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Modeling Spontaneous Metastatic Renal Cell Carcinoma mRCC in Mice Following Nephrectomy
Published on: April 29, 2014
Safety profile of temsirolimus in patients with metastatic renal cell carcinoma
Ivan Levakov1, Sasa Vojinov, Goran Marusic
1Urology Clinic, Clinical Center of Vojvodina, Novi Sad, Serbia.
Purpose:
Various targeted disease-specific therapeutics are currently approved, demonstrating a survival benefit over therapy with interferon-alpha (IFN-α) in patients with metastatic renal cell carcinoma (mRCC). Temsirolimus, a highly specific inhibitor of the mammalian target of rapamycin (mTOR), improves the overall and progression-free survival of high-risk patients with mRCC. The purpose of this study was to estimate the effects of temsirolimus on several laboratory parameters and to report the potential adverse events (AEs) in patients with mRCC.
Methods:
This research was a controlled, open, prospective and partly retrospective randomized study that included 60 patients up to 65 years of age, divided into the experimental and control group, each containing 30 patients. Patients in the experimental group were treated with temsirolimus. The control group comprised patients in the same stage of disease, treated with IFN-α. The effect of therapy in both groups was monitored during the first year of administration.
Results:
The overall incidence of AEs was 40% in both groups. Sixteen laboratory parameters were analyzed and the total number of deviations from the reference range was 263 in the experimental group and 229 in the control group. The total number of AEs regarding patient general clinical condition in the experimental group was 193 (asthenia 53.3%, urinary infection 43.3% and pyrexia 40%) and 175 in the control group (pyrexia 76.7%, asthenia 50% and tremor 50%).
Conclusion:
Monitoring the renal function parameters during the temsirolimus administration has proved that the therapy had no significant influence on the remaining kidney function. By evaluating the AEs we concluded that there was no significant difference in the number of AEs of all grades between the groups, while the laboratory parameters and physical status deterioration differed qualitatively.
Insights
Temsirolimus and interferon-alpha (IFN-α) showed similar adverse event rates in metastatic renal cell carcinoma (mRCC) patients. Temsirolimus did not significantly impact kidney function, though laboratory and physical status changes differed qualitatively between treatments.
Area of Science:
- Oncology
- Pharmacology
- Nephrology
Background:
- Metastatic renal cell carcinoma (mRCC) treatment has advanced with targeted therapies offering survival benefits over interferon-alpha (IFN-α).
- Temsirolimus, a mammalian target of rapamycin (mTOR) inhibitor, has demonstrated efficacy in improving survival for high-risk mRCC patients.
Purpose of the Study:
- To evaluate the effects of temsirolimus on laboratory parameters in mRCC patients.
- To assess and report potential adverse events (AEs) associated with temsirolimus therapy in mRCC.
- To compare temsirolimus with IFN-α regarding laboratory changes and AEs.
Main Methods:
- A controlled, open-label, prospective, and partly retrospective randomized study involving 60 mRCC patients (≤65 years).
- Patients were divided into two groups: experimental (temsirolimus) and control (IFN-α), each with 30 participants.
- Therapeutic effects and adverse events were monitored over the first year of treatment.
Main Results:
- The overall incidence of adverse events was 40% in both the temsirolimus and IFN-α groups.
- Laboratory parameter deviations occurred 263 times in the temsirolimus group versus 229 times in the IFN-α group.
- Common AEs included asthenia and pyrexia in both groups; urinary infection was frequent with temsirolimus, and tremor with IFN-α.
Conclusions:
- Temsirolimus administration did not significantly affect residual renal function in mRCC patients.
- No significant difference in the overall number of grade-related AEs was observed between temsirolimus and IFN-α.
- Qualitative differences were noted in laboratory parameters and physical status deterioration between the two treatment groups.
