TY - JOUR
T1 - Double-blind phase III randomized trial of the antiprogestin agent mifepristone in the treatment of unresectable meningioma
T2 - SWOG s9005
AU - Ji, Yongli
AU - Rankin, Cathryn
AU - Grunberg, Steven
AU - Sherrod, Andy E.
AU - Ahmadi, Jamshid
AU - Townsend, Jeannette J.
AU - Feun, Lynn G.
AU - Fredericks, Ruth K.
AU - Russell, Christy A.
AU - Kabbinavar, Fairooz F.
AU - Stelzer, Keith J.
AU - Schott, Anne
AU - Verschraegen, Claire
N1 - Publisher Copyright:
Copyright © 2015 American Society of Clinical Oncology. All rights reserved.
Copyright:
Copyright 2016 Elsevier B.V., All rights reserved.
PY - 2015/12/1
Y1 - 2015/12/1
N2 - Purpose Progesterone receptors are expressed in approximately 70% of meningiomas. Mifepristone is an oral antiprogestational agent reported to have modest activity in a phase II study. This multicenter, prospective, randomized, placebo-controlled phase III trial conducted by SWOG was planned to define the role of mifepristone in the treatment of unresectable meningioma. Patients and Methods Eligible patients were randomly assigned to receive either mifepristone or placebo for 2 years unless disease progressed. Patients who were stable or responding to protocol therapy after 2 years had the option to continue with the same blinded therapy. Serial follow-up allowed assessment of efficacy and toxicity. Time to treatment failure and overall survival were ascertained for all randomly assigned patients. On progression, patients receiving placebo could cross over and receive active drug. Results Among 164 eligible patients, 80 were randomly assigned to mifepristone and 84 to placebo. Twenty-four patients (30%) were able to complete 2 years of mifepristone without disease progression, adverse effects, or other reasons for discontinuation. Twenty-eight patients (33%) in the placebo arm completed the 2-year study. There was no statistical difference between the arms in terms of failure-free or overall survival. Conclusion Long-term administration of mifepristone was well tolerated but had no impact on patients with unresectable meningioma.
AB - Purpose Progesterone receptors are expressed in approximately 70% of meningiomas. Mifepristone is an oral antiprogestational agent reported to have modest activity in a phase II study. This multicenter, prospective, randomized, placebo-controlled phase III trial conducted by SWOG was planned to define the role of mifepristone in the treatment of unresectable meningioma. Patients and Methods Eligible patients were randomly assigned to receive either mifepristone or placebo for 2 years unless disease progressed. Patients who were stable or responding to protocol therapy after 2 years had the option to continue with the same blinded therapy. Serial follow-up allowed assessment of efficacy and toxicity. Time to treatment failure and overall survival were ascertained for all randomly assigned patients. On progression, patients receiving placebo could cross over and receive active drug. Results Among 164 eligible patients, 80 were randomly assigned to mifepristone and 84 to placebo. Twenty-four patients (30%) were able to complete 2 years of mifepristone without disease progression, adverse effects, or other reasons for discontinuation. Twenty-eight patients (33%) in the placebo arm completed the 2-year study. There was no statistical difference between the arms in terms of failure-free or overall survival. Conclusion Long-term administration of mifepristone was well tolerated but had no impact on patients with unresectable meningioma.
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U2 - 10.1200/JCO.2015.61.6490
DO - 10.1200/JCO.2015.61.6490
M3 - Article
C2 - 26527781
AN - SCOPUS:84949961173
VL - 33
SP - 4093
EP - 4098
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
SN - 0732-183X
IS - 34
ER -