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Updated: May 5, 2026

A Syngeneic Mouse Model of Metastatic Renal Cell Carcinoma for Quantitative and Longitudinal Assessment of Preclinical Therapies
Published on: April 12, 2017
Temsirolimus for advanced renal cell carcinoma
Lothar Bergmann1, Luise Maute, Michael Guschmann
1Medizinische Klinik II, J.W. Goethe Universität, Theodor-Stern-Kai 7, D-60590 Frankfurt, Germany.
Abstract:
Renal cell carcinomas (RCCs) represent one of the ten leading cancer entities with an increasing incidence especially in the western world. Unfortunately, about 25% of the patients develop metastatic RCC (mRCC) associated with a most unfavorable prognosis. In the recent years, various new agents targeting VEGF or VEGF receptor (VEGFR) or the mTOR pathway have been approved for the treatment of mRCC with significant prolongation of progression-free survival and, in part, of overall survival (OS). Targeting the mTOR kinase is an interesting option for mRCC. Temsirolimus, one of the available mTOR inhibitors, has been approved as a single agent in poor-risk mRCC patients based on the pivotal Phase III trial showing a significant superiority in OS versus IFN-α or temsirolimus + IFN-α, which has been verified by a pivotal Phase III trial. The benefit has been shown for clear cell carcinoma and papillary RCC as well. For poor prognosis patients, temsirolimus improves median survival by 3.6 months. In second-line treatment compared with sorafenib following first-line treatment with sunitinib temsirolimus showed a relative progression-free survival benefit for patients with nonclear cell RCC with temsirolimus. The median OS for the temsirolimus group was 12.27 and 16.64 months for the sorafenib group. In 2007, the US FDA granted approval for temsirolimus for the treatment of advanced RCC.
Insights
Temsirolimus, an mTOR inhibitor, offers improved survival for metastatic renal cell carcinoma (mRCC) patients, particularly those with poor prognosis. It provides a survival benefit in both first and second-line treatments for advanced kidney cancer.
Area of Science:
- Oncology
- Pharmacology
Background:
- Renal cell carcinoma (RCC) is a leading cancer with increasing incidence.
- Metastatic RCC (mRCC) carries a poor prognosis, with 25% of patients developing the advanced stage.
- Targeting the mTOR pathway has emerged as a viable treatment strategy for mRCC.
Purpose of the Study:
- To evaluate the efficacy of temsirolimus, an mTOR inhibitor, in treating metastatic renal cell carcinoma (mRCC).
- To assess the impact of temsirolimus on overall survival (OS) and progression-free survival (PFS) in various RCC subtypes and risk groups.
Main Methods:
- Review of pivotal Phase III trials comparing temsirolimus with interferon-alfa (IFN-α) and its combination.
- Analysis of second-line treatment data comparing temsirolimus with sorafenib in non-clear cell RCC.
- Examination of US FDA approval data for temsirolimus in advanced RCC.
Main Results:
- Temsirolimus demonstrated significant superiority in OS compared to IFN-α or combination therapy in poor-risk mRCC patients.
- The drug improved median survival by 3.6 months for poor prognosis patients.
- In second-line treatment for non-clear cell RCC, temsirolimus showed a relative PFS benefit compared to sorafenib, although median OS was lower.
Conclusions:
- Temsirolimus is an effective treatment option for advanced renal cell carcinoma, especially for poor-risk patients.
- Its efficacy extends to clear cell and papillary RCC subtypes.
- Temsirolimus received US FDA approval in 2007 for advanced RCC treatment.
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