There were 71% men and the mean age was 62 years with 41% of patients being 65 years of age or older. The majority was nephrectomized (87%) and had previously received cytokine therapy (52%). The mean daily dose for the entire study population and the subgroups varied between 650 mg and 676 mg. Also, the number of dose reductions (1 versus 2 versus 3 versus 4+) varied between 22% and 24%, 11% and 13%, 5% and 10% and 5% and 15%, respectively. The authors claimed that sorafenib is well tolerated even in the subgroup of elderly patients.
This trial on a large number of patients confirms that sorafenib has acceptable side effects, which predominantly occur within 3 months. However, we still do not know the possible relation between the individually given dose and individual bioavailability and efficacy as well as side effects. Ideally, plasma levels would be obtained for every patient to perform drug monitoring and correlate the findings to efficacy and side effects. For whatever reason(s) these tests are not available. Thus the individual benefit for the patients is still difficult to predict.
Presented by M.O. Grimm, et al. at the Deutsche Gesellschaft für Urologie (DGU) - 63rd Annual Congress - September 14 - 17, 2011 - Congress Center - Hamburg, Germany
Reported for UroToday by Christian Doehn, MD, PhD, Urologikum Lubeck, Lubeck, Germany.
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