Side Effects of ribociclib: A Synthesis of Findings from 26 Studies

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Original Abstract of the Article

Main Research Findings

Ribociclib is a new drug used in combination with hormone therapy for patients with metastatic breast cancer that is hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-). 24 , 13 . Numerous clinical trials have shown that ribociclib significantly improves progression-free survival for patients with metastatic breast cancer. 16 . However, some side effects have been reported with ribociclib. 16 , 20 . It is important to be aware of these side effects and address them appropriately.

Reasons for Side Effects

Ribociclib inhibits the growth of cancer cells by blocking cyclin-dependent kinase (CDK) 4/6, a protein involved in cell cycle progression. 13 . CDK4/6 promotes the phosphorylation of Rb protein, a protein essential for cell division. Rb protein inhibits the transition from the G1 phase to the S phase of the cell cycle. Ribociclib inhibits CDK4/6, thereby inhibiting the phosphorylation of Rb protein and blocking cell cycle progression. This action inhibits the growth of cancer cells. However, CDK4/6 is also involved in the growth of normal cells. Therefore, ribociclib can also inhibit the growth of normal cells. This is thought to be the reason for ribociclib's side effects.

Common Side Effects

Hematological Side Effects

The most common side effects of ribociclib are hematological side effects such as leukopenia, neutropenia, and thrombocytopenia. 16 , 10 . These side effects occur because ribociclib inhibits the growth of normal cells, suppressing the production of blood cells in the bone marrow.

Gastrointestinal Side Effects

Ribociclib can cause gastrointestinal side effects such as nausea, vomiting, diarrhea, and loss of appetite. 16 , 20 , 12 , 4 . These side effects may be caused by ribociclib irritating the gastrointestinal mucosa.

Liver Side Effects

Ribociclib can cause liver side effects such as elevated liver enzyme levels., 14 . These side effects may be caused by ribociclib placing a burden on the liver.

Skin Side Effects

Ribociclib can cause skin side effects such as rash, itching, and pigmentation. 9 , 15 , 1 . These side effects may be caused by ribociclib directly affecting the skin.

Other Side Effects

Ribociclib can also cause side effects such as fatigue, headache, visual disturbances, and hair loss. 12 , 2 , 20 .

Measures to Counteract Side Effects

Measures to Counteract Hematological Side Effects

To prevent hematological side effects, blood tests such as white blood cell counts are performed before ribociclib is administered. 16 . If the white blood cell count decreases, ribociclib administration may be temporarily discontinued or the dosage may be reduced. 16 . If necessary, drugs that increase white blood cells may be administered.

Measures to Counteract Gastrointestinal Side Effects

Antiemetics may be administered before ribociclib administration to reduce gastrointestinal side effects. 16 . Antidiarrheal medications may be prescribed if diarrhea is severe.

Measures to Counteract Liver Side Effects

Liver function tests are performed before ribociclib administration to prevent liver side effects. 16 . If liver enzyme levels are elevated, ribociclib administration may be temporarily discontinued or the dosage may be reduced.

Measures to Counteract Skin Side Effects

Steroid ointments may be prescribed before ribociclib administration to reduce skin side effects. 9 . It is also important to reduce sun exposure by wearing sunscreen, hats, etc.

Comparison of Research

Similarities in Research

Many studies have shown that ribociclib is an effective treatment for patients with HR+, HER2- metastatic breast cancer. 24 , 13 , 16 . In addition, side effects such as hematological side effects, gastrointestinal side effects, liver side effects, and skin side effects have been reported with ribociclib. 16 , 10 , 20 , 12 , 4 , , 14 , 9 , 15 , 1 .

Differences in Research

The side effects of ribociclib may vary from patient to patient. 22 . In addition, ribociclib may interact with other drugs. 23 .

Points to Note Regarding Application in Real Life

Ribociclib is an effective drug for the treatment of metastatic breast cancer, but it is important to understand the risk of side effects. 16 , 20 . When taking ribociclib, follow your doctor's instructions and consult your doctor immediately if you experience any side effects. 16 .

Limitations of Current Research

Research on the side effects of ribociclib is still insufficient. 18 . In particular, further research is needed on the interactions between ribociclib and other drugs. 23 .

Future Research Directions

The side effects of ribociclib need to be investigated in more detail. 18 . Methods to reduce the side effects of ribociclib need to be developed. 16 . Furthermore, the interactions of ribociclib with other drugs need to be investigated. 23 .

