Adrenal gland
Barbara Altieri 1 , Mario Detomas 1 , Otilia Kimpel 1 , Marcus Quinkler 2 , Letizia Canu 3 , Massimo Mannelli 3 , Anna Angelousi 4 , Gregory Kaltsas 4 , Yasir S. Elhassan 5 , Silvia Della Casa 6 , Maria C. De Martino 7 , Felix Megerle 8 , Cristina L. Ronchi 8 , Matthias Kroiss 8 & Martin Fassnacht 8
1Division of Endocrinology and Diabetes, Department of Internal Medicine I, University Hospital of Würzburg; [email protected]; 2Endocrinology in Charlottenburg, Berlin, Germany; 3Department of Experimental and Clinical Biomedical Sciences “Mario Serio”, University of Florence, Florence, Italy; 4Department of Pathophysiology, National and Kapodistrian University of Athens, Athens, Greece; 5Institute of Metabolism and System Research, University of Birmingham and Centre for Endocrinology, Diabetes and Metabolism (CEDAM), Birmingham, UK; 6Division of Endocrinology and Metabolism, Catholic University of the Sacred Heart, Rome, Italy; 7Department of Clinical Medicine and Surgery, Federico II University, Naples, Italy; 8Division of Endocrinology and Diabetes, Department of Internal Medicine I, University Hospital of Würzburg, Würzburg, Germany
Background: Mitotane is the only drug approved for the treatment of adrenocortical carcinoma (ACC). Although adverse effects (AEs) associated to its use are frequent, detailed information are very limited. Aim was to evaluate the AEs of mitotane monotherapy in ACC patients. Methods: We performed a retrospective multicenter study including 311 ACC patients (F=200, median age 49 yrs) treated with mitotane as first line of medical treatment. Presence and grade of AEs were collected from medical records and classified according to the CTCAE 5.0 criteria. Results: Median duration of mitotane monotherapy was 20 (1-203) months, during which we observed 3004 AEs with a rate per patients of 9.6 (0-30). The number of AEs significantly correlated with AUC of mitotane levels (P<0.001, rs=0.23) and duration of treatment (P<0.001, rs=0.21). Among the laboratory changes, GGT, cholesterol and triglycerides increase were the most frequent (88%, 70% and 42% of cases, respectively). Low-lipidic therapies, including statins and fenofibrate, were used only in 38% and 6% of cases, respectively. Apart from glucocorticoids, specific hormone replace therapy was administrated in 121/172 (70%) patients with hypothyroidism, 44/90 (49%) patients with hypomineralcortisolism, and 20/47 (42%) men with hypogonadism. The most frequent clinical AEs included gastrointestinal and general disorders, such as asthenia (68%), nausea (53%), diarrhea (45%), and anorexia (37%), as well as neurological and psychiatric disorders, such as concentration impairment (33%), vertigo (36%) and depression (22%). Moreover, infections and adrenal crises were reported in 14% of cases. Grade 4 AEs were reported in 24 cases (8%). Mitotane was permanently discontinued due to AEs in 14% of patients. Conclusion: The rate of AEs per patients is higher than previously showed and several less common AEs were found. This first comprehensive overview of mitotane AEs might be helpful in the daily clinical management of ACC patients.
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Endocrine Abstracts
ISSN 1470-3947 (print) | ISSN 1479-6848 (online)
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