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Everolimus

Everolimus, a versatile drug, is being extensively studied in clinical trials for its potential in treating various medical conditions. These trials are exploring its efficacy and safety in diseases ranging from cancer to rare genetic disorders. This article summarizes key findings from recent clinical trials investigating the use of everolimus in different patient populations.

Table of Contents

What is Everolimus?

Everolimus is a medication used to treat various types of cancer and other conditions. It’s also known by several other names, including RAD001, Afinitor, and Certican[1][2]. Everolimus belongs to a class of drugs called mTOR inhibitors, which work by blocking certain proteins that help cancer cells grow and divide[3].

How Everolimus Works

Everolimus works by targeting a specific protein in the body called mTOR (mammalian target of rapamycin). This protein plays a crucial role in cell growth and division. By inhibiting mTOR, everolimus can slow down or stop the growth of cancer cells[3]. It’s important to note that while everolimus can be effective against certain types of cancer, it doesn’t work for all types of cancer or for all patients.

Conditions Treated with Everolimus

Everolimus has been studied and used to treat several types of conditions, including:

  • Certain types of breast cancer: Specifically, hormone receptor-positive, HER2-negative breast cancer that has spread to other parts of the body (metastasized)[2].
  • Kidney cancer: Everolimus is approved for use in advanced kidney cancer[4].
  • Certain types of lymphoma: Including cutaneous T-cell lymphoma (CTCL)[5].
  • Chondrosarcoma: A type of bone cancer[3].
  • Certain neuroendocrine tumors: Including those in the pancreas, lung, or gastrointestinal tract.
  • After organ transplantation: To help prevent rejection of the transplanted organ[6].

How Everolimus is Administered

Everolimus is typically taken orally (by mouth) in the form of tablets. The dosage and frequency can vary depending on the condition being treated and the patient’s individual needs. In most cases, everolimus is taken once daily, either with or without food[5]. It’s important to take everolimus exactly as prescribed by your doctor and to not change your dose without consulting your healthcare provider first.

Everolimus in Combination Therapies

In many cases, everolimus is used in combination with other treatments to enhance its effectiveness. Some examples include:

  • Combination with hormone therapy for breast cancer[2].
  • Used alongside other chemotherapy drugs for various types of cancer[7].
  • Combined with other targeted therapies to potentially improve outcomes[1].

Potential Side Effects

Like all medications, everolimus can cause side effects. Some common side effects may include:

  • Mouth sores or ulcers
  • Fatigue
  • Diarrhea
  • Decreased appetite
  • Nausea
  • Skin rash
  • Increased risk of infections

It’s important to discuss potential side effects with your healthcare provider and report any unusual symptoms you experience while taking everolimus[8].

Ongoing Research and Future Prospects

Researchers continue to study everolimus to better understand its potential uses and to improve its effectiveness. Some areas of ongoing research include:

  • Testing everolimus in combination with other drugs for various types of cancer[9].
  • Investigating its use in rare cancers, such as fibrolamellar liver cancer[8].
  • Exploring its potential in treating other conditions beyond cancer.

As research continues, we may discover new ways to use everolimus more effectively or identify additional conditions that may benefit from this medication.

Condition Key Findings Dosage Notable Outcomes
Metastatic Breast Cancer Everolimus combined with endocrine therapy may restore sensitivity in resistant cases 10 mg daily Improved progression-free survival
Metastatic Colorectal Cancer Studied in combination with cetuximab and irinotecan 1.66 mg to 7.5 mg daily Clinical benefit observed in some patients
Renal Angiomyolipoma in TSC Effective in reducing angiomyolipoma volume 10 mg daily 50% or greater reduction in AML volume in many patients
Neuroendocrine Tumors Studied in combination with radiolabeled somatostatin analogue Varies by study Potential for improved tumor response
Left Ventricular Hypertrophy Investigated for potential to reduce left ventricular mass Not specified Results pending

FAQ

  • What is everolimus and how does it work? Everolimus is a medication that inhibits the mTOR protein, which plays a role in cell growth and division. It works by slowing down certain processes in cells, potentially helping to treat various conditions including certain cancers and genetic disorders.
  • In which medical conditions is everolimus being studied? Everolimus is being studied in various conditions including metastatic breast cancer, metastatic colorectal cancer, neuroendocrine tumors, renal angiomyolipoma associated with tuberous sclerosis complex, and left ventricular hypertrophy in kidney transplant recipients.
  • What are some potential side effects of everolimus? Common side effects of everolimus may include mouth sores, diarrhea, nausea, fatigue, and increased risk of infections. In clinical trials, researchers closely monitor patients for adverse events and serious adverse events to ensure safety.
  • How is everolimus administered in clinical trials? In most clinical trials, everolimus is administered orally as tablets, typically once daily. The dosage may vary depending on the specific condition being studied and the trial protocol.
  • What are some promising results from everolimus clinical trials? Clinical trials have shown promising results in various areas, including improved progression-free survival in some cancer patients, reduction in angiomyolipoma volume in patients with tuberous sclerosis complex, and potential benefits in combination therapies for certain types of tumors.

