ECE2011 Oral Communications Neuroendocrinology (6 abstracts)
Etoposide, doxorubicin, cisplatin, and mitotane versus streptozotocin and mitotane in adrenocortical carcinoma: preliminary results from the first international phase III trial: the FIRM-ACT study
Martin Fassnacht 1 , Massimo Terzolo 2 , Bruno Allolio 1 , Eric Baudin 3 , Harm Haak 4 , Alfredo Berruti 2 , Hans-Helge Mueller 5 & Britt Skogseid 6
1University Hospital Würzburg, University of Würzburg, Würzburg, Germany; 2University Hospital Orbassano, University of Turin, Turin, Italy; 3Institute Gustave-Roussy, University of Paris Sud Villejuif, Paris, France; 4Máxima Medical Centre, Eindhoven, The Netherlands; 5University of Munich, Munich, Germany; 6Uppsala University Hospital, Uppsala, Sweden.
Background: No randomized trials have been conducted in adrenocortical carcinoma (ACC) patients. Treatment recommendations for this rare but aggressive disease have been based on data from small phase II trials. We have now performed the first randomized phase III trial, comparing etoposide, doxorubicin, cisplatin, plus mitotane (EDP-M) against streptozotocin plus mitotane (Sz-M).
Methods: Three-hundred and four chemotherapy-naive patients with ACC not amenable to radical surgery were randomly assigned to receive either EDP-M or Sz-M until progression. In case of progression, the alternative regimen was offered to the patient. The primary endpoint was overall survival. Key secondary endpoints were time to progression and response to second line therapy.
Results: One hundred and fifty-one patients randomized to EDP-M as first-line treatment received 608 cycles (scheduled every 28 days) and 153 patients in the Sz-M group 634 cycles (every 21 days). Forty-seven patients experienced 87 serious adverse events (SAE) during first-line treatment with EDP-M in comparison 37 patients with 68 SAEs in the Sz-M group (P=0.199). Median overall survival in the EDP-M and Sz-M groups (107 and 124 deaths, respectively) were 14.8 and 12.0 months, respectively (HR 0.79, 95% CI, 0.61 to 1.02, P=0.069). Median time to progression was 5.0 vs 2.1 months (HR 0.54, 0.42 to 0.68, P<0.001). Patients treated with EDP-M after failure of Sz-M (n=83) had a median time to progression of 6.2 months. In contrast, time to progression in 75 patients treated with Sz-M as second line was only 2.1 months. In both groups, patients pre-treated with mitotane had a similar outcome compared to mitotane-naïve patients.
Conclusions: Although a trend towards better overall survival in patients with advanced ACC treated with EDP-M as first-line therapy was observed, overall survival was not significantly different between groups. However, EDP-M significantly prolonged time to tumor progression compared with Sz-M. Thus, new treatment regimens for advanced ACC should be tested against EDP-M.
Volume 26
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Endocrine Abstracts
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