Palbociclib: First Global Approval

Dhillon, Sohita

doi:10.1007/s40265-015-0379-9

Cited by 125 publications

(117 citation statements)

References 35 publications

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“…It efficiently induces a G1 cell cycle arrest and subsequent cytostasis in vitro and in vivo [1][2][3][4][5]. Palbociclib has recently received FDA approval for treatment of estrogen receptor positive, human epidermal growth factor receptor 2 negative (ER+/HER2-) advanced breast cancer [6]. Many other clinical trials are ongoing, including one for treatment of retinoblastoma (Rb) proficient glioblastoma (GBM) (Clintrial.gov identifier: NCT01227434).…”

Section: Introductionmentioning

confidence: 99%

P-glycoprotein and breast cancer resistance protein restrict the brain penetration of the CDK4/6 inhibitor palbociclib

et al. 2015

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Section: Introductionmentioning

confidence: 99%

P-glycoprotein and breast cancer resistance protein restrict the brain penetration of the CDK4/6 inhibitor palbociclib

et al. 2015

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“…12–14 Administration of one of the three CDK4/6 inhibitors with a strong CYP3A inhibitor (e.g. itraconazole) should be avoided, as well as administration with strong (e.g.…”

Section: Cdk4/6 Inhibitor Drug Interactionmentioning

confidence: 99%

Management of adverse events during cyclin-dependent kinase 4/6 (CDK4/6) inhibitor-based treatment in breast cancer

2018

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Cyclin-dependent kinase (CDK) 4/6 inhibitors have shown great results in numerous clinical trials and have improved the clinical outcome for patients with hormone-receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer significantly. To date, three CDK4/6 inhibitors are approved by the US Food and Drug Administration (FDA): palbociclib, ribociclib and abemaciclib; the first two compounds are aproved by the European Medicines Agency (EMA) as well. In combination with endocrine therapy, all of them led to significantly improved progression-free survival compared with endocrine therapy alone. The aim of this article is to give an overview of the efficacy data and to describe the CDK4/6 inhibitor-based treatment-associated adverse events, including hematological and nonhematological adverse events. In addition, it describes the corrrect approach to patient monitoring and adverse event mangement and summarizes the current recommendations for dose reductions and dose interruptions regarding the key adverse events, such as neutropenia, diarrhea, QTc prolongation and hepatobiliary toxicity. Accurate patient monitoring and management of the side effects is crucial, as several clinical trials in early breast cancer are in progress and may lead to an additional approval in the neo-/adjuvant setting.

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“…The use of palbociclib against the cyclin-dependent kinases CDK4 and CDK6 has successfully been used in advanced breast cancer [58] and it is under evaluation in many other cancer types in phase II and III clinical trials [59]. In EC, Dosil et al [60] performed the first preclinical study to test the therapeutic potential of palbociclib; specifically, this was tested in the endometrial malignancies driven by Pten deficiency.…”

Section: Endometrial Cancer Pdx Modelsmentioning

confidence: 99%

Patient-Derived Xenograft Models for Endometrial Cancer Research

Moiola

Lopez-Gil

Cabrera

et al. 2018

IJMS

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Endometrial cancer (EC) is the most common malignancy of the genital tract among women in developed countries. Recently, a molecular classification of EC has been performed providing a system that, in conjunction with histological observations, reliably improves EC classification and enhances patient management. Patient-derived xenograft models (PDX) represent nowadays a promising tool for translational research, since they closely resemble patient tumour features and retain molecular and histological features. In EC, PDX models have already been used, mainly as an individualized approach to evaluate the efficacy of novel therapies and to identify treatment-response biomarkers; however, their uses in more global or holistic approaches are still missing. As a collaborative effort within the ENITEC network, here we describe one of the most extensive EC PDX cohorts developed from primary tumour and metastasis covering all EC subtypes. Our models are histologically and molecularly characterized and represent an excellent reservoir of EC tumour samples for translational research. This review compiles the information on current methods of EC PDX generation and their utility and provides new perspectives for the exploitation of these valuable tools in order to increase the success ratio for translating results to clinical practice.

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Palbociclib: First Global Approval

Cited by 125 publications

References 35 publications

P-glycoprotein and breast cancer resistance protein restrict the brain penetration of the CDK4/6 inhibitor palbociclib

P-glycoprotein and breast cancer resistance protein restrict the brain penetration of the CDK4/6 inhibitor palbociclib

Management of adverse events during cyclin-dependent kinase 4/6 (CDK4/6) inhibitor-based treatment in breast cancer

Patient-Derived Xenograft Models for Endometrial Cancer Research

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