Please use this identifier to cite or link to this item: https://hdl.handle.net/2440/76549
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Type: Journal article
Title: Combination chemotherapy in advanced adrenocortical carcinoma
Author: Torpy, D.
Citation: New England Journal of Medicine, 2012; 366(23):2189-2197
Publisher: Massachusetts Medical Soc
Issue Date: 2012
ISSN: 0028-4793
1533-4406
Statement of
Responsibility: 
Martin Fassnacht... David J. Torpy... et al.
Abstract: BACKGROUND: Adrenocortical carcinoma is a rare cancer that has a poor response to cytotoxic treatment. METHODS: We randomly assigned 304 patients with advanced adrenocortical carcinoma to receive mitotane plus either a combination of etoposide (100 mg per square meter of body-surface area on days 2 to 4), doxorubicin (40 mg per square meter on day 1), and cisplatin (40 mg per square meter on days 3 and 4) (EDP) every 4 weeks or streptozocin (streptozotocin) (1 g on days 1 to 5 in cycle 1; 2 g on day 1 in subsequent cycles) every 3 weeks. Patients with disease progression received the alternative regimen as second-line therapy. The primary end point was overall survival. RESULTS: For first-line therapy, patients in the EDP–mitotane group had a significantly higher response rate than those in the streptozocin–mitotane group (23.2% vs. 9.2%, P<0.001) and longer median progression-free survival (5.0 months vs. 2.1 months; hazard ratio, 0.55; 95% confidence interval [CI], 0.43 to 0.69; P<0.001); there was no significant between-group difference in overall survival (14.8 months and 12.0 months, respectively; hazard ratio, 0.79; 95% CI, 0.61 to 1.02; P=0.07). Among the 185 patients who received the alternative regimen as second-line therapy, 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. Patients who did not receive the alternative second-line therapy had better overall survival with first-line EDP plus mitotane (17.1 month) than with streptozocin plus mitotane (4.7 months). Rates of serious adverse events did not differ significantly between treatments. CONCLUSIONS: Rates of response and progression-free survival were significantly better with EDP plus mitotane than with streptozocin plus mitotane as first-line therapy, with similar rates of toxic events, although there was no significant difference in overall survival. (Funded by the Swedish Research Council and others; FIRM-ACT ClinicalTrials.gov number, NCT00094497.)
Keywords: FIRM-ACT Study Group
Humans
Adrenocortical Carcinoma
Adrenal Cortex Neoplasms
Cisplatin
Mitotane
Streptozocin
Doxorubicin
Etoposide
Antineoplastic Combined Chemotherapy Protocols
Disease-Free Survival
Quality of Life
Adult
Aged
Middle Aged
Female
Male
Young Adult
Intention to Treat Analysis
Kaplan-Meier Estimate
Rights: Copyright © 2013 Massachusetts Medical Society. All rights reserved.
DOI: 10.1056/NEJMoa1200966
Published version: http://dx.doi.org/10.1056/nejmoa1200966
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