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, SunYoung Rha, Sergio Bracarda, Amit Bahl, Yen Chuan Ou, Dennis Kim, Ashok Panneerselvam, Oezlem Anak, Viktor Grünwald

Research output: Contribution to journalArticle

18 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 languageEnglish
Pages (from-to)143-149
Number of pages7
JournalUrology
Volume81
Issue number1
DOIs
Publication statusPublished - 2013 Jan 1

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Renal Cell Carcinoma
Safety
Pneumonia
Therapeutics
Compassionate Use Trials
Vascular Endothelial Growth Factor Receptor
Hyperglycemia
Protein-Tyrosine Kinases
Everolimus
Clinical Trials
Pharmaceutical Preparations
Neoplasms

All Science Journal Classification (ASJC) codes

  • Urology

Cite this

Van Den Eertwegh, A. J. M., Karakiewicz, P., Bavbek, S., Rha, S., Bracarda, S., Bahl, A., ... Grünwald, V. (2013). Safety of everolimus by treatment duration in patients with advanced renal cell cancer in an expanded access program. Urology, 81(1), 143-149. https://doi.org/10.1016/j.urology.2012.09.019
Van Den Eertwegh, Alfonsus J.M. ; Karakiewicz, Pierre ; Bavbek, Sevil ; Rha, SunYoung ; Bracarda, Sergio ; Bahl, Amit ; Ou, Yen Chuan ; Kim, Dennis ; Panneerselvam, Ashok ; Anak, Oezlem ; Grünwald, Viktor. / Safety of everolimus by treatment duration in patients with advanced renal cell cancer in an expanded access program. In: Urology. 2013 ; Vol. 81, No. 1. pp. 143-149.
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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.",
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Van Den Eertwegh, AJM, Karakiewicz, P, Bavbek, S, Rha, S, Bracarda, S, Bahl, A, Ou, YC, Kim, D, Panneerselvam, A, Anak, O & Grünwald, V 2013, 'Safety of everolimus by treatment duration in patients with advanced renal cell cancer in an expanded access program', Urology, vol. 81, no. 1, pp. 143-149. https://doi.org/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. / Van Den Eertwegh, Alfonsus J.M.; Karakiewicz, Pierre; Bavbek, Sevil; Rha, SunYoung; Bracarda, Sergio; Bahl, Amit; Ou, Yen Chuan; Kim, Dennis; Panneerselvam, Ashok; Anak, Oezlem; Grünwald, Viktor.

In: Urology, Vol. 81, No. 1, 01.01.2013, p. 143-149.

Research output: Contribution to journalArticle

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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, SunYoung

AU - Bracarda, Sergio

AU - Bahl, Amit

AU - Ou, Yen Chuan

AU - Kim, Dennis

AU - Panneerselvam, Ashok

AU - Anak, Oezlem

AU - Grünwald, Viktor

PY - 2013/1/1

Y1 - 2013/1/1

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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