Related Experiment Video

Updated: Apr 17, 2026

Development of a Human Preclinical Model of Osteoclastogenesis from Peripheral Blood Monocytes Co-cultured with Breast Cancer Cell Lines
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Development of a Human Preclinical Model of Osteoclastogenesis from Peripheral Blood Monocytes Co-cultured with Breast Cancer Cell Lines

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The ORCHIDEE study: gathering new evidence on the use of everolimus in clinical practice

Mimma Rizzo, Giacomo Cartenì, Giovanni Pappagallo

    Tumori
    |February 18, 2015
    PubMed

    Insights

    This study evaluated everolimus in metastatic renal cell carcinoma patients. It identified factors predicting outcomes for targeted therapy in real-world clinical practice.

    Area of Science:

    • Oncology
    • Clinical Pharmacology

    Background:

    • Randomized clinical trials (RCTs) establish intervention efficacy but may lack real-world generalizability.
    • Observational studies complement RCTs, especially for targeted therapies with unique tolerability profiles.
    • Post-approval evaluation of targeted therapies in real-world populations is crucial.

    Purpose of the Study:

    • To evaluate the effectiveness and safety of everolimus in clinical practice.
    • To identify factors predicting favorable outcomes in patients with metastatic renal cell carcinoma (mRCC) treated with everolimus.
    • To assess everolimus as a second-line treatment for mRCC after vascular endothelial growth factor tyrosine kinase inhibitor (VEGF TKI) failure.

    Main Methods:

    • The ORCHIDEE study is a multicenter, single-arm, phase IV observational cohort study.
    • Enrollment of approximately 200 mRCC patients from 20 Italian centers over 24 months.
    • Focus on patients receiving everolimus after first-line VEGF TKI treatment.

    Main Results:

    • This section is not detailed in the abstract.
    • Further analysis will focus on identifying predictive factors for treatment success.
    • Safety and effectiveness data in a real-world setting will be characterized.

    Conclusions:

    • Observational studies like ORCHIDEE are warranted for evaluating targeted therapies in routine practice.
    • Understanding factors predictive of outcomes can optimize everolimus use in mRCC.
    • Real-world data collection is essential for comprehensive drug evaluation post-approval.

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