Conclusion

Ribociclib is an effective drug for the treatment of metastatic breast cancer, but it is important to understand the risk of side effects. 24 , 16 . When taking ribociclib, follow your doctor's instructions and consult your doctor immediately if you experience any side effects. 16 .

Keywords
Benefit Keywords
Breast cancer treatment
1
Improved progression-free survival
2
Breast cancer treatment
Well tolerated
3
Palliative RT
4
Breast cancer treatment
7
Sarcoma treatment
Synergistic growth inhibition
8
Metastatic breast cancer treatment
10
Breast cancer treatment
Easy application
Patient compliance
11
Breast cancer treatment
13
Improved breast cancer outcomes
15
Improved breast cancer outcome
16
Improved patient outcomes
17
CDK 4/6 safety
CDK 4/6 tolerability
Cost effectiveness
18
Improved efficacy in breast cancer
Maintains quality of life
Prolongs survival
19
Breast cancer treatment
Improved survival
Quality of life
20
CDK 4/6 inhibitor
mBC treatment
21
cancer drug safety
piperazine ring activation prediction
22
Improved treatment
23
Improved antitumor activity
Treatment responses
24
Cancer drug safety
26
Risk Keywords
Cutaneous side effects
Phototoxicity
1
Vortex keratopathy
2
Gastrointestinal toxicity
4
Chemotherapy ineffectiveness
Drug-natural product interactions
5
Acute kidney injury
Rhabdomyolysis
6
Diarrhea
Neutropenia
7
DI-SCLE
9
Fatigue
Gastrointestinal side effects
Hepatic toxicities
Lung injury
Mucositis
Myelosuppression
QTc prolongation
10
Liver toxicity
Skin reactions
Vitiligo
11
Hallucinations
Hematological toxicities
Infections
12
Cardiotoxicity
Therapy resistance
13
Hepatotoxicity
14
Fatigue
Gastrointestinal side effects
Hematological toxicity
Vitiligo-like lesions
15
Diarrhea
Hepatobiliary toxicity
Neutropenia
QTc prolongation
16
Complex adverse events
17
Resistance to treatment
19
Adherence challenges
Side effects
20
Adverse effects
Low adherence
21
drug toxicity
22
Drug interactions
23
Hallucinations
Hematological toxicities
Infections
25
Gastrointestinal disorders
Hematologic disorders
26
Literature analysis of 26 papers
Positive Content
20
Neutral Content
0
Negative Content
6
Article Type
1
0
0
5
22
1.

Case Report: Ribociclib-induced phototoxicity presented as dyschromia with subsequent bullae formation.

Author: JhanJyun-Yan, WangWei-En, ChuSung-Chao, ChengChiu-Hsuan, ChangChung-Hsing

Breast cancer treatment
Cutaneous side effects
Phototoxicity

This case report describes a rare but significant side effect of ribociclib, a drug used for treating breast cancer. The patient developed phototoxicity, a reaction to sunlight, that manifested as skin discoloration and blistering. This highlights the importance of educating patients about sun protection measures while taking ribociclib.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.

Language : English

2.

Vortex keratopathy associated with ribociclib.

Author: TürkelAlper, ÖzdoğanSibel, YekedüzEmre, ŞeyranErdoğan, KaraçinCengiz, AteşÖztürk

Improved progression-free survival
Vortex keratopathy

This case report describes a rare side effect of vortex keratopathy in a breast cancer patient treated with ribociclib, a cyclin-dependent kinase 4/6 inhibitor.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

3.

Ribociclib therapy in peritoneal carcinomatosis secondary to HER2-negative metastatic breast cancer: A clinical case with a positive outcome.

Author: GuarinoStefania, StocchiLucia, MassaioliChiara

Breast cancer treatment
Well tolerated

Ribociclib is an effective treatment for advanced breast cancer with bone, liver, lung, and brain metastases.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

5.

Toxicity Derived from Interaction between Natural Compounds and Cancer Therapeutic Drugs Metabolized by CYP3A4: Lessons Learned from Two Clinical Case Reports.

Author: OrzettiSabrina, BaldoPaolo

Chemotherapy ineffectiveness
Drug-natural product interactions

This study presents two clinical cases of cancer patients who experienced adverse drug reactions (ADRs) as a result of using natural products in combination with chemotherapy.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.

Language : English

6.

Ribociclib may potentiate rosuvastatin effect in causing late onset rhabdomyolysis.

