(HealthDay News) – For patients with advanced adrenocortical cancer, mitotane plus a combination of etoposide, doxorubicin, and cisplatin (EDP) is superior to streptozocin-mitotane for rates of response and progression-free survival, but does not improve overall survival, according to a study published online May 2 in the New England Journal of Medicine.
Martin Fassnacht, MD, from the University of Würzburg in Germany, and colleagues randomized 304 patients with advanced adrenocortical carcinoma to receive mitotane plus either EDP every four weeks or streptozocin every three weeks. The alternative treatment was given as second-line therapy for patients with disease progression.
For first-line therapy, the investigators found that, compared with those in the streptozocin-mitotane group, patients in the EDP-mitotane group had a significantly higher response rate (23.2% vs. 9.2%) and longer median progression-free survival (5 vs. 2.1 months). There was no significant between-group difference in overall survival. The median duration of progression-free survival was 5.6 months in the EDP-mitotane group and 2.2 months in the streptozocin-mitotane group among 185 patients who received the alternative regimen as second-line therapy. For patients who did not receive the alternative second-line therapy, overall survival was superior with EDP-mitotane versus streptozocin-mitotane (17.1 vs. 4.7 months). There was no difference in the rates of serious adverse events between the groups.
“Although a significant improvement in overall survival was not achieved with EDP plus mitotane as first-line therapy, this regimen had higher antitumor efficacy as both first- and second-line therapy than did streptozocin plus mitotane, with a similar rate of serious adverse events,” the authors write.
A substudy within this study was funded by HRA Pharma; several authors disclosed financial relationships with pharmaceutical companies, including HRA Pharma.