) · Cell Reports · doi:10.1016/j.celrep.2023.113198 · Cited by 64
“8,13 Moreover, CDK4/6i monotherapy is ineffective in treating patients with metastatic triple-negative breast cancer (TNBC), the most aggressive subtype.”
BackgroundResistance mechanisms and therapeutic strategies of CDK4 and CDK6 kinase targeting in cancer
Asciolla, J. J., Wu, X., Adamopoulos, C., Gavathiotis, E., & Poulikakos, P. I. (2025) · Nature Cancer · doi:10.1038/s43018-024-00893-z · Cited by 66
“Ribociclib (LEE011, Novartis) 48–50 , the second CDK4/6 inhibitor to gain FDA approval, is structurally related to palbociclib and demonstrates a similar therapeutic profile and comparable adverse effects, most notably neutropenia, which is reversible after a week-long drug holi-day 51 .”
Neuroendocrine breast carcinoma: a rare but challenging entity
Trevisi, E., Salvia, A. L., Daniele, L., Brizzi, M. P., Rosa, G. D., Scagliotti, G. V., & Maïo, M. D. (2020) · Medical Oncology · doi:10.1007/s12032-020-01396-4 · Cited by 61
Wu, H., & Chu, P. (2021) · International Journal of Molecular Sciences · doi:10.3390/ijms22020636 · Cited by 59
Enserink, J. M., & Chymkowitch, P. (2022) · International Journal of Molecular Sciences · doi:10.3390/ijms23031293 · Cited by 60
The Growing Role of CDK4/6 Inhibitors in Treating Hormone Receptor-Positive Advanced Breast Cancer
Shah, A. N., & Cristofanilli, M. (2017) · Current Treatment Options in Oncology · doi:10.1007/s11864-017-0443-7 · Cited by 62
Inhibitors targeting CDK4/6, PARP and PI3K in breast cancer: a review
Husna, S. M. N., Tan, H. T., Mohamud, R., Dyhl-Polk, A., & Wong, K. K. (2018) · Therapeutic Advances in Medical Oncology · doi:10.1177/1758835918808509 · Cited by 61
Martin, J., Handorf, E. A., Montero, A. J., & Goldstein, L. J. (2022) · The Oncologist · doi:10.1093/oncolo/oyac075 · Cited by 59
Inhibition of nuclear Wnt signalling: challenges of an elusive target for cancer therapy
Lyou, Y., Habowski, A. N., Chen, G. T., & Waterman, M. L. (2017) · British Journal of Pharmacology · doi:10.1111/bph.13963 · Cited by 56
“…on inhibitors of cyclin-dependent kinases (CDK) CDK4 and CDK6, rather than directly targeting CCND1, has been successful and led to two FDA-approved drugs (palbociclib and ribociclib) for patients with advanced breast cancer (Finn et al., 2015, 2016; Turner et al., 2015; Hortobagyi et al., 2016).”
To Cycle or Fight—CDK4/6 Inhibitors at the Crossroads of Anticancer Immunity
Ameratunga, M., Kipps, E., Okines, A. F. C., & Lopez, J. S. (2018) · Clinical Cancer Research · doi:10.1158/1078-0432.ccr-18-1999 · Cited by 61
“Subsequent larger phase III trials have not only confirmed these results (7, 39, 40), but also extended the proof of principle of synergy in combining other CDK4/6 inhibitors with the selective ER degrader, fulvestrant (41, 42), or the antiestrogen, tamoxifen (40, 43).”
BackgroundMcCartney, A., Bonechi, M., Luca, F. D., Biagioni, C., Curigliano, G., Moretti, E., Minisini, A. M., Bergqvist, M., Benelli, M., Migliaccio, I., et al. (2020) · Clinical Cancer Research · doi:10.1158/1078-0432.ccr-19-3271 · Cited by 61
“Similarly, 12% of patients assigned to ribociclib plus letrozole in MONALEESA-2 recorded censored events within the first 2 months of trial entry (2), and of those on the abemaciclib arm of MONARCH-3, 17% incurred censored observations within the first 4 months (3).”
