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Cancer Chemotherapy and Pharmacology
Published in: Cancer Chemotherapy and Pharmacology 6/2009

01-05-2009 | Original Article

Experiences and practical conclusions concerning temsirolimus use and adverse event management in advanced renal cell carcinoma within a compassionate use program in Germany

Authors: Holger Gerullis, Lothar Bergmann, Luise Maute, Christoph Eimer, Thomas Otto

Published in: Cancer Chemotherapy and Pharmacology | Issue 6/2009

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Abstract

Purpose

To detail tolerance of temsirolimus in a routine practice setting within a compassionate use program for patients with renal cell carcinoma.

Methods

We treated 32 patients with advanced renal cell carcinoma with temsirolimus within the German compassionate use program on an individual patient basis free of charge according to EU guidelines at our two institutions. Twenty-five milligrams of temsirolimus was applied weekly in an inpatient clinical setting. Adverse events were classified following National Cancer Institute Common Toxicity Criteria.

Results

No dose modification or therapy interruptions were necessary due to adverse events. Adverse events like asthenia/fatigue were observed in 43.8%, increased creatinine in 40.6%, mucositis in 31.3%, secondary diabetes in 28.1%, hypothyreosis in 12.5% and rash in 12.5%, hypercholesterolemia and hypertriglyceridemia in 9.3% of the patients.

Conclusion

Therapy with temsirolimus in advanced renal cell carcinoma is well tolerated. In a routine practice setting it results in a predictable adverse event profile that can be managed medically.
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Metadata
Title
Experiences and practical conclusions concerning temsirolimus use and adverse event management in advanced renal cell carcinoma within a compassionate use program in Germany
Authors
Holger Gerullis
Lothar Bergmann
Luise Maute
Christoph Eimer
Thomas Otto
Publication date
01-05-2009
Publisher
Springer-Verlag
Published in
Cancer Chemotherapy and Pharmacology / Issue 6/2009
Print ISSN: 0344-5704
Electronic ISSN: 1432-0843
DOI
https://doi.org/10.1007/s00280-008-0835-2

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