Effects of ribociclib: A Synthesis of Findings from 14 Studies

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Original Abstract of the Article

Main research findings

Ribociclib has shown promising immunomodulatory effects in patients with hormone receptor-positive (HR+) breast cancer, according to findings from the RIBECCA trial. 9 Inhibitors of the cyclin-dependent kinases 4 and 6 (CDK4/6i) have significantly improved clinical outcomes in patients with advanced HR+ breast cancer and have demonstrated favorable antitumor immune responses in preclinical studies. 9 A network meta-analysis of seven studies involving 5,347 patients showed that CDK4/6 inhibitors, including ribociclib, combined with nonsteroidal anti-inflammatory drugs (NSAIDs) resulted in significant improvements in progression-free survival (PFS) and overall survival (OS) compared to NSAIDs alone. 11 From a cost-effectiveness perspective, abemaciclib plus NSAI was found to be the most cost-effective option in China. 11 The FDA has approved ribociclib for the treatment of HR+, HER2-negative advanced or metastatic breast cancer in both male and female patients. 2

Benefits and Risks

Benefits Summary

Ribociclib may offer several benefits for patients with HR+ breast cancer, including: • Improved progression-free survival (PFS) and overall survival (OS) • Effective treatment for both male and female patients • Promising immunomodulatory effects

Risks Summary

Ribociclib may also be associated with certain risks, including: • Bone marrow suppression • Gastrointestinal toxicity • Interstitial lung disease (ILD) • Visual hallucinations • QT prolongation

Comparison Across Studies

Commonalities

Multiple studies have consistently demonstrated the effectiveness of ribociclib in treating HR+ breast cancer patients. 9 、 13 、 10 Many studies have investigated ribociclib in combination with endocrine therapies such as aromatase inhibitors and fulvestrant. 9 、 13 、 10

Differences

Differences among studies include the patient population, the specific type of endocrine therapy used, and the endpoints evaluated. 13 、 10 For instance, the MONALEESA-2, -3, and -7 trials demonstrated significant improvements in PFS and OS with ribociclib plus endocrine therapy compared to endocrine therapy alone. 10 The COMPLEEMENT-1 trial showed the effectiveness of ribociclib plus endocrine therapy in male patients with HR+ breast cancer. 2

Consistency and Contradictions

Multiple studies have demonstrated that ribociclib offers both efficacy and safety in the treatment of HR+ breast cancer. 9 、 13 、 10 However, some studies have indicated the risk of side effects associated with ribociclib use. 7 、 1 These side effects can be mitigated through appropriate monitoring and management. 7

Real-World Implications

Ribociclib is a promising treatment option for patients with HR+ breast cancer, but it is crucial to be aware of the potential side effects. 7 、 1 Ribociclib should be used under the guidance of a healthcare professional. 7

Limitations of Current Research

Current research may not have fully evaluated the long-term effects and side effects associated with ribociclib use. 7 Further research is needed to assess the incidence and severity of side effects associated with ribociclib use. 7

Future Research Directions

Further research is necessary to evaluate the long-term effects and side effects of ribociclib. 7 Research on combination therapies involving ribociclib and other drugs is also required. 7

Conclusion

Ribociclib is a promising treatment option for patients with HR+ breast cancer. 9 、 13 、 10 However, it is important to be aware of the potential side effects. 7 、 1 Ribociclib should be used under the guidance of a healthcare professional. 7

Literature analysis of 14 papers
Positive Content
13
Neutral Content
0
Negative Content
1
Article Type
2
1
0
2
14
1.

Ribociclib-induced pulmonary infiltrates in a patient with breast cancer.

Author: ÜnsalOktay, ÖzetAhmet

Breast cancer treatment
Pulmonary infiltrates

A case report describes a 48-year-old female patient with breast cancer who developed pulmonary infiltrates secondary to Ribociclib therapy.

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

Language : English

2.

FDA Approval Summary: Ribociclib Indicated for Male Patients with Hormone Receptor-Positive, HER2-Negative Advanced or Metastatic Breast Cancer.

Author: GaoJennifer J, OsgoodChristy L, FengZhou, BloomquistErik W, TangShenghui, ChangC J George, RicksTiffany K, HouSherry C, PierceWilliam F, RiveraDonna R, PazdurRichard, KluetzPaul G, Amiri-KordestaniLaleh

Breast cancer treatment
Ribociclib efficacy

Ribociclib is a drug that is used to treat breast cancer. The FDA recently approved ribociclib for the treatment of male patients with hormone receptor-positive, HER2-negative advanced or metastatic breast cancer. The efficacy of ribociclib was based on previous clinical trials and studies in both male and female patients.

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

Language : English

3.

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

4.

Comparative efficacy and safety of different combinations of three CDK4/6 inhibitors with endocrine therapies in HR+/HER-2 - metastatic or advanced breast cancer patients: a network meta-analysis.

Author: LiuYiyuan, WuJinyao, JiZeqi, ChenLingzhi, ZouJuan, ZhengJiehua, LinWeixun, CaiJiehui, ChenYaokun, ZhengDaitian, ChenYexi, LiZhiyang

Improved cancer control
Increased survival
Drug toxicity

This network meta-analysis evaluated the efficacy and safety of various combinations involving three cyclin-dependent kinase 4/6 (CDK4/6) inhibitors and endocrine therapies (ETs) in patients with metastatic or advanced hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer.

Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

5.

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

6.

CDK4/6 Inhibitors in Advanced HR+/HER2 - Breast Cancer: A Multicenter Real-World Data Analysis.

Author: MüllerCarolin, KiverVerena, SolomayerErich-Franz, WagenpfeilGudrun, NeebCaroline, BlohmerJens-Uwe, AbramianAlina Valik, MaassNicolai, SchützFlorian, Kolberg-LiedtkeCornelia, RalserDamian Johannes, RambowAnna-Christina

Breast cancer treatment

This study presents real-world data on the use of CDK4/6 inhibitors (CDK4/6i) in combination with endocrine therapy for hormone receptor-positive, HER2-negative, advanced breast cancer (HR+/HER2- ABC). It compares this real-world data to the data from randomized controlled trials (RCTs).

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

Language : English

8.

Randomized Phase II Trial of Endocrine Therapy With or Without Ribociclib After Progression on Cyclin-Dependent Kinase 4/6 Inhibition in Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Metastatic Breast Cancer: MAINTAIN Trial.

Author: KalinskyKevin, AccordinoMelissa K, ChiuzanCodruta, MundiPrabhjot S, SakachElizabeth, SatheClaire, AhnHeejoon, TrivediMeghna S, NovikYelena, TierstenAmy, RaptisGeorge, BaerLea N, OhSun Y, ZelnakAmelia B, WisinskiKari B, AndreopoulouEleni, GradisharWilliam J, Stringer-ReasorErica, ReidSonya A, O'DeaAnne, O'ReganRuth, CrewKatherine D, HershmanDawn L

MBC treatment
OS improvement
PFS improvement

CDK4/6 inhibitors are medications that are used to treat breast cancer. This abstract describes a study that is investigating whether it is beneficial to continue using a CDK4/6 inhibitor after the cancer has progressed.

Clinical Trial, Phase IIA Phase II trial is a trial that further evaluates the efficacy and safety of a new drug or treatment, whose safety has been confirmed to some extent in a Phase I trial, in a small number of patients.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
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

9.

Treatment with ribociclib shows favourable immunomodulatory effects in patients with hormone receptor-positive breast cancer-findings from the RIBECCA trial.

Author: PeukerCaroline A, YaghobramziSarvenaz, GrunertCorinna, KeilholzLuisa, GjergaEnio, HennigSteffen, SchaperSigrid, NaIl-Kang, KellerUlrich, BruckerSara, DeckerThomas, FaschingPeter, FehmTanja, JanniWolfgang, KümmelSherko, SchneeweissAndreas, SchulerMartin, LüftnerDiana, BusseAntonia

Immune response activation
Improved clinical outcomes
Potential for combination therapy

This study investigated the effects of ribociclib, a CDK4/6 inhibitor, on peripheral immune responses in patients with metastatic hormone receptor-positive (HR+) breast cancer. Treatment with ribociclib upregulated signatures associated with an activated adaptive immune system and decreased immunosuppressive cytokine signaling. It also decreased Treg cell frequencies and induced CD4+ naive T cells, suggesting that ribociclib activates an existing immune response rather than inducing a de novo response.

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

10.

Intrinsic subtype and overall survival of patients with advanced HR+/HER2- breast cancer treated with ribociclib and ET: correlative analysis of MONALEESA-2, -3, -7.

Author: PratAleix, SolovieffNadia, AndreFabrice, O'ShaughnessyJoyce, CameronDavid A, JanniWolfgang, SonkeGabe S, YapYoon-Sim, YardleyDenise A, PartridgeAnn H, ThuerigenAstrid, ZarateJuan Pablo, LteifAgnes, SuFei, CareyLisa A

Improved OS
Improved PFS

This study evaluated the association of intrinsic subtypes with overall survival (OS) in the MONALEESA-2, -3, -7 trials. The analysis aims to understand how intrinsic subtypes impact OS in HR+/HER2- advanced breast cancer (ABC) patients treated with ribociclib + endocrine therapy.

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

Language : English

12.

CDK4/6 inhibition in hormone receptor-positive/HER2-negative breast cancer: Biological and clinical aspects.

Author: WekkingDemi, LeoniVera Piera, LambertiniMatteo, DessìMariele, PrettaAndrea, CadoniAndrea, AtzoriLuigi, ScartozziMario, SolinasCinzia

BC treatment
Immunomodulation
Improved treatment regimens

CDK4/6 inhibitors are proving effective in treating breast cancer, with three agents approved for use. Beyond cell-cycle arrest, these inhibitors have potential anti-tumor effects and show promise in adjuvant and neoadjuvant settings. This review discusses the immunomodulatory and metabolic impacts of these drugs, along with clinical trial outcomes.

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

13.

HR+/HER2- Advanced Breast Cancer Treatment in the First-Line Setting: Expert Review.

Author: JerzakKatarzyna J, BouganimNathaniel, Brezden-MasleyChristine, EdwardsScott, GelmonKaren, HenningJan-Willem, HiltonJohn F, SehdevSandeep

Breast cancer treatment
Improved survival

This narrative review provides best-practice recommendations for first-line treatment of HR+/HER2- advanced breast cancer in Canada. Ribociclib + aromatase inhibitor is the preferred treatment for de novo advanced disease or relapse after adjuvant endocrine therapy. Ribociclib or abemaciclib + fulvestrant is preferred for patients with early relapse. Abemaciclib or palbociclib may be used when ribociclib is not suitable. Endocrine therapy alone may be used in cases of contraindication to CDK4/6 inhibitors or limited life expectancy.

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.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

14.

Quantitative Assessment of Ribociclib Exposure-Response Relationship to Justify Dose Regimen in Patients with Advanced Breast Cancer.

Author: JiYan, DarsteinChristelle, YangShu, QuinlanMichelle, ChakravarttyArunava, ZarateJuan Pablo, ChakrabortyAbhijit, HoYu-Yun

ABC treatment
Improved OS
Neutropenia
QT prolongation

This study found that ribociclib's dose can be adjusted to manage neutropenia and QT interval prolongation while maintaining efficacy in patients with advanced breast cancer.

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

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