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

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

doi:10.1200/JCO.2015.61.6490

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

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

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, …

Journal of clinical oncology, Vol.33(34), pp.4093-4098

2015-12-01

DOI: https://doi.org/10.1200/JCO.2015.61.6490

PMCID: PMC4669593

PMID: 26527781

Abstract

Meningioma - drug therapy

Prognosis

Prospective Studies

Double-Blind Method

Follow-Up Studies

Humans

Middle Aged

Male

Survival Rate

Meningeal Neoplasms - mortality

Young Adult

Meningioma - pathology

Progestins - antagonists & inhibitors

Meningeal Neoplasms - drug therapy

Aged, 80 and over

Adult

Female

Aged

Hormone Antagonists - therapeutic use

Meningeal Neoplasms - pathology

Neoplasm Staging

Meningioma - mortality

Mifepristone - therapeutic use

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. 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. 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. Long-term administration of mifepristone was well tolerated but had no impact on patients with unresectable meningioma.

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Collaboration types: Domestic collaboration
Citation topics: 1 Clinical & Life Sciences; 1.113 Brain Imaging; 1.113.1562 Meningioma
Web Of Science research areas: Oncology
ESI research areas: Clinical Medicine

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Title: Double-Blind Phase III Randomized Trial of the Antiprogestin Agent Mifepristone in the Treatment of Unresectable Meningioma: SWOG S9005
Creators: Yongli Ji - Yongli Ji, Steven Grunberg, and Claire Verschraegen, University of Vermont Cancer Center, Burlington, VT; Cathryn Rankin, SWOG Statistical Center, Seattle, WA; Andy E. Sherrod, Jamshid Ahmadi, and Christy A. Russell, University of Southern California; Fairooz F. Kabbinavar, University of California Los Angeles, Los Angeles, CA; Jeannette J. Townsend, University of Utah Medical Center, Salt Lake City, UT; Lynn G. Feun, University of Miami, Miami, FL; Ruth K. Fredericks, University of Mississippi Medical Center, Jackson, MS; Keith J. Stelzer, Celilo Cancer Center, the Dalles, OR; and Anne Schott, University of Michigan, Ann Arbor, MI
Cathryn Rankin - Yongli Ji, Steven Grunberg, and Claire Verschraegen, University of Vermont Cancer Center, Burlington, VT; Cathryn Rankin, SWOG Statistical Center, Seattle, WA; Andy E. Sherrod, Jamshid Ahmadi, and Christy A. Russell, University of Southern California; Fairooz F. Kabbinavar, University of California Los Angeles, Los Angeles, CA; Jeannette J. Townsend, University of Utah Medical Center, Salt Lake City, UT; Lynn G. Feun, University of Miami, Miami, FL; Ruth K. Fredericks, University of Mississippi Medical Center, Jackson, MS; Keith J. Stelzer, Celilo Cancer Center, the Dalles, OR; and Anne Schott, University of Michigan, Ann Arbor, MI
Steven Grunberg - Yongli Ji, Steven Grunberg, and Claire Verschraegen, University of Vermont Cancer Center, Burlington, VT; Cathryn Rankin, SWOG Statistical Center, Seattle, WA; Andy E. Sherrod, Jamshid Ahmadi, and Christy A. Russell, University of Southern California; Fairooz F. Kabbinavar, University of California Los Angeles, Los Angeles, CA; Jeannette J. Townsend, University of Utah Medical Center, Salt Lake City, UT; Lynn G. Feun, University of Miami, Miami, FL; Ruth K. Fredericks, University of Mississippi Medical Center, Jackson, MS; Keith J. Stelzer, Celilo Cancer Center, the Dalles, OR; and Anne Schott, University of Michigan, Ann Arbor, MI