BackgroundCook, M. M., Rabadi, L. S. A., Kaempf, A. J., Saraceni, M. M., Savin, M. A., & Mitri, Z. I. (2020) · The Oncologist · doi:10.1002/onco.13609 · Cited by 57
Epigenetic Therapies and Biomarkers in Breast Cancer
Brown, L. J., Achinger-Kawecka, J., Portman, N., Clark, S. J., Stirzaker, C., & Lim, E. (2022) · Cancers · doi:10.3390/cancers14030474 · Cited by 64
Long-term breast cancer response to CDK4/6 inhibition defined by TP53-mediated geroconversion
Kudo, R., Safonov, A. M., Jones, C., Moiso, E., Dry, J. R., Shao, H., Nag, S., da Silva, E. M., Yildirim, S. Y., Li, Q., et al. (2024) · Cancer Cell · doi:10.1016/j.ccell.2024.09.009 · Cited by 61
“In HR+ breast cancer, CDK4/6i are standard of care promoting relapse free and overall survival (6-11).”
Everolimus-based combination therapies for HR+, HER2− metastatic breast cancer
O’Shaughnessy, J., Beck, J. T., & Royce, M. (2018) · Cancer Treatment Reviews · doi:10.1016/j.ctrv.2018.07.013 · Cited by 61
Self-citationHuemer, F., Leisch, M., Geisberger, R., Melchardt, T., Rinnerthaler, G., Zaborsky, N., & Greil, R. (2020) · International Journal of Molecular Sciences · doi:10.3390/ijms21082856 · Cited by 60
Cousins, E. M., Goldfarb, D., Yan, F., Roques, J., Darr, D., Johnson, G. L., & Major, M. B. (2017) · Molecular Cancer Research · doi:10.1158/1541-7786.mcr-17-0468 · Cited by 59
“Neutropenia and leukopenia were the most commonly reported grade 3 or 4 adverse event in ribociclib-treated patients in a recent phase III trial (40).”
BackgroundPrecision Oncology, Signaling, and Anticancer Agents in Cancer Therapeutics
Advani, D., Sharma, S., Kumari, S., Ambasta, R. K., & Kumar, P. (2021) · Anti-Cancer Agents in Medicinal Chemistry · doi:10.2174/1871520621666210308101029 · Cited by 63
Functional Genomic Analysis of CDK4 and CDK6 Gene Dependency across Human Cancer Cell Lines
Zhang, Z., Golomb, L., & Meyerson, M. M. (2022) · Cancer Research · doi:10.1158/0008-5472.can-21-2428 · Cited by 57
Luo, L., Yang, P., Mastoraki, S., Rao, X., Wang, Y., Kettner, N. M., Raghavendra, A. S., Tripathy, D., Damodaran, S., Hunt, K. K., et al. (2025) · Molecular Cancer · doi:10.1186/s12943-025-02226-9 · Cited by 59
participants, O. B. O. T. I. T., Palmieri, C., Stein, R. C., Liu, X., Hudson, E., Nicholas, H., Sasano, H., Guestini, F., Holcombe, C., Barrett, S., et al. (2017) · Breast Cancer Research and Treatment · doi:10.1007/s10549-017-4328-z · Cited by 57
“More recently, it has been demonstrated that the addition of either an mTOR inhibitor or a CDK4/6 inhibitor to an AI can significantly improve the outcomes of women with ER-positive metastatic breast cancer [17, 35].”
BackgroundBonechi, M., Galardi, F., Biagioni, C., Luca, F. D., Bergqvist, M., Neumüller, M., Guarducci, C., Boccalini, G., Gabellini, S., Migliaccio, I., et al. (2018) · Oncotarget · doi:10.18632/oncotarget.24700 · Cited by 55
Neoadjuvant Therapy for Breast Cancer: Established Concepts and Emerging Strategies
Steenbruggen, T. G., van Ramshorst, M. S., Kok, M., Linn, S. C., Smorenburg, C. H., & Sonke, G. S. (2017) · Drugs · doi:10.1007/s40265-017-0774-5 · Cited by 57
“At this moment, palbociclib in combination with letrozole or fulvestrant [77] is approved by the FDA and EMA for treatment of women with hormone receptor- positive/HER2-negative MBC. Ribociclib in combination with an AI is also approved by the FDA and is currently under review by the EMA [74].”
