ECE2011 Poster Presentations Adrenal cortex (41 abstracts)
Is plasma mitotane level >30 mg/l a serious adverse event in patients with adrenocortical carcinoma (ACC)?: a retrospective analysis of the French COMETE network
S M D Mauclere-Denost 1 , A T Tabarin 1 , D D Drui 2 , L C Chaillous 2 , S S Salenave 3 , S L Leboulleux 4 , O C Chabre 5 , C D C Do-Cao 6 , H D Dubourg 1 , M L C Cuvelier 7 , J Y Young 3 & E B Baudin 4
1Department of Endocrinology, Haut-Lévêque Hospital, University of Bordeaux, Pessac, France; 2Department of Endocrinology, University of Nantes, Nantes, France; 3Department of Endocrinology, Kremlin Bicêtre Hospital, Le Kremlin Bicêtre, France; 4Department of Nuclear Medicine and Endocrine Tumors, Institut Gustave Roussy, Villejuif, France; 5Department of Endocrinology, University of Grenoble, Grenoble, France; 6Department of Endocrinology, University of Lille, Lille, France; 7Department of Pediatry, University of Calais, Calais, France.
Background: Mitotane antitumor efficacy is related to plasma levels. Objective responses have been associated with mitotane plasma levels >14 mg/l. However, high plasma levels >20 or >30 mg/l are at higher risk of toxicity, especially neurotoxicity. National-based survey is lacking to evaluate the frequency and severity of high mitotane plasma levels. Our aim was to retrospectively describe serious adverse events (SAE).
Methods: Mitotane plasma levels, SAE and grade 3–4 toxicities were recorded in ACC patients, followed between 09/2006 and 05/2010 in the French COMETE network. Plasma mitotane levels were monitored by the Lysosafe service. Grading of toxicity was done with NCI. NCTAE (version 3) criteria. SAE is defined by: death, life threatening, hospitalization, persistent disability, congenital anomaly / birth defect or other medically important events.
Results: A mitotane plasma levels >30 pg/ml was observed in.15 out of 310 (4.8%) patients. Fifteen assays >30 mg/l were identified among 2057 analysed (0.72%). The median mitotane plasma level was 35.76 mg/l, after a median time of 8 months from mitotane initiation, corresponding to a median mitotane dosage of 4.5 g/day. Grade-3 toxicity was observed in 8/15 (53.3%) patients (vertigo, nausea, anorexia, alopecia, hypotension and gynecologic bleeding) and a grade 4 toxicity in 6/15 (40%) patients (asthenia, vigilance trouble, anorexia, abdominal pain and aplasia). Hospitalization was required in 6/15 patients (40%). A life threatening SAE was observed in 1/15 (6.7%) due to severe sepsis in aplasia, related to mitotane therapy. No patient died or suffered from sequelae, and no unexpected SAE was observed.
Conclusion: Mitotane plasma levels >30 mg/l is a rare event. A SAE was observed in 8/15 (53%) patients and 10/15 (66.7%) experienced a grade 3–4 toxicity. We therefore suggest that the plasma mitotane cut-off of 30 mg/l should not be exceeded until a better understanding of the mechanisms that drive clinical toxicity.
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Endocrine Abstracts
ISSN 1470-3947 (print) | ISSN 1479-6848 (online)
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