Session: MON 1-36-Adrenal Incidentaloma & Carcinoma
Poster Board MON-23
Methods: In this prospective open-label multicenter trial, forty mitotane-naïve patients with locally advanced or metastatic ACC were enrolled. Assignment to one of the two dosing regimens (high-dose and low-dose) was done on a case by case basis by the respective local investigator. The predefined study duration was twelve weeks. Adverse events were monitored throughout the study.
Results: Ten out of 20 patients on the high-dose regimen reached plasma concentrations ≥ 14mg/L after a median of 46 days (18-81 days) compared to 4 of 12 patients on the low-dose regimen after a median of 55 days (46-74 days, p=0.286). Mean cumulative mitotane dose was significantly higher in the high-dose group (440 ± 142g versus 272 ± 121g, p=0.013). Median maximum plasma level was 14.3 mg/L (6.3-29.7) in the high-dose group (n=20) and 11.3 mg/L (5.5-20.0) in the low-dose group (n=12, p=0.235). There was no significant difference between the two groups in the incidence and severity of adverse events.
Conclusions: The high-dose start-up regimen did not result in significantly higher mitotane levels or shorter time to reach therapeutic levels, but did result in higher cumulative doses. Toxicity in the high dose regimen was not observed to be greater than in the low-dose regimen. Hormonal changes should be expected and may need additional treatment.
Disclosure: MT: Ad Hoc Consultant, HRA Pharma. RC: Employee, HRA Pharma. Nothing to Disclose: TK, EB, BA, SL, FM, HH, MF
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