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Title: $718 LONG-TERM FOLLOW-UP OF A MULTICENTER PHASE II STUDY OF ABIRATERONE ACETATE (AA) + LOW-DOSE PREDNISONE (P) IN CHEMOTHERAPY-NAIVE MCRPC DEMONSTRATING RADIOGRAPHIC FLARES DISCORDANT WITH SEROLOGIC MEASURES OF RESPONSE
Abstract: You have accessJournal of UrologyProstate Cancer: Advanced1 Apr 2011718 LONG-TERM FOLLOW-UP OF A MULTICENTER PHASE II STUDY OF ABIRATERONE ACETATE (AA) + LOW-DOSE PREDNISONE (P) IN CHEMOTHERAPY-NAIVE MCRPC DEMONSTRATING RADIOGRAPHIC FLARES DISCORDANT WITH SEROLOGIC MEASURES OF RESPONSE Charles J. Ryan, Eleni Efstathiou, Shreya Shah, Matthew R. Smith, Mary-Ellen Taplin, Glenn J. Bubley, Christopher J. Logothetis, Thian Kheoh, Christine Kilian, Christopher M. Haqq, Arturo Molina, and Eric J. Small Charles J. RyanCharles J. Ryan San Francisco, CA More articles by this author , Eleni EfstathiouEleni Efstathiou Houston, TX More articles by this author , Shreya ShahShreya Shah Berkeley, CA More articles by this author , Matthew R. SmithMatthew R. Smith Boston, MA More articles by this author , Mary-Ellen TaplinMary-Ellen Taplin Boston, MA More articles by this author , Glenn J. BubleyGlenn J. Bubley Boston, MA More articles by this author , Christopher J. LogothetisChristopher J. Logothetis Houston, TX More articles by this author , Thian KheohThian Kheoh Los Angeles, CA More articles by this author , Christine KilianChristine Kilian San Francisco, CA More articles by this author , Christopher M. HaqqChristopher M. Haqq Los Angeles, CA More articles by this author , Arturo MolinaArturo Molina Los Angeles, CA More articles by this author , and Eric J. SmallEric J. Small San Francisco, CA More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2011.02.1686AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES AA is a selective androgen biosynthesis inhibitor that blocks the action of CYP17. Preclinical and early clinical studies suggest that AA potently inhibits persistent androgen synthesis from adrenal and intratumoral sources, thus suppressing an important growth stimulus for mCRPC. AA + P has recently been shown to improve overall survival in mCRPC progressing after docetaxel (De Bono et al, ESMO 2010). The aim of this study was to assess the efficacy and safety of AA + P in chemotherapy-naive patients (pts) with mCRPC, and to assess the frequency of interpretation of bone scans that is discordant with PSA and clinical response. METHODS COU-AA-002 was a single-arm, open-label, multicenter, phase II study of 1000 mg AA with 5 mg po P BID in continuous 28-day cycles. Primary end point: pts achieving a ≥ 50% PSA decline by Week 12. Secondary end points: objective radiographic response (RECIST), time to PSA progression (TTPP), overall survival and clinical benefit of disease stabilization, change in ECOG status and safety. Bone scan flare was evaluated for all pts who had scans available at baseline, 4, and 7 months. RESULTS Between October 2007 and May 2008, 33 pts with mCRPC were enrolled. A ≥ 50% PSA decline at Week 12 was seen in 22 pts (67%). Maximal PSA declines of ≥ 50% and ≥ 90% were seen in 26 (79%) and 15 (46%) pts, respectively, with undetectable PSA levels (≤ 0.1 ng/mL) in 2 pts. Overall, an objective tumor response occurred in 9/33 (27%) as partial responses; 2 had stable disease. The median time on therapy was 63 weeks (range, 8–104 weeks), with 15 (46%) pts still on treatment. Median TTPP was 71 weeks (95% CI; 40 weeks, not estimable). ECOG-PS improved from 1 to 0 in 8 (24%) pts. Bone scan flare was observed in 30% overall and in 10/23 (43.5%) of those who experienced a decline in PSA. Adverse events were mainly grade 1 to 2, with the most common being fatigue (46%), hot flush (30%), bone pain (24%), peripheral edema (24%), arthralgia (21%), dizziness (21%), and hypokalemia (21%). CONCLUSIONS Clinical response to AA + P was frequent and durable in chemotherapy-naive pts with mCRPC, with over 50% on therapy for > 1 year. The high rate of bone scan flare indicates that further investigation is needed to clarify the clinical meaning of this phenomenon. AA + P was well tolerated. Maturing data from the COU-AA-302 phase 3 study comparing AA/P to placebo/P will further clarify the effects of abiraterone in chemotherapy-naive mCRPC. © 2011 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 185Issue 4SApril 2011Page: e288-e289 Advertisement Copyright & Permissions© 2011 by American Urological Association Education and Research, Inc.MetricsAuthor Information Charles J. Ryan San Francisco, CA More articles by this author Eleni Efstathiou Houston, TX More articles by this author Shreya Shah Berkeley, CA More articles by this author Matthew R. Smith Boston, MA More articles by this author Mary-Ellen Taplin Boston, MA More articles by this author Glenn J. Bubley Boston, MA More articles by this author Christopher J. Logothetis Houston, TX More articles by this author Thian Kheoh Los Angeles, CA More articles by this author Christine Kilian San Francisco, CA More articles by this author Christopher M. Haqq Los Angeles, CA More articles by this author Arturo Molina Los Angeles, CA More articles by this author Eric J. Small San Francisco, CA More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...