Double-Blind Phase III Randomized Trial of the Antiprogestin Agent Mifepristone in the Treatment of Unresectable Meningioma: SWOG S9005.

Abstract

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.

• Authors: Yongli Ji, Cathryn Rankin, Steven Grunberg, Andy E Sherrod, Jamshid Ahmadi, Jeannette J Townsend, Lynn G Feun, Ruth K Fredericks, Christy A Russell, Fairooz F Kabbinavar, Keith J Stelzer, Anne Schott, Claire Verschraegen
• Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology (J Clin Oncol) Vol. 33 Issue 34 Pg. 4093-8 (Dec 01 2015) ISSN: 1527-7755 [Electronic] United States
• PMID: 26527781 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, N.I.H., Extramural)
• Copyright: © 2015 by American Society of Clinical Oncology.

Chemical References

• Hormone Antagonists
• Progestins
• Mifepristone

Topics

• Adult
• Aged
• Aged, 80 and over
• Double-Blind Method
• Female
• Follow-Up Studies
• Hormone Antagonists (therapeutic use)
• Humans
• Male
• Meningeal Neoplasms (drug therapy, mortality, pathology)
• Meningioma (drug therapy, mortality, pathology)
• Middle Aged
• Mifepristone (therapeutic use)
• Neoplasm Staging
• Progestins (antagonists & inhibitors)
• Prognosis
• Prospective Studies
• Survival Rate
• Young Adult