BackgroundSelf-citationTostivint, E. P., Kirova, Y., Lusque, A., Campone, M., Geffrelot, J., Mazouni, C., Mailliez, A., Pasquier, D., Madranges, N., Firmin, N., et al. (2018) · Annals of Surgical Oncology · doi:10.1245/s10434-018-6831-9 · Cited by 56
Self-citationThein, K. Z., Htut, T. W., Ball, S., Swarup, S., Sultan, A., & Oo, T. H. (2020) · Breast Cancer Research and Treatment · doi:10.1007/s10549-020-05783-3 · Cited by 56
“…3 (Cristofanilli et al., 2016) + + + + + + MONARCH 2 (Sledge et al., 2017) + + + + + + MONARCH 3 (Goetz et al., 2017) + + + + + + MONALEESA 2 (Hortobagyi et al., 2016) + + + + + + MONALEESA 3 (Slamon et al., 2018) + + + + + + MONALEESA 7 (Tripathy et al., 2018) + + + + + + Abbreviations: +…”
BackgroundMolecular Mechanisms of Anti-Estrogen Therapy Resistance and Novel Targeted Therapies
Özyurt, R., & Özpolat, B. (2022) · Cancers · doi:10.3390/cancers14215206 · Cited by 55
“The combination of standard anti-estrogen therapy with these inhibitors improved survival rates in patients with ER+ BC [242,245,246].”
BackgroundBrägelmann, J., Dammert, M. A., Dietlein, F., Heuckmann, J. M., Choidas, A., Böhm, S., Richters, A., Basu, D., Tischler, V., Lorenz, C., et al. (2017) · Cell Reports · doi:10.1016/j.celrep.2017.08.082 · Cited by 53
“…reported high rates of side effects and dose-limiting toxicities (Kumar et al., 2015; Morales and Giordano, 2016), but more selective compounds such as ri- bociclib (CDK4 and CDK6) demonstrated the feasibility of CDK inhibition even as first-line cancer treatment (Hortobagyi et al., 2016).”
BackgroundCurrent Therapeutic Progress of CDK4/6 Inhibitors in Breast Cancer
Wu, Y., Zhang, Y., Pi, H., & Sheng, Y. (2020) · Cancer Management and Research · doi:10.2147/cmar.s250632 · Cited by 56
A role of FDG-PET/CT for response evaluation in metastatic breast cancer?
Hildebrandt, M. G., Naghavi‐Behzad, M., & Vogsen, M. (2022) · Seminars in Nuclear Medicine · doi:10.1053/j.semnuclmed.2022.03.004 · Cited by 55
Navarro-Yepes, J., Kettner, N. M., Rao, X., Bishop, C. S., Bui, T. N., Wingate, H. F., Raghavendra, A. S., Wang, Y., Wang, J., Şahin, A. A., et al. (2023) · Cancer Research · doi:10.1158/0008-5472.can-23-0705 · Cited by 55
Kassem, L. M. H., Shohdy, K. S., Lasheen, S., Abdel-Rahman, O. M., & Bachelot, T. (2017) · Breast Cancer · doi:10.1007/s12282-017-0818-4 · Cited by 53
Self-citationUpdate on cardio-oncology: Novel cancer therapeutics and associated cardiotoxicities
Guha, A., Armanious, M. A., & Fradley, M. G. (2018) · Trends in Cardiovascular Medicine · doi:10.1016/j.tcm.2018.06.001 · Cited by 54
Liu, D., Wu, J., Lin, C., Andriani, L., Ding, S., Shen, K., & Zhu, L. (2020) · Frontiers in Oncology · doi:10.3389/fonc.2020.580112 · Cited by 53
Rose, T. L., Chism, D. D., Alva, A. S., Deal, A. M., Maygarden, S. J., Whang, Y. E., Kardos, J., Drier, A., Basch, E., Godley, P. A., et al. (2018) · British Journal of Cancer · doi:10.1038/s41416-018-0229-0 · Cited by 52
Clinicopathologic Features of Acute Kidney Injury Associated With CDK4/6 Inhibitors
Gupta, S., Caza, T. N., Herrmann, S. M., Sakhiya, V., & Jhaveri, K. D. (2021) · Kidney International Reports · doi:10.1016/j.ekir.2021.11.033 · Cited by 53
“Hypophosphatemia 0 (0) 7 (4) 0 (0) 7 (3)”
Sartaj, A., Annu, Biswas, L., Verma, A. K., Sahoo, P. K., Baboota, S., & Ali, J. (2022) · BioMed Research International · doi:10.1155/2022/6009309 · Cited by 56
“Because of this, the cell cycle is apprehended, inhibiting the cancer cell growth [3, 4].”
