Adrenal gland tumors, adrenocortical carcinoma - adjuvant therapy
There is limited and controversial clinical trial information about adjuvant mitotane use. See the references for additional case series and expert recommendation articles.
Regimen #1, Wängberg et al. 2010
Patients started on adjuvant mitotane within 4 weeks of their surgical resection.
- Mitotane (Lysodren) 2000 mg PO per day (frequency not specified, such as whether the total daily dose was divided into a few doses throughout the day); within the first 2 to 3 months, Mitotane (Lysodren) dose was adjusted to achieve a target therapeutic drug level of 14 to 20 mg/L
2 to 3-year course
Regimen #2, Haak et al. 1994
Haak et al. 1994 concluded that "mitotane treatment in adrenocortical carcinoma is effective only when high serum levels [trough of at least 14 mg/L] can be achieved."
- Mitotane (Lysodren) 1000 to 2000 mg PO QID (total dose per day: 4000 to 8000 mg), with target mitotane trough of above 14 mg/L
2-year course "if resection was judged to be complete or for 1 year after apparent disappearance of the tumour"
- Hydrocortisone (Cortef) 30 to 120 mg per day or Fludrocortisone (Florinef) 0.1 to 0.4 mg per day
- Metoclopramide (Reglan) and Loperamide (Imodium) prn "gastrointestinal side-effects"
Vassilopoulou-Sellin R, Guinee VF, Klein MJ, Taylor SH, Hess KR, Schultz PN, Samaan NA. Impact of adjuvant mitotane on the clinical course of patients with adrenocortical cancer. Cancer. 1993 May 15;71(10):3119-23. link to original article PubMed
Haak HR, Hermans J, van de Velde CJ, Lentjes EG, Goslings BM, Fleuren GJ, Krans HM. Optimal treatment of adrenocortical carcinoma with mitotane: results in a consecutive series of 96 patients. Br J Cancer. 1994 May;69(5):947-51. link to original article contains verified protocol PubMed content property of HemOnc.org
Terzolo M, Angeli A, Fassnacht M, Daffara F, Tauchmanova L, Conton PA, Rossetto R, Buci L, Sperone P, Grossrubatscher E, Reimondo G, Bollito E, Papotti M, Saeger W, Hahner S, Koschker AC, Arvat E, Ambrosi B, Loli P, Lombardi G, Mannelli M, Bruzzi P, Mantero F, Allolio B, Dogliotti L, Berruti A. Adjuvant mitotane treatment for adrenocortical carcinoma. N Engl J Med. 2007 Jun 7;356(23):2372-80. link to original article PubMed
Veytsman I, Nieman L, Fojo T. Management of endocrine manifestations and the use of mitotane as a chemotherapeutic agent for adrenocortical carcinoma. J Clin Oncol. 2009 Sep 20;27(27):4619-29. doi: 10.1200/JCO.2008.17.2775. Epub 2009 Aug 10. link to original article PubMed
Wängberg B, Khorram-Manesh A, Jansson S, Nilsson B, Nilsson O, Jakobsson CE, Lindstedt S, Odén A, Ahlman H. The long-term survival in adrenocortical carcinoma with active surgical management and use of monitored mitotane. Endocr Relat Cancer. 2010 Feb 18;17(1):265-72. doi: 10.1677/ERC-09-0190. Print 2010 Mar. link to original article contains verified protocol PubMed