NDLI: Comparison of two mitotane starting dose regimens in patients with advanced adrenocortical carcinoma.

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Comparison of two mitotane starting dose regimens in patients with advanced adrenocortical carcinoma.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Terzolo, M. Chadarevian, R. Skogseid, B. Haak, H. R. Baudin, E. Mueller, H. H. Leboulleux, S. Allolio, B. Mantero, F. Fassnacht, M. Kerkhofs, T. M.
Description	Country affiliation: Netherlands Author Affiliation: Kerkhofs TM ( MD, Department of Internal Medicine, Máxima Medical Center, Ds. Th. Fliednerstraat 1, 5631 BM Eindhoven, The Netherlands. t.kerkhofs@mmc.nl.)
Abstract	CONTEXT: Mitotane is the only approved drug for treatment of adrenocortical carcinoma. Its pharmacokinetic properties are not fully elucidated and different dosing regimens have never been compared head to head. OBJECTIVE: The objective of the study was to investigate the relationship between mitotane dose and plasma concentration comparing two dosing regimens. DESIGN/SETTING: This was a prospective, open-label, multicenter trial of a predefined duration of 12 weeks. PATIENTS/INTERVENTIONS: Forty mitotane-naïve patients with metastatic adrenocortical carcinoma were assigned to a predefined low- or high-dose regimen by the local investigator. Thirty-two patients could be evaluated in detail. MAIN OUTCOME MEASURE: The difference in median mitotane plasma levels between both treatment groups was measured. RESULTS: Despite a difference in mean cumulative dose (440 ± 142 g vs 272 ± 121 g), median maximum plasma levels were not significantly different between the two groups [high dose 14.3 mg/L (range 6.3-29.7, n = 20) vs 11.3 mg/L (range 5.5-20.0, n = 12), P = .235]. Ten of 20 patients on the high-dose regimen reached plasma concentrations of 14 mg/L or greater after 46 days (range 18-81 d) compared with 4 of 12 patients on the low-dose regimen after 55 days (range 46-74 d, P = .286). All patients who reached 14 mg/L at 12 weeks displayed a level of 4.1 mg/L or greater 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 ± 494 mg/L · d vs 555 ± 168 mg/L · d (P = .080). CONCLUSIONS: The high-dose starting regimen resulted in neither significantly different mitotane levels nor 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.
ISSN	0021972X
e-ISSN	19457197
Journal	The Journal of Clinical Endocrinology & Metabolism
Issue Number	12
Volume Number	98
Language	English
Publisher	Oxford University Press
Publisher Date	2013-12-01
Publisher Place	United States
Access Restriction	Open
Subject Keyword	Adrenal Cortex Neoplasms Drug Therapy Adrenal Cortex Drug Effects Adrenocortical Carcinoma Antineoplastic Agents, Hormonal Pharmacokinetics Mitotane Pathology Blood Administration & Dosage Adverse Effects Therapeutic Use Antineoplastic Combined Chemotherapy Protocols Biotransformation Dichlorodiphenyl Dichloroethylene Dose-response Relationship, Drug Drug Interactions Drug Monitoring Gastrointestinal Diseases Chemically Induced Physiopathology Neoplasm Staging Neurotoxicity Syndromes Phenylacetates Severity Of Illness Index Clinical Trial Comparative Study Multicenter Study Research Support, Non-u.s. Gov't Discipline Endocrinology Discipline Metabolism
Content Type	Text
Resource Type	Article
Subject	Biochemistry (medical) Endocrinology, Diabetes and Metabolism Clinical Biochemistry Biochemistry Endocrinology

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