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Mitotane
Abstract: Mitotane use in inoperable adrenal cortical carcinoma
Mitotane (1-10 g/d) was admin to 115
patients (35 men, 65 women; 89/115 in 41-60 yr age range, and 15/115 <21
yr old, 5 boys, 10 girls) with inoperable adrenal cortical carcinoma.
Beginning treatment dose was 1-6 g/d in 80% of patients; max dose was
5-10 g/d for 72%, and maintenance dosages ranged from 0.5-20 g/d.
Duration of therapy ranged from 21 d to 36 mo. (mean 7 mo), with
regression of tumor, absence of clinical benefit, and adverse reaction
being primary reasons for discontinuing mitotane. Decreased steroid
excretion >30% was seen in 52/61 patients with elevated pretreatment
urinary steroid excretion levels. Tumor regression in 46/75 patients
occurred 10 d to 19 mo. (mean 4 wk) after start of therapy, with 34/36
patients showing tumor regression also showing a steroid response. Mean
duration of tumor regression was 6 mo and mean patient survival was
8.4 mo.
(range 21 d to 41.3 mo). A definite clinical response occurred in
54%,
questionable response in 5%, and no response in 41%. Toxic reactions
seen in 91/109 patients were: gastrointestinal, neuromyal, dermal, and
leukopenia (4/109). On autopsy, the tumor-free adrenal gland was
atrophied in 15/21 cases.
References
Lubitz JA, Freeman L, Okun R. Mitotane use in inoperable adrenal
cortical carcinoma. JAMA; 223(10):1109-1112
1973.

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| Regimen |
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| Mitotane....... 6 - 15 mg /
kg PO (in 3 - 4 divided doses) QD |
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Summary |
Mitotane use in inoperable adrenal cortical carcinoma |
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Overall Response
Rate |
54% |
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Overall Survival |
8.4 months |
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Toxicity |
Gastrointestinal, neuromyal, dermal, and leukopenia |
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