Recent Advances in CDK Inhibitors for Cancer Therapy
Heptinstall, A. B., Adiyasa, I., Cano, C., & Hardcastle, I. R. (2018) · Future Medicinal Chemistry · doi:10.4155/fmc-2017-0246 · Cited by 52
Endocrine Therapy for Breast Cancer: A Model of Hormonal Manipulation
Johnston, S. J., & Cheung, K. (2018) · Oncology and Therapy · doi:10.1007/s40487-018-0062-x · Cited by 52
Ribociclib plus letrozole and concomitant palliative radiotherapy for metastatic breast cancer
Meattini, I., Desideri, I., Scotti, V., Simontacchi, G., & Livi, L. (2018) · The Breast · doi:10.1016/j.breast.2018.08.096 · Cited by 52
“profile of the combined approach in line with main published data [1,4,5].”
ResultEndocrine Therapy for Breast Cancer in the Primary Care Setting
Awan, A. A., & Esfahani, K. (2018) · Current Oncology · doi:10.3747/co.25.4139 · Cited by 53
Xu, B., Sun, T., Zhang, Q., Zhang, P., Yuan, Z., Jiang, Z., Wang, X., Cui, S., Teng, Y., Hu, X., et al. (2020) · Annals of Oncology · doi:10.1016/j.annonc.2020.10.600 · Cited by 50
The evolution of cyclin dependent kinase inhibitors in the treatment of cancer
Jhaveri, K. L., Burris, H. A., Yap, T. A., Hamilton, E. P., Rugo, H. S., Goldman, J. W., Dann, S. G., Liu, F., Wong, G. Y., Krupka, H. I., et al. (2021) · Expert Review of Anticancer Therapy · doi:10.1080/14737140.2021.1944109 · Cited by 56
“Ribociclib has been associated with corrected QT (QTc) interval prolongation [41] and hepatobiliary toxicity [79], which requires additional monitoring.”
Self-citationNMR-Fragment Based Virtual Screening: A Brief Overview
Singh, M., Tam, B., & Akabayov, B. (2018) · Molecules · doi:10.3390/molecules23020233 · Cited by 54
“LEE011 (ribociclib) [51] Novartis/Astex Cyclic dependent kinase CDK4/6 (Breast cancer) Approved X-ray Crystallography Vemurafenib [131] Plexxikon B-Raf-V600E (metastatic melanoma) Approved HCS/X-ray”
BackgroundBardia, A., Gucalp, A., DaCosta, N., Gabrail, N. Y., Danso, M. A., Ali, H. Y., Blackwell, K., Carey, L., Eisner, J. R., Baskin-Bey, E. S., et al. (2018) · Breast Cancer Research and Treatment · doi:10.1007/s10549-018-4813-z · Cited by 53
Self-citationNagaraj, G., & Ma, C. X. (2020) · Advances in Therapy · doi:10.1007/s12325-020-01552-2 · Cited by 51
Molecular Biomarkers for Contemporary Therapies in Hormone Receptor-Positive Breast Cancer
Freelander, A., Brown, L. J., Parker, A. J., Segara, D., Portman, N., Lau, B., & Lim, E. (2021) · Genes · doi:10.3390/genes12020285 · Cited by 52
“Reference [31] [32] [19] [17] [16] [33] [34] [35]”
Pharmacogenomics in the era of next generation sequencing – from byte to bedside
Russell, L. E., Zhou, Y., Almousa, A. A., Sodhi, J. K., Nwabufo, C. K., & Lauschke, V. M. (2021) · Drug Metabolism Reviews · doi:10.1080/03602532.2021.1909613 · Cited by 52
Cyclin-Dependent Kinase 4 and 6 Inhibitors in Cell Cycle Dysregulation for Breast Cancer Treatment
Susanti, N. M. P., & Tjahjono, D. H. (2021) · Molecules · doi:10.3390/molecules26154462 · Cited by 49
“Ribociclib (7-cyclopentyl-N,N-dimethyl-2-[(5-piperazin-1-ylpyridin-2-yl)amino]pyrrol o[2,3-d]pyrimidine-6-carboxamide) is also an FDA-approved CDK4/CDK6 inhibitor combined with a fulvestrant or aromatase inhibitor for ER-positive/HER2-negative advanced breast cancer treatment in postmenopausal women [84,101].”
BackgroundInhibition of CK1ε potentiates the therapeutic efficacy of CDK4/6 inhibitor in breast cancer
Dang, F., Nie, L., Zhou, J. R., Shimizu, K., Chu, C., Wu, Z., Fassl, A., Ke, S., Wang, Y., Zhang, J., et al. (2021) · Nature Communications · doi:10.1038/s41467-021-25700-6 · Cited by 52
Targeting CDK4 and 6 in Cancer Therapy: Emerging Preclinical Insights Related to Abemaciclib
Wander, S. A., O’Brien, N. A., Litchfield, L. M., O’Dea, D., Guimaraes, C. M., Slamon, D. J., & Goel, S. (2022) · The Oncologist · doi:10.1093/oncolo/oyac138 · Cited by 49
Grinshpun, A., Tolaney, S. M., Burstein, H. J., Jeselsohn, R. M., & Mayer, E. L. (2023) · npj Breast Cancer · doi:10.1038/s41523-023-00520-7 · Cited by 49
Naci, H., Zhang, Y., Woloshin, S., Guan, X., Xu, Z., & Wagner, A. K. (2024) · The Lancet Oncology · doi:10.1016/s1470-2045(24)00152-9 · Cited by 52
Cell cycle machinery in oncology: A comprehensive review of therapeutic targets
Cavalu, S. D., Abdelhamid, A. M., Saber, S., Elmorsy, E. A., Hamad, R. S., Abdel‐Reheim, M. A., Yahya, G., & Salama, M. M. (2024) · The FASEB Journal · doi:10.1096/fj.202400769r · Cited by 57
Neoadjuvant Trials in ER+ Breast Cancer: A Tool for Acceleration of Drug Development and Discovery
Zotano, Á. G., & Arteaga, C. L. (2017) · Cancer Discovery · doi:10.1158/2159-8290.cd-17-0228 · Cited by 49
“Conversely, the high activity of palbociclib in the neoadjuvant setting (39, 40) supports two large ongoing phase III adjuvant trials: the PENELOPE-B study of standard endocrine therapy ± palbociclib for one year in patients with ER+ breast cancer and residual disease after neoadjuvant chemotherapy (NCT01864746); and…”
Self-citationBreast Cancer in the Central Nervous System: Multidisciplinary Considerations and Management
Lin, N., Gaspar, L. E., & Soffietti, R. (2017) · American Society of Clinical Oncology Educational Book · doi:10.1200/edbk_175338 · Cited by 48
Cortés, J., Im, S., Holgado, E., Pérez-García, J. M., Schmid, P., & Chávez‐MacGregor, M. (2017) · Cancer Treatment Reviews · doi:10.1016/j.ctrv.2017.09.011 · Cited by 48
Immunotherapy in pancreatic adenocarcinoma—overcoming barriers to response
Rosenberg, A. J., & Mahalingam, D. (2018) · Journal of Gastrointestinal Oncology · doi:10.21037/jgo.2018.01.13 · Cited by 48
“In breast cancer, inhibitors of CDK4/6 demonstrated efficacy in combination with endocrine therapy for hormone-responsive breast cancer in the metastatic setting (126,127).”
BackgroundJanni, W., Alba, E., Bachelot, T., Diab, S., Gil‐Gil, M., Beck, T., Ryvo, L., López‐López, R., Tsai, M. L., Esteva, F. J., et al. (2018) · Breast Cancer Research and Treatment · doi:10.1007/s10549-017-4658-x · Cited by 49
Self-citationBeyond the Cell Cycle: Enhancing the Immune Surveillance of Tumors Via CDK4/6 Inhibition
Chaikovsky, A. C., & Sage, J. (2018) · Molecular Cancer Research · doi:10.1158/1541-7786.mcr-18-0201 · Cited by 50
CDK4/6 inhibitors in breast cancer: beyond hormone receptor-positive HER2-negative disease
Matutino, A. R. B., Amaro, C. P., & Verma, S. (2018) · Therapeutic Advances in Medical Oncology · doi:10.1177/1758835918818346 · Cited by 49
Self-citationVernieri, C., Corti, F., Nichetti, F., Ligorio, F., Manglaviti, S., Zattarin, E., Rea, C. G., Capri, G., Bianchi, G., & de Braud, F. (2020) · Breast Cancer Research · doi:10.1186/s13058-020-01271-0 · Cited by 51
Managing therapeutic resistance in breast cancer: from the lncRNAs perspective
Peng, L., Jiang, J., Tang, B., Nice, E. C., Zhang, Y., & Xie, N. (2020) · Theranostics · doi:10.7150/thno.49922 · Cited by 48
“CDK4/6 inhibitors such as palbociclib [97], ribociclib [98] and abemaciclib [99] combined with endocrine agents have exhibited significant PFS benefit and are approved by the FDA as the standard treatment for ER+, HER2- advanced BC patients (Figure 1).”
BackgroundTargeting Aberrant FGFR Signaling to Overcome CDK4/6 Inhibitor Resistance in Breast Cancer
Sobhani, N., Fassl, A., Mondani, G., Generali, D., & Otto, T. (2021) · Cells · doi:10.3390/cells10020293 · Cited by 49
Targeted Therapeutic Options and Future Perspectives for HER2-Positive Breast Cancer
Ferrando‐Díez, A., Felip, E., Pous, A., Bergamino, M. A., & Vila, M. M. (2022) · Cancers · doi:10.3390/cancers14143305 · Cited by 48
Ongoing unmet needs in treating estrogen receptor-positive/HER2-negative metastatic breast cancer
Başaran, G., Twelves, C. J., Dieras, V. C., Cortés, J., & Awada, A. H. (2017) · Cancer Treatment Reviews · doi:10.1016/j.ctrv.2017.12.002 · Cited by 49
Preusser, M., Mattos‐Arruda, L. D., Thill, M., Criscitiello, C., Bartsch, R., Ruhstaller, T., de Azambuja, E., & Zielinski, C. C. (2018) · ESMO Open · doi:10.1136/esmoopen-2018-000368 · Cited by 47
Xiong, Y., Li, T., Assani, G., Ling, H., Zhou, Q., Zeng, Y., Zhou, F., & Zhou, Y. (2019) · Biomedicine & Pharmacotherapy · doi:10.1016/j.biopha.2019.108602 · Cited by 51
Raschi, E., & Ponti, F. D. (2019) · Frontiers in Pharmacology · doi:10.3389/fphar.2019.01235 · Cited by 48
Mouron, S. A., Manso, L., Caleiras, E. J., Rodríguez‐Peralto, J. L., Rueda, O. M., Caldas, C., Colomer, R., Quintela-Fandiño, M., & Bueno, M. J. (2021) · Breast Cancer Research · doi:10.1186/s13058-021-01398-8 · Cited by 50
Triple-negative breast cancer: new treatment strategies in the era of precision medicine
Wu, S., Wang, H., Shao, Z., & Jiang, Y. (2020) · Science China Life Sciences · doi:10.1007/s11427-020-1714-8 · Cited by 50
CDK 4/6 inhibitors combined with radiotherapy: A review of literature
Bosacki, C., Bouleftour, W., Sotton, S., Vallard, A., Daguenet, É., Ouaz, H., Cojocaru, I., Moslemi, D., Malekzadeh, M., & Magné, N. (2020) · Clinical and Translational Radiation Oncology · doi:10.1016/j.ctro.2020.11.010 · Cited by 48
Targeting CDK4/6 for Anticancer Therapy
Qi, J., & Ouyang, Z. (2022) · Biomedicines · doi:10.3390/biomedicines10030685 · Cited by 49
Goetz, M. P., Hamilton, E. P., Campone, M., Hurvitz, S. A., Cortés, J., Johnston, S. R. D., Llombart‐Cussac, A., Kaufman, P. A., Toi, M., Jérusalem, G., et al. (2023) · Clinical Cancer Research · doi:10.1158/1078-0432.ccr-22-3573 · Cited by 47
Self-citationKappel, C., Elliott, M. J., Kumar, V., Nadler, M. B., Desnoyers, A., & Amir, E. (2024) · Scientific Reports · doi:10.1038/s41598-024-53151-8 · Cited by 48
“In phase III trials, CDK4/6 inhibitors trials, palbociclib, ribociclib, and abemaciclib have shown a consistent improvement in progression-free survival (PFS) when combined with an aromatase inhibitor (AI), fulvestrant, or tamoxifen 4,5 with the hazard ratios for PFS ranging between 0.50 and 0.59.”
BackgroundInfluentialHormone Receptor–Positive, HER2-Negative Metastatic Breast Cancer: Redrawing the Lines
Matutino, A. R. B., Joy, A. A., Brezden‐Masley, C., Chia, S., & Verma, S. (2018) · Current Oncology · doi:10.3747/co.25.4000 · Cited by 49
Self-citationZhang, B., & Long, E. F. (2019) · Breast Cancer Research and Treatment · doi:10.1007/s10549-019-05190-3 · Cited by 46
Gul, A., Leyland-Jones, B., Dey, N., & De, P. K. (2018) · Europe PMC (PubMed Central) · Cited by 45
Migliaccio, I., Bonechi, M., McCartney, A., Guarducci, C., Benelli, M., Biganzoli, L., Leo, A. D., & Malorni, L. (2020) · Cancer Treatment Reviews · doi:10.1016/j.ctrv.2020.102136 · Cited by 50
Palbociclib-mediated cell cycle arrest can occur in the absence of the CDK inhibitors p21 and p27
Pennycook, B. R., & Barr, A. R. (2021) · Open Biology · doi:10.1098/rsob.210125 · Cited by 45
New therapeutic opportunities for women with low-grade serous ovarian cancer
Moujaber, T., Balleine, R. L., Gao, B., Madsen, I., Harnett, P. R., & DeFazio, A. (2021) · Endocrine Related Cancer · doi:10.1530/erc-21-0191 · Cited by 47
Hormonoresistance in advanced breast cancer: a new revolution in endocrine therapy
Augereau, P., Patsouris, A., Bourbouloux, E., Gourmelon, C., Lacourtoisie, S. A., Rigaud, D. B., Soulié, P., Frenel, J., & Campone, M. (2017) · Therapeutic Advances in Medical Oncology · doi:10.1177/1758834017693195 · Cited by 46
Self-citationTreatment for the endocrine resistant breast cancer: Current options and future perspectives
Liu, C., Wu, C., Petrossian, K., Huang, T., Tseng, L., & Chen, S. (2017) · The Journal of Steroid Biochemistry and Molecular Biology · doi:10.1016/j.jsbmb.2017.07.001 · Cited by 50
Self-citationManagement of Adverse Events Due to Cyclin-Dependent Kinase 4/6 Inhibitors
Ettl, J. (2019) · Breast Care · doi:10.1159/000499534 · Cited by 45
Keratin 19 regulates cell cycle pathway and sensitivity of breast cancer cells to CDK inhibitors
Sharma, P., Alsharif, S., Bursch, K. L., Parvathaneni, S., Anastasakis, D. G., Chahine, J. J., Fallatah, A., Nicolas, K., Sharma, S., Hafner, M., et al. (2019) · Scientific Reports · doi:10.1038/s41598-019-51195-9 · Cited by 47
Zhang, P., Xu, B., Gui, L., Wang, W., Xiu, M., Zhang, X., Sun, G., Zhu, X., & Zou, J. (2021) · Biomarker Research · doi:10.1186/s40364-021-00271-2 · Cited by 47
Yang, L., Xue, J., Yang, Z., Wang, M., Yang, P., Dong, Y., He, X., Bao, G., & Peng, S. (2021) · Annals of Palliative Medicine · doi:10.21037/apm-21-1096 · Cited by 47
“Both preclinical research and clinical trials have demonstrated activity of CDK4/6 inhibitors (CDK4/6Is) (palbociclib, ribociclib, and abemaciclib) in HR(+) BC (13,14,17-20).”
BackgroundBhurta, D., & Bharate, S. B. (2021) · Medicinal Research Reviews · doi:10.1002/med.21856 · Cited by 47
“Ribociclib (LEE‐011, 2) is the next orally active CDK inhibitor from the same chemical class, which has received FDA approval for advanced breast cancer as a combination with fulvestrant.(52,53) Eli Lilly discovered CDK4/6 inhibitor abemaciclib (LY2835219, 3), which exhibits excellent in vivo efficacy in several tumor…”
BackgroundBruno, L. I., Ostinelli, A., Waisberg, F., Enrico, D. H., Ponce, C., Rivero, S. G., Blanco, A., Zarbá, M., Loza, M., Fabiano, V., et al. (2022) · JCO Precision Oncology · doi:10.1200/po.21.00140 · Cited by 49
Abdelmalak, M., Singh, R., Anwer, M. I., Ivanchenko, P., Randhawa, A., Ahmed, M., Ashton, A. W., Du, Y., Jiao, X., & Pestell, R. G. (2022) · Cancers · doi:10.3390/cancers14215388 · Cited by 45
Jhaveri, K. L., & Marmé, F. (2023) · Cancer Treatment Reviews · doi:10.1016/j.ctrv.2023.102670 · Cited by 49
A single institution experience with palbociclib toxicity requiring dose modifications
Gong, J., Cho, M. T., Yu, K. W., Waisman, J. R., Yuan, Y., & Mortimer, J. E. (2017) · Breast Cancer Research and Treatment · doi:10.1007/s10549-017-4606-9 · Cited by 45
“0001) in the phase III MONALEESA-2 trial [6].”
BackgroundXu, F., Xia, Y., Feng, Z., Lin, W., Xue, Q., Jiang, J., Yu, X., Peng, C., Luo, M., Yang, Y., et al. (2019) · Europe PMC (PubMed Central) · Cited by 47
Cyclin-dependent kinase inhibitors in brain cancer: current state and future directions
Jurić, V., & Murphy, B. M. (2020) · Cancer Drug Resistance · doi:10.20517/cdr.2019.105 · Cited by 46
“Separate Phase III clinical trials using CDK4/6 inhibitors, palbociclib, abemaciclib and ribociclib showed an increase in median progression-free survival (PFS) of patients, approximately 7-10 months, when compared to placebo treated groups([5-7]).”
BackgroundInfluentialSmall Molecule CDK Inhibitors for the Therapeutic Management of Cancer
Goel, B., Tripathi, N., Bhardwaj, N., & Jain, S. K. (2020) · Current Topics in Medicinal Chemistry · doi:10.2174/1568026620666200516152756 · Cited by 45
Sollena, P., Nikolaou, V. A., Soupos, N., Kotteas, E. A., Voudouri, D., Stratigos, A., Fattore, D., Annunziata, M. C., Orlandi, A., Nardo, L. D., et al. (2020) · Breast Cancer Research and Treatment · doi:10.1007/s10549-020-05914-w · Cited by 46
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
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 ›
Are you an author, or do you see a problem with this page? Request a review