Andy E Sherrod - Yongli Ji, Steven Grunberg, and Claire Verschraegen, University of Vermont Cancer Center, Burlington, VT; Cathryn Rankin, SWOG Statistical Center, Seattle, WA; Andy E. Sherrod, Jamshid Ahmadi, and Christy A. Russell, University of Southern California; Fairooz F. Kabbinavar, University of California Los Angeles, Los Angeles, CA; Jeannette J. Townsend, University of Utah Medical Center, Salt Lake City, UT; Lynn G. Feun, University of Miami, Miami, FL; Ruth K. Fredericks, University of Mississippi Medical Center, Jackson, MS; Keith J. Stelzer, Celilo Cancer Center, the Dalles, OR; and Anne Schott, University of Michigan, Ann Arbor, MI
Jamshid Ahmadi - Yongli Ji, Steven Grunberg, and Claire Verschraegen, University of Vermont Cancer Center, Burlington, VT; Cathryn Rankin, SWOG Statistical Center, Seattle, WA; Andy E. Sherrod, Jamshid Ahmadi, and Christy A. Russell, University of Southern California; Fairooz F. Kabbinavar, University of California Los Angeles, Los Angeles, CA; Jeannette J. Townsend, University of Utah Medical Center, Salt Lake City, UT; Lynn G. Feun, University of Miami, Miami, FL; Ruth K. Fredericks, University of Mississippi Medical Center, Jackson, MS; Keith J. Stelzer, Celilo Cancer Center, the Dalles, OR; and Anne Schott, University of Michigan, Ann Arbor, MI
Jeannette J Townsend - Yongli Ji, Steven Grunberg, and Claire Verschraegen, University of Vermont Cancer Center, Burlington, VT; Cathryn Rankin, SWOG Statistical Center, Seattle, WA; Andy E. Sherrod, Jamshid Ahmadi, and Christy A. Russell, University of Southern California; Fairooz F. Kabbinavar, University of California Los Angeles, Los Angeles, CA; Jeannette J. Townsend, University of Utah Medical Center, Salt Lake City, UT; Lynn G. Feun, University of Miami, Miami, FL; Ruth K. Fredericks, University of Mississippi Medical Center, Jackson, MS; Keith J. Stelzer, Celilo Cancer Center, the Dalles, OR; and Anne Schott, University of Michigan, Ann Arbor, MI
Lynn G Feun - Yongli Ji, Steven Grunberg, and Claire Verschraegen, University of Vermont Cancer Center, Burlington, VT; Cathryn Rankin, SWOG Statistical Center, Seattle, WA; Andy E. Sherrod, Jamshid Ahmadi, and Christy A. Russell, University of Southern California; Fairooz F. Kabbinavar, University of California Los Angeles, Los Angeles, CA; Jeannette J. Townsend, University of Utah Medical Center, Salt Lake City, UT; Lynn G. Feun, University of Miami, Miami, FL; Ruth K. Fredericks, University of Mississippi Medical Center, Jackson, MS; Keith J. Stelzer, Celilo Cancer Center, the Dalles, OR; and Anne Schott, University of Michigan, Ann Arbor, MI
Ruth K Fredericks - Yongli Ji, Steven Grunberg, and Claire Verschraegen, University of Vermont Cancer Center, Burlington, VT; Cathryn Rankin, SWOG Statistical Center, Seattle, WA; Andy E. Sherrod, Jamshid Ahmadi, and Christy A. Russell, University of Southern California; Fairooz F. Kabbinavar, University of California Los Angeles, Los Angeles, CA; Jeannette J. Townsend, University of Utah Medical Center, Salt Lake City, UT; Lynn G. Feun, University of Miami, Miami, FL; Ruth K. Fredericks, University of Mississippi Medical Center, Jackson, MS; Keith J. Stelzer, Celilo Cancer Center, the Dalles, OR; and Anne Schott, University of Michigan, Ann Arbor, MI
Christy A Russell - Yongli Ji, Steven Grunberg, and Claire Verschraegen, University of Vermont Cancer Center, Burlington, VT; Cathryn Rankin, SWOG Statistical Center, Seattle, WA; Andy E. Sherrod, Jamshid Ahmadi, and Christy A. Russell, University of Southern California; Fairooz F. Kabbinavar, University of California Los Angeles, Los Angeles, CA; Jeannette J. Townsend, University of Utah Medical Center, Salt Lake City, UT; Lynn G. Feun, University of Miami, Miami, FL; Ruth K. Fredericks, University of Mississippi Medical Center, Jackson, MS; Keith J. Stelzer, Celilo Cancer Center, the Dalles, OR; and Anne Schott, University of Michigan, Ann Arbor, MI
