Adjuvant mitotane treatment for adrenocortical carcinoma

Background
Adrenocortical carcinoma is a rare neoplasm characterized by a high risk of recurrence after radical resection. Whether the use of mitotane is beneficial as an adjuvant treatment has been controversial. Our aim was to evaluate the efficacy of adjuvant
mitotane in prolonging recurrence-free survival.
Methods
We performed a retrospective analysis involving 177 patients with adrenocortical cancer who had undergone radical surgery at 8 centers in Italy and 47 centers in Germany between 1985 and 2005. Adjuvant mitotane was administered to 47 Italian
patients after radical surgery (mitotane group), whereas 55 Italian patients and 75 German patients (control groups 1 and 2, respectively) did not receive adjuvant treatment after surgery.
Results
Baseline features in the mitotane group and the control group from Italy were similar; the German patients were significantly older (P = 0.03) and had more stage I or II adrenocortical carcinomas (P = 0.02) than did patients in the mitotane group. Recurrence-free survival was significantly prolonged in the mitotane group, as compared with the two control groups (median recurrence-free survival, 42 months, as compared
with 10 months in control group 1 and 25 months in control group 2; hazard ratios for recurrence, 2.91 (95% confidence interval [CI], 1.77 to 4.78; P<0.001) and 1.97 (95% CI, 1.21 to 3.20; P = 0.005), respectively. Multivariate analysis indicated that mitotane
treatment had a significant advantage for recurrence-free survival. Adverse events associated with mitotane were mainly of grade 1 or 2, but temporary dose reduction was needed in 13% of patients.
Conclusions
Adjuvant mitotane may prolong recurrence-free survival in patients with radically resected adrenocortical carcinoma.