Safety of everolimus by treatment duration in patients with advanced renal cell cancer in an expanded access program

Alfonsus J.M. Van Den Eertwegh; Pierre Karakiewicz; Sevil Bavbek; Sun Young Rha; Sergio Bracarda; Amit Bahl; Yen Chuan Ou; Dennis Kim; Ashok Panneerselvam; Oezlem Anak; Viktor Grünwald

doi:10.1016/j.urology.2012.09.019

Safety of everolimus by treatment duration in patients with advanced renal cell cancer in an expanded access program

Alfonsus J.M. Van Den Eertwegh, Pierre Karakiewicz, Sevil Bavbek, Sun Young Rha, Sergio Bracarda, Amit Bahl, Yen Chuan Ou, Dennis Kim, Ashok Panneerselvam, Oezlem Anak, Viktor Grünwald

Department of Internal Medicine

Research output: Contribution to journal › Article › peer-review

19 Citations (Scopus)

Abstract

Objective: To retrospectively analyze the effects of treatment duration on outcomes of everolimus treatment of patients in the RAD001 Expanded-Access Clinical Trial in RCC (REACT) program. Methods: Patients with metastatic renal cell carcinoma refractory to vascular endothelial growth factor receptor-tyrosine kinase inhibitor received everolimus (10 mg once daily), with dosing interruption or modifications allowed for toxicity. All serious and grade 3/4 adverse events and grade 1/2 adverse events leading to a change in drug administration were reported. Tumor response was evaluated using Response Evaluation Criteria In Solid Tumors. Results: The study stratified 1367 evaluable patients into treatment duration groups of <3 months, ≥3 and <6 months, ≥6 months and <1 year, and ≥1 year. Pneumonia, noninfectious pneumonitis, and hyperglycemia occurred more frequently in patients receiving everolimus for ≥1 year but did not result in treatment discontinuations. First occurrence of adverse events presented early in the treatment course for most patients. Treatment duration of ≥6 months was associated with improved disease control rates. Conclusion: Everolimus is well tolerated in patients with metastatic renal cell carcinoma for treatment durations ≥1 year and not associated with cumulative toxicity.

Original language	English
Pages (from-to)	143-149
Number of pages	7
Journal	Urology
Volume	81
Issue number	1
DOIs	https://doi.org/10.1016/j.urology.2012.09.019
Publication status	Published - 2013 Jan

Bibliographical note

Funding Information:
Financial Disclosure: S. Bavbek has received consulting fees and honoraria from Novartis, Pfizer, GlaxoSmithKline, Sanofi-Aventis, and Bayer. S. Bracarda has received consulting fees from Pfizer, Sanofi-Aventis, Jannsen, Boehringer-Ingelheim, GlaxoSmithKline, and Novartis and has held nonremunerative positions of influence for Bayer Schering Pharma. A. Bahl has received research grants from Sanofi and served as advisor to Sanofi, Amgen, Roche, and Novartis. D. Kim and O. Anak own stock in and are employees of Novartis. A. Panneerselvam is an employee of Novartis. V. Grünwald has received consulting fees and served as speaker for Pfizer. Other authors have no disclosures.

Funding Information:
Funding Support: Editorial assistance in the preparation of this manuscript was provided by Karen Miller-Moslin, Ph.D., and Clare Lee, Ph.D., of ApotheCom (Yardley, PA), and was funded by Novartis Pharmaceuticals Corporation .

All Science Journal Classification (ASJC) codes

Urology

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1016/j.urology.2012.09.019

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title = "Safety of everolimus by treatment duration in patients with advanced renal cell cancer in an expanded access program",

abstract = "Objective: To retrospectively analyze the effects of treatment duration on outcomes of everolimus treatment of patients in the RAD001 Expanded-Access Clinical Trial in RCC (REACT) program. Methods: Patients with metastatic renal cell carcinoma refractory to vascular endothelial growth factor receptor-tyrosine kinase inhibitor received everolimus (10 mg once daily), with dosing interruption or modifications allowed for toxicity. All serious and grade 3/4 adverse events and grade 1/2 adverse events leading to a change in drug administration were reported. Tumor response was evaluated using Response Evaluation Criteria In Solid Tumors. Results: The study stratified 1367 evaluable patients into treatment duration groups of <3 months, ≥3 and <6 months, ≥6 months and <1 year, and ≥1 year. Pneumonia, noninfectious pneumonitis, and hyperglycemia occurred more frequently in patients receiving everolimus for ≥1 year but did not result in treatment discontinuations. First occurrence of adverse events presented early in the treatment course for most patients. Treatment duration of ≥6 months was associated with improved disease control rates. Conclusion: Everolimus is well tolerated in patients with metastatic renal cell carcinoma for treatment durations ≥1 year and not associated with cumulative toxicity.",

author = "{Van Den Eertwegh}, {Alfonsus J.M.} and Pierre Karakiewicz and Sevil Bavbek and Rha, {Sun Young} and Sergio Bracarda and Amit Bahl and Ou, {Yen Chuan} and Dennis Kim and Ashok Panneerselvam and Oezlem Anak and Viktor Gr{\"u}nwald",

