Mitotane action and efficacy

Mitotane is an oral medication used to treat patients with inoperable functional or non-functioning adrenocortical cancer. Adrenocortical carcinoma is a rare cancer that responds poorly to cytotoxic treatments.

Methods:Randomly assign304 patients with advanced adrenocortical cancer to receive mitotane combined with etoposide(100mg/ m2body surface area, day2-4day), adriamycin(40mg/m2< span>, day 1) and cisplatin (40mg/m2, day 3-4days)(EDP)treatment, once every 4weeks, or receive streptozotocin(1 g, treatment on days 1-5); take 2 g) on days 1 of subsequent cycles. Patients with progressive disease received alternative regimens as second-line therapy. The primary endpoint was overall survival.

Results:For first-line treatment, the response rate of patients in the EDP-mitotane group was significantly higher than that of streptozotocin- Mitotane group(23.2% vs. 9.2%, P<0.001)and longer median progression-free survival(5.0monthly ratio2.1month; hazard ratio, 0.55; 95%Confidence interval[CI], 0.43 to 0.69; p < 0.001); There was no significant difference in overall survival between groups( were 14.8 months and12.0 months; hazard ratio, 0.79; 95% CI, 0.61 to 1.02; P=0.07). Among 185 patients who received an alternative regimen as second-line treatment, the median progression-free survival was EDP-mitotane. an>5.6 months, and the streptozotocin-mitotane group was 2.2 months. In patients who did not receive alternative second-line therapy, the overall survival rate of first-line EDP plus mitotane was 17.1 months. >)better than patients treated with streptozotocin plus mitotane(4.7months). The incidence of serious adverse events did not differ significantly between treatment groups.

Conclusion:EDPThe response rate and progression-free survival rate of plus mitotane were significantly better than those of streptozotocin plus mitotane as first-line treatment, and the incidence of toxic events was similar, although the overall survival rate was not significantly different.

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