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Poster display

3550 - The influence of old age on everolimus exposure in patients with cancer

Date

10 Oct 2016

Session

Poster display

Presenters

Annelieke Willemsen

Citation

Annals of Oncology (2016) 27 (6): 68-99. 10.1093/annonc/mdw365

Authors

A.E.C.A.B. Willemsen1, C. van Herpen2, T.C. Schneider3, D. de Wit4, E. Kapiteijn3, N.P. van Erp5

Author affiliations

  • 1 Medical Oncology, Radboud University Medical Centre Nijmegen, 6500HB - Nijmegen/NL
  • 2 Medical Oncology, Radboud University Medical Centre Nijmegen, Nijmegen/NL
  • 3 Clinical Oncology, Leiden University Medical Center (LUMC), Leiden/NL
  • 4 Clinical Pharmacy And Toxicology, Leiden University Medical Center (LUMC), Leiden/NL
  • 5 Pharmacy, Radboud University Medical Centre Nijmegen, Nijmegen/NL
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Abstract 3550

Background

When starting treatment with everolimus in elderly cancer patients (pts), clinicians are often concerned about everolimus related toxicity. Elderly pts frequently have comorbidities and are considered more fragile. Therefore, upfront dose reduction of everolimus to prevent toxicity is applied more readily in elderly pts. However, very limited data are available on the pharmacokinetics (PK) in elderly pts and therefore, the influence of age on everolimus PK in cancer pts is yet unknown. The objective of this study was to determine the effect of age on everolimus PK.

Methods

In two PK studies in pts with either metastatic breast cancer or advanced thyroid cancer treated with everolimus 10mg OD, everolimus PK was compared between elderly pts (age ≥ 70 years ) and control pts (age 

Results

19 elderly and 56 control pts were included. Comparative PK data are shown in table 1. Everolimus exposure in both whole blood and plasma did not differ significantly between the two groups. Dose reductions or discontinuations due to toxicity occurred in 42% of elderly and 40% of control pts (p = .73). Table: results.

Parameter Control (n = 56); mean (range; SD) Elderly (n = 19); mean (range; SD) P
Age (years) 57.5 (37-69) 73.4 (70-80)
Whole blood AUC0-24 580.0 (223.1) 507.9 (182.3) .208
Plasma AUC0-24 209.1 (79.3) 190.0 (66.3) .349

AUC0–24 = area under concentration–time curve from zero to 24 hours, µg*h/L

Conclusions

Everolimus PK is not affected by older age. Upfront dose adjustment, such as frequently considered in elderly pts, is not supported by PK and clinical data and needs to be reconsidered.

Clinical trial identification

NCT01948960 AND NCT01118065

Legal entity responsible for the study

Radboud University Medical Center

Funding

Novartis

Disclosure

All authors have declared no conflicts of interest.

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