International consensus on mitotane treatment in pediatric patients with adrenal cortical tumors: indications, therapy, and management of adverse effects.
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Riedmeier Maria, Antonini Sonir R R, Brandalise Silvia, Costa Tatiana El Jaick B, Daiggi Camila M, de Figueiredo Bonald C, de Krijger Ronald R, De Sá Rodrigues Karla Emília, Deal Cheri, Del Rivero Jaydira, Engstler Gernot, Fassnacht Martin, Fernandes Luiz Canali Gabriela C, Molina Carlos A Fernandes, Gonc Elmas Nazli, Gültekin Melis, Haak Harm R, Guran Tulay, Hendriks Allaird Emile J, Idkowiak Jan, Kuhlen Michaela, Malkin David, Meena Jagdish Prasad, Pamporaki Christina, Pinto Emilia, Puglisi Soraya, Ribeiro Raul C, Thompson Lester D R, Yalcin Bilgehan, Van Noesel Max, Wiegering Verena
Аннотация
METHODS: 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.
RESULTS: 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 mg/kg/d (1500 mg/m²/d) which can be increased up to 4000 mg/m2/d. Blood levels should range between 14 and 20 mg/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.
CONCLUSIONS: 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.