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Open AccessArticle

Mitotane Concentrations Influence the Risk of Recurrence in Adrenocortical Carcinoma Patients on Adjuvant Treatment

1
Internal Medicine, Department of Clinical and Biological Sciences, San Luigi Gonzaga Hospital, University of Turin, 10043 Orbassano, Italy
2
Endocrinology Unit, Department of Medicine DIMED, University-Hospital of Padua, 35128 Padova, Italy
3
Endocrinology Unit, Department of Clinical Medicine and Surgery, University of Naples Federico II, 80131 Naples, Italy
4
Endocrinology Unit, Hospital “Casa Sollievo della Sofferenza”, IRCCS, 71013 San Giovanni Rotondo, Italy
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Department of Human Pathology of Adulthood and Childhood ‘G. Barresi’, University of Messina, 98125 Messina, Italy
6
Division of Endocrinology, Department of Clinical and Molecular Sciences (DISCLIMO), Polytechnic University of Marche, 60121 Ancona, Italy
7
Endocrinology, Department of Clinical and Molecular Medicine, Sant’Andrea Hospital, Sapienza University of Rome, 00189 Roma, Italy
8
Endocrinology Division, Department of Clinical and Experimental Medicine, ARNAS Garibaldi, University of Catania, 95122 Catania, Italy
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Division of Endocrinology and Metabolic Diseases, University-Hospital Gemelli, IRCSS, Catholic University of the Sacred Heart, 00168 Rome, Italy
10
Statistical Unit, Department of Clinical and Biological Sciences, University of Turin, 10143 Orbassano, Italy
11
Endocrinology Unit, Department of Experimental and Clinical Biomedical Sciences, University of Florence, 50134 Florence, Italy
12
Endocrinology, Hospital Niguarda Ca’ Granda, 20121 Milan, Italy
*
Author to whom correspondence should be addressed.
J. Clin. Med. 2019, 8(11), 1850; https://doi.org/10.3390/jcm8111850
Received: 24 September 2019 / Revised: 27 October 2019 / Accepted: 31 October 2019 / Published: 2 November 2019
(This article belongs to the Section Molecular Diagnostics)
Mitotane is used as a post-operative adjuvant treatment for patients with adrenocortical carcinoma. Monitoring of plasma mitotane concentrations is recommended, but we do not know what impact target concentrations have on patient outcome. To answer this question, we retrospectively analyzed patient records in the Lysosafe Online® database (HRA Pharma, France) for patients who were treated for ≥6 months and who had ≥3 measurements of plasma mitotane levels during follow-ups at 11 tertiary centers in Italy from 2005 to 2017. We identified 110 patients treated with adjuvant mitotane for a median of 46 months (IQR, interquartile range, 28–62) with a median maintenance dose of 2.0 g/day (IQR 1.5–2.5). Achievement of target mitotane concentrations (≥14 mg/L) required a median of 8 months (IQR 5–19). Female sex was associated inversely with the dose, while body mass index (BMI) was correlated positively. Multivariate analysis showed that the Ki67 index and time to achieve the target range of plasma mitotane were independent predictors of recurrence-free survival (RFS). In a separate multivariate model, considering only the maintenance phase (month 7 to month 36, M7–M36) of treatment, the time in the target range of plasma mitotane was associated with a significantly lower risk of recurrence (Hazard Ratio, HR = 0.93; 0.88–0.98, p < 0.01). The prognostic implications of the time in target range and the time needed to reach target mitotane concentrations support the use of mitotane monitoring and may inform practice. View Full-Text
Keywords: adrenocortical carcinoma; mitotane; prognosis; recurrence; survival adrenocortical carcinoma; mitotane; prognosis; recurrence; survival
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Puglisi, S.; Calabrese, A.; Basile, V.; Ceccato, F.; Scaroni, C.; Simeoli, C.; Torlontano, M.; Cannavò, S.; Arnaldi, G.; Stigliano, A.; Malandrino, P.; Saba, L.; Altieri, B.; Della Casa, S.; Perotti, P.; Berchialla, P.; De Filpo, G.; Canu, L.; Loli, P.; Reimondo, G.; Terzolo, M. Mitotane Concentrations Influence the Risk of Recurrence in Adrenocortical Carcinoma Patients on Adjuvant Treatment. J. Clin. Med. 2019, 8, 1850.

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