Fairooz F Kabbinavar - Yongli Ji, Steven Grunberg, and Claire Verschraegen, University of Vermont Cancer Center, Burlington, VT; Cathryn Rankin, SWOG Statistical Center, Seattle, WA; Andy E. Sherrod, Jamshid Ahmadi, and Christy A. Russell, University of Southern California; Fairooz F. Kabbinavar, University of California Los Angeles, Los Angeles, CA; Jeannette J. Townsend, University of Utah Medical Center, Salt Lake City, UT; Lynn G. Feun, University of Miami, Miami, FL; Ruth K. Fredericks, University of Mississippi Medical Center, Jackson, MS; Keith J. Stelzer, Celilo Cancer Center, the Dalles, OR; and Anne Schott, University of Michigan, Ann Arbor, MI
Keith J Stelzer - Yongli Ji, Steven Grunberg, and Claire Verschraegen, University of Vermont Cancer Center, Burlington, VT; Cathryn Rankin, SWOG Statistical Center, Seattle, WA; Andy E. Sherrod, Jamshid Ahmadi, and Christy A. Russell, University of Southern California; Fairooz F. Kabbinavar, University of California Los Angeles, Los Angeles, CA; Jeannette J. Townsend, University of Utah Medical Center, Salt Lake City, UT; Lynn G. Feun, University of Miami, Miami, FL; Ruth K. Fredericks, University of Mississippi Medical Center, Jackson, MS; Keith J. Stelzer, Celilo Cancer Center, the Dalles, OR; and Anne Schott, University of Michigan, Ann Arbor, MI
Anne Schott - Yongli Ji, Steven Grunberg, and Claire Verschraegen, University of Vermont Cancer Center, Burlington, VT; Cathryn Rankin, SWOG Statistical Center, Seattle, WA; Andy E. Sherrod, Jamshid Ahmadi, and Christy A. Russell, University of Southern California; Fairooz F. Kabbinavar, University of California Los Angeles, Los Angeles, CA; Jeannette J. Townsend, University of Utah Medical Center, Salt Lake City, UT; Lynn G. Feun, University of Miami, Miami, FL; Ruth K. Fredericks, University of Mississippi Medical Center, Jackson, MS; Keith J. Stelzer, Celilo Cancer Center, the Dalles, OR; and Anne Schott, University of Michigan, Ann Arbor, MI
Claire Verschraegen - Yongli Ji, Steven Grunberg, and Claire Verschraegen, University of Vermont Cancer Center, Burlington, VT; Cathryn Rankin, SWOG Statistical Center, Seattle, WA; Andy E. Sherrod, Jamshid Ahmadi, and Christy A. Russell, University of Southern California; Fairooz F. Kabbinavar, University of California Los Angeles, Los Angeles, CA; Jeannette J. Townsend, University of Utah Medical Center, Salt Lake City, UT; Lynn G. Feun, University of Miami, Miami, FL; Ruth K. Fredericks, University of Mississippi Medical Center, Jackson, MS; Keith J. Stelzer, Celilo Cancer Center, the Dalles, OR; and Anne Schott, University of Michigan, Ann Arbor, MI. claire.verschraegen@uvmhealth.org
Publication Details: Journal of clinical oncology, Vol.33(34), pp.4093-4098
Publisher: United States
Grant note: CA180846 / NCI NIH HHS CA180819 / NCI NIH HHS CA180801 / NCI NIH HHS U10 CA180801 / NCI NIH HHS CA02115 / NCI NIH HHS U10 CA020319 / NCI NIH HHS CA45461 / NCI NIH HHS U10 CA058882 / NCI NIH HHS N01 CA045560 / NCI NIH HHS U10 CA180846 / NCI NIH HHS CA67663 / NCI NIH HHS U10 CA180818 / NCI NIH HHS U10 CA045560 / NCI NIH HHS CA46282 / NCI NIH HHS CA180820 / NCI NIH HHS U10 CA067663 / NCI NIH HHS N01 CA035431 / NCI NIH HHS CA180818 / NCI NIH HHS U10 CA045461 / NCI NIH HHS CA35192 / NCI NIH HHS U10 CA035431 / NCI NIH HHS N01 CA035176 / NCI NIH HHS CA180858 / NCI NIH HHS U10 CA180819 / NCI NIH HHS U10 CA180888 / NCI NIH HHS U10 CA035176 / NCI NIH HHS U10 CA180834 / NCI NIH HHS N01 CA013612 / NCI NIH HHS CA58882 / NCI NIH HHS U10 CA180830 / NCI NIH HHS U10 CA046282 / NCI NIH HHS U10 CA035119 / NCI NIH HHS U10 CA013612 / NCI NIH HHS U10 CA035192 / NCI NIH HHS U10 CA180835 / NCI NIH HHS U10 CA180820 / NCI NIH HHS CA180835 / NCI NIH HHS N01 CA035119 / NCI NIH HHS CA20319 / NCI NIH HHS U10 CA180858 / NCI NIH HHS CA180888 / NCI NIH HHS CA73590 / NCI NIH HHS CA180830 / NCI NIH HHS U10 CA073590 / NCI NIH HHS CA180834 / NCI NIH HHS
Academic Unit: Miller School of Medicine; UMMG Dept of Medicine - Hematology/Oncology
Language: English
Resource Type: Journal article
PMID: 26527781
PMCID: PMC4669593
Record Identifier: 991031577287702976