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`Mark J. Ratain, MD, FASCO
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`A randomized trial of abiraterone acetate (AA) administered with 1 of 4 glucocorticoid (GC) regimens in metastatic castration-resistant
`prostate cancer (mCRPC) patients (pts).
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`Subcategory:
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`Prostate Cancer - Advanced Disease
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`Category:
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`Genitourinary Cancer
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`Meeting:
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`2016 Genitourinary Cancers Symposium
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`Session Type and Session Title:
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`Poster Session A: Prostate Cancer
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`Abstract Number:
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`261
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`Poster Board Number:
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`Poster Session A Board #L10
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`Citation:
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`J Clin Oncol 34, 2016 (suppl 2S; abstr 261)
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`Author(s):
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`Gerhardt Attard, Axel S. Merseburger, Cora N. Sternberg, Linda Cerbone, Federica Recine, Robert J. Jones, Susan Feyerabend, Alfredo Berruti, Steven Joniau, Peter Schatteman, Lajos Geczi, Peter
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`Tenke, Patrick Werbrouck, Florence Lefresne, Florence Nave Shelby, Marjolein Lahaye, Corinna Pick, Bertrand F. Tombal; The Institute of Cancer Research and The Royal Marsden Hospital, London,
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`United Kingdom; Department of Urology, University of Lübeck, Lübeck, Germany; Department of Medical Oncology, San Camillo and Forlanini Hospital, Rome, Italy; University of Glasgow, Beatson West
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`of Scotland Cancer Centre, Glasgow, United Kingdom; Studienpraxis Urologie, Nürtingen, Germany; Medical Oncology, University of Brescia, Spedali Civili Hospital, Brescia, Italy; University Hospitals
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`Leuven, Leuven, Belgium; Onze-Lieve-Vrouwziekenhuis, Aalst, Belgium; Chemotherapy C and Clinical Pharmacology Department, National Institute of Oncology, Budapest, Hungary; Jahn Ferenc Dél-
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`Pesti Kórház, Urology Department, Budapest, Hungary; AZ Groeninge, Kortrijk, Belgium; Janssen-Cilag, Paris, France; Janssen-Cilag, Tilburg, Netherlands; Janssen-Cilag, Neuss, Germany; Institut de
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`Recherche Expérimental et Clinique, Université Catholique de Louvain, Brussels, Belgium
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`Abstract Disclosures
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`Abstract:
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`Background: AA is approved for mCRPC, coadministered with prednisone (P) (5 mg BID) to prevent adverse events (AEs) associated with mineralocorticoid excess (ME). Lower GC doses had not
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`previously been formally evaluated in combination with AA. Methods: This was an open-label, multicenter, phase 2 trial (NCT01867710) of asymptomatic chemotherapy-naïve mCRPC pts randomized
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`1:1:1:1 to AA (1000 mg QD) plus P 5 mg BID or P 5 mg QD or P 2.5 mg BID or dexamethasone (DEX) 0.5 mg QD. Pts who had previously received GC or ketoconazole were excluded. The primary end
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`point was no ME (% of pts experiencing neither hypokalemia nor hypertension during the first 24 weeks of treatment).Secondary end points included additional safety, as well as response rate in the first
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`24 weeks, defined as a decline in prostate-specific antigen (PSA) ≥ 50% confirmed after 4 weeks. Results: 164 pts were randomized; 133 (81.6%) completed 24 weeks’ treatment. Median age: 70
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`years. Table 1 shows the rates of ME, hypertension, hypokalemia and PSA response. Changes in HbA1c values were minimal and observed in 16 (10.7%) pts. Conclusions: These data suggest that P 5
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`mg BID, which is approved in combination with AA, and DEX 0.5 mg QD, are effective in preventing ME-associated AEs, and that P 2.5 mg BID and P 5 mg QD can be safely used with appropriate
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`monitoring. The suggestion of a higher PSA response rate with DEX 0.5 mg QD arm warrants further validation. Clinical trial information: NCT01867710
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`No MEa, n/N (%)
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`Hypokalemiaa, n/N (%)
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`Overall
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` Grade 3
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`Hypertensiona, n/N (%)
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`Overall
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` Grade 3
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`≥ 50% PSA response at
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`Week 12, n/N (%)
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`No change in HbA1c, n/N (%)b
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`P 5 mg BID
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`P 5 mg QD
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`P 2.5 mg BID
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`DEX 0.5 mg QD
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`n = 41
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`n = 41
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`n = 40
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`n = 42
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`27/34 (79.4)
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`17/37 (45.9)
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`22/35 (62.9)
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`28/37 (75.7)
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`3/41 (7.3)
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`0
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`6/41 (14.6)
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`2/41 (4.9)
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`3/39 (7.7)
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`0
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`6/41 (14.6)
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`3/41 (7.3)
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`15/41 (36.6)
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`6/41 (14.6)
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`12/39 (30.8)
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`5/39 (12.8)
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`20/35 (57.1)
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`24/34 (70.6)
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`17/37 (45.9)
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`4/42 (9.5)
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`0
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`5/42 (11.9)
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`1/42 (2.4)
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`31/39 (79.5)
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`28/38 (73.7)
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`34/36 (94.4)
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`37/37 (100)
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`35/39 (89.7)
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`N = Evaluable pts. aAccording to the National Cancer Institute Common Terminology Criteria for Adverse Events V4.0. No grade 4 occurred. bChange at end point versus baseline.
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`Abstracts by Gerhardt Attard:
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`http://meetinglibrary.asco.org/content/158284-172
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`11/15/2016 A randomized trial of abiraterone acetate (AA) administered with 1 of 4 glucocorticoid (GC) regimens in metastatic castration-resistant prostate cancer …
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`Loco-regional treatment (LRT) for M1 at diagnosis prostate cancer (PCa) patients (pts) and impact on overall survival (OS): A retrospective analysis.
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`Meeting: 2016 Genitourinary Cancers Symposium | Abstract No: 280 | First Author: Diletta Bianchini
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`Category: Genitourinary Cancer - Prostate Cancer - Advanced Disease
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`PSA levels after dexamethasone withdrawal (DW) in castration resistant prostate cancer (CRPC).
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`Meeting: 2016 Genitourinary Cancers Symposium | Abstract No: 278 | First Author: Zafeiris Zafeiriou
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`Category: Genitourinary Cancer - Prostate Cancer - Advanced Disease
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`More
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`ASSOCIATED POSTER
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`Meeting: 2016 Genitourinary Cancers Symposium
`Presenter: Gerhardt Attard
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`View Poster
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`http://meetinglibrary.asco.org/content/158284-172
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