Real world incidence and management of adverse events in patients with HR+, HER2− metastatic breast cancer receiving CDK4 and 6 inhibitors in a United States community setting

Price, Gregory L.; Sudharshan, Lavanya; Ryan, Paula D.; Rajkumar, Jonathan; Sheffield, Kristin M.; Smyth, Emily Nash; Guimaraes, Claudia Morato; Rybowski, Sarah; Carter, Gebra Cuyún; Gathirua-Mwangi, Wambui G.; Huang, Yu‐Jing

doi:10.1080/03007995.2022.2073122

Cited by 10 publications

(6 citation statements)

References 44 publications

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“…The results also reflect those observed in large real-world studies in which more unselected patients were included (e.g., older patients or those with poorer performance status) [ [33] , [34] , [35] , [36] , [37] ]. A retrospective study by De Michele et al showed that among 1430 patients treated with first-line palbociclib in combination with letrozole or letrozole alone, the effect on OS was even greater than the value attained in our meta-analysis (HR = 0.55, 95% CI 0.4–0.77) in patients older than 70 years.…”

Section: Discussionsupporting

confidence: 80%

The role of CDK4/6 inhibitors in older and younger patients with breast cancer: A systematic review and meta-analysis

et al. 2023

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Section: Discussionsupporting

confidence: 80%

The role of CDK4/6 inhibitors in older and younger patients with breast cancer: A systematic review and meta-analysis

et al. 2023

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“…Although meta-analyses of clinical trials and retrospective studies conducted in the United States have compared the AE pro les of CDK4/6 inhibitors [11,12], the current study analysed a large sample of global pharmacovigilance ABE or PAL data. To the best of our knowledge, this is the rst study to comprehensively evaluate differences in AE frequency between PAL and ABE using a large-scale database, rather than relying on data from clinical trials or single-country study.…”

Section: Discussionmentioning

confidence: 99%

A comparison between the adverse event profiles of patients receiving palbociclib and abemaciclib: analysis of two real-world databases

Takeda,

Sugimoto,

Matsumoto

et al. 2024

Int J Clin Pharm

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Background: Palbociclib and abemaciclib are cyclin-dependent kinase (CDK) 4/6 inhibitors currently used to treat breast cancer. Although their therapeutic e cacies are considered comparable, differences of adverse event (AE) pro les between the two drugs remain unclear.Aim: We analysed two real-world databases, the World Health Organization's VigiBase and the Food and Drug Administration Adverse Event Reporting System (FAERS), to identify the differences in AE pro les between palbociclib and abemaciclib.Method: Data of patients with breast cancer receiving palbociclib or abemaciclib recorded until December 2022 were extracted from the VigiBase and FAERS databases. In total, 200 types of AEs were analysed. The reporting odds ratios were calculated using a disproportionality analysis.Results: Cytopenia was frequently reported in patients receiving palbociclib, while interstitial lung disease and diarrhoea were frequently reported in those receiving abemaciclib. Moreover, psychiatric and nervous system disorders were more common in the palbociclib group, whereas renal and urinary disorders were more common in the abemaciclib group. Conclusion:This study was the rst to show comprehensive disparities in the AE pro les between palbociclib and abemaciclib and highlighted the importance of considering these when selecting a suitable CDK4/6 inhibitor to ensure safe and favourable outcomes for patients with breast cancer. Impact statementsIn addition to cytopenia, many adverse events, including psychiatric and nervous system disorders, are potentially more frequent in patients receiving palbociclib compared to abemaciclib. Interstitial lung disease, diarrhoea, and renal and urinary disorders are potentially more frequent in patients receiving abemaciclib compared to palbociclib.The identi cation of adverse event pro les for palbociclib and abemaciclib contributes to drug selection that minimizes the risk of adverse events for individual patients.

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“…Ribociclib is well known as a strong CYP3A4/5 time-dependent inhibitor, especially when administered at a 600 mg dose, and the FDA leaflet recommends to avoid the concomitant use of strong CYP3A inhibitors (e.g., clarithromycin, protease inhibitor for HIV and HCV, itraconazole, ketoconazole, posaconazole, voriconazole, ritonavir, saquinavir) because of the increase in the recorded CDKis plasma exposure that may lead to increased toxicity ( 36 ). Clinical decision about choosing Ribociclib for our patient was based on efficacy data showed by MONALEESA-7 trial, the only available study enrolling premenopausal MBC patient exclusively, and on the favorable manageability profile reported in patients with impairment of hepatic or renal function ( 37 , 38 ).…”

Section: Discussionmentioning

confidence: 99%

Ribociclib in newly diagnosed hepatitis B infection: A case report

et al. 2023

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Breast cancer is the most frequently diagnosed cancer in women worldwide. Actually CDK4/6 inhibitor Ribociclib is approved for the treatment of metastatic hormone-positive and human epidermal growth factor receptor 2 (HER 2)-negative breast cancer, but comorbidities like infectious or cardiovascular diseases may limit its use.Case reportA 45-year-old woman was diagnosed with metastatic breast cancer in September 2021; also, her hepatitis screening resulted positive for hepatitis B infection. Patient assumed eradicative therapy for hepatitis and bit after started oncological therapy with Ribociclib.OutcomeFrequent check of hepatological function was observed since start of eradicative therapy; liver transaminases and bilirubin kept to not rise despite start of oncological treatment with Ribociclib. Patient’s Performance Status was also not compromised and revaluation at 4, 9 and 13 months showed partial response and then stable disease.Discussionhepatotoxicity of Ribociclib is reported as a possible side effect, and often positivity for hepatitis is cause of exclusion from therapy; in our case, no hepatotoxicity was noted and patient obtained response in terms of control of both infectious and oncological diseases.

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Real world incidence and management of adverse events in patients with HR+, HER2− metastatic breast cancer receiving CDK4 and 6 inhibitors in a United States community setting

Cited by 10 publications

References 44 publications

The role of CDK4/6 inhibitors in older and younger patients with breast cancer: A systematic review and meta-analysis

The role of CDK4/6 inhibitors in older and younger patients with breast cancer: A systematic review and meta-analysis

A comparison between the adverse event profiles of patients receiving palbociclib and abemaciclib: analysis of two real-world databases

Ribociclib in newly diagnosed hepatitis B infection: A case report

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