title: Efficacy and safety of mitotane in the treatment of adrenocortical carcinoma: A retrospective study in 34 Belgian patients.
abstract: OBJECTIVE
  Evaluation of patient characteristics and mitotane use in the treatment of adrenocortical carcinoma (ACC) over a 4-year period in Belgium.
  
  
  METHODS
  This was a multicentre retrospective review of the outcome of 34 patients treated with mitotane for ACC during the period [01/2008-12/2011] (12 diagnosed before and 22 diagnosed during the study period) and evaluated up to 06/2013.
  
  
  RESULTS
  Patient and tumour characteristics were consistent with those generally described for ACC. Mean age at diagnosis was 46.5 years, most patients were female (62%), had functioning ACC (65%) and advanced tumours (ENSAT stages III or IV: 82%). Therapeutic mitotane plasma levels (14-20 mg/L) were achieved at least once in 70% of the cohort, after a median of 4 months, and were maintained for more than 2 months in 61% of evaluable patients. Mitotane-related adverse effects were observed in 66% of patients, were never serious, and included gastrointestinal, neurological, neuropsychological, hormonal, dermatologic and metabolic effects. Most patients (88%) discontinued mitotane, mainly due to tumour progression. Multivariate analysis showed that ENSAT stage was a prognostic factor for overall (OS) and disease-free survival (DFS); OS was also influenced independently by achievement of therapeutic mitotane plasma levels for at least two consecutive months.
  
  
  CONCLUSIONS
  Patient and tumour characteristics were consistent with previously published data. OS and DFS were mostly influenced by ENSAT stage at diagnosis. Achieving therapeutic levels of mitotane for at least two consecutive months seemed to positively influence OS, but such levels were not reached or sustained in some patients.
authors.affiliation: Department of endocrinology and nutrition, cliniques universitaires Saint-Luc, avenue Hippocrate 10, 1200 Brussels, Belgium. Electronic address: dominique.maiter@uclouvain.be.
authors.forename: Dominique
authors.initials: D
authors.lastname: Maiter
authors.affiliation: Department of endocrinology, UZ Leuven, Herestraat, 3000 Leuven, Belgium. Electronic address: marie.bex@uzleuven.be.
authors.forename: Marie
authors.initials: M
authors.lastname: Bex
authors.affiliation: Department of endocrinology, Liège university hospital, domaine du Sart Tilman, 4000 Liège, Belgium. Electronic address: laurent_vroonen@hotmail.com.
authors.forename: Laurent
authors.initials: L
authors.lastname: Vroonen
authors.affiliation: Department of endocrinology, center for sexology and gender, Ghent university hospital, De Pintelaan 185 9 K12 IE, 9000 Gent, Belgium. Electronic address: guy.tsjoen@ugent.be.
authors.forename: Guy
authors.initials: G
authors.lastname: T'Sjoen
authors.affiliation: Department of medical oncology, institut Bordet, Free university of Brussels, rue Héger-Bordetstraat 1, 1000 Brussels, Belgium. Electronic address: thierry.gil@bordet.be.
authors.forename: Thierry
authors.initials: T
authors.lastname: Gil
authors.affiliation: HRA Pharma headquarters, 15, rue Béranger, 75003 Paris, France. Electronic address: c.banh@hra-pharma.com.
authors.forename: Camille
authors.initials: C
authors.lastname: Banh
authors.affiliation: HRA Pharma headquarters, 15, rue Béranger, 75003 Paris, France. Electronic address: r.chadarevian@hra-pharma.com.
authors.forename: Rita
authors.initials: R
authors.lastname: Chadarevian
mesh_terms: D000293:Adolescent; D000306:Adrenal Cortex Neoplasms / Q000188:drug therapy*; D018268:Adrenocortical Carcinoma / Q000188:drug therapy*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018931:Antineoplastic Agents, Hormonal / Q000009:adverse effects / Q000627:therapeutic use*; D001530:Belgium; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D008939:Mitotane / Q000009:adverse effects / Q000627:therapeutic use*; D012189:Retrospective Studies; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D018931:Antineoplastic Agents, Hormonal; D008939:Mitotane
keywords: Adrenal glands; Adrenocortical carcinoma; Adénocarcinomes corticosurrénaliens; Cancer; Corticosurrénalome; Glandes surrénales; Mitotane