Author: TeoSiaw Wee, HayesTheresa, GomeJames

Acute kidney injury
Rhabdomyolysis

This case report describes a woman with metastatic hormone receptor positive breast cancer who developed rhabdomyolysis and acute kidney injury while on a combination therapy of ribociclib and rosuvastatin. The report highlights the potential risk of rhabdomyolysis associated with this drug combination and underscores the importance of continued vigilance for this side effect, even after long-term therapy.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

7.

Establishment of an analytical method for simultaneous quantitation of CDK4/6 inhibitors, aromatase inhibitors, and an estrogen receptor antagonist in human plasma using LC-ESI-MS/MS.

Author: SatoYu, ShigetaKensuke, HirasawaTensei, SatoToshihiro, OguraJiro, MaekawaMasamitsu, EbataAkiko, HamanakaYohei, TadaHiroshi, IshidaTakanori, KikuchiMasafumi, ManoNariyasu

Breast cancer treatment
Diarrhea
Neutropenia

This study describes a simple, highly sensitive, and specific liquid chromatography/electrospray ionization tandem mass spectrometry method for simultaneous quantitation of CDK4/6 inhibitors, aromatase inhibitors, and an estrogen receptor antagonist.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

8.

SAR-096: Phase II clinical trial of ribociclib in combination with everolimus in advanced dedifferentiated liposarcoma (DDL), and leiomyosarcoma (LMS).

Author: MovvaSujana, MatloobSahar, HandorfElizabeth A, ChoyEdwin, MerriamPriscilla, FliederDouglas B, CaiKathy Q, ZhouYan, TetzlaffEric D, PaganCheyenne, BarkerEmma, VeggebergRosanna, ZumpanoDelia, RinkLori, von MehrenMargaret, GeorgeSuzanne

Sarcoma treatment
Synergistic growth inhibition

This study highlights the potential of combining ribociclib, a CDK4 inhibitor, and everolimus, an mTOR inhibitor, for the treatment of advanced desmoid-type fibromatosis (DDL) and leiomyosarcoma (LMS). The combination has shown synergistic growth inhibition in multiple tumor models, suggesting that this combination could be beneficial in patients.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

9.

Subacute cutaneous lupus erythematosus following ribociclib therapy for metastatic breast cancer.

Author: Collada SánchezVictoria Lucia, Álvarez CriadoJavier, Martinez MartinVirginia, Zamora AuñonPilar, Espinosa ArranzEnrique, Mayor IbargurenAnder, Nacher JimenezInmaculada, Herrero AmbrosioAlicia

DI-SCLE

Drug-induced subacute cutaneous lupus erythematosus (DI-SCLE) has been linked to various medications, including anti-hypertensives, TNF-α inhibitors, and chemotherapy drugs. Recent reports suggest a potential association with cyclin-dependent kinase (CDK) 4/6 inhibitors, palbociclib and abemaciclib.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

10.

Ribociclib-Induced Pneumonitis: A Case Report.

Author: AlgwaizGhada, BadranAhmed Ali, ElshenawyMahmoud A, Al-TweigeriTaher

Metastatic breast cancer treatment
Fatigue
Gastrointestinal side effects
Hepatic toxicities
Lung injury
Mucositis
Myelosuppression
QTc prolongation

Cyclin-dependent kinase 4/6 (CDK 4/6) inhibitors are effective in treating hormone receptor-positive, HER2-negative metastatic breast cancer, but they can cause side effects such as myelosuppression, mucositis, fatigue, gastrointestinal issues, hepatic toxicities, and QTc prolongation.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.

Language : English

12.

Ribociclib-induced visual hallucination in a patient with metastatic breast cancer.

Author: KapaganTanju, BulutNilufer, DemirerSerhat, ErdemGokmen Umut

Hallucinations
Hematological toxicities
Infections

CDK 4/6 inhibitors are commonly used for HR+/HER2- breast cancer. This study reports frequent side effects associated with these inhibitors, including hematological toxicities, infections, and QT prolongation. However, no cases of hallucination related to CDK 4/6 inhibitor use have been reported in the English literature.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

13.

CDK4/6 inhibitors: basics, pros, and major cons in breast cancer treatment with specific regard to cardiotoxicity - a narrative review.

Author: PavlovicDragica, NiciforovicDanijela, PapicDragana, MilojevicKatarina, MarkovicMarina

Breast cancer treatment
Cardiotoxicity
Therapy resistance

CDK4/6 inhibitors are a promising therapy for hormone receptor-positive metastatic breast cancer. While they have significant benefits, cardiotoxicity remains a concern. This review examines the mechanisms of CDK4/6 inhibitors in cancer and discusses the clinical advantages and adverse events, particularly cardiotoxicity.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

14.

