Everolimus and Malignancy after Solid Organ Transplantation: A Clinical Update
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Updated: Mar 12, 2026

TBase - an Integrated Electronic Health Record and Research Database for Kidney Transplant Recipients
Published on: April 13, 2021
Hallvard Holdaas1, Paolo De Simone2, Andreas Zuckermann3
1Section of Nephrology, Department of Transplant Medicine, Oslo University Hospital, Rikshospitalet, Postboks 4950 Nydalen, 0424 Oslo, Norway.
Abstract:
Malignancy after solid organ transplantation remains a major cause of posttransplant mortality. The mammalian target of rapamycin (mTOR) inhibitor class of immunosuppressants exerts various antioncogenic effects, and the mTOR inhibitor everolimus is licensed for the treatment of several solid cancers. In kidney transplantation, evidence from registry studies indicates a lower rate of de novo malignancy under mTOR inhibition, with some potentially supportive data from randomized trials of everolimus. Case reports and small single-center series have suggested that switch to everolimus may be beneficial following diagnosis of posttransplant malignancy, particularly for Kaposi's sarcoma and nonmelanoma skin cancer, but prospective studies are lacking. A systematic review has shown mTOR inhibition to be associated with a significantly lower rate of hepatocellular carcinoma (HCC) recurrence versus standard calcineurin inhibitor therapy. One meta-analysis has concluded that patients with nontransplant HCC experience a low but significant survival benefit under everolimus monotherapy, so far unconfirmed in a transplant population. Data are limited in heart transplantation, although observational data and case reports have indicated that introduction of everolimus is helpful in reducing the recurrence of skin cancers. Overall, it can be concluded that, in certain settings, everolimus appears a promising option to lessen the toll of posttransplant malignancy.
Insights
Mammalian target of rapamycin (mTOR) inhibitors like everolimus show promise in reducing post-transplant cancers. Switching to everolimus may benefit transplant patients diagnosed with certain malignancies, particularly skin cancers and hepatocellular carcinoma.
Area of Science:
- Oncology
- Transplantation Medicine
- Immunosuppression
Background:
- Malignancy is a significant cause of mortality following solid organ transplantation.
- Mammalian target of rapamycin (mTOR) inhibitors possess antioncogenic properties and everolimus is approved for treating several cancers.
- Registry and trial data suggest mTOR inhibition may lower de novo malignancy rates in kidney transplant recipients.
Approach:
- Review of registry studies, randomized trials, case reports, and meta-analyses concerning mTOR inhibitors, specifically everolimus.
- Evaluation of everolimus's impact on de novo malignancy, post-transplant malignancy treatment, and cancer recurrence in solid organ transplant recipients.
- Assessment of evidence in kidney and heart transplantation, including specific cancers like Kaposi's sarcoma, nonmelanoma skin cancer, and hepatocellular carcinoma (HCC).
Key Points:
- Everolimus may reduce de novo malignancy rates in kidney transplant patients.
- Switching to everolimus might benefit patients with post-transplant Kaposi's sarcoma and nonmelanoma skin cancer.
- mTOR inhibition is associated with lower HCC recurrence rates compared to calcineurin inhibitors, with potential survival benefits observed in non-transplant HCC patients.
Conclusions:
- Everolimus demonstrates potential in mitigating post-transplant malignancy.
- Further prospective studies are needed to confirm the benefits of switching to everolimus for specific post-transplant malignancies.
- Everolimus represents a promising therapeutic option for reducing the burden of cancer after solid organ transplantation in select cases.
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