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The median and range of sirolimus levels of each patient are included in Table 2.
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There was no correlation between maximum or median sirolimus levels and development of the toxicities requiring discontinuation of sirolimus or the diagnosis of acute GVHD.
Sirolimus levels throughout this period of follow-up were within the target range (6.3 10.5 μg/L).
The median sirolimus level on day 0 was 6.2 ng/ml (range < 2.5 – 27.3) in all patients.
Blood levels of sirolimus after SCJ administration peaks on day 0 to dose-dependent levels: 3.62 ng/ml for a dose of 440 μg and 9.32 ng/ml for a dose of 1,320 μg [18].
Secondary objectives were evaluation of the safety and tolerability of the combination, response rate, overall survival (OS) and the influence of sirolimus on the blood levels of erlotinib as well as correlation between drug levels and antitumour activity.
It is also important to recognize that the lowest therapeutic levels of sirolimus in organ transplant and cardiac patients are 5 to 15 ng/ml [19].
This study evaluated two immunoassays, the CEDIA® assay and the MEIA® assay, used for the measurement of whole blood levels of sirolimus in organ transplant recipients.
Target trough levels of sirolimus were 4 to 6.5 µg/L.
Trough levels of sirolimus were checked on day 15 (D15) and then monthly and maintained between 4 and 20 ng ml 1.
However, even in the studies with the highest maximum trough levels of sirolimus (20 ng/mL), a significant protective effect for non-NMSCs was not found.
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