Ribociclib-induced hepatotoxicity.

Author: ErMuhammed Muhiddin, ArazMurat, HendemEngin, EryılmazMelek Karakurt, ArtaçMehmet

Hepatotoxicity

Ribociclib is a CDK 4/6 inhibitor used to treat breast cancer. However, it can cause hepatotoxicity, which is a serious side effect. In this case, the patient experienced grade 3 hepatotoxicity after receiving ribociclib and had to stop treatment. After switching to palbociclib, a different CDK 4/6 inhibitor, the patient's liver function returned to normal.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

17.

Management of toxicities associated with targeted therapies for HR-positive metastatic breast cancer: a multidisciplinary approach is the key to success.

Author: CazzanigaMarina Elena, DanesiRomano, GirmeniaCorrado, InvernizziPietro, ElveviAlessandra, UguccioniMassimo,

Improved patient outcomes
Complex adverse events

This review discusses the benefits and risks of targeted therapies for HR-positive, HER2-negative locally advanced or metastatic breast cancer. While these agents improve patient outcomes compared to conventional endocrine therapy, they are associated with complex and potentially severe adverse events.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

20.

PRECYCLE: multicenter, randomized phase IV intergroup trial to evaluate the impact of eHealth-based patient-reported outcome (PRO) assessment on quality of life in patients with hormone receptor positive, HER2 negative locally advanced or metastatic breast cancer treated with palbociclib and an aromatase inhibitor or palbociclib and fulvestrant.

Author: DegenhardtTom, FaschingPeter A, LüftnerDiana, MüllerVolkmar, ThomssenChristoph, SchemChristian, WitzelIsabell, DeckerThomas, TeschHans, KümmelSherko, UleerChristoph, WuerstleinRachel, HoffmannOliver, WarmMathias, MarschnerNorbert, SchinkötheTimo, KatesRonald E, SchumacherJohannes, OtrembaBurkhard, ZaissMatthias, HarbeckNadia, SchmidtMarcus,

Breast cancer treatment
Improved survival
Quality of life
Adherence challenges
Side effects

This abstract discusses the importance of adherence to therapy in patients with metastatic breast cancer (MBC) who are receiving treatment with a cycline-dependent kinase 4/6 (CDK 4/6) inhibitor.

Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Clinical Trial, Phase IVPost-marketing surveillance. Monitors long-term safety/efficacy after approval.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

24.

Clinical outcomes of cyclin-dependent kinase 4-6 (CDK 4-6) inhibitors in patients with male breast cancer: A multicenter study.

Author: YıldırımHasan Çağrı, MutluEmel, ChalabiyevElvin, ÖzenMiraç, KeskinkılıçMerve, ÖnSercan, ÇelebiAbdussamet, DursunBengü, AcarÖmer, KahramanSeda, AykanMusa Barış, KamanÖmür, DoğanAkif, ErdoğanAtike Pınar, Melisa CelayirÖzde, GünençDamla, GüvenDeniz Can, Vedat Bayoğluİbrahim, YavuzşenTuğba, Hacıbekiroğluİlhan, İnançMevlüde, KılıçkapSaadettin, YalçınŞuayib, AksoySercan

Improved antitumor activity
Treatment responses

This study investigates the treatment responses of metastatic hormone receptor-positive, HER2-negative male breast cancer patients treated with CDK 4-6 inhibitors in a real-world cohort.

Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

25.

Ribociclib-induced visual hallucination in a patient with metastatic breast cancer.

Author: KapaganTanju, BulutNilufer, DemirerSerhat, ErdemGokmen Umut

Hallucinations
Hematological toxicities
Infections

CDK 4/6 inhibitors are commonly used for HR+/HER2- breast cancer. This study reports frequent side effects associated with these inhibitors, including hematological toxicities, infections, and QT prolongation. However, no cases of hallucination related to CDK 4/6 inhibitor use have been reported in the English literature.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

26.

Intensive safety monitoring program of antineoplastic medicines: A pilot study in a Portuguese oncology hospital.

Author: MendesDiogo, RigueiroGraça, SilvaRui S, PenedonesAna, AlvesCarlos, SousaGabriela, Batel-MarquesFrancisco

Cancer drug safety
Gastrointestinal disorders
Hematologic disorders

This intensive safety monitoring program was feasible and allowed identifying serious and unexpected adverse drug reactions in cancer patients.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Observational StudyResearch that observes and collects data on participants' behavior and outcomes in their natural state, without intervention.

Language : English

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