Long-term Outcomes of Adjuvant Mitotane Therapy in Patients with Radically Resected Adrenocortical Carcinoma.
J Clin Endocrinol Metab. 2017 Jan 11;:
Authors: Berruti A, Grisanti S, Pulzer A, Claps M, Daffara F, Loli P, Mannelli M, Boscaro M, Arvat E, Tiberio G, Hahner S, Zaggia B, Porpiglia F, Volante M, Fassnacht M, Terzolo M
Context: in 2007, a large retrospective case-control study provided evidence that adjuvant mitotane prolongs recurrence-free survival (RFS) in patients with radically resected adrenocortical carcinoma (ACC).
Objective and design: We aimed to confirm the prognostic role of adjuvant mitotane in the same series after 9 additional years of follow-up.
Setting, Patients and Interventions: 162 ACC patients included in the previous study, who did not recur or die after a landmark period of 3 months, were considered. 47 patients were enrolled in 4 Italian centers where adjuvant mitotane was routinely recommended (mitotane group), 45 patients in 4 Italian centers where no adjuvant strategy was undertaken (control group 1), and 70 German patients left untreated after surgery (control group 2).
Main Outcome Measures: The primary aim was RFS, the secondary was overall survival (OS).
Results: at multivariate analysis, an increased risk of recurrence was found in both control cohorts (group 1: Hazard Ratio [HR] 2.98, 95% CI: 1.75-5.09, p <0.0001; group 2: HR 2.61, 95% CI: 1.56-4.36, p <0.0001) compared to the mitotane group. The risk of death was significantly higher in control group 1 (HR 2.03 95% CI:1.17-3.51 p = 0.011) but not in control group 2 (HR 1.60, 95% CI: 0.94-2.74, p = 0.083), which had better prognostic factors and more aggressive treatment of recurrences than control group 1. The benefit of adjuvant mitotane on RFS was observed regardless of the hormone secretory status.
Conclusions: adjuvant mitotane is associated with prolonged RFS, without any apparent influence by the tumor secretory status. The retrospective nature of the study is a major limitation.
PMID: 28324035 [PubMed - as supplied by publisher]