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

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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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Abbreviations

TEMSR:

Temsirolimus

CUP:

Compassionate use program

AE:

Adverse event

RCC:

Renal cell carcinoma

EU:

European Union

QoL:

Quality of life

CTX:

Chemotherapy

MSKCC:

Memorial Sloan-Kettering Cancer Center

NCICTC:

National Cancer Institute Common Toxicity Criteria

EMEA:

European Medicines Agency

CHMP:

Committee for medicinal products for human use

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Acknowledgments

The authors thank Dr. C. Heuck for his excellent language support. All authors were investigators of the CUP. L. Bergmann and T. Otto were members of an advisory board of Wyeth Pharma, Germany. These positions had no influence on the outcome of the analysis.

Conflict of interest statement

There was no potential performance of this program.

Author information

Authors and Affiliations

  1. Department of Urology, Lukas Hospital, Neuss, Germany

    Holger Gerullis, Christoph Eimer & Thomas Otto

  2. Department of Internal Medicine II, Hematology and Oncology, J. W. Goethe-University, Frankfurt am Main, Germany

    Lothar Bergmann & Luise Maute

  3. West German Cancer Center (WTZ), University of Essen,  Essen, Germany

    Holger Gerullis & Thomas Otto

Authors
  1. Holger Gerullis
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  2. Lothar Bergmann
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  3. Luise Maute
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  4. Christoph Eimer
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  5. Thomas Otto
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Corresponding author

Correspondence to Holger Gerullis.

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Gerullis, H., Bergmann, L., Maute, L. et al. Experiences and practical conclusions concerning temsirolimus use and adverse event management in advanced renal cell carcinoma within a compassionate use program in Germany. Cancer Chemother Pharmacol 63, 1097–1102 (2009). https://doi.org/10.1007/s00280-008-0835-2

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  • DOI: https://doi.org/10.1007/s00280-008-0835-2

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