Double-Blind Phase III Randomized Trial of the Antiprogestin Agent XXXX in the Treatment of Unresectable @entity1653 : SWOG S9005.

@entity1 @entity137 @entity1420 @entity1653 @entity3927
PURPOSE: @entity1420 receptors are expressed in approximately 70% of @entity1653 . @entity3927 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 @entity3927 in the treatment of unresectable @entity1653 . @entity1 AND METHODS: Eligible @entity1 were randomly assigned to receive either @entity3927 or placebo for 2 years unless disease progressed. @entity1 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 @entity137 . Time to treatment failure and overall survival were ascertained for all randomly assigned @entity1 . On progression, @entity1 receiving placebo could cross over and receive active drug. RESULTS: Among 164 eligible @entity1 , 80 were randomly assigned to @entity3927 and 84 to placebo. Twenty-four @entity1 (30%) were able to complete 2 years of @entity3927 without disease progression, adverse effects, or other reasons for discontinuation. Twenty-eight @entity1 (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 @entity3927 was well tolerated but had no impact on @entity1 with unresectable @entity1653 .
