{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,28]],"date-time":"2026-07-28T02:48:05Z","timestamp":1785206885342,"version":"3.55.0"},"reference-count":46,"publisher":"Oxford University Press (OUP)","issue":"4","license":[{"start":{"date-parts":[[2024,3,29]],"date-time":"2024-03-29T00:00:00Z","timestamp":1711670400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"funder":[{"name":"IZKF","award":["Z-02CSP\/23"],"award-info":[{"award-number":["Z-02CSP\/23"]}]},{"name":"DFG German Research Foundation","award":["314061271-TRR 205"],"award-info":[{"award-number":["314061271-TRR 205"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2024,3,30]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Objective<\/jats:title>\n                  <jats:p>Mitotane is an important cornerstone in the treatment of pediatric adrenal cortical tumors (pACC), but experience with the drug in the pediatric age group is still limited and current practice is not guided by robust evidence. Therefore, we have compiled international consensus statements from pACC experts on mitotane indications, therapy, and management of adverse effects.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>A Delphi method with 3 rounds of questionnaires within the pACC expert consortium of the international network groups European Network for the Study of Adrenal Tumors pediatric working group (ENSAT-PACT) and International Consortium of pediatric adrenocortical tumors (ICPACT) was used to create 21 final consensus statements.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>We divided the statements into 4 groups: environment, indications, therapy, and adverse effects. We reached a clear consensus for mitotane treatment for advanced pACC with stages III and IV and with incomplete resection\/tumor spillage. For stage II patients, mitotane is not generally indicated. The timing of initiating mitotane therapy depends on the clinical condition of the patient and the setting of the planned therapy. We recommend a starting dose of 50\u2005mg\/kg\/d (1500\u2005mg\/m\u00b2\/d) which can be increased up to 4000\u2005mg\/m2\/d. Blood levels should range between 14 and 20\u2005mg\/L. Duration of mitotane treatment depends on the clinical risk profile and tolerability. Mitotane treatment causes adrenal insufficiency in virtually all patients requiring glucocorticoid replacement shortly after beginning. As the spectrum of adverse effects of mitotane is wide-ranging and can be life-threatening, frequent clinical and neurological examinations (every 2-4 weeks), along with evaluation and assessment of laboratory values, are required.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>The Delphi method enabled us to propose an expert consensus statement, which may guide clinicians, further adapted by local norms and the individual patient setting. In order to generate evidence, well-constructed studies should be the focus of future efforts.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/ejendo\/lvae038","type":"journal-article","created":{"date-parts":[[2024,3,28]],"date-time":"2024-03-28T17:10:34Z","timestamp":1711645834000},"page":"G15-G24","source":"Crossref","is-referenced-by-count":18,"title":["International consensus on mitotane treatment in pediatric patients with adrenal cortical tumors: indications, therapy, and management of adverse effects"],"prefix":"10.1093","volume":"190","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3273-1794","authenticated-orcid":false,"given":"Maria","family":"Riedmeier","sequence":"first","affiliation":[{"name":"University Hospital W\u00fcrzburg, Department of Pediatrics, Division of Pediatric Hematology, Oncology and Stem Cell Transplantation, University of Wuerzburg , Wuerzburg 97080 , Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sonir R R","family":"Antonini","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Ribeirao Preto Medical School, University of Sao Paulo, Ribeirao Preto , Sao Paulo 14051-200 , Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Silvia","family":"Brandalise","sequence":"additional","affiliation":[{"name":"Boldrini Children\u2019s Hospital , Department of Pediatrics, S\u00e3o Paulo 13083-210 , Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tatiana El Jaick B","family":"Costa","sequence":"additional","affiliation":[{"name":"Service of Pediatric Oncology, Hospital Infantil Joana de Gusm\u00e3o , Florian\u00f3polis, SC 88025-301 , Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Camila M","family":"Daiggi","sequence":"additional","affiliation":[{"name":"Boldrini Children\u2019s Hospital , Department of Pediatrics, S\u00e3o Paulo 13083-210 , Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bonald C","family":"de Figueiredo","sequence":"additional","affiliation":[{"name":"Instituto de Pesquisa Pel\u00e9 Pequeno Pr\u00edncipe , Curitiba 80250-060 , Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ronald R","family":"de Krijger","sequence":"additional","affiliation":[{"name":"Department of Pathology, University Medical Center Utrecht , Utrecht 3584 CS , The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karla Em\u00edlia","family":"De S\u00e1 Rodrigues","sequence":"additional","affiliation":[{"name":"Pediatric Department, Barretos Cancer Hospital , S\u00e3o Paulo 14784-400 , Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cheri","family":"Deal","sequence":"additional","affiliation":[{"name":"Research Center, CHU Sainte-Justine and University of Montreal , Montreal, Qu\u00e9bec H3T 1C5 , Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9710-4030","authenticated-orcid":false,"given":"Jaydira","family":"Del Rivero","sequence":"additional","affiliation":[{"name":"Developmental Therapeutics Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health , Bethesda, MD 20892 , United States"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gernot","family":"Engstler","sequence":"additional","affiliation":[{"name":"St. Anna Kinderspital, Department of Pediatrics, Medical University Vienna , Vienna 1090 , Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6170-6398","authenticated-orcid":false,"given":"Martin","family":"Fassnacht","sequence":"additional","affiliation":[{"name":"Department of Medicine, Division of Endocrinology and Diabetes, University Hospital, University of Wuerzburg , Wuerzburg 97080 , Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gabriela C","family":"Fernandes Luiz Canali","sequence":"additional","affiliation":[{"name":"Oncologia, Pequeno Principe Hospital , Curitiba 80250-060, PR, Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carlos A Fernandes","family":"Molina","sequence":"additional","affiliation":[{"name":"Department of Surgery and Anatomy, Ribeirao Preto Medical School, University of Sao 15 Paulo, Ribeirao Preto , Sao Paulo 14049-900 , Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elmas Nazli","family":"Gonc","sequence":"additional","affiliation":[{"name":"Department of Pediatric Endocrinology, Faculty of Medicine, Hacettepe University , Ankara 06230 , Turkey"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Melis","family":"G\u00fcltekin","sequence":"additional","affiliation":[{"name":"Department of Radiation Oncology, Faculty of Medicine, Hacettepe University , Ankara 06100 , Turkey"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Harm R","family":"Haak","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, M\u00e1xima MC , Eindhoven 5631 BM\/Veldhoven 5504 DB , The Netherlands"},{"name":"CAPHRI School for Public Health and Primary Care, Ageing and Long-Term Care, Maastricht University , Maastricht 616 6200 MD , The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2658-6866","authenticated-orcid":false,"given":"Tulay","family":"Guran","sequence":"additional","affiliation":[{"name":"Department of Paediatric Endocrinology and Diabetes, Marmara University School of Medicine , Istanbul 34722 , Turkey"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emile J","family":"Hendriks Allaird","sequence":"additional","affiliation":[{"name":"Department of Paediatrics, University of Cambridge , Cambridge CB20QQ , United Kingdom"},{"name":"Department of Paediatric Endocrinology and Diabetes, Cambridge University Hospitals NHS Foundation Trust , Cambridge CB20QQ , United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jan","family":"Idkowiak","sequence":"additional","affiliation":[{"name":"Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham , Birmingham B152TT , United Kingdom"},{"name":"Department of Endocrinology, Birmingham Women's and Children's Hospital NHS Foundation Trust , Birmingham B46NH , United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4577-0503","authenticated-orcid":false,"given":"Michaela","family":"Kuhlen","sequence":"additional","affiliation":[{"name":"Pediatrics and Adolescent Medicine, Faculty of Medicine, University of Augsburg , Augsburg 86135 , Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Malkin","sequence":"additional","affiliation":[{"name":"Division of Haematology\/Oncology, The Hospital for Sick Children, University of Toronto , Toronto, Ontario M5G1X8 , Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jagdish Prasad","family":"Meena","sequence":"additional","affiliation":[{"name":"Division of Pediatric Oncology, Department of Pediatrics, Mother & Child Block, All India Institute of Medical Sciences , New Delhi 110029 , India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christina","family":"Pamporaki","sequence":"additional","affiliation":[{"name":"Department of Medicine III, University Hospital Carl Gustav Carus , TU Dresden, Dresden 01307, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emilia","family":"Pinto","sequence":"additional","affiliation":[{"name":"St. Jude Children\u2019s Research Hospital , Memphis, TN 38105 , United States"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2883-6139","authenticated-orcid":false,"given":"Soraya","family":"Puglisi","sequence":"additional","affiliation":[{"name":"Internal Medicine, Department of Clinical and Biological Sciences, San Luigi Gonzaga Hospital, University of Turin , Orbassano 10043 , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Raul C","family":"Ribeiro","sequence":"additional","affiliation":[{"name":"Department of Oncology, St Jude Children\u2019s Research Hospital , Memphis, TN 38105 , United States"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lester D R","family":"Thompson","sequence":"additional","affiliation":[{"name":"Pathology, Head and Neck Pathology Consultations , Woodland Hills, CA 91364 , United 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