title: Double-Blind Phase III Randomized Trial of the Antiprogestin Agent Mifepristone in the Treatment of Unresectable Meningioma: SWOG S9005.
abstract: OBJECTIVE
  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.
  
  
  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.
  
  
  CONCLUSIONS
  Long-term administration of mifepristone was well tolerated but had no impact on patients with unresectable meningioma.
authors.affiliation: 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.
authors.forename: Yongli
authors.initials: Y
authors.lastname: Ji
authors.affiliation: 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.
authors.forename: Cathryn
authors.initials: C
authors.lastname: Rankin
authors.affiliation: 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.
authors.forename: Steven
authors.initials: S
authors.lastname: Grunberg
authors.affiliation: 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.
authors.forename: Andy E
authors.initials: AE
authors.lastname: Sherrod
authors.affiliation: 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.
authors.forename: Jamshid
authors.initials: J
authors.lastname: Ahmadi
authors.affiliation: 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.
authors.forename: Jeannette J
authors.initials: JJ
authors.lastname: Townsend
authors.affiliation: 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.
authors.forename: Lynn G
authors.initials: LG
authors.lastname: Feun
authors.affiliation: 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.
authors.forename: Ruth K
authors.initials: RK
authors.lastname: Fredericks
authors.affiliation: 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.
authors.forename: Christy A
authors.initials: CA
authors.lastname: Russell
authors.affiliation: 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.
authors.forename: Fairooz F
authors.initials: FF
authors.lastname: Kabbinavar
authors.affiliation: 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.
authors.forename: Keith J
authors.initials: KJ
authors.lastname: Stelzer
authors.affiliation: 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.
authors.forename: Anne
authors.initials: A
authors.lastname: Schott
authors.affiliation: 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.
authors.forename: Claire
authors.initials: C
authors.lastname: Verschraegen
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006727:Hormone Antagonists / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008577:Meningeal Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008579:Meningioma / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008875:Middle Aged; D015735:Mifepristone / Q000627:therapeutic use*; D009367:Neoplasm Staging; D011372:Progestins / Q000037:antagonists & inhibitors*; D011379:Prognosis; D011446:Prospective Studies; D015996:Survival Rate; D055815:Young Adult
chemical_list: D006727:Hormone Antagonists; D011372:Progestins; D015735:Mifepristone