TUESDAY, Sept. 5, 2023 (HealthDay News) -- Mitotane does not show a significant improvement in the relapse rate and is associated with adverse events in patients with adrenocortical carcinoma considered to be at low-to-intermediate risk for recurrence, according to a phase 3 study published online Aug. 21 in The Lancet Diabetes & Endocrinology.
Massimo Terzolo, M.D., from the University of Turin in Italy, and colleagues assessed the efficacy and safety of adjuvant mitotane (45 patients) versus surveillance alone (46 patients) following complete tumor resection in patients with adrenocortical carcinoma considered to be at low to intermediate risk for recurrence.
The researchers found that five-year recurrence-free survival was 79 percent in the mitotane group versus 75 percent in the surveillance group (hazard ratio, 0.74; 95 percent confidence interval [CI], 0.30 to 1.85). Five-year overall survival was not significantly different between the groups (95 versus 86 percent in the mitotane and surveillance groups). There were two deaths in the mitotane group and five in the surveillance group. Adverse events were seen in all 42 patients who received mitotane, and 19 percent discontinued treatment. The study was discontinued prematurely due to slow recruitment.
“Adjuvant mitotane might not be indicated in patients with low-grade, localized adrenocortical carcinoma considering the relatively good prognosis of these patients,” the authors write.
Two authors disclosed ties to the pharmaceutical industry.