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Comparison of Two M...
Comparison of Two Mitotane Starting dose Regimens in Patients with Advanced Adrenocortical Carcinoma
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Kerkhofs, Tm (författare)
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Baudin, E (författare)
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Terzolo, M (författare)
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Allolio, B (författare)
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Chadarevian, R (författare)
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Mueller, Hh (författare)
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- Skogseid, Britt (författare)
- Uppsala universitet,Endokrin tumörbiologi
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Leboulleux, S (författare)
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Mantero, F (författare)
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Haak, Hr (författare)
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Fassnacht, M (författare)
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(creator_code:org_t)
- The Endocrine Society, 2013
- 2013
- Engelska.
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Ingår i: Journal of Clinical Endocrinology and Metabolism. - : The Endocrine Society. - 0021-972X .- 1945-7197. ; 98:12, s. 2281-
- Relaterad länk:
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https://academic.oup...
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
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- Context:Mitotane is the only approved drug for treatment of adrenocortical carcinoma(ACC). Its pharmacokinetic properties are not fully elucidated and different dosing regimens have never been compared head-to-head.Objective:To investigate the relationship between mitotane dose and plasma concentration comparing two dosing regimens.Design/Setting:Prospective open-label multicenter trial of a predefined duration of twelve weeks.Patients/Interventions:Forty mitotane-naïve patients with metastatic ACC were assigned to a predefined low- or high-dose regimen by the local investigator. Thirty-two could be evaluated in detail.Main Outcome Measure:Difference in median mitotane plasma levels between both treatment groups.Results:Despite a difference in mean cumulative dose (440±142g versus 272±121g), median maximum plasma levels were not significantly different between the two groups (high-dose 14.3mg/L (6.3-29.7,n=20) versus 11.3mg/L (5.5-20.0,n=12), p=0.235). Ten out of twenty patients on the high-dose regimen reached plasma concentrations ≥14mg/L after 46 days (18-81 days) compared to four of twelve patients on the low-dose regimen after 55 days (46-74 days,p=0.286). All patients who reached 14mg/L at 12 weeks displayed a level ≥4.1 mg/L on day 33 (100% sensitivity). There were no significant differences in frequency and severity of adverse events. Among patients not receiving concomitant chemotherapy mitotane exposure was higher in the high-dose group: 1013±494mg.d/L versus 555±168mg.d/L, p=0.080.Conclusions:The high-dose starting regimen did neither result in significantly different mitotane levels nor in a different rate of adverse events, but concomitant chemotherapy influenced these results. Thus, for mitotane monotherapy the high-dose approach is favorable, whereas for combination therapy a lower dose seems reasonable.
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Kerkhofs, Tm
-
Baudin, E
-
Terzolo, M
-
Allolio, B
-
Chadarevian, R
-
Mueller, Hh
-
visa fler...
-
Skogseid, Britt
-
Leboulleux, S
-
Mantero, F
-
Haak, Hr
-
Fassnacht, M
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visa färre...
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Uppsala universitet