作者: Martin Fassnacht , Massimo Terzolo , Bruno Allolio , Eric Baudin , Harm Haak
关键词: Internal medicine 、 Medicine 、 Surgery 、 Adverse effect 、 Etoposide 、 Combination chemotherapy 、 Gastroenterology 、 Hazard ratio 、 Regimen 、 Adrenocortical carcinoma 、 Intention-to-treat analysis 、 Mitotane
摘要: A b s t r ac Background Adrenocortical carcinoma is a rare cancer that has poor response to cytotoxic treatment. Methods We randomly assigned 304 patients with advanced adrenocortical re ceive mitotane plus either combination of etoposide (100 mg per square meter body-surface area on days 2 4), doxorubicin (40 day 1), and cisplatin 3 4) (EDP) every 4 weeks or streptozocin (streptozotocin) (1 g 1 5 in cycle 1; subsequent cycles) weeks. Patients disease progression received the alternative regimen as second-line therapy. The primary end point was overall survival. Results For first-line therapy, EDP–mitotane group had significantly higher rate than those streptozocin–mitotane (23.2% vs. 9.2%, P<0.001) longer median progression-free survival (5.0 months 2.1 months; hazard ratio, 0.55; 95% confidence interval [CI], 0.43 0.69; P<0.001); there no significant between-group difference (14.8 12.0 months, respectively; 0.79; CI, 0.61 1.02; P = 0.07). Among 185 who duration 5.6 2.2 group. did not receive therapy better EDP (17.1 month) (4.7 months). Rates serious adverse events differ between treatments. Conclusions were similar rates toxic events, although (Funded by Swedish Research Council others; FIRM-ACT ClinicalTrials.gov number, NCT00094497.)