note = "Funding Information: Financial Disclosure: S. Bavbek has received consulting fees and honoraria from Novartis, Pfizer, GlaxoSmithKline, Sanofi-Aventis, and Bayer. S. Bracarda has received consulting fees from Pfizer, Sanofi-Aventis, Jannsen, Boehringer-Ingelheim, GlaxoSmithKline, and Novartis and has held nonremunerative positions of influence for Bayer Schering Pharma. A. Bahl has received research grants from Sanofi and served as advisor to Sanofi, Amgen, Roche, and Novartis. D. Kim and O. Anak own stock in and are employees of Novartis. A. Panneerselvam is an employee of Novartis. V. Gr{\"u}nwald has received consulting fees and served as speaker for Pfizer. Other authors have no disclosures. Funding Information: Funding Support: Editorial assistance in the preparation of this manuscript was provided by Karen Miller-Moslin, Ph.D., and Clare Lee, Ph.D., of ApotheCom (Yardley, PA), and was funded by Novartis Pharmaceuticals Corporation . ",

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doi = "10.1016/j.urology.2012.09.019",

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T1 - Safety of everolimus by treatment duration in patients with advanced renal cell cancer in an expanded access program

AU - Van Den Eertwegh, Alfonsus J.M.

AU - Karakiewicz, Pierre

AU - Bavbek, Sevil

AU - Rha, Sun Young

AU - Bracarda, Sergio

AU - Bahl, Amit

AU - Ou, Yen Chuan

AU - Kim, Dennis

AU - Panneerselvam, Ashok

AU - Anak, Oezlem

AU - Grünwald, Viktor

N1 - Funding Information: Financial Disclosure: S. Bavbek has received consulting fees and honoraria from Novartis, Pfizer, GlaxoSmithKline, Sanofi-Aventis, and Bayer. S. Bracarda has received consulting fees from Pfizer, Sanofi-Aventis, Jannsen, Boehringer-Ingelheim, GlaxoSmithKline, and Novartis and has held nonremunerative positions of influence for Bayer Schering Pharma. A. Bahl has received research grants from Sanofi and served as advisor to Sanofi, Amgen, Roche, and Novartis. D. Kim and O. Anak own stock in and are employees of Novartis. A. Panneerselvam is an employee of Novartis. V. Grünwald has received consulting fees and served as speaker for Pfizer. Other authors have no disclosures. Funding Information: Funding Support: Editorial assistance in the preparation of this manuscript was provided by Karen Miller-Moslin, Ph.D., and Clare Lee, Ph.D., of ApotheCom (Yardley, PA), and was funded by Novartis Pharmaceuticals Corporation .

PY - 2013/1

Y1 - 2013/1

N2 - Objective: To retrospectively analyze the effects of treatment duration on outcomes of everolimus treatment of patients in the RAD001 Expanded-Access Clinical Trial in RCC (REACT) program. Methods: Patients with metastatic renal cell carcinoma refractory to vascular endothelial growth factor receptor-tyrosine kinase inhibitor received everolimus (10 mg once daily), with dosing interruption or modifications allowed for toxicity. All serious and grade 3/4 adverse events and grade 1/2 adverse events leading to a change in drug administration were reported. Tumor response was evaluated using Response Evaluation Criteria In Solid Tumors. Results: The study stratified 1367 evaluable patients into treatment duration groups of <3 months, ≥3 and <6 months, ≥6 months and <1 year, and ≥1 year. Pneumonia, noninfectious pneumonitis, and hyperglycemia occurred more frequently in patients receiving everolimus for ≥1 year but did not result in treatment discontinuations. First occurrence of adverse events presented early in the treatment course for most patients. Treatment duration of ≥6 months was associated with improved disease control rates. Conclusion: Everolimus is well tolerated in patients with metastatic renal cell carcinoma for treatment durations ≥1 year and not associated with cumulative toxicity.

AB - Objective: To retrospectively analyze the effects of treatment duration on outcomes of everolimus treatment of patients in the RAD001 Expanded-Access Clinical Trial in RCC (REACT) program. Methods: Patients with metastatic renal cell carcinoma refractory to vascular endothelial growth factor receptor-tyrosine kinase inhibitor received everolimus (10 mg once daily), with dosing interruption or modifications allowed for toxicity. All serious and grade 3/4 adverse events and grade 1/2 adverse events leading to a change in drug administration were reported. Tumor response was evaluated using Response Evaluation Criteria In Solid Tumors. Results: The study stratified 1367 evaluable patients into treatment duration groups of <3 months, ≥3 and <6 months, ≥6 months and <1 year, and ≥1 year. Pneumonia, noninfectious pneumonitis, and hyperglycemia occurred more frequently in patients receiving everolimus for ≥1 year but did not result in treatment discontinuations. First occurrence of adverse events presented early in the treatment course for most patients. Treatment duration of ≥6 months was associated with improved disease control rates. Conclusion: Everolimus is well tolerated in patients with metastatic renal cell carcinoma for treatment durations ≥1 year and not associated with cumulative toxicity.

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Safety of everolimus by treatment duration in patients with advanced renal cell cancer in an expanded access program

Abstract

Bibliographical note

All Science Journal Classification (ASJC) codes

UN SDGs

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