Ongoing Clinical Trials on Everolimus

  • A study comparing XL092 versus everolimus in patients with previously treated advanced or metastatic neuroendocrine tumors

    Recruiting

    4 1 1 1
    Investigated drugs:
    Austria Belgium France Germany Italy The Netherlands +2

  • Study of PF-07248144 and fulvestrant in adults with hormone receptor-positive, HER2-negative advanced or metastatic breast cancer who had progression after CDK4/6 inhibitor therapy

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Bulgaria Czechia Finland France Germany +8

  • Study of Everolimus and Resistance Training to Improve Bone Formation in Healthy Postmenopausal Women

    Recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark

  • Study of immunosuppression reduction in kidney transplant patients with septic shock or respiratory failure receiving drug combination therapy in intensive care

    Recruiting

    4 1 1 1
    Investigated drugs:
    France

  • Study on Everolimus and Exercise to Prevent Bone Loss in Healthy Postmenopausal Women

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark

  • Study of Lutetium (177Lu) Oxodotreotide for Patients with Recurrent Meningioma Without Surgery or Radiotherapy Options

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Denmark France Germany Italy The Netherlands +2

  • Study on Elacestrant and Everolimus for Patients with Advanced ER+/HER2- Breast Cancer Resistant to Endocrine Therapy and CDK4/6 Inhibitors

    Recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Czechia France Germany Greece Italy +1

  • Study on Everolimus for Preventing Rejection in Adult Kidney Transplant Patients

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study on zAvatar Test for Treatment Decisions in Relapsed Ovarian Cancer and Metastatic Breast Cancer Using Palbociclib and Drug Combination for Eligible Patients

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Portugal

  • Study on RYZ101 for Patients with Advanced Gastroenteropancreatic Neuroendocrine Tumors After Previous Treatment

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France The Netherlands Spain

Glossary

  • Angiomyolipoma (AML): A type of benign tumor that primarily consists of fat, blood vessels, and smooth muscle cells. It most commonly occurs in the kidneys and is often associated with tuberous sclerosis complex.
  • Tuberous Sclerosis Complex (TSC): A rare genetic disorder that causes non-cancerous tumors to grow in various organs of the body, including the brain, skin, heart, lungs, and kidneys.
  • Progression-Free Survival (PFS): The length of time during and after treatment that a patient lives with the disease but it does not get worse. PFS is often used in clinical trials to evaluate the effectiveness of cancer treatments.
  • mTOR: Stands for 'mammalian target of rapamycin'. It's a protein that regulates cell growth, proliferation, and survival. Everolimus works by inhibiting mTOR.
  • Neuroendocrine Tumors (NETs): A type of tumor that begins in specialized cells called neuroendocrine cells. These cells have traits similar to those of nerve cells and hormone-producing cells.
  • RECIST Criteria: Response Evaluation Criteria in Solid Tumors. It's a standard way to measure how well a cancer patient responds to treatment, used in many clinical trials.
  • Adverse Event (AE): Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure.
  • Serious Adverse Event (SAE): An adverse event that results in death, is life-threatening, requires hospitalization, causes significant disability, or is otherwise medically significant.
  • Pharmacokinetics (PK): The study of how a drug is absorbed, distributed, metabolized, and excreted by the body. PK parameters are often evaluated in clinical trials.
  • Left Ventricular Hypertrophy: A condition where the muscle wall of the heart's left pumping chamber (left ventricle) becomes thickened (hypertrophied).

References

  1. https://clinicaltrials.gov/study/NCT01854606
  2. https://clinicaltrials.gov/study/NCT00912340
  3. https://clinicaltrials.gov/study/NCT02008019
  4. https://clinicaltrials.gov/study/NCT01252251
  5. https://clinicaltrials.gov/study/NCT01637090
  6. https://clinicaltrials.gov/study/NCT02864706
  7. https://clinicaltrials.gov/study/NCT00423865
  8. https://clinicaltrials.gov/study/NCT01642186
  9. https://clinicaltrials.gov